Home

PharmSpec 2.1 Software User Guide

1. HIAC Fig 7 8 Review and Approve Dialog The Review And Approve dialog lists all the test results that are not approved in the Select Test Result area in a tree structure Expanding a test procedure node displays the test results for this procedure that are not approved The user can select any of the tests from the list The Review button is enabled only if less than four users have reviewed the selected result and not yet approved The Approve button is enabled if the selected test result is reviewed by at least one user and not yet approved The Review and Approve buttons will be enabled only if you have the corresponding privileges The user can review the result by entering the review comments and clicking on the Review button At least one reviewer and a maximum of four reviewers can review any test result A test result can be approved if at least one person has reviewed it To approve a test result the user has to enter the approval comments and click the Approve button Only one user can approve a result A report once approved cannot be reviewed anymore To review approve a test the user has to first select the required test from the Select Test Result group Under each test type procedure the tests due for review approval are listed These are identified by the date amp time values that correspond to the date time at which the test was run Results for the selected test are listed on the right pane of the dialog
2. 3 System Configuration 3 1 Hardware Settings You have to set up the hardware and the operating parameters before starting to use the system with the 9703 or 9705 sampler Otherwise the software can be used only in the Simulation Demo mode The software will prompt the user to configure the 9703 or 9705 on first use by opening the Hardware Settings dialog is the user has the appropriate permissions Configure the system during initial set up or whenever there is a change in the hardware components or the operating parameters used You can set up the hardware by selecting Setup gt Hardware Settings This invokes the Hardware Settings dialog This menu is enabled only for a user who has the required privilege to do this Hardware settings xi M Configure Current Test Setup Add Modify Remove I Simulation Sensor Communication Sensor Counter Sampler Port com Model HrLD400E y Model sos y Model poa gt Counter Baud Rate 3200 Serial No fr n y Serial No rosez y Serial No foret y A Ser Das Sampler Data Current Setup Print Setup PHA Type Liquid Model JHRLD400CE Syringe Size fic mL I Auto Print On oe F 3 XMax 77 Calibration Mode Single bt Fom Operating Parameters Calibration Date 2000 06 26 Calibration Due 2003 12 12 Modify Field Names s i CE Parameters View Volume 4 85 eis Pow 60 Sample Volume mL 5 Channel Size j
3. Limited Warranty Hach Ultra Analytics warrants that the software will perform substantially in accordance with the accompanying printed materials for a period of ninety 90 days from the date of receipt Any hardware accompanying the software is covered by a separate Limited Warranty This software Limited Warranty does not apply to hardware Customer Remedies Hach Ultra Analytics entire liability and your exclusive remedy shall be at Hach Ultra Analytics option either a return of the price paid or b repair or replacement of the software that does not meet Hach Ultra Analytics Limited Warranty and that is returned to Hach Ultra Analytics with a copy of the purchase order This Limited Warranty is void if failure of the software has resulted from accident abuse or misapplication Any replacement software will be warranted for the remainder of the original warranty period or thirty 30 days whichever is longer HIAC PharmSpec 2 Manual Overview 7 of 136 HIAC No Other Warranties Except as expressly provided above Hach Ultra Analytics disclaims all warranties either express or implied including but not limited to implied warranties of merchantability and fitness for a particular purpose with respect to the software the accompanying written materials and any accompanying hardware No Liability for Consequential Damages In no event shall Hach Ultra Analytics or its suppliers be liable for any damages whatsoever in
4. HIAC User Guide 62 of 136 User Guide System Configuration PharmSpec 2 You can configure the sample identifiers Sample IDs for the Run Counter Test by clicking on the Sample ID button in the Hardware Settings dialog This invokes the Configure Sample ID dialog which allows the user to enter the sample ID values Configure Sample ID E Xl No of fields le Field Name 1 loa Field Name 2 Sampe Field Name 3 O Field Name 4 y Field Name 5 Field Name 6 Cancel Help Fig 6 14 Configure Sample ID Dialog You have to enter the number of sample ID fields maximum of six sample ID fields can be entered The numbers of edit boxes for entering the sample id depends on this number You can then save it by clicking the OK button or discard it by clicking on the Cancel button HIAC Edition 3 KSS March 2006 PharmSpec 2 Running Sample Tests and Reviewing Results 63 of 136 7 Running Sample Tests and Reviewing Results 7 1 Run Procedural Test You can run a procedural test by choosing Sample Tests gt Run Procedural Test You can also run the Procedural test by pressing the F7 key on the keyboard To run a procedural test you have to first select the test procedure Steps for running the tests are discussed below 1 The currently selected test procedure name can be seen in the Standard Procedures selection window on the PharmSpec main screen toolbar If you do not want to change th
5. 4 3 Sub Menu Details a View Profile Each user can to view his her profile and the name of administrator who created the user For this go to User gt View Profile This displays the User profile dialog for the logged in user The User Profile dialog lists all the rights of the user It also lists the user role operator supervisor calibration technician or administrator and the administrator who has created the user This menu item is available for all user roles User Profile Administrator x User Role Administrator Created By System Rights View Profile Run Tests View or Print Reports Review Reports Setup Test System Approve Reports Define Test Procedure View Print Activity Logs Run Instrument Standardization Tests Load Create Procedures Disable Obsolete Procedures Administration Setup xl Fig 4 3 User Profile Dialog User Guide HIAC KSS March 2006 Edition 3 PharmSpec 2 Getting Started 37 of 136 HIAC b Change Password Each user must be able to change his password The user can change the password by choosing User gt Change Password This displays the Change Password dialog Change Password 3 Dld Password New Password Confirm New Password Cancel Help Fig 4 4 Change Password Dialog You have to enter the old password followed by your new password Re enter the new password for confirmation The administrator sets the mi
6. Calibration Date 2000 06 26 View Volume 2 rn Calibration Due 2003 1212 y mia ioe Rate on In Concentration Limit 35 00 Calibration Data Call Size my Size my 30100 frs ff Fig 6 5 Modify Sensor Dialog HIAC KSS March 2006 Edition 3 KSS March 2006 Edition 3 PharmSpec 2 System Configuration 55 of 136 Select Sensor fe to impare ax Look in a Debug v e et Er My Network pe Files of type Sensor files sen y Cancel I A Fig 6 6 Import Sensor Dialog The sensor data consists of following parameters When you add a new sensor you need to define all these parameters In the Modify mode it allows you to modify most of these parameters except the model type and serial number e Type of the sensor Liquid Air Model of the sensor You can enter the model number or select one from the list e Calibration mode The Sensor Calibration mode could be either single or dual In case of Dual mode there are two sets of calibration data to be entered Cal 1 and Cal 2 The second set is disabled in case of the single mode sensors Note Dual mode is not available in PharmSpec 2 1 Serial number of the sensor Date of calibration e Expiration date for the calibration e View Volume Nominal Flow Rate e Concentration Limit e User shall enter the particle sizes for the calibration and the mi
7. Place Sample into clean glassware Agitate Degas Rest Size Cumulative Count Cumulative Counts for 30 seconds Agitate again Enter sample volume below m Parameters Sample Volume mL 5 000 Review Approve Save Only Queue Print Run Test Close Help Fig 11 9 KP Counting Accuracy Dialog The counting accuracy test is designed to ensure that the particle counter counts fall exactly within the range specified by the Korean Pharmacopoeia It is generally recommended to run a pre test using the less expensive standard 10 micron PSL particles before running the formal test with the RM Reference Material Edition ch 2006 KSS Mar User Guide HIAC PharmSpec 2 9703 Only Pulse Height Analyzer 93 of 136 12 9703 Only Pulse Height Analyzer HIAC Note This feature is not available for the 9705 You can view the plot data by clicking on the PHA button in any of the Standardization test dialogs Click the menu Sample Test gt PHA to bring up the PHA screen On doing so the Pulse Height Analyzer screen is displayed In this screen you can do the following 1 To determine a specific millivolt response for a given particle size use the vertical Probe line to point to that area on the graph Move the Probe using the mouse with click and drag or other screen control device The millivolt response value is displayed below the lower right cor
8. Result Details The review data name of the reviewer and review comments date of review are listed in the User Guide 70 of 136 Running Sample Tests and Reviewing Results PharmSpec 2 Review Details field The current user cannot modify the comments written by another reviewer The user has to enter comments and click the Review or Approve button as appropriate On clicking the Review or Approve button the user is prompted to enter the password again The Secure Operation dialog is displayed wherein the user has to enter his password Secure Operation E xj User Validation Enter Password l Cancel Help Fig 7 9 Secure Operation Dialog The comment is accepted only if the entered password is that of the logged in user The maximum number characters permitted for comments are 166 On entering the comments and clicking on the Review or Approve button the entered comments and the user details are updated Note If four persons have already reviewed the result the Review button is disabled If the user does not have the approve privilege the Approve button is disabled User Guide HIAC KSS March 2006 Edition 3 PharmSpec 2 View the Audit Trail Activity Log 71 of 136 8 View the Audit Trail Activity Log 8 1 View Activity Logs The Administrator Supervisor can view the activity log of system To do this select Reports gt View Activity Logs This invokes the View Activity Logs d
9. User Guide Procedure Loader PharmSpec 2 a User ID A Password Cancel Help Fig 16 2 Procedure Loader Login Dialog This is a separate application On entering a valid User ID and password the Procedure Loader is launched There are 3 options on the main menu Load To load a test procedure Help Online Help Exit To exit the Procedure Loader application To load a new procedure click the Load button Now you will be prompted to select the procedure update file MS Access file with mdb extension distributed by Hach Ultra Analytics It is assumed that the database file is available in one of the local or network drive folders My Documents r My Computer co a cu e File name Jiapver My Network PE Files of type Exported Acces Database mdb Cancel Zi Fig 16 3 Procedure Export File Selection HIAC KSS March 2006 Edition 3 Edition 3 KSS March 2006 PharmSpec 2 Procedure Loader 121 of 136 After selecting the database which contains the required procedure updates click the Open button Now you will be prompted to enter the license key Enter License Key x Enter License Key DISDFISDIASIAJHAHASHGASHJAGHASJNASJAAJHA om Fig 16 4 License Key Validation Dialog After entering the license key click the OK button to proceed Click the Cancel button to close the dialog and return to main dialog If the license key is
10. 1 Volume Accuracy viii TL FIG RAE 11 3 Moving VIO dans stagne n ons ner eesediste 11 4 Sensor Resolution 11 5 Electronic Resolution russes 11 6 USP Counting Accuracy cccccccccononccnncncccnonanannncnnnnnnnnnnns 11 7 JP Counting AGCUrTACY femtende 11 8 KP Counting Accuracy uinniisnaismseniksngeslteengn dv 9703 Only Pulse Height Analyzer Help ASIN Help EE 13 2 Help on Shortcut Keys sisas csi 13 3 COMEN sis fees ir ann nent 13 4 About PharmSpec 2 14 Procedure Builder 15 16 17 18 19 14 1 Load Create Test Procedure 14 2 Procedure Builder Steps nsnnssnsnrnnerrrrrrnrrrerrrerrreee 14 3 Load Create Report Template ccccccccccccccnccos 14 4 Report Template StepS coccccccccccccnccononononononinininess Database Restorer Procedure Loader PharmSpec Admin Tool PharmSpec License Update Tool PharmSpec Simulation Application Appendix A Service Information A 1 Technical Support Information Table of Contents PharmSpec 2 HIAC KSS March 2006 Edition 3 PharmSpec 2 Manual Overview 5 of 136 Manual Overview HIAC About This Manual The information in this manual has been carefully checked and is believed to be accurate However Hach Ultra Analytics assumes no responsibility for any inaccuracies that may be contained in this manual In no event will Hach Ultra Analytics be liable for direct indirect special incidental or consequential damages resu
11. 120 Procedure Export File Selection 120 License Key Validation Dialog lt ooominiinociiai tios 121 Procedure Selection Dialog oocomommomrmrimeacccaaac as 122 PharmSpec Admin Tool 123 PharmSpec License Update 125 Simulator Application Window 127 133 of 136 User Guide 134 of 136 User Guide Annex PharmSpec 2 HIAC KSS March 2006 Edition 3 KSS March 2006 Edition 3 PharmSpec 2 User Notes User Notes 135 of 136 HIAC User Guide Global Headquarters 6 route de Compois G P 212 CH 1222 Vesenaz Geneva Switzerland Tel 41 22 855 91 00 Fax 41 22 855 91 99 Americas Headquarters 481 California Avenue Grants Pass Oregon 97526 USA Tel 1 800 866 7889 1 541 472 6500 Fax 1 541 479 3057 www hachultra com 2003 2006 Hach Ultra Analytics Inc All rights reserved Trademarks are property of their respective owners Specifications are subject to change without notice
12. 8 Reviewer Administrator Reviewed Date 2003 01 23 12 36 05 PM Approver Administrator Approved Date 2003 01 23 01 03 19 PM HIAC PharmSpec JP Counting Accuracy Test FAILED Export Close Help HIAC Fig 9 2 View Report Dialog The result is displayed in detail in the selected procedure format on clicking the View button The details include the sample ID values user input values test results the user who had run the test date of running the test and review and approve details for the test report The report will also display following details Whether the data of the first run was discarded included in the calculations e Pass Criteria for the test Space for manual signatures in case of Save Only type of reports You can print the generated report on clicking the Print button You can also export it to EXCEL or any CSV format by clicking on the Export button In case of exporting to CSV format you have to specify the separator delimiter User Guide 76 of 136 Generating Historical Data Reports PharmSpec 2 9 2 Old Version PharmSpec 1 4 Reports User Guide The software allows the user to read historical test results data generated by PharmSpec 1 4 and generate reports This can by done by selecting Reports gt Pharm 1 4 Reports This invokes the Pharm1 4 Reports Dialog Pharm1 4 Reports 3 x Database C Pharmt 4 DATA DATAOOT C e Report Type Counting Accuracy y Report
13. 9705 System or HIAC 9703 System consisting of An HRLD 150 HRLD 400 or HRLD 600 sensor e Model 9703 Sampler firmware version 1 1 or higher e A counter PCB internal with firmware version 12 or higher b Software Specifications e Operating Systems supported e Microsoft Windows NT 4 0 Workstation Service Pack 6a or later e Microsoft Windows 2000 Microsoft Windows Microsoft Windows XP Microsoft Windows Microsoft NET framework Internet Explorer 5 5 or greater e Microsoft Excel to access PharmSpec 1 4 reports 2 2 Installation Procedure PharmSpec provides a simple mechanism for installing the software using an Installation Wizard HIAC User Guide 12 0f 136 User Guide Installation PharmSpec 2 Note Installation of this program requires that you have ADMINISTRATOR privileges on the computer If necessary contact your IT department to verify if you have ADMINISTRATOR privileges in order to proceed with the installation To install the software insert the installation disk into the appropriate drive If AUTORUN is active on your system the installation Setup software will automatically be started Note If the installation software does not automatically start from Windows Explorer double click the Setup EXE file from the CD ROM drive Click the OK button if the default installation location is acceptable or else browse and specify a different location The next step will ask which drive will be u
14. AAA 51 Fig 6 4 Add Sensor AP 52 Fig 6 5 Modify Sensor Dialog 54 Fig 6 6 Import Sensor DAN A re 55 Fig 6 7 Remove Sensor Dialog suu 56 Fig 6 8 Add Counter DA fessen 57 Fig 6 9 Remove Counter Dialog iii iii 57 131 of 136 User Guide 132 of 136 User Guide Annex PharmSpec 2 Fig 6 10 Add Sampler Dialog siii a c 58 Fig 6 11 Modify Sampler Dialog oommommrmarmammaraririic nn nntr 59 Fig 6 12 Remove Sampler Dialogue 59 Fig 6 13 Operating Parameters Dialog 2 ueueeresmnnienenmentsanieseee re meneesmsnienide 61 Fig 6 14 Configure Sample ID Dialog oooooocccccncnncccccconcccccccnananancncncncnnnnnannn noo 62 Fig 7 1 Sample Identification Dialogo pinne aan 63 Fig 7 2 Run Test Dialog EN id 64 Fig 7 3 Review Approve Comments Dialog 65 Fig 7 4 User Authentication DIO te 65 Fig 7 5 Review Approve Comments Dialog 66 Fig 7 6 Sample Identification Dialogues 67 Fig 7 7 Run Counter Window ea Nantes 68 Fig 7 8 Review and Approve Dialog siii a 69 Fig 7 9 Secure Operation Dialog sii 70 Fig 8 1 View Activity Logs Dialog ccseesceeeeeeeeeeeentneeeeeeeeeeesenneeeeeeeeeeennnsaaaes 71 Fig 9 1 gt Historical Reports OO near ees cde ai nent 13 Fig 9 2 View Report DIQIOG ne de NRA te anti 75 Fig 9 3 Ol
15. Size CumulativeCount Cumulative Counts for 30 seconds Agitate again Enter sample volume below m Parameters Sample Volume mL 5 000 Review Approye Save Only Queue Print Run Test Fig 11 8 JP Counting Accuracy Dialog The counting accuracy test is designed to ensure that the particle counter counts fall exactly within the range specified by Supplement I to the Japanese Pharmacopoeia It is generally recommended to run a pre test using the less expensive standard 10 micron PSL particles before running the formal test with the RM Reference Material HIAC User Guide 92 of 136 Running Instrument Standardization Tests PharmSpec 2 11 8 KP Counting Accuracy The user can run the KP Counting Accuracy Test by selecting Standardization KPCountingAccuracy from IST Standards selection window and then clicking the Sample Test gt Run IST menu This pops up the Sample Identification dialog to enter the information about the challenge particles used for the test This information is then stored with the test results and printed out on request This enables the PharmSpec system to provide a paperless history of the calibration work that has been performed on the system You can enter the sample IDs and then click the Continue button This will pop up the KP Counting Accuracy dialog Standardization KPCountingAccuracy Test Description Result
16. Stop Test button A ticker is displayed on the screen to inform the operator that the test run is in progress 5 After running the test the operator can perform any one of the following actions Save Only This option is used either for informal tests you do not want to review approve these tests or when you want to put the signatures on the hard copy printout of the test report In this case the operator can just save the results For this click the Save Only button Queue The user queues the result for the purpose of reviewing and approving it on screen later For this click the Queue button Review Ifthe user has the appropriate privileges he she may review and approve the Approve results after running the test To do this click the Review Approve button On doing so the Review Approve Comments dialog is displayed Review Approve Comments x ae bm z Fig 7 3 Review Approve Comments Dialog In the Review Approve Comments dialog you can enter the review comments and then press the Review button When this button is pressed the user authentication dialog will pop up prompting you enter your password User Authentication xj gt Validate User 7 Enter your Password Cancel Help Fig 7 4 User Authentication Dialog HIAC User Guide 66 of 136 Running Sample Tests and Reviewing Results PharmSpec 2 If you have the privilege to approve the test results y
17. a predefined format in a file This sensor details file shall have an extension sen To import the sensor data select the radio button corresponding to import following which the Import From control is enabled The user is then allowed to select the path and file from which the user has to import the sensor An Open File dialog is displayed from which the user can select the path and file User can import it and modify the details if required excluding type model and serial number You can remove a sensor from the system The currently selected sensor is deleted by clicking on the Remove button User Guide 20 of 136 User Guide System Configuration PharmSpec 2 Modify Sensor xi Import From C Add amp Modify Remove Import EA Sensor Details Type Liquid Z Model HRLD400CE Calibration Mode Singe gt Serial No roen y Calibration Date 2000 06 26 View Volume 2 rn Calibration Due 2003 1212 y mia ioe Rate on In Concentration Limit 35 00 Calibration Data Call Size my Size my 30100 frs ff Fig 3 5 Modify Sensor Dialog HIAC KSS March 2006 Edition 3 KSS March 2006 Edition 3 HIAC PharmSpec 2 System Configuration 21 0f 136 Select Sensor file to import E 2 x Look in I Debug v e eE My Network pe Files of type Sensor files sen y Cancel I A Fig 3 6 Impor
18. parameter values of PHA graph from the PHA section These are the starting and ending points for the x axis on the PHA display The value for the ending point must be at least 30 units greater than the starting point f Operating Parameters You can view the operating parameters such as sample volume number of runs dilution factor Channel sizes tare volume etc in the Operating Parameters section of Hardware Settings dialog Most of these Operating Parameters except for the tare parameters are used exclusively for the RUN Counter test The tare parameters Tare Volume and the Multi stroke Tare are used by other tests also The Modify button in the Hardware Settings dialog can be used to modify these parameters Clicking on the Modify button invokes the Operating Parameters dialog User Guide HIAC PharmSpec 2 System Configuration 27 0f 136 Operating Parameters E xj m Parameters Sample Volume mL 5 00 Channel Size pm Channel Size pm 5 00 1 3 No of Runs 3 10 000 2 20 000 10 Dilution Factor 1 00 3 11 Tare Volume mL ho 00 4 12 Multi stroke Tare ml for 5 I Discard First Run 6 14 Show this screen at the beginning of 7 15 each test 8 16 TELET TA FLEET oe Fig 3 13 Operating Parameters Dialog You can enter the channel setting details These are Sample Volume for the Run Counter test Number of runs for the Run Counter test e Dilution factor for the Run Counter tes
19. the Continue button This invokes the Run Counter dialog This dialog displays the results obtained from the counter and the calculated result It also displays the user who has run the test date of running the test sample IDs etc You can print the result by clicking on the Print button User Guide 68 of 136 Running Sample Tests and Reviewing Results PharmSpec 2 Run Counter Run Counter Test Report Sensor Model Sensor Serial 1 Operator Name Administrator Sample Date 2005 12 05 Number of Runs 3 Sample Volume 5 00 Run 1 Included Result Size p Cumulative Count Differential Count Cumulative Counts mL Differential Counts mL 25 000 2 00 0 00 0 40 0 00 30 000 2 00 2 00 0 40 0 40 Run 3 2 000 10 00 4 00 2 00 0 80 5 000 6 00 3 00 1 20 0 60 10 000 3 00 1 00 0 60 0 20 15 000 2 00 1 00 0 40 0 20 20 000 1 00 1 00 0 20 0 20 25 000 0 00 0 00 0 00 0 00 30 000 0 00 0 00 0 00 0 00 Average 2 000 13 00 5 67 2 60 1 13 5 000 7 33 3 67 1 47 0 73 10 000 3 67 2 00 0 73 0 40 15 000 1 67 0 67 0 33 0 13 20 000 1 00 0 33 0 20 0 07 25 000 0 67 0 00 0 13 0 00 30 000 0 67 0 67 013 0 133 lt gt Remote Close Print Help Fig 7 7 Run Counter Window 7 3 Review and Approve Once a procedural test is run the test results have to be reviewed and approved Special privileges are needed for the user to do the same The user can Review Approve the results by choosing Review And Approve menu This invokes the Review And Ap
20. to Step 1 of the Report Template steps b Load This option can be used if you want to make some minor variant of an existing report template or to view the details of an existing report template For this select the Load option radio button Now the Select Report Template selection window box will be enabled and you can HIAC User Guide Edition 3 KSS March 2006 PharmSpec 2 Procedure Builder 111 of 136 select the required report template from the list Click the OK button after selecting the required report template This will take you to Step 1 of the Report Template steps 14 4 Report Template Steps a Step1 Configure Report Title Name This is the first step of configuring a report template Here the user configures the Report Titles maximum of 4 titles can be configured for a report For each title the text of the title its alignment font and color properties can be configured Wizard Step 1 Configure Title names of the Report Titles Alignment Font Color Sample JEP 4 3 lt 2 3 19 gt Environmer Center y Sample Left Sample Left v Sample Pe EL PELLE Left z Sample lt Previous Finish Print Cancel Help Fig 14 15 Title Configuration Dialog Enter the Title name in the Titles edit field A report should have at least one title The Next button will not be enabled without this You can choose the alignment option Left Cen
21. 05 System includes both the sampler and a sensor in one unit This manual provides the basic information about Version 2 0 of the PharmSpec software The main features of the PharmSpec 2 software are listed below Compliance to requirements of the FDA 21 CFR Part 11 e Data analysis using the USP lt 788 gt EP JP and KP procedural standards or using user defined test procedure e Analysis of single or multiple runs e Up to 16 channels e Ability to review approve test results e Historical Report capabilities Ability to print out reports or view them on screen e Historical data backup archive restore e Procedure Builder to define custom test procedures 1 1 What s new in PharmSpec 2 1 Compatibility with the HIAC 9705 Liquid Particle Counting System HIAC User Guide 10 of 136 User Guide Introduction PharmSpec 2 HIAC KSS March 2006 Edition 3 Edition 3 KSS March 2006 PharmSpec 2 Installation 11 of 136 2 Installation 2 1 System Requirements a Hardware Specifications A PC with following recommended configuration Minimum Configuration e Pentium 133 MHz 96 MB RAM e Video 1024 x 768 minimum e 320 MB Free Hard Disk space RS 232 serial communications port Recommended Configuration Pentium Ill class processor 450 MHz e 128 MB or 256 MB RAM 128 is OK 256 is preferred e Video 1024 x 768 minimum 500 MB Free Hard Disk space RS 232 serial communications port HIAC
22. 2 Add Sensor xi Import From Add Modify Remove Import EA Sensor Details Type Liquid y Model Calibration Mode Single z Serial No Calibration Date 2003 01 23 y View Volume EE 01 v Nominal Flow Rate Calibration Due 2003 01 23 mL Min m Concentration Limit Calibration Data Cal Size my Size my A OS EE Pr TT Tr g A LL A OS EE EE S LL A Pr TT Fig 3 4 Add Sensor Dialog HIAC KSS March 2006 Edition 3 PharmSpec 2 System Configuration HIAC 19 of 136 The user can perform any one of the following operations Add a Sensor Modify Sensor Data Import Sensor Data Remove Sensor User can add a new sensor to the system User has to check the radio button corresponding to Add User has to specify all the details including type model and serial number in this case All controls on the dialog will be enabled in this case User can modify the parameters Calibration data in most cases of an existing sensor For this user has to select the radio button corresponding to Modify The user has to first select the Model and then the Serial No of the sensor and then modify the details User will not be allowed to modify the type model and serial number Instead of adding a new sensor using the Add option and by entering the sensor data the user can import sensor data from a file For this the sensor data should be available in
23. Arm Serial No Lift arm after test completed Lift arm after each run Syringe Size Fig 3 10 Add Sampler Dialog You can add new sampler details by clicking on the Add radio button You can enter the value for model serial number and select a syringe size from the Syringe Size selection window selection window for the sampler Available syringe sizes are 1 ml 10 ml and 25ml You can also select the model number from the list if available On the 9703 you also have to select the option for lifting the arm lift the arm after each run or after the completion of the test You can then save the details by clicking on the Save button for later retrieval and use If you prefer to manually raise the arm at the end of each test or sample then simply do not check the box for Lift Arms database User can select a model and serial number from the existing list and change the syringe size of the selected sampler and the lift arm behavior You can then save the details by clicking on the Save button for later retrieval and use Note The HIAC 9705 does not use an arm for sampling so this option is not available to 9705 users HIAC KSS March 2006 Edition 3 PharmSpec 2 System Configuration HIAC Modify Sampler 3 25 of 136 C Add Modify Remove ar Model SAMP1 M Lift Arm Lift Arm Serial No 5a5672 y Lift arm after test completed Syringe Size Fo mL y L
24. COM4 Note For the 9705 set the Baud Rate to USB Sensor The user can select the model and serial number of the sensor used in the current test set up Counter The user can select the model and serial number of the counter used in the current test set up Sampler The user can select the model and serial number of the sampler used in the current test set up Simulator There is a check box named Simulator The user selects this to run the system in simulation mode This invokes a confirmation message prompting the user to confirm the change to simulator mode x Do you want to set simulation mode Fig 3 2 Simulator Mode Confirmation Dialog The user can select the simulator mode by clicking the Yes button on this confirmation message All the other controls in the Configure Current Test Set Up are disabled in this case In simulation mode the application will not communicate with the hardware gt User Guide HIAC KSS March 2006 Edition 3 PharmSpec 2 System Configuration 17 of 136 Hardware Settings a x Configure Current Test Setup Add Modify Remove IV Simulation Sensor Communication Sensor Counter Sampler Part COM1 v Model HALD400CE gt Model 9703 z Model pa 3 7 courier Baud Rate 18200 Le Serial No Fos2n Le Serial No Fose7 Le Serial No G78TY Le Sampler
25. Dilution Factor 1 00 3 11 Tare Volume mL ho 00 4 12 Multi stroke Tare ml for 5 I Discard First Run 6 14 Show this screen at the beginning of 7 15 each test 8 16 TELET TA FLEET oe Fig 6 13 Operating Parameters Dialog You can enter the channel setting details These are Sample Volume for the Run Counter test Number of runs for the Run Counter test e Dilution factor for the Run Counter test e Tare volume a volume drawn preceding the SAMPLE volume It occurs on the first stroke of a given run This is to remove any fluids from a previous run or bubbles etc if the tubing is empty and to ensure that the sample data obtained is only from the fluid from the container currently in place on the 9703 or 9705 e Multi stroke tare gets the liquid up to speed e Channel PharmSpec supports up to 16 size channels User can also specify following conditions e Discard first run If this option is selected for the Run Counter Test the test results of the first run will be ignored in the computations but will still be displayed and stored Show this screen at the beginning of each test If this option is selected while running the Run Counter Test the Operating Parameters dialog will be displayed at the beginning of the test This is intended to provide information to the operator before running a test enabling the operator to confirm that these settings are correct for the test they are about to run
26. Edition 3 KSS March 2006 KSS March 2006 Edition 3 PharmSpec 2 Getting Started 35 of 136 _ieix User Setup Sample Test Review And Approve Reports Help ena a 1 51 6 14 ll 5 Standard Procedures JP XIV Reagent y IST Standards Standardization M ovingwWindow y MODE Simulation Fig 4 2 PharmSpec Main Window 4 2 Main Menu Details a User This is the main menu for the user activities The user activities include viewing the profile of a user changing password log out the currently logged in user and exiting the application b Setup This is the main menu for all set up activities of the system There are options under this menu for setting up the hardware Administration set up disabling obsolete test procedures sampler control data storage activities and selecting the report type c Sample Test This is the main menu for running the tests This menu contains options for running a Procedural Test Run Counter Test or the Instrument Standardization Test HIAC User Guide 36 of 136 Getting Started PharmSpec 2 d Review And Approve This is the menu for reviewing and approving test results e Reports This menu contains options for viewing all the reports You may view activity logs historical reports and PharmSpec 1 4 reports f Help This menu provides a choice of these HELP related functions Using Help Help on Shortcut Keys Contents and About PharmSpec 2
27. Field Name 5 Field Name 6 mH Cancel Help Fig 3 14 Configure Sample ID Dialog You have to enter the number of sample ID fields maximum of six sample ID fields can be entered The numbers of edit boxes for entering the sample id depends on this number You can then save it by clicking the OK button or discard it by clicking on the Cancel button 3 3 Disable Obsolete Procedures The Supervisor Administrator can disable any one of the obsolete test procedures if he she has the privilege to do so All the obsolete procedures are moved to obsolete mode and thereby will not be available for running the tests The obsolete procedures can be reactivated by a supervisor administrator Operator is permitted to use only the active procedures to runa procedural test only the active procedures are listed in the choices for Standard Procedures selection window on the PharmSpec toolbar To disable enable test procedures the user has to choose Set up gt Disable Obsolete Procedures On clicking the Disable Obsolete Procedures menu Disable Obsolete Procedures dialog is displayed User Guide HIAC PharmSpec 2 System Configuration 29 of 136 Disable Obsolete Procedures x Active Procedures Obsolete Procedures JP XIV Reagent JP XIV SVI lt 100mL EP 4 3 Test 1 4 EP 4 3 Test 18 JP XIVTLVI JP XIVTSVI lt 25mL t EE LE OK Cancel Help Fig 3 15 Disable Obso
28. Geneon ate Sampler Data Current Setup Print Setup PHA o Min 4 Type Liquid Model HALD 400CE Syringe Size io mL I Auto Print On XMax 77 Calibration Mode Single Serial No fos211 Operating Parameters Calibration Date 2000 06 26 Calibration Due 2003 12 12 Modify Field Names gt i jo Parameters View Volume 85 sie Pow 60 i Sample Volume mL 5 Channel Size um aus 7 70 imit E m Calibration Data heinu 2 Dilution Factor fi Tare Volume ml fi Multi stroke Tare mL jo IT Discard First Run IT Show this screen at the beginning of each test Print Fig 3 3 Simulator Selection b Add Modify Remove Sensor Counter Sampler The user can add new hardware components sensor counter and sampler to the existing inventory or modify the parameters of the existing ones The user can also remove a hardware component from the inventory Sensor The user can add new sensors to the system modify existing sensor data or remove a sensor from the inventory There is an additional option to import sensor data from a file so that the user need not enter the data manually While configuring the current test setup user has to choose a sensor from the sensor inventory To add modify remove a sensor click the Sensor button in the Hardware Settings dialog This invokes the Add Sensor dialog HIAC User Guide 18 0f 136 User Guide System Configuration PharmSpec
29. IBRATION TECHNICIAN role or as a type of ADMINISTRATOR with this additional right assigned The IST Standards selection window contains Volume Accuracy test Flow Rate test Moving Window test Sensor Resolution test Electronic Resolution test USP Counting Accuracy test JP Counting Accuracy test and KP Counting Accuracy test Based on the license key of the installed software the list may or may not show all of these tests Steps for running an Instrument Standardization Test are discussed below 1 2 3 4 The currently selected IST name can be seen in the IST Standards selection window on the PharmSpec main screen toolbar If you do not want to change this you can ignore this step and go directly to step 2 If you want to run a test procedure other than the one shown in the toolbar click the IST Standards selection window The available list of IST procedures is shown here You can select the required test procedure from this list click the Sample Test gt Run IST menu This invokes the Test window corresponding to the IST selected The test window contains The top left corner of each screen provides the operator with instructions specific to the test the operator is performing The section immediately below the instructions lists the parameters required to run the test Each parameter shows a default value The user can change these values within permissible limits The right side of the screen consists of
30. OMPTLY RETURN THE SOFTWARE MEDIA SUCH AS DISKS AND ACCOMPANYING ITEMS INCLUDING PRINTED MATERIALS TO HACH ULTRA ANALYTICS FOR A FULL REFUND Grant of License This Hach Ultra Analytics License Agreement License permits you to use one copy of the specified version of the software product identified above software on any single computer provided the software is in use on only one computer at any time The software is in use on a computer when it is loaded into the temporary memory i e RAM or installed into the permanent memory e g hard disk optical disk or other storage device of that computer If User Guide 6 of 136 User Guide Manual Overview PharmSpec 2 you have multiple Licenses for the software then at any time you may have as many copies of the software in use as you have Licenses Copyright The software is owned by Hach Ultra Analytics and is protected by United States copyright laws and international treaty provisions Therefore you must treat the software like any other copyrighted material e g a book or musical recording except that you may either a make one copy of the software media for backup or archival purposes or b transfer the software to a single hard disk provided you keep the original solely for backup or archival purposes You may not copy the written materials accompanying the software Other Restrictions You may not reverse engineer decompile disassemble or crea
31. Table 5 1 Default Role Privileges Calibration Technician Administrator Privileges Operator Supervisor Run tests V View and print reports y View profile y V Set up test system hardware and operating parameters Approve test results Load and create test procedures including report templates Enable disable test procedures View and print activity logs Perform instrument standardization tests Administer user accounts Backup and archive databases Configure system a Add User Administrator can add a new user and set the details for the new user by clicking on the Add User button This invokes the Add a New User dialog KSS March 2006 Edition 3 User Guide HIAC Edition 3 KSS March 2006 PharmSpec 2 User Administration 41 of 136 HIAC Add a New User E x m Properties Full Name Jerry Thompson User Role Supervisor y Description fenh User ID Ped Password as Confirm Password SES Options User must change password on next logon IV Account never expires Account expires on 2003 03 18 Cancel User Rights Help Fig 5 2 Add New User Dialog Administrator assigns a User ID user name user role and password to the new user The maximum number of characters for the password is twenty Minimum length of User ID and user name is four Administrator sets certain options for the new user The o
32. Template path CAPham1 ADATA Options Starting Date 1990 01 01 Sample ID None y Ending Date 2003 01 23 y Operator Operator 2002 11 14 02 44 33 PM AAA 2002 11 14 02 44 53 PM 2003 01 01 11 05 25 AM 2003 01 01 11 05 37 4M 2003 01 01 11 36 42 AM 2003 01 01 11 36 54 AM 2003 01 01 11 55 18 AM 2003 01 01 11 55 33 4M Fig 9 3 Older Version Report Dialog You have to first select the database file that contains the test results from PharmSpec 1 4 and also the Report template path path for SDF RDF files The reports type available in this database are displayed in the Report type selection window and the user can select the required one from this list Use the DATE Starting Date amp Ending Date Operator Sample identifier filters to select the required test and then click the Apply button This action filters the test results as per the given criteria and displays the filtered list in the reverse chronological HIAC KSS March 2006 Edition 3 KSS March 2006 Edition 3 PharmSpec 2 Generating Historical Data Reports 77 of 136 order of date This filtered list contains the Date Time information and the Operator name The user can view a result in detail by selecting the required report from this list and clicking on the View button or double click the selected report item x HIAC Royco PharmSpec v1 4 Particle Counting Accuracy Test Report Field ID1 Sensor M
33. This also lists the calibration data c Sampler Data You can view the syringe size for the currently selected sampler as per the Current Test Set up in the Sampler Data section of Hardware Settings dialog d Print Setup You can opt for auto print of test result after running the test To do this check the Auto Print On checkbox in the Print Setup section e 9703 Only PHA For the 9703 you can configure the Xmin and XMax parameter values of PHA graph from the PHA section These are the starting and ending points for the x axis on the PHA display The value for the ending point must be at least 30 units greater than the starting point f Operating Parameters You can view the operating parameters such as sample volume number of runs dilution factor Channel sizes tare volume etc in the Operating Parameters section of Hardware Settings dialog Most of these Operating Parameters except for the tare parameters are used exclusively for the RUN Counter test The tare parameters Tare Volume and the Multi stroke Tare are used by other tests also The Modify button in the Hardware Settings dialog can be used to modify these parameters Clicking on the Modify button invokes the Operating Parameters dialog User Guide HIAC PharmSpec 2 System Configuration 61 of 136 Operating Parameters E xj m Parameters Sample Volume mL 5 00 Channel Size pm Channel Size pm 5 00 1 3 No of Runs 3 10 000 2 20 000 10
34. User Guide 104 of 136 C User Guide Procedure Builder PharmSpec 2 The Next gt gt button will be enabled when all values are entered If invalid data is entered appropriate messages will be shown to the user To reset the grid select the primary computation once more Clicking on the Next gt gt button takes you to the next step Clicking on the lt lt Previous button takes you to the previous step Click the Cancel button to close the dialog Click the Help button to get to the Help function Step 3 Define Pass Fail Criteria In this step you can configure the PASS FAIL criteria for the test procedure The user can define the counts Sum Average of a particular particle size per unit volume mL Container required for the test to be declared passed The PASS criteria may consist of one or more particle sizes Wizard Step 3 Pass Fail Criteria Settings Pass Fail Critena Delete Options Select Row y Delete lt lt Previous Finish Print Cancel Help Fig 14 6 Pass Fail Criteria Setting Dialog HIAC KSS March 2006 Edition 3 KSS March 2006 Edition 3 PharmSpec 2 Procedure Builder 105 of 136 You can go to the next step by clicking on the Next gt gt button or go back to the previous steps by clicking on the lt lt Previous button d Step 4 Define Help Details In this step you can configure the operator instructions to be displayed
35. User Guide PHARMSPEG 2 SOFTWARE EXCELLENCE IN PROCESS ANALYTICS PharmSpec 2 User Guide KSS March 2006 Edition 3 KSS March 2006 Edition 3 PharmSpec 2 Table of Contents Table of Contents HIAC 1 Introduction 1 1 What s new in PharmSpec 2 17 Installation 2 1 System Requirements ss 2 2 Installation Procedure ss Setting up the System System Configuration 3 1 Hardware Settings AA ie dite etats 3 2 come RE D deny ators sanscreaetics 3 3 Disable Obsolete Procedures oocccccccnccccccnnccnnccninnnnnnnineninininininininininnns 3 4 9703 Sampler Control 3 0 Report Types Getting Started 4 1 User Interface siens 4 2 Main Menu Details is 4 3 Sub Menu Details User Administration 5 1 Administration 5 2 User Levels System Configuration 6 1 Hardware Settings A annee lan dl lan en 62 COIN A eee ede Running Sample Tests and Reviewing Results 7 1 Run Procedural Test 7 2 RUM Counter see 7 3 Review and Approve renn View the Audit Trail Activity Log 8 1 View Activity Logs ui ii Generating Historical Data Reports 9 1 Historical Reports 9 2 Old Version PharmSpec 1 4 Reports oooocccnccccccnnnccccccconocnccccnnanccninnnnnos x9 3 of 136 User Guide 4 of 136 User Guide 10 11 12 13 Data Backup Archival Running Instrument Standardization Tests 11
36. Wizard Step 7 Configured Test Procedure Information f 3 4 xj Procedure Name EP 43 Environmentl Procedure Details Sample Identifiers Lot ID Batch ID Computation Parameters Parameter Name Sample Volume mL lt lt Previous Next gt gt Finish Print Help Fig 14 12 Test Procedure Information Dialog 109 of 136 click the Previous button to go to the previous step Click the Finish button to complete the configuration activity and save the procedure If the procedure saved successfully the following message will be shown Click OK User Guide 110 of 136 Procedure Builder PharmSpec 2 x D 4 new procedure created Name User Defined 4 3 Environment Fig 14 13 Procedure Created Dialog click the Print button to print the procedure details Click the Cancel button to close the dialog Click the Help button to activate the HELP function 14 3 Load Create Report Template You can create a new report template or edit the details of an existing report template and save it to another name The buttons Load and Create in the Report Template facilitate this Create a new report template 3 J x Mode Create C Load Select Report Template Cancel Help Fig 14 14 Load Create Report Template Dialog a Create To create a new report template select the Create option radio button and click the OK button This will take you
37. allation You can run this utility directly from the PharmSpec CD AdminUtility AdminTool exe PharmSpec Admin Tool z mi xj Fig 17 1 PharmSpec Admin Tool To reset the PharmSpec System s administrator password to the default password of 123456 click the Reset System button Click the Exit button to exit from the tool HIAC User Guide 124 of 136 User Guide PharmSpec Admin Tool PharmSpec 2 HIAC KSS March 2006 Edition 3 PharmSpec 2 PharmSpec License Update Tool 125 of 136 18 PharmSpec License Update Tool HIAC This tool is used to update the PharmSpec Software license key The software can be upgraded to licensed mode even if initially it is installed in the Demo mode Also the software license can be updated when you buy additional software plug in modules or the Test Procedures from Hach Ultra You can start this tool using Start gt Programs gt PharmSpec 2 gt License Update x Installed Components Mode EP Licensed JP Licensed PharmSpec 2 0 Licensed Procedure Builder Licensed USP Licensed Y Upgrade License Sales Order No Cutomer Name Enter new license key Fig 18 1 PharmSpec License Update In this dialog you can see the current status of installed modules components and the license mode licensed demo mode To update the license check the Upgrade License check box If PharmSpec was installed in Demo mode then user will have to
38. am pt ni 1 10 m Calibration Data Line i Dilution Factor fi 2 Tare Volume mL Sa Multi stroke Tare mL fr IT Discard First Run i a E Shui i screen at the beginning of Cancel Print Help Fig 3 1 Hardware Settings Dialog This dialog is organized into multiple sections Each section is explained below To set up a new system the first step is to configure or add Sensor s Counter s and the Sampler s The next step is to define the current setup components by selecting the Sensor HIAC User Guide 16 of 136 System Configuration PharmSpec 2 Counter and the Sampler used in the system and the communication parameters such as the Port number and the Baud rate Then you need to set the Operating Parameters The 9705 uses sensors and counters e The 9703 uses sensors and samplers a Configure Current Test Set up A user can have an inventory of more than one Sensor Counter and Sampler but only one each of these components will be used in a test setup at any given time In addition to this the COM port of the computer to which the hardware unit is connected and the Baud rate need to be set The Configure Current Test Setup group allows the user to configure all these Communication The user can select the port and baud rate required for communicating with the HIAC 9703 or 9705 The available options for Port number are COM1 COM2 COM3 and
39. ase make sure that the PharmSpec main application Procedure Builder Procedure Loader is not running in the system The access to this utility is restricted only to the privileged users Being a database restoration utility it has a separate user account and does not use the PharmSpec user accounts User validation is done using the User ID and password The installation comes with a default User ID admin and password 123456 After successful login it pops up the Database Restore dialog Database Restore E x Restore as PharmSpecDB Options C Database Full Quick Browse File flg PRE AAA p Mee 2 ER RS E EN Ed Close Help Change Password Clear DB Lo Fig 15 1 Database Restore Dialog The Restore as field shows the PharmSpec database name There are two options for the database restoration e Database Full Only Database Full Quick After selecting one of the options you have to select the files backup archive from which the data is to be restored Based on the restoration option selected Full Only Full Quick you need to select both or either of the files To select the file click the respective button having caption This will invoke a file selection dialog User Guide 118 of 136 User Guide Database Restorer PharmSpec 2 After selecting the file s click the Restore button User must note that computer should b
40. ation Tests 89 of 136 Standardization_ElectronicResolution Test 1000 is 0000 Lou 1000 g 10 000 Hevlen Approye save Wry Wueue Fig 11 6 Electronic Resolution Dialog HIAC User Guide 90 of 136 Running Instrument Standardization Tests PharmSpec 2 11 6 USP Counting Accuracy The user can run the USP Counting Accuracy Test by selecting Standardization USPCountingAccuracy from the IST Standards selection window and then clicking the Sample Test gt Run IST menu This pops up the Sample Identification dialog to enter the information about the challenge particles used for the test This information is then stored with the test results and printed out on request This enables the PharmSpec system to provide a paperless history of the calibration work that has been performed on the system You can enter the sample IDs and then click the Continue button This will pop up the USP Counting Accuracy dialog Standardization USPCountingAccuracy Test Description Result Input USP particle Count Reference Standard Rest Size Cumulative Count Pass Fail criteria into the following fields Parameters 10 pm Lower Limit 3250 000 10 pm Upper Limit 4250 000 Lower Ratio 1500 Upper Ratio 350 Save Only Gueue Print Continu
41. available in future releases If you choose International then reports are displayed in the local language with English sub titles If you choose English Only the report is displayed in English but the review approval comments would be in the local language if they were written in the local language User Guide 32 of 136 User Guide System Configuration PharmSpec 2 HIAC KSS March 2006 Edition 3 PharmSpec 2 Getting Started 33 of 136 4 Getting Started 4 1 User Interface PharmSpec user interface consists of the following Table 4 1 User Interface Components Component Function PharmSpec Main Application Used to configure the test set up run the tests and view results reports activity logs Procedure Builder Used to create custom Test Procedures This is an optional mod ule It is needed only if the user wants to create his her own test procedures Procedure Loader Used to import new Test Procedures into the current setup Database Restorer Used to recover lost data can restore data from the backup or archived files License Update Tool Used to upgrade the license key for the PharmSpec Software Simulation Application Used to set some pre defined result values that will be received by the PharmSpec application while running the tests Admin Tool Used to reset the administrator password This application is not installed in the system To run this utility user needs the Pharm Sp
42. behavior You can then save the details by clicking on the Save button for later retrieval and use Note This option is unavailable on the 9705 User Guide HIAC KSS March 2006 Edition 3 PharmSpec 2 System Configuration HIAC Modify Sampler 3 59 of 136 C Add Modify Remove ar Model SAMP1 M Lift Arm Lift Arm Serial No 5a5672 y Lift arm after test completed Syringe Size Fo mL y Lift arm after each run Close Help Fig 6 11 Modify Sampler Dialog Remove Sampler Remove Sampler 4 You can delete a sampler which is not in use from the system The title of the dialog becomes Remove Sampler and the Save button becomes Remove By clicking on the Remove button the user is prompted for confirmation before the Sampler is deleted Xl C Add C Modify Remove FT LittArm Model Lift Arm Serial No 545672 y Lift arm after test completed Syringe Size Fo E Lift arm after each run Close Help Fig 6 12 Remove Sampler Dialog User Guide 60 of 136 System Configuration PharmSpec 2 b Sensor Data You can view the details of the currently selected sensor as per the Current Test Set up in the Sensor Data section of the Hardware Settings dialog Sensor details include the type model calibration mode serial number calibration date calibration due date volume flow rate and concentration limit
43. cel Help Fig 14 8 Report Template Settings Dialog HIAC Edition 3 ch 2006 KSS Mar PharmSpec 2 Procedure Builder 107 of 136 If you want to select a report template from the available list choose the Select option This will enable the Select button Now click the Select button and this will pop up the report template selection dialog enabling the user to select an existing template from the list Select Report Template E x IST ElectronicReso ReportTemplate IST FlowRate ReportTemplate IST JPCounting ccuracy ReportTemplate IST_MovingWindow_ReportT emplate IST_SenResol_ReportT emplate IST_USPCount cc_ReportT emplate IST_Volume ccu_ReportT emplate JP_LVILRPT_xI JP_Reagent_RPT_xl JP SVI RPT USP EVT RPFT Template USP Lvl RPT 26 USP_SWI_RPT Gk Cancel Help Fig 14 9 Report Template Select Dialog To create a new report template select the Create option This will enable the Create button Now click the Create button and this will pop up Report template wizard You will now be guided through a series of steps to define the report template The user has an alternate option to create a report template from the opening dialog of the Procedure Builder by selecting the Report button You can go to the next step by clicking on the Next gt gt button or go back to the previous steps by clicking on the lt lt Previous button f Step 6 Save the procedure In th
44. cluding without limitation damages for loss of business profits business interruption loss of business information or other pecuniary loss arising out of the use or inability to use this Hach Ultra Analytics product even if Hach Ultra Analytics has been advised of the possibility of such damages If you acquired this product in the United States this Agreement is governed by the laws of the State of Oregon Revision History e PharmSpec 2 User Guide Revision 3 March 2006 Hach Ultra Analytics Inc e PharmSpec 2 0 User s Manual Revision 2 0 May 2003 Pacific Scientific Instruments Acknowledgements Intel and Pentium Ill are registered trademarks of the Intel Corporation e Microsoft Microsoft Excel Microsoft Internet Explorer Windows Windows 2000 and Windows XP are trademarks or registered trademarks of the Microsoft Corporation User Guide 8 of 136 User Guide Manual Overview PharmSpec 2 HIAC KSS March 2006 Edition 3 PharmSpec 2 Introduction 9 of 136 1 Introduction PharmSpec is a Microsoft Windows application that works in conjunction with HIAC s particle counters and samplers as a data acquisition and analysis system It is fully compatible with the HIAC 9703 and 9705 Systems These systems collect data and analyzes it using the USP lt 788 gt EP JP or KP procedural standards or user defined test procedures e The 9703 System consists of a Model 9703 sampler plus a liquid sensor e The 97
45. der Version Report Dialogues 76 Fig 9 4 Previous Version Report Dialog ooooooocicocococccccncccanananncccccnonanannnnnnnos 77 Fig 10 1 Fig 10 2 Fig 10 3 Backup Configuration Dialog oooooiccoccccnnnnnnicnonccccnnnnnnnnnnanannncnnnncnnnnno 79 Schedule Backup Dialog Lasses a 80 Archive Configuration Dialog coooooocccccnnnccocccccccccnonananoncccnnnnnnanannnnnos 81 Fig 11 1 Volume Accuracy Test Dialog cima qneeenrva 84 Fig 11 2 Flow Rate Dialog gaa rd diia 85 Fig 11 3 Moving Window Test Dialog uirasaetuoeadeanmmandneniindeendd 86 Fig 11 4 Sensor Resolution DIA at 87 Fig 11 5 Sample Identification Dialog ocoonnncicnnnncccnnnninnananaccccncanannnnann noo 88 Fig 11 6 Electronic Resolution Dalgg 2 a 89 Fig 11 7 USP Counting Accuracy Dialog susctesirmstaaia incio 90 Fig 11 8 JP Counting Accuracy Dialog aci 91 Fig 11 9 KP Counting Accuracy Dialog sameiet iia 92 Fig 12 1 PHA for Cumulative Counts per mL 94 Fig 12 2 PHA for Cumulative Counts per mL 95 Fig 14 1 Procedure DUO ostia diana 99 Fig 14 2 Procedure Builder Login Dialog iciccccccscceesenccscveeeestssnceneneesesaasncaernes 100 Fig 14 3 Create New Procedure Dialog 101 Fig 14 4 Sample Identification Settings Dialog oooooocccccnnoniciconicccaninananannn nos 102 Fig 14 5 Computation and Parameter Setting Dialog 103 Fig 14 6 Pass Fail Crit
46. dure Builder Steps a Step1 Define Sample Identifiers You can define the sample identifier names e g Lot ID Batch ID A maximum of six sample identifiers can be defined for a procedure These create fields that the operator must respond to at the beginning of the resulting test process You can select the number of sample identifiers required and only that many fields are activated HIAC User Guide 102 of 136 Procedure Builder PharmSpec 2 Wizard Step 1 Sample Identification Settings Number of Sample Identifiers 2 Field Name 1 Lot ID Field Name 2 Batch ID Next gt gt Finish Print Cancel Help Fig 14 4 Sample Identification Settings Dialog After configuring the sample identifier names click the Next gt gt button b Step 2 Define computation methods and parameters Next you configure the computation method the parameters and their attributes First select the Primary Computation method from the selection window box Based on the Primary Computation method selected the Secondary computation will be automatically listed Parameters for the selected primary computation will be listed in the Computation Parameter Grid The parameters include the sample Size Number of containers minimum number of runs gt etc and this depends on the computation method selected You cannot select a parameter more than once Some of these parameters may be constant values and
47. e Close Help Fig 11 7 USP Counting Accuracy Dialog The counting accuracy test is designed to ensure that the particle counter counts fall exactly Within the range specified by the USP Particle Count Set The standard specifies that the count at 10 um plus the ratio of the counts at 10 and 15 um need to conform to the values accompanying the USP Particle Count RS Reference Standard material It is recommended that a pre test using standard 10 micron PSL particles be done before using the USP Particle Count RS User Guide HIAC Edition 3 KSS March 2006 PharmSpec 2 Running Instrument Standardization Tests 91 of 136 11 7 JP Counting Accuracy The user can run the JP Counting Accuracy Test by selecting Standardization JPCountingAccuracy from the IST Standards selection window and then clicking the Sample Test gt Run IST menu This pops up the Sample Identification dialog to enter the information about the challenge particles used for the test This information is then stored with the test results and printed out on request This enables the PharmSpec system to provide a paperless history of the calibration work that has been performed on the system You can enter the sample IDs and then click the Continue button This will pop up the JP Counting Accuracy dialog Standardization JPCountingAccuracy Test Description Result Place Sample into clean glassware Agitate Degas Result
48. e RESTARTED before running the Restore application You can change the password of this utility by clicking on the Change Password button HIAC Edition 3 KSS March 2006 KSS March 2006 Edition 3 PharmSpec 2 Procedure Loader 119 of 136 16 Procedure Loader Procedure Loader is a utility to upload licensed test procedure updates from a distributable procedure update pack Whenever the procedures undergo change Hach Ultra Analytics personnel will create new test procedures validate them and generate a distributable pack of the procedure updates for the end users Hach Ultra Analytics will distribute this to the users depending on the service agreement or contract terms with Hach Ultra Analytics or at the discretion of Hach Ultra Analytics in the form of a checksum protected database MS Access file The end users can load the procedure updates from the distributable pack using this utility You can start this tool using Start gt Programs gt PharmSpec 2 gt Procedure Loader Before starting this utility please make sure that the PharmSpec main application or the Procedure Builder is not running in the system Procedure Loader Fig 16 1 Procedure Loader The access to this utility is restricted only to the privileged users Supervisor Administrator User validation is done using the User ID and password This module has the System Lockout User Logout and Lockout features HIAC User Guide 120 of 136
49. ec CD This shall be used only in emergency conditions To launch the PharmSpec main application any one of the following methods could be used e Goto Start gt Programs gt PharmSpec 2 gt PharmSpec Double click the shortcut to PharmSpec on the desktop Before beginning to use the software you have to first log in to the system Log in using a User ID and password The administrator assigns a User ID and password to a new user The software comes with a default administrator user with User ID admin and password 123456 On your first log into the software you are by default prompted to change your password However the administrator can disable this feature The login dialog is shown in Figure 4 1 HIAC User Guide 34 of 136 User Guide Getting Started PharmSpec 2 a User ID Password Cancel Help Fig 4 1 User Login Dialog After logging in successfully the PharmSpec 2 application will be available The PharmSpec 2 Main Application window consists of an upper portion with menus for various user actions and selection window boxes to select the test procedures for running the tests and a status bar at the bottom which consists of three parts On the left most portion of the bottom display will be any status message and on the right most side one icon to indicate the busy idle state of the system and another icon to show whether the system is in simulation mode or online HIAC
50. enter the Sales Order Number Customer Name and the license key in the respective fields If you are already a licensed user you need to enter only the new license key After this click the Upgrade button The License Tool will validate the license key and update the license of PharmSpec If the license key entered is invalid it will validate the Sales Order Number Customer name etc an error message will be shown click the Exit button to close the License Update Tool User Guide 126 of 136 User Guide PharmSpec License Update Tool PharmSpec 2 HIAC KSS March 2006 Edition 3 PharmSpec 2 PharmSpec Simulation Application 19 PharmSpec Simulation Application HIAC 127 of 136 This tool is used to set the parameters and ranges for simulated data that is used in the procedures and IST tests while simulation mode is active The details that are input will be used by the PharmSpec application while in the Simulation Demo mode You can start this tool using Start gt Programs gt PharmSpec 2 gt Simulation Application Simulator Application 8 g ix Simulation Type Difterential Counts C Random Numbers Chandi 500 4 C Fined Numbers Chernel2 fio Chamel3 0 4 Number of Simulations fT pes a Chamel5 P Select Simulation hy Channel 6 pb 3 Chant 0 Chm PD 4 Channel 9 Channel 10 Channel 11 Channel 12 Channel 13 Channel 14 Channel 15 Channel 16 Fig 19 1 Simulator Appl
51. er the review comments and then press the Review button When this button is pressed the User Authentication dialog will pop up prompting you enter your password If you have the privilege to approve the test results if you desire you can enter the approval comments and then press the Approve button As in the case of review the user authentication dialog will pop up prompting you enter your password After performing Save Only Queue or Review Approve the Run Test button will set its status to Start Again On clicking this button the test will start over again The user can print the result by clicking on the Print button 11 1 Volume Accuracy Standardization YolumeAccuracy Test The user can run the Volume Accuracy Test by selecting Standardization VolumeAccuracy from IST Standards selection window and then clicking the Sample Test gt Run IST menu This invokes the Volume Accuracy Test dialog Description Set tare volume Place fluid into a beaker Weigh Rest Size Measured Volume the beaker plus fluid and enter the weight in the Initial Weight field Place the beaker on the sampler Press Run Test Result m Parameters Tare Volume mL 000 Density 100 Initial Weight 0000 Print Run Test Save Only Bueue User Guide Fig 11 1 Volume Accuracy Test Dialog HIAC PharmSpec 2 Running Ins
52. eria Setting Dialog 104 Fig 14 7 Help Information Setting Dialog cocosommsrmiiia 105 Fig 14 8 Report Template Settings Dialog 106 Fig 14 9 Report Template Select Dialog 107 Fig 14 10 Save Configuration Dialog acicate maneter 108 Fig 14 11 Error Message ii ta ide 108 Fig 14 12 Test Procedure Information Dialog 109 Fig 14 13 Procedure Created Dialogue 110 HIAC PharmSpec 2 Annex HIAC Fig 14 14 Fig 14 15 Fig 14 16 Fig 14 17 Fig 14 18 Fig 14 19 Fig 14 20 Fig 15 1 Fig 16 1 Fig 16 2 Fig 16 3 Fig 16 4 Fig 16 5 Fig 17 1 Fig 18 1 Fig 19 1 Load Create Report Template Dialog 110 Title Configuration Dialog in 111 Field Configuration Dialog ooccoooniconccccnnnnnoconocacanccnnncccnnnnrarnnnnnno 112 Test Parameters and Result Configuration Dialog 113 Report Template Preview Dialog 114 Save Report Template Dialog 115 Save Report Template Error Message 116 Database Restore Dialogues 117 Procedure Loader isitma ipe ii ada 119 Procedure Loader Login Dial0g 2er sssressssrrsssnsssissunus
53. ers Dialog 11 sc2 2ccccnsesscescnctseecssesenssecrestertedenssveectesee 27 Fig 3 14 Configure Sample ID Dialog oooooooccccccoccncoconccccnnonncananccncnncnnnnnnnan anno 28 Fig 3 15 Disable Obsolete Procedures Dialogue 29 Fig 3 16 Sampler Control Dialog ssusininnisaa ir rl 30 Fig 3 17 Report Type DI nes ie tae 31 Table 4 1 User Interface Components 33 Fig 4 1 User Login Dialog A A aies 34 Fig 4 2 PharmSpec Main Window ner mie 35 Fig 4 3 User Profile Dialog ooo is 36 Fig 4 4 Change Password Dialog os 37 Fig 4 5 Logout Confirmation DISlOJ sis iia ii blende duene 37 Fig 4 6 Exit Confirmation Dialogues a 38 Fig 5 1 Administration Dialog immanent s dan A Ai 39 Table 5 1 Default Role Privileges nrnnnnnnnnnnnnnnvononennnnnrnnnnvnnnnnennvnnnnnnnnnnnnennenn 40 Fig 5 2 Add New User Dialog it 41 Fig 5 3 Operator User Rights Dialog 42 Fig 5 4 Supervisor User Rights Dia log i00 cccccesscssececscseeseeseesssneaneneseneveascnszees 43 Fig 5 5 Calibration Technician User Rights DIalo9 ooooonincconccccnnnnimmooconoss 44 Fig 5 6 Administrator User Rights Dialog 45 Fig 5 7 Modify User Details Dialog coi ii 46 Fig 5 8 System Settings DighO isi icon as 47 Fig 6 1 Hardware Settings Dialog as 49 Fig 6 2 Simulator Mode Confirmation Dialog 50 Fig 6 3 Simulator SOIC CHON A A a A
54. ess the Archive dialog On doing so Archive Configuration dialog is displayed User Guide HIAC KSS March 2006 Edition 3 KSS March 2006 Edition 3 PharmSpec 2 Data Backup Archival Archive Configuration amp Local Disk D v D PharmBackup rchive 2003 02 18 b Close Help Archive Drive Archive Data earlier than Archive Fig 10 3 Archive Configuration Dialog 81 of 136 You can select the archive location Drive and can initiate the archive action by clicking on the Archive button When the data is archived the corresponding test results and the activity log data will be deleted from the current PharmSpec database User can also configure the amount of data to be archived by setting the Archive Data earlier than field Archiving of historical data is strictly a manual operation and is only available to the Administrator level of user HIAC User Guide 82 of 136 User Guide Data Backup Archival PharmSpec 2 HIAC KSS March 2006 Edition 3 PharmSpec 2 Running Instrument Standardization Tests 83 of 136 11 Running Instrument Standardization Tests HIAC You can run an instrument standardization test by selecting an instrument standardization test from the IST Standards selection window and then clicking the Run IST menu You can also do this by using the function key F2 This operation is only available to a user with the CAL
55. f required Operator selection window lists all the users of the system Sample ID selection window lists the sample IDs corresponding to the selected test procedure Sample ID will have None as the default selection User has to select the required sample ID from the selection window and then the edit box for entering the sample ID value will be shown The user has to select a sample ID and the edit box for entering the sample ID is displayed The user will then have to enter the value of the sample ID for which he has to view the reports The Starting date and the Ending date fields display the current date by default You may or may not specify the other fields On Selecting the Apply button it displays all the reports for the selected test procedure for the current date for all the users If the user selects a sample ID then the value for that sample ID is also listed in the report details The user can select a particular report and click the View button or double click the report This invokes the View Report dialog HIAC KSS March 2006 Edition 3 PharmSpec 2 Generating Historical Data Reports 75 of 136 HIAC PharmSpec JP Counting Accuracy Test Report sensor Model Simulation Sensor Serial Number Simulation Operator Name Administrator sample Date 2003 01 23 12 02 39 PM sample Volume mL 5 Runl Included Run No Particle Size um Cumulative Count Cumulative Counts mL Run 1 5 414 82
56. he test This information is then stored with the test results and printed out on request This enables the PharmSpec system to provide a paperless history of the calibration work that has been performed on the system You can enter the sample ID information and then click the Continue button This invokes the Moving Window Test dialog Standardization MovingWindow Test Description Result Mix a sample containing the particle standard to Result Size DbservedMV Expected MV have concentration of between 1000 and 5000 m Parameters Mean Particle Size 1 000 Queue Print Run Test Fig 11 3 Moving Window Test Dialog 11 4 Sensor Resolution The user can run the Sensor Resolution Test by selecting Standardization SensorResolution from the IST Standards selection window and then clicking the Sample Test gt Run IST menu This invokes the Sample Identification dialog to enter the information about the challenge particles used for the test This information is then stored with the test results and printed out on request This enables the PharmSpec system to provide a paperless history of the S calibration work that has been performed on the system You can enter the sample IDs and then click the Continue button This invokes the Sensor Resolution Test dialog User Guide HIAC KSS March 2006 Edition 3 PharmSpec 2 Running Instr
57. ialog View Activity Logs E xi Activity Logs Filtering Options Date Time User Activity From 2003 01 1512 40 00PM xl User ay To 2003 01 2312 40 20PM y Activity an Description 2003 01 23 12 26 22 PM Administrator Operating Parameters Number of runs changed y 2003 01 23 12 26 22 PM Administrator Channel value entered outside of calibration range 2003 01 23 12 25 54 PM Administrator Sample ids for counter changed 2003 01 23 12 25 13 PM Administrator Run Counter Test Started 2003 01 23 12 23 51 PM Administrator Run Counter Test Completed 2003 01 23 12 22 54 PM Administrator Run Counter Test Started 2003 01 23 12 20 23 PM Administrator TEST FAILED WITH USP 26 Environment 2003 01 23 12 20 15 PM Administrator Run Started with Recipe USP 26 Environment 2003 01 23 12 18 45 PM System Proper ShutDown PharmSpec 2003 01 23 12 18 28 PM Administrator Automatic Logout 2003 01 23 12 17 27 PM Administrator Automatic lockout 2003 01 23 12 16 22 PM Administrator TEST STARTED WITH Standardization Volum 2003 01 23 12 16 17 PM Administrator TEST FAILED WITH Standardization_Yolumed 2003 01 23 12 16 10 PM Administrator TEST STARTED WITH Standardization Volum 2003 01 23 12 16 03 PM Administrator TEST STARTED WITH Standardization Volum 2003 01 23 12 16 00 PM Administrator TEST FAILED WITH Standardization Volume 2003 01 23 12 15 49 PM Administrator TEST STARTED WITH Standardization Volum Print Exp
58. ication Window lidad lilal E Chose B The user can select the Random number mode or a Fixed number mode for the simulation If the user selects the Random number mode then all the test run results will be random To use the fixed number mode follow the steps below 1 Select the number of simulations There can be a maximum of 10 sequential simulations 2 From the Select Simulation selection window box the user can select which one of the simulation sequences first second third etc depending on the number of simulations selected is to be displayed 3 Once the user selects the simulation from the selection window box the user can fill in the channel values required There can be a maximum of 16 channels for each simulation Please note that this will be the differential count and the application will calculate the cumulative counts based on this The actual number of size channels and the size label for these channels is set in the Main Application using Hardware Settings At a later stage if the user wants to cut down the number of simulations from a previous setup say from 10 to 5 the user can just change the number of simulations to 5 and save The application will now use only the data listed in 1 through 5 to perform the next simulations User Guide 128 of 136 User Guide PharmSpec Simulation Application PharmSpec 2 HIAC KSS March 2006 Edition 3 Edition 3 KSS March 2006 Phar
59. ift arm after each run Close Help Fig 3 11 Modify Sampler Dialog Remove Sampler Remove Sampler 4 You can delete a sampler which is not in use from the system The title of the dialog becomes Remove Sampler and the caption of the Save button becomes Remove By clicking on the Remove button the user is prompted for confirmation before the Sampler is deleted Xl C Add C Modify Remove FT LittArm Model Lift Arm Serial No 545672 y Lift arm after test completed Syringe Size Fo E Lift arm after each run Close Help Fig 3 12 Remove Sampler Dialog User Guide 26 of 136 System Configuration PharmSpec 2 b Sensor Data You can view the details of the currently selected sensor as per the Current Test Set up in the Sensor Data section of the Hardware Settings dialog Sensor details include the type model calibration mode serial number calibration date calibration due date volume flow rate and concentration limit This also lists the calibration data c Sampler Data You can view the syringe size for the currently selected sampler as per the Current Test Set up in the Sampler Data section of Hardware Settings dialog d Print Setup You can opt for auto print of test result after running the test To do this check the Auto Print On checkbox in the Print Setup section e PHA For the 9703 you can configure the Xmin and XMax
60. ileges of the user c System Settings Administrator can set the system setting parameters To do this click the System Settings button in the Administrator dialog On doing so the System Settings dialog is displayed User Guide HIAC KSS March 2006 Edition 3 PharmSpec 2 User Administration 47 of 136 HIAC System Settings x M Configure System Automatic User Logout Minimum Length of Lockout Time 15 Mins Password 6 Logout Time 60 Mins User ID 4 2 M System Lockout Settings Lockout Time 30 Mins Password Expiring 60 Days Frequency No of Attempts Account Expiring Alert f 0 Days Security Level Low DK Cancel a Fig 5 8 System Settings Dialog The Administrator can set the parameters related to Auto Lockout Auto Logout System Lockout and periodic revision of Password These parameters are Auto Lockout time e Auto Logout time e System Lockout time Number of consecutive unsuccessful login attempts The system is locked or the user is logged out after the specified timeouts The administrator can also set the minimum number of characters permitted for User ID and password The password expiring frequency and the user account expiring alert are also configured from this dialog The parameter Password Expiring Frequency decides the frequency days at which the user has to change the password If a user account is due fo
61. in the screen during the test run These instructions are displayed on the top left corner of the window while running the test Type the required text in the window The maximum number of characters that can be entered is 166 Wizard Step 4 Help Information Settings Place 50mL filtered water into clean glassware Agitate Degas for 30 seconds Agitate again Enter sample volume below lt lt Previous ner Finish Print Cancel Help Fig 14 7 Help Information Setting Dialog You can go to the next step by clicking on the Next gt gt button or go back to previous steps by clicking on the lt lt Previous button HIAC User Guide 106 of 136 e User Guide Procedure Builder PharmSpec 2 Step 5 Define Report Template In this step you can specify the report template required for the procedure When the test results are retrieved from PharmSpec the report will be formatted as per the template configured here You can either create a new report template or select an existing one and associate it with the procedure being configured As part of the report template configuration the content data to be displayed and the presentation font color etc information can defined Wizard Step 5 Report Template Settings Create Select Report Template C Create Create Select Select EP EVT FPT 43 lt lt Previous Finish Print Can
62. irmation Calibration Data Q Do you want to remove this sensor 201 3 8 30 3 063 fi 2 50 3 am _ Fig 3 7 Remove Sensor Dialog 3 2 Counter Add Counter The user can add a new counter to the system Clicking on the Counter button in Hardware Settings dialog does this This invokes the Add Counter dialog User Guide HIAC KSS March 2006 Edition 3 KSS March 2006 Edition 3 PharmSpec 2 System Configuration 23 of 136 Add Counter Fig 3 8 Add Counter Dialog The user has to enter the model and serial number of the counter You can also select the model number from the list if available You can save these details by clicking on the Save button for later retrieval and use Remove Counter You can remove a counter which is no longer in use from the system The title of the dialog becomes Remove Counter and the caption of the Save When the Remove button is clicked a confirmation message is displayed prompting the user to confirm removal of the counter Remove Counter Fig 3 9 Remove Counter Dialog HIAC User Guide 24 of 136 User Guide System Configuration PharmSpec 2 a Sampler Add Modify Sampler The user can add a new sampler or edit an existing sampler To do this click the Sampler button in Hardware Settings dialog This invokes the Add Sampler dialog Add Sampler 3 x Add C Modify Remove Model 3 F Lift Arm ode Lift
63. is you can ignore this step and go directly to step 2 If you want to run a test procedure other than the one shown in the toolbar click the Standard Procedures selection window The available list of test procedures is listed here You can select the required test procedure from this list 2 click the Sample Tests gt Run Procedural Test menu This invokes the Sample Identification dialog You have to first enter the sample identifier data configured for the selected test procedure Sample Identification i x Lot ID Lot 23 Batch ID Batch 23 Cancel Help Fig 7 1 Sample Identification Dialog The sample identifiers listed are the ones pre configured for a particular test procedure For example the sample IDs for a particular test procedure could be Lot ID and Batch ID and you are asked to enter the value for these sample identifiers HIAC User Guide 64 of 136 Running Sample Tests and Reviewing Results PharmSpec 2 3 On entering the sample ID values and clicking the continue button the Procedural Test window is displayed The Procedural Test window contains The top left corner of each screen provides the operator with instructions specific to the test the operator is performing The section immediately below the instructions lists the parameters required to run the test Each parameter shows a default value The user can change these values within permissible limits The most common pa
64. is step you can save the configured procedure by specifying a name Once saved the procedure is protected and no one can modify it If changes are needed a copy can be created and changes made to the copy but the resulting procedure must then be saved to another name To set the Procedure name first select the test type from Test Type selection window The only option available as of now for the end user is User Defined Then enter the test name The procedure name will automatically be generated HIAC User Guide 108 of 136 Procedure Builder PharmSpec 2 Wizard Step 6 Save Configuration E o o x Test Type User Defined v Test Name 4 3 Environment Procedure Name User efined 4 3 Environment lt lt Previous nen Finish Print Cancel Help Fig 14 10 Save Configuration Dialog Now click the Next gt gt button If the procedure name you specified already exists in the system the following message will be shown upon clicking the Next gt gt button mx x 4 procedure with this name already exists Please give another name Fig 14 11 Error Message User Guide HIAC KSS March 2006 Edition 3 KSS March 2006 Edition 3 PharmSpec 2 Procedure Builder HIAC You can go to the previous steps by clicking on the lt lt Previous button g Step7 Procedure Information Here you can view the details of the procedure just configured
65. layed prompting the user to confirm removal of the counter Remove Counter Fig 6 9 Remove Counter Dialog HIAC User Guide 58 of 136 System Configuration PharmSpec 2 a Sampler Add Modify Sampler The user can add a new sampler or edit an existing sampler To do this click the Sampler button in Hardware Settings dialog This invokes the Add Sampler dialog Add Sampler 3 x Add C Modify Remove F Lift Arm Model z Lift Arm Lift arm after test completed Serial No a A f t arm after each 7 Syringe Size Lift arm after each run Fig 6 10 Add Sampler Dialog You can add new sampler details by clicking on the Add radio button You can enter the value for model serial number and select a syringe size from the Syringe Size selection window for the sampler Available syringe sizes are 1 ml 10 ml and 25ml You can also select the model number from the list if available On the 9703 you also may select the option for lifting the arm lift the arm after each run or after the completion of the test You can then save the details by clicking on the Save button for later retrieval and use If you prefer to manually raise the arm at the end of each test or sample then simply do not check the box for Lift Arm User can select a model and serial number from the existing list and change the syringe size of the selected sampler and the lift arm
66. lete Procedures Dialog In the Disable Obsolete Procedure dialog Active Procedures lists all the active Procedures configured in the system You can select a Procedure from this and move it to the Obsolete Procedures by clicking on the gt button You can move all the Procedures from the Active Procedures list to the Obsolete Procedures list be clicking on the gt gt button You can select a Procedure from the Obsolete Procedures list and make it active by clicking on the lt button All the Procedures can be made active by clicking on the lt lt button On clicking the OK button all the Procedures in the Active Procedures list are listed in the Standard Procedures selection window on the main screen toolbar 3 4 9703 Sampler Control For the 9703 you can initiate some of the hardware commands mechanical movements get firmware version number etc directly for initializing or setting up the hardware The commands are sent directly to the hardware through the driver To do this choose Set up gt Sampler Control On doing so the Sampler Control dialog is displayed Edition 3 KSS March 2006 User Guide 30 of 136 System Configuration PharmSpec 2 Sampler Control E xj Load Syringe Prime Back Flush Versions Abort Stop Arm Up ED 5 Fig 3 16 Sampler Control Dialog Sampler Control dialog supports the following commands Load Syringe Prime Back Flush Arm U
67. lic etc Wizard Step 3 Configure fonts for Test Parameter and Results HIAC m Parameters Result Data Alignment Left hr Alignment Center h Font En Font DE Color T Color pA Sample Sample Sample Sample F lt lt Previous n Finish Print Cancel Help Fig 14 17 Test Parameters and Result Configuration Dialog User Guide 114 of 136 d User Guide Procedure Builder PharmSpec 2 To configure the Font for the parameters click the Font button in the Parameter group box To configure the color for the parameters click the Color button in the Parameter group box Similarly the Font and Color can be configured for the Result Data by clicking on the respective buttons in the Result Data group box If the Font and the Color properties are not configured it will use the default values sample text will be displayed for previewing the font and color properties click the Next gt gt button to go to the next step Click the Cancel button to close the dialog Click the Help button to get the help Step 4 Preview Report Template Here you can preview the configured report template Wizard Step 4 Preview Report Template EP 4 3 lt 2 9 19 gt Environment Test Parameter Name Parameter Value Cumulative Count Summation 00 00 00 00 lt lt Previous Finish Print Cancel Help Fig 14 18 Report Tem
68. livolts 20 55 Zoom Out Print Help Fig 12 2 PHA for Cumulative Counts per mL You can view the PHA results in either Log or Linear format by choosing the corresponding radio buttons You can also print the resulting graph by clicking on the Print button HIAC User Guide 96 of 136 User Guide 9703 Only Pulse Height Analyzer PharmSpec 2 HIAC KSS March 2006 Edition 3 Edition 3 KSS March 2006 PharmSpec 2 Help 97 of 136 13 Help Help is provided for all main screen dialogs and controls Help on using Help Help for Shortcut Keys Help Contents and About info of PharmSpec 2 are displayed 13 1 Using Help The user can get the details of how to use the help by choosing Help gt Using help 13 2 Help on Shortcut Keys The user can get help on shortcut keys by choosing Help gt Help on Shortcut Keys 13 3 Contents The user can get the entire help contents listed by choosing Help gt Contents 13 4 About PharmSpec 2 The user can get the details about PharmSpec and its version by choosing Help gt About PharmSpec 2 HIAC User Guide 98 of 136 User Guide Help PharmSpec 2 HIAC KSS March 2006 Edition 3 KSS March 2006 Edition 3 PharmSpec 2 Procedure Builder 99 of 136 14 Procedure Builder Procedure Builder is an optional utility to create custom procedures for PharmSpec 2 It also allows you to load an existing test procedure copy it modify the copy a
69. llivolt values for the size There must be a minimum of four sizes and millivolt values The user can then save the details by clicking on the Save button HIAC User Guide 56 of 136 System Configuration PharmSpec 2 Import From Add Modify Remove Import E Sensor Details Type liquid z Model haoso F Calibration Mode Singe gt Serial No roen y Calibration Date 2000 06 26 View Volume m Calibration Due 20031212 pleie fom In Concentration Limit 35 00 Confirmation Calibration Data Q Do you want to remove this sensor 201 3 8 30 3 063 fi 2 50 3 am _ Fig 6 7 Remove Sensor Dialog 6 2 Counter Add Counter The user can add a new counter to the system Clicking on the Counter button in Hardware Settings dialog does this This invokes the Add Counter dialog User Guide HIAC KSS March 2006 Edition 3 KSS March 2006 Edition 3 PharmSpec 2 System Configuration 57 of 136 Add Counter Fig 6 8 Add Counter Dialog The user has to enter the model and serial number of the counter You can also select the model number from the list if available You can save these details by clicking on the Save button for later retrieval and use Remove Counter You can remove a counter which is no longer in use from the system The title of the dialog becomes Remove Counter When the Remove button is clicked a confirmation message is disp
70. lting from any defect or omission in this manual even if advised of the possibility of such damages In the interest of continued product development Hach Ultra Analytics reserves the right to make improvements in this manual and the products it describes at any time without notice or obligation Published in the United States of America Hach Ultra Analytics P N 701227 Edition 3 March 2006 Copyright O 2003 2006 by Hach Ultra Analytics All rights reserved No part of the contents of this manual may be reproduced or transmitted in any form or by any means without the written permission of Hach Ultra Analytics Safety Conventions WARNING A warning is used to indicate a condition which if not met could cause serious personal injury and or death Do not move beyond a warning until all conditions have been met CAUTION A caution is used to indicate a condition which if not met could cause damage to the equipment Do not move beyond a caution until all conditions have been met Note A note is used to indicate important information or instructions that should be considered before operating the equipment Software Agreement This Agreement and the product invoice or receipt are proof of license THIS IS LEGAL AGREEMENT BETWEEN YOU EITHER AN INDIVIDUAL OR AN ENTITY AND HACH ULTRA ANALYTICS BY USING THE SOFTWARE YOU ARE AGREEING TO BE BOUND BY THE TERMS OF THIS AGREEMENT IF YOU DO NOT AGREE TO THE TERMS OF THIS AGREEMENT PR
71. mSpec 2 Service Information 129 of 136 Appendix A Service Information A 1 Technical Support Information HIAC Technical Support Engineers are available to provide high quality advice and recommendations for applications product operation measurement specifications hardware and software factory and customer site training Please provide name company phone fax model number serial number and comment or question Call 1 541 472 6500 Toll Free 800 866 8854 US CA Fax 1 541 474 7414 6 00 AM to 5 00 PM Pacific Time Monday through Friday Email TechSupportGP hachultra com User Guide 130 of 136 User Guide Service Information PharmSpec 2 HIAC KSS March 2006 Edition 3 PharmSpec 2 Annex Annex HIAC Tables and illustrations Fig 3 1 Hardware Settings Dialog a 15 Fig 3 2 Simulator Mode Confirmation Dialog 16 Fig 3 3 Simulator SCIOCHON Lasse 17 Fig 3 4 Add Sensor DAN senda eda 18 Fig 3 5 Modify Sensor Dicc iiiii sd ceniacypes dai taceeeiiextedabeses 20 Fig 3 6 Import Sensor D D leon nts hands mveeuan snake bisensidaehaate 21 Fig 3 7 Remove Sensor DIalog lt lt oooomommmrrmr tener 22 Fig 3 8 Add Counter Dialog aper eee 23 Fig 3 9 Remove Counter Dialog usines 23 Fig 3 10 Add Sampler DIOS 24 Fig 3 11 Modify Sampler DIO sana is it aiii 25 Fig 3 12 Remove Sampler DENG usseciddia dida 25 Fig 3 13 Operating Paramet
72. nd save it under another name custom procedure thus created will be available in the PharmSpec 2 procedure list and can be run just like any other licensed test procedure Each test procedure is associated with a report template The Procedure Builder also allows you to define a new report template or import an existing one copy it modify the copy and save it in another name You can start this utility using Start gt Programs gt PharmSpec 2 gt Procedure Builder Before starting this utility please close the PharmSpec main application or the Procedure Loader if either of these applications is running on the system Procedure Builder fa Procedure f Fig 14 1 Procedure Builder The access to this utility is restricted only to the privileged users Supervisor Administrator User validation is done using the User ID and password This module has the System Lockout user Logout and User Lockout features HIAC User Guide 100 of 136 Procedure Builder PharmSpec 2 a User ID Password Cancel Help Fig 14 2 Procedure Builder Login Dialog Procedure Generation is a step by step procedure You can go back to a previous dialog if required At each step the user defines the data to be collected the calculation to be done with the results and the rules for running the test The procedures once created and saved cannot be modified later To modify an existing procedure a copy i
73. ner of the graph Note The indicated millivolt response is dependent upon the Calibration Data entered in the current Hardware Settings menu If the current Calibration Data is not representative of the current sensor being used erroneous values will be shown 2 To zoom in on a portion of the graph drag and drop the mouse across that portion of the graph while holding the left mouse button The range of particle sizes displayed on the full graph is set by the calibration limits of the sensor The user can view the plotting for differential counts if the user selects the radio button Differential Counts per mL User Guide 94 of 136 User Guide 9703 Only Pulse Height Analyzer PharmSpec 2 4 E 3 a 3 o o o KG E E D 48000 0 43220 1 38440 2 33660 3 28880 4 24100 5 19320 6 14540 7 9760 8 4930 9 201 0 8 0 20 0 26 0 Particle Sizes Microns ZO0M Out Fig 12 1 PHA for Cumulative Counts per mL HIAC KSS March 2006 Edition 3 KSS March 2006 Edition 3 PharmSpec 2 9703 Only Pulse Height Analyzer 95 of 136 You can view the plot for cumulative counts if you select the radio button corresponding to Cumulative Counts per mL 48000 0 432201 38440 2 336603 28880 4 24100 5 19320 6 145407 9760 8 4980 9 201 0 8 0 y 20 0 26 0 Cumulative C ounts Per mL Particle Sizes Microns Size um 20 55 Differential Counts per mL Linear i C Log Mil
74. nimum number of characters for the password This menu option is available for all users During first login this dialog is automatically displayed if this feature is set by the administrator and in such cases the user cannot proceed without changing the password This dialog also invokes on expiry of the password c Logout The user can logout from the system by choosing User gt Logout A confirmation message is displayed prompting the user to confirm logging out action CT x Are you sure you want to logout Fig 4 5 Logout Confirmation Dialog You can log out of the system by clicking on the OK button or cancel the logout by clicking on the Cancel button You may not be allowed to logout while running a test You can log out only after you have completed the running of the current test If you attempt to log out without saving the test run details a confirmation message is displayed prompting you to save the unsaved changes if any User Guide 38 of 136 Getting Started PharmSpec 2 It is possible for a different user to log in after you have logged off d Exit You can exit the application by choosing User gt Exit This invokes a confirmation to the user ox 2 Are you sure you want to exit PharmSpec OK NE Fig 4 6 Exit Confirmation Dialog On clicking on the OK button of this confirmation dialog the current user is logged out and you exit the application Exit menu is not enabled if a
75. o the system modify existing sensor data or remove a sensor from the inventory There is an additional option to import sensor data from a file so that the user need not enter the data manually While configuring the current test setup user has to choose a sensor from the sensor inventory To add modify remove a sensor click the Sensor button in the Hardware Settings dialog This invokes the Add Sensor dialog HIAC User Guide 52 of 136 User Guide System Configuration PharmSpec 2 Add Sensor xi Import From Add Modify Remove Import EA Sensor Details Type Liquid y Model Calibration Mode Single z Serial No Calibration Date 2003 01 23 y View Volume EE 01 v Nominal Flow Rate Calibration Due 2003 01 23 mL Min m Concentration Limit Calibration Data Cal Size my Size my A OS EE Pr TT Tr g A LL A OS EE EE S LL A Pr TT Fig 6 4 Add Sensor Dialog HIAC KSS March 2006 Edition 3 PharmSpec 2 System Configuration HIAC 53 of 136 The user can perform any one of the following operations Add a Sensor Modify Sensor Data Import Sensor Data Remove Sensor User can add a new sensor to the system User has to check the radio button corresponding to Add User has to specify all the details including type model and serial number in this case All controls on the dialog will be enabled in this case User can modif
76. odel HRLD 150 Field2 ID2 Sensor Serial Number 93120452 Field3 ID3 Operator Name Field4 ID4 Sample Date 2002 11 14 02 44 33 PM Field ID5 Field ID6 10 pra Lower Limit 3250 10 pra Upper Limit 4250 Lower Ratio 15 Upper Ratio 135 Sample Volume mL 5 Run No Particle Size pra Cumulative Count Run 1 10 110 15 10 Run 2 10 410 15 10 Run 3 10 510 15 10 Average 10 460 15 10 Export Close Help Fig 9 4 Previous Version Report Dialog You can print the generated report by clicking on the Print button You can also export it to EXCEL or any CSV format by clicking on the Export button In case of exporting to CSV format you have to specify the separator delimiter HIAC User Guide 78 of 136 User Guide Generating Historical Data Reports PharmSpec 2 HIAC KSS March 2006 Edition 3 PharmSpec 2 Data Backup Archival 79 of 136 10 Data Backup Archival a Data Storage The Data Storage Menu contains menu options for data reconstruction The Backup and Archive menu options facilitate this b Backup It is possible to take a backup of the current system data You can configure the details for the backup For this click the Setup gt Data Storage gt Backup menu On doing so the Backup Configuration dialog is displayed Backup Configuration E x Backup Drive amp Local Disk C y C PharmBackup Backup Select Backup Mode Full Quick Schedule Backup Now Cl
77. ort Close Help Fig 8 1 View Activity Logs Dialog The user can retrieve information stored in the logs based on a given criteria The criteria could be one among the following Range From To of DATE and TIME e User name All specific user name e Type of activity or action All specific activity HIAC User Guide 72 of 136 User Guide View the Audit Trail Activity Log PharmSpec 2 The user can specify the criteria and view the logs based on the criteria The Activity selection window lists following activities All System Lockout Password Change Database Archive Backup Database Corrupted Run started completed stopped Test Result Review Approve User Login Logout Shutdown Automatic Lockout Logout Configuration Change Procedure Created Loaded Run Counter System Date Modified On clicking the Apply button the reports for the specified criteria are displayed The activities are displayed in the reverse chronological order of date It is possible to export the output to common formats such as EXCEL or WORD or CSV by clicking on the Export button In case of exporting to CSV format you have to specify the separator delimiter You can print the log by clicking on the Print button HIAC KSS March 2006 Edition 3 PharmSpec 2 Generating Historical Data Reports 73 of 136 9 Generating Historical Data Reports 9 1 Historical Reports The user can generate view prin
78. ose Help Fig 10 1 Backup Configuration Dialog Here you can select the location to which the backup has to be taken You can opt for complete FULL backup or differential QUICK backup by clicking on the radio button Full or Quick The Quick selection will cause a backup of only the data that has been added since the previous backup occurred A Full backup will cause a complete copy of the current database to occur After selecting the backup mode you can initiate the backup action by clicking on the Backup Now button You can also schedule the backup activity so that the backup is taken automatically at scheduled intervals To configure the backup frequency daily weekly every week days time etc click the Schedule button On clicking this button the Schedule Backup dialog is displayed HIAC User Guide 80 of 136 Data Backup Archival PharmSpec 2 Schedule Backup 3 xj C Weekly Monthly Daily Frequency Occurs once at 12 00 00 PM Occurs every fi Minutets Fig 10 2 Schedule Backup Dialog Click the OK button to save the details c Archive Archiving data makes the database smaller Once data has been archived it cannot be merged back into the PharmSpec without losing the current data Only archive data that is no longer needed You can archive the data in the system to a selected folder Click the Setup gt Data Storage gt Archive menu to acc
79. ou can enter the approval comments and then press the Approve button As in the case of review the user authentication dialog will pop up prompting you enter your password Review Approve Comments E x Fig 7 5 Review Approve Comments Dialog The user can also print the result by clicking on the Print button 7 2 Run Counter You can run the Run Counter Test by choosing Sample Tests gt Run Counter You can also run this test by pressing the F9 key on the keyboard Setup details for the Run Counter Test are set from the Hardware Settings dialog Operating parameters Once all the Setup procedures are completed the user can run the Run Counter test and collect the data This is a non procedural test default test without any Pass Fail checking that uses only the Operating Parameter values Clicking on Run Counter menu invokes the Sample Identification dialog User Guide HIAC J6 Edition 3 KSS March PharmSpec 2 Running Sample Tests and Reviewing Results 67 of 136 Edition 3 KSS March 2006 HIAC Sample Identification E x Lot ID Lot 123 Batch ID 81 tch123 Sample ID lt 3 gt Samp 23 Cancel Help Fig 7 6 Sample Identification Dialog Sample Identification dialog displays the sampled identifiers configured for the Run Counter Test You have to enter the values for these sample identifiers for example the values for the Lot ID Batch ID etc and then click
80. ounter and Sampler but only one each of these components will be used in a test setup at any given time In addition to this the COM port of the computer to which the hardware unit is connected and the Baud rate need to be set The Configure Current Test Setup group allows the user to configure all these Communication The user can select the port and baud rate required for communicating with the HIAC 9703 or 9705 The available options for Port number are COM1 COM2 COM3 and COM4 are 9705 the COM port is set to USB and the baud rate cannot be selected Sensor The user can select the model and serial number of the sensor used in the current test set up Counter The user can select the model and serial number of the counter used in the current test set up Sampler The user can select the model and serial number of the sampler used in the current test set up Simulator There is a check box named Simulator The user selects this to run the system in simulation mode This invokes a confirmation message prompting the user to confirm the change to simulator mode x Do you want to set simulation mode Fig 6 2 Simulator Mode Confirmation Dialog The user can select the simulator mode by clicking the OK button on this confirmation message All the other controls in the Configure Current Test Set Up are disabled in this case In simulation mode the application will not communicate with the hardware User Guide HIAC KSS Ma
81. p Version Abort Stop 3 5 Report Type Note Load Syringe moves the syringe plunger to its maximum extension to allow removal of the syringe This command causes the sample to be drawn into the sampler in order to eliminate air and to ensure that the sample is present in the sensor when counting commences This command reverses the sample flow through the 9703 9705 system to provide a way of clearing sensor blockages This command raises the sensor arm to allow removal and or interchange of sample bottles 9703 only This command retrieves the version of the firmware and the model of sampler This command cancels the above operations This functionality is disabled for PharmSpec 2 1 All reports appear in English You can select the language of reports For this choose Set Up gt Report Type On selecting this option the Report Type dialog is displayed User Guide HIAC dition 3 March 2006 E KSS HIAC PharmSpec 2 System Configuration 31 of 136 Report Type E x Report Settings Local Language International C English Only Cancel Help Fig 3 17 Report Type Dialog To view the reports in the local language select the Local language option On doing so the reports are displayed in the local language the language selection is made at the time of installation Note In PharmSpec version 2 0 only English is supported Local Language support will be
82. plate Preview Dialog click the Next gt gt button to go to the next step Click the Cancel button to close the dialog Click the Help button to get the help HIAC Edition 3 KSS March 2006 Edition 3 KSS March 2006 HIAC PharmSpec 2 Procedure Builder 115 of 136 e Step 5 Save Report Template In this step you can specify the name for the configured report template and save it Wizard Step 5 Save Report Template Report Template Name EP EVT APT 4 3 Finish Print Help lt lt Previous Fig 14 19 Save Report Template Dialog click the Previous button to go to the previous step You can enter the name for the report template in the edit box and then click the Finish button to save the report template While saving the template if the user specified report template name already exists in the system the following message will be shown User Guide 116 of 136 User Guide Procedure Builder PharmSpec 2 Fig 14 20 Save Report Template Error Message On successful save operation a confirmation message will be shown HIAC KSS March 2006 Edition 3 PharmSpec 2 Database Restorer 117 of 136 15 Database Restorer HIAC This utility is used to restore the data from the backup or archived iles You can start this tool using Start gt Programs gt PharmSpec 2 1 gt Database Restorer Before starting this utility ple
83. prove dialog User Guide HIAC KSS March 2006 Edition 3 PharmSpec 2 Running Sample Tests and Reviewing Results 69 of 136 x Select Test Result Result Details Standardization ElectronicResolution Sensor Model Simulation Standardization ElectronicResolution 2003 01 23 12 04 26 Sensor SerialNo Simulation Operator Name Administrator Standardization ElectronicResolution 2003 01 23 12 04 36 Sample Date 2003 01 23 12 02 39 PM Standardization ElectronicResolution 2003 01 23 12 04 44 Standardization FlowRate Standardization FlowRate 2003 01 23 12 03 51 Standardization JPCounting ccuracy Standardization JPCounting ccuracy 2003 01 23 12 02 39 Standardization JPCounting ccuracy 2003 01 23 12 02 46 Standardization JPCounting ccuracy 2003 01 23 12 02 56 Standardization JPCounting ccuracy 2003 01 23 12 02 59 E Standardization VWolume amp ccuracy Standardization Volume ccuracy 2003 01 23 12 03 15 Standardization Wolume ccuracy 2003 01 23 12 03 32 Standardization Volume ccuracy 2003 01 23 12 15 49 Standardization Wolume ccuracy 2003 01 23 12 16 10 Sample Volume ml 5 Run Details Run No Part Size pm Cumulative Count Cumulative Counts mL 1 5 414 82 8 Standardization JPCounting ccuracy FAILED Review Details Reviewer 1 Administrator Review comment of Administrator Reviewed Enter Comments Do not use these characters and Approve Close Help
84. ptions are Change the password on the next login If this option is set the user must change the password on next login Change password dialog invokes at user login Account Never Expires If it is not set then the user becomes an inactive user after the specified date The expiry date will show the current date by default Administrator then assigns the privileges to the user by clicking on the User Rights button in the Add User dialog This invokes the User Rights dialog This dialog is based on the user type selected in the previous screen as the User Role selection window If the user is an Operator then the user rights dialog displayed is as follows User Guide 42 of 136 User Guide User Administration PharmSpec 2 Rights of Operator E x User Rights Options Select Rights Default Rights View Profile Review Reports View or Print Reports Selected Rights Fig 5 3 Operator User Rights Dialog An Operator has the privilege to View profile View or print reports along with certain additional privileges The Administrator can assign the privileges to a user The privileges available for an Operator are Run Tests and Review Reports If the user is a Supervisor then the user rights dialog screen displayed would be as follows HIAC KSS March 2006 Edition 3 KSS March 2006 Edition 3 PharmSpec 2 User Administration 43 of 136 HIAC Rights of Supervisor xj User Rights Options Select Righ
85. r expiry the user will get an alert in advance and the parameter Account Expiring Alert represents this period Once a user account is expired the account will be disabled and the user cannot log into the system On receiving the alert the user can contact the administrator and initiate actions to extend the validity of the account if required The level of security HIGH or LOW selected during installation is displayed in the System Settings dialog but cannot be changed once it is initially set in the Installation process User Guide 48 of 136 User Guide User Administration PharmSpec 2 HIAC KSS March 2006 Edition 3 dition 3 PharmSpec 2 System Configuration 49 of 136 6 System Configuration 6 1 Hardware Settings Hardware Settings You have to set up the hardware and the operating parameters before starting to use the system with the 9703 or 9705 sampler Otherwise the software can be used only in the Simulation Demo mode You have to configure the system during initial set up or whenever there is a change in the hardware components or the operating parameters used You can set up the hardware by selecting Setup gt Hardware Settings This invokes the Hardware Settings dialog This menu is enabled only for a user who has the required privilege to do this xl M Configure Current Test Setup Add Modify Remove I Simulation Sensor Comm
86. rameters for a test are sample volume and the number of runs The right side of the screen consists of the report area for the test The results of the test are displayed here The result data displayed can vary procedure to procedure The test outcome PASS or FAIL will be displayed at the bottom after completion of all test runs The lower part of the screen has buttons the operator could use to access help files print the results run stop the test review approve result queue or save the result and close the dialog USP 26 Environment Description Parameters Sample Volume mL No Of Runs Result pecs 50mL eat en iia ean Resut size Cumulative Count glassware Agitate Degas for seconds Agitate again Enter sample Run Num 1 10 159800 0 volume below 25 27600 0 Run Num 2 10 209400 209400 25 74600 74600 Run Num 3 10 162200 371600 50 25 26600 101200 TEST FAILED WITH USP 26 Environment Review Approve Save Only Queue Print Close Help Fig 7 2 Run Test Dialog 4 You have to click the Run Test button to run the test The test result is displayed after User Guide running the tests The caption on the Run Test button changes to Stop Test while the HIAC dition 3 KSS March 2006 E PharmSpec 2 Running Sample Tests and Reviewing Results 65 of 136 test is running You can stop the test run by clicking on the
87. rch 2006 Edition 3 PharmSpec 2 System Configuration 51 of 136 Hardware Settings a x Configure Current Test Setup Add Modify Remove IV Simulation Sensor Communication Sensor Counter Sampler Part COM1 v Model HALD400CE gt Model 9703 z Model pa 3 7 courier Baud Rate 18200 Le Serial No Fos2n Le Serial No Fose7 Le Serial No G78TY Le Sampler Geneon ate Sampler Data Current Setup Print Setup PHA o Min 4 Type Liquid Model HALD 400CE Syringe Size io mL I Auto Print On XMax 77 Calibration Mode Single Serial No fos211 Operating Parameters Calibration Date 2000 06 26 Calibration Due 2003 12 12 Modify Field Names gt i jo Parameters View Volume 85 sie Pow 60 i Sample Volume mL 5 Channel Size um aus 7 70 imit E m Calibration Data heinu 2 Dilution Factor fi Tare Volume ml fi Multi stroke Tare mL jo IT Discard First Run IT Show this screen at the beginning of each test Print Fig 6 3 Simulator Selection b Add Modify Remove Sensor Counter Sampler The user can add new hardware components sensor counter and sampler to the existing inventory or modify the parameters of the existing ones The user can also remove a hardware component from the inventory Sensor The user can add new sensors t
88. s Wiew or Print Reports Review Reports Setup Test System Approve Reports Define Test Procedure Selected Rights Help Fig 5 6 Administrator User Rights Dialog 45 of 136 An Administrator has all the privileges of the Operator Calibration Technician and Supervisor To set the Rights for a user select the required right from the Select Rights list and click the gt button The selected right will now be listed under Selected Rights To remove a Right select the required Right from the Selected Rights and click the lt button After assigning all required Rights click the OK button of the User Rights dialog The new or modified User is added to the system on clicking the OK button of the Add a New User Dialog b Modify User The user details can be modified later if required The Administrator can modify the user details by clicking on the Modify User button This invokes the Modify User Details dialog The Password and Confirm Password dialogs contain a predefined number of asterisks This is not the same as the number of characters in the password of that user HIAC User Guide 46 of 136 User Administration PharmSpec 2 i Modify User Details of Jerry Thompson Fig 5 7 Modify User Details Dialog You cannot modify the User ID Administrator can set or reset the user rights for the user by clicking on the User Rights button The User Rights dialog is displayed with the current priv
89. s created Changes are made to the copy and the modified copy is stored under a new name There are 4 options on the main menu Procedure To load or create a test procedure Report To load or create a report template Help Online Help Exit To exit the Procedure Builder application 14 1 Load Create Test Procedure User Guide From this dialog you can create a new test procedure or Load an existing test procedure copy it modify the copy and then save it under another name Click the Cancel button to close the dialog HIAC 6 Edition 3 KSS March PharmSpec 2 Procedure Builder 101 of 136 Create a new procedure 22 xj Mode Create C Load Select Procedure EZ Cancel Help Print Fig 14 3 Create New Procedure Dialog a Create To create a new test procedure select the Create option radio button and click the OK button This will take you to Step 1 of the Procedure Builder steps b Load This option can be used if you want to make some minor user defined variant of an existing test procedure or to view the details of an existing test procedure For this select the Load option radio button Now the Select Procedure selection window box will be enabled and you can select the required procedure from the list Click the OK button after selecting the required test procedure This will take you to Step 1 of the Procedure Builder steps 14 2 Proce
90. sed for creating the PharmSpec Database Note A complete installation of the main application NET environment and MSDE support may take up to 15 minutes to complete The Wizard then takes you through a series of installation screens and in each of these you have to proceed by clicking on the Next button PharmSpec 2 consists of the main PharmSpec user application and add on applications like Procedure Loader Database Restoration Module etc The user can configure PharmSpec 2 during the installation set up The following pre requisites have to be specified at the time of installation Language selection You can select a language of your choice during installation This language is used in PharmSpec 2 for all controls This cannot be reset later In this release only English is available Date and Time format The user can configure the format for displaying date and time This format is used for displaying all date and time fields in PharmSpec 2 The date time format cannot be reset later Security Level The user can select the level of security This controls how the system will operate in response to an attempt to reset the system after a System Lock out has occurred due to an invalid access attempt There are 2 levels of security HIGH and LOW When the system has been installed with HIGH security then only someone with Administrator rights can restart the software before the end of the LOCKOUT TIME period If the s
91. some like sample volume need to be collected when the operator runs the test 2 User Guide HIAC KSS March 2006 Edition 3 PharmSpec 2 Procedure Builder 103 of 136 Configure the values for the Minimum limit Default value Maximum Limit and the mode The mode shall be Read Only Read Write or Invisible Read Only mode means the value cannot be modified while running the test but the value will be displayed in the screen Read Write means the value will be displayed in the screen and also can be modified while running the test e Invisible mode is used to configure internal parameters which are not required to be visible while running the test The check box Discard First Run can be checked if the results of the first run of the test should not be included in the calculations If this option is selected the data from the first run will be displayed and saved but will not be used in any of the following calculations such as computing averages etc Wizard Step 2 Computation and Parameter Settings Select Computation Methods Secondary Computation Primary Computation I Discard First Run Cumulative Count Summation Parameter Inputs Computation Parameters Sample Volume mL 5 Read Only No Of Runs 5 5 Read Only lt lt Previous Finish Print Cancel Help Fig 14 5 Computation and Parameter Setting Dialog HIAC
92. t e Tare volume a volume drawn preceding the SAMPLE volume It occurs on the first stroke of a given run This is to remove any fluids from a previous run or bubbles etc if the tubing is empty and to ensure that the sample data obtained is only from the fluid from the container currently in place on the 9703 or 9705 e Multi stroke tare drawn to bring the fluid up to speed Channel PharmSpec supports up to 16 size channels User can also specify following conditions e Discard first run If this option is selected for the Run Counter Test the test results of the first run will be ignored in the computations but will still be displayed and stored Show this screen at the beginning of each test If this option is selected while running the Run Counter Test the Operating Parameters dialog will be displayed at the beginning of the test This is intended to provide information to the operator before running a test enabling the operator to confirm that these settings are correct for the test they are about to run HIAC User Guide 28 of 136 System Configuration PharmSpec 2 You can configure the sample identifiers Sample IDs for the Run Counter Test by clicking on the Sample ID button in the Hardware Settings dialog This invokes the Configure Sample ID dialog which allows the user to enter the sample ID values Configure Sample ID 3 x No of fields le Field Name 1 koa Field Name 2 Sampe Field Name 3 Poo Field Name 4 o
93. t the reports for the tests run in the past in a pre defined format For this choose Reports gt Historical Reports This invokes the Historical Reports dialog Historical Reports E x Test Details 7 Test USP Test Procedure 26 Environment h m Options Starting Date 20030123 x SampleID None y Ending Date 2003 01 23 y Dperator fan y 2003 01 23 12 22 49 PM Administrator Fig 9 1 Historical Reports Dialog The user has to first select the type of test USP EP JP KP User Defined Run Counter Standardization from the Test selection window Test procedures for the selected test type are then listed in Test Procedure selection window The user then selects a test procedure from the Test Procedure selection window and then further filters the list using the keys Starting Date amp Ending Date Operator Name and Sample ID After selecting the filtering options the user has to click the Apply button This action filters the test results as per the given criteria and displays HIAC User Guide 74 of 136 User Guide Generating Historical Data Reports PharmSpec 2 the filtered list in the reverse chronological order of date This filtered list contains the Date Time information and the Operator name Finally selecting one of the reports from the list displays the test report by a click the View button or a double click the selected report item and it can be printed i
94. t Sensor Dialog The sensor data consists of following parameters When you add a new sensor you need to define all these parameters In the Modify mode it allows you to modify most of these parameters except the model and the serial number Type of the sensor Liquid Air e Model of the sensor Enter the model number or select one from the list e Calibration mode Note Only liquid sensors are supported at this time The Sensor Calibration mode could be either single or dual In case of Dual mode there are two sets of calibration data to be entered Cal 1 and Cal 2 The second set is disabled in case of the single mode sensors Note Dual mode is not supported at this time Serial number of the sensor Date of calibration Expiration date for the calibration e View Volume Nominal Flow Rate e Concentration Limit User shall enter the particle sizes for the calibration and the millivolt values for the size There must be a minimum of four sizes and millivolt values The user can then save the details by clicking on the Save button User Guide 22 of 136 System Configuration PharmSpec 2 Import From Add Modify Remove Import E Sensor Details Type liquid z Model haoso F Calibration Mode Singe gt Serial No roen y Calibration Date 2000 06 26 View Volume m Calibration Due 20031212 pleie fom In Concentration Limit 35 00 Conf
95. te derivative works from the software This License plus the original invoice for the software comprise the proof of license to exercise the rights granted herein and both must be retained by you You may not rent or lease the software but you may transfer your rights under this License on a permanent basis provided you transfer this License the original invoice the software and all accompanying printed materials retain no copies and the recipient agrees to the terms of this License If you later receive an Update to this software or if this software is an Update to a prior version any transfer must include both the update and all prior versions of the software U S Government Restricted Rights The SOFTWARE and documentation are provided with RESTRICTED RIGHTS Use duplication or disclosure by the Government is subject to restrictions as set forth in subparagraph c 1 ii of the Rights in Technical Data and Computer Software clause at DFARS 252 227 7013 or subparagraphs c 1 and 2 of the Commercial Computer Software Restricted Rights at 48 CFR 52 227 19 as applicable Manufacturer is Hach Ultra Analytics 481 California Ave Grants Pass OR 97526 Export Restrictions The software may be subject to the export controls of the United States Departments of State and Commerce You must fully comply with all applicable U S export regulations governing export destination ultimate end user and other restrictions relating to the software
96. ter or Right from the Alignment selection window To configure the Font for the title click the Font button To configure the color click the Color button If the Font and the Color properties are not configured it will use the default values sample text will be displayed for previewing the font and color properties HIAC User Guide 112 of 136 Procedure Builder PharmSpec 2 click the Next gt gt button to go to the next step Click the Cancel button to close the dialog Click the Help button to get the help b Step 2 Configure Fields In this step you can configure the headers for the data to be shown in the report The color and font properties of the headers are also set here Wizard Step 2 Configure Headers Header 1 Cumulative Count y Number of Head id z Header 2 Summation y Alignment Center y Font Color Sample Sample lt lt Previous Finish Print Cancel Help Fig 14 16 Field Configuration Dialog Header represents the result data that is displayed for each test run To configure the headers first enter the number of headers required According to the number of headers the header selection boxes will appear Select the header names from these boxes For example it could be Size Cumulative count or particles mL The user can configure up to a maximum of 8 fields The user can choose the alignment option Left Center or Right for the headers from
97. test is currently running User Guide HIAC KSS March 2006 Edition 3 KSS March 2006 Edition 3 PharmSpec 2 User Administration 39 of 136 5 User Administration 5 1 Administration HIAC Administrator manages the user and the system settings new user is added or the details of an existing user can be modified The Administrator also sets the system parameters To do this choose Set Up gt Administration This invokes the Administration dialog Only an administrator can access this menu and this option is disabled for all other users CalTech Default Technician Add User Modify User System Settings Help Fig 5 1 Administration Dialog The Administration dialog lists all the available users The users listed depend on the user type selected User type can be selected from the View Users combo selection box The user list can be filtered using the following three options All users Active users Inactive users User Guide 40 of 136 User Administration PharmSpec 2 5 2 User Levels The users operating the system are organized into the four groups or levels shown in Table 5 1 When new users are added to the system they only receive the default priviledges of their role unless the Administrator specifically grants them additional privileges Users can view their role privileges and the name of the administrator responsible from the View Profile menu option
98. the Alignment selection window This will placed the header at the selected position at the top of the related column p User Guide HIAC PharmSpec 2 Procedure Builder 113 of 136 To configure the Font for the headers click the Font button To configure the color click the Color button If the font and the color properties are not configured it will use the default values sample text will be displayed for previewing the font and color properties click the Next gt gt button to go to the next step Click the Cancel button to close the dialog Click the Help button to get the help c Step 3 Configure Test Parameters and Result Here you can specify the font and color properties for the parameters such as sample identifiers sample volume etc and the Result data Test parameters are the parameters displayed at the top of the report These include the sample ids the user who has run the test sampler model sensor serial sample date total number of runs or sample volume The user can specify the alignment left right or center and the font properties Font details include the font style size color and the attributes of the font bold italic etc Test result is the result obtained after running the test The user can specify the alignment of the result value in each column left right or center and the font properties Font details include the font style size color and the attributes of the font bold ita
99. the report area for the test The results of the test are displayed here The result data displayed can vary procedure to procedure The lower part of the screen has buttons the operator could use to access help files print the results run stop the test Review Approve result Queue or save the result and close the dialog You have to click the Run Test or Continue Test button to run the test The test result is displayed on completion of the test The caption on the Run Test button changes to Stop Test while running the test You can stop abort the test by clicking on the Stop Test button After running the test the operator can perform any one of the following actions Save Only This option is used either for informal tests you do not want to review approve these tests or when you want to put signatures on the hard copy printout of the test report In this case the operator can just save the results For this click the Save Only button Queue The user queues the result for the purpose of reviewing and approving it later For this click the Queue button User Guide 84 of 136 Running Instrument Standardization Tests PharmSpec 2 Review If the user has the appropriate privileges he she may review and Approve approve the results after running the test To do this click the Review Approve button On doing so the Review Approve Comments dialog is displayed In the Review Approve Comments dialog you can ent
100. trument Standardization Tests 85 of 136 This test is designed to ensure that the sampler volume is accurate to within a 5 range of the desired volume 11 2 Flow Rate The user can run the Flow Rate Test by selecting Standardization FlowRate from IST Standards selection window and then clicking the Sample Test gt Run IST menu This will pop up the Flow Rate dialog Standardization FlowRate Test Description Tr Enter Measured elapsed time taken for second run Size E Observed Flow Rate mL Min Press Run Test 0 000 60 00 0 000 60 00 0 000 60 00 Parameters Second Measured Time Sec TEST PASSED WITH Standardization_FlowRate e Save Only Queue Print Re emote lose Help Fig 11 2 Flow Rate Dialog This test requires the use of a certified chronometer or stopwatch to determine the beginning and end points of the counting process The user will need to time the process and record the data from two successive runs The resulting values are averaged to determine the flowrate of the system dition 3 2006 E March KSS HIAC User Guide 86 of 136 Running Instrument Standardization Tests PharmSpec 2 11 3 Moving Window The user can run the Moving Window Test by selecting Standardization MovingWindow from IST Standards selection window and then clicking the Sample Test gt Run IST menu This invokes the Sample Identification dialog to enter the information about the challenge particles used for t
101. ts Default Rights Setup Test System Approve Reports Define Test Procedure View Print Activity Logs Review Reports Load Create Procedures Disable Obsolete Procedures Selected Rights Fig 5 4 Supervisor User Rights Dialog The Supervisor has all the privileges of an Operator The Administrator can set some additional privileges to the supervisor If the user is a Calibration Technician then the user rights dialog displayed would be as follows User Guide 44 of 136 User Guide User Administration PharmSpec 2 Rights of Calibration Technician User Rights Options Select Rights Default Rights View Profile Run Tests View or Print Reports Review Reports Selected Rights Setup Test System Run Instrument Standardization T E El Cancel Help Fig 5 5 Calibration Technician User Rights Dialog The Calibration Technician is a type of user who will perform Instrument Standardization Tests This person will be either a person from Hach Ultra Analytics or a person trained by Hach Ultra Analytics If the user is an Administrator then the user rights dialog displayed would be as follows HIAC KSS March 2006 Edition 3 2006 Ed March KSS PharmSpec 2 User Administration Rights of Administrator E Xl User Rights Options Select Rights Run Instrument Standardization T Administration Setup Backup Archive Default Rights Wiew Profile Run Test
102. ument Standardization Tests 87 of 136 Standardization SensorResolution Test Description Result Input the data found on the sample bottle Use Res CE CE either std dev or coefficient of variation Parameters Mean Particle Size 1 000 Coeff Of Variance 0 000 Standard Deviation 0 000 Review Approve Save Only Queue Print Run Test Close Help Fig 11 4 Sensor Resolution Dialog 11 5 Electronic Resolution The user can run the Electronic Resolution Test by selecting Standardization ElectronicResolution from the IST Standards selection window and then clicking the Sample Test gt Run IST menu This pops up the Sample Identification dialog to enter the information about the challenge particles used for the test This information is then stored with the test results and printed out on request This enables the PharmSpec system to provide a paperless history of the calibration work that has been performed on the system HIAC User Guide 88 of 136 User Guide Running Instrument Standardization Tests PharmSpec 2 Sample Identification Continue Fig 11 5 Sample Identification Dialog You can enter the sample IDs and then click the Continue button This will pop up the Electronic Resolution dialog HIAC KSS March 2006 Edition 3 KSS March 2006 Edition 3 PharmSpec 2 Running Instrument Standardiz
103. unication Sensor Counter Sampler Port COM1 Model HALDADOCE Model 9703 v Model EC Counter Baud Rate 18200 y Serial No F06211 v Serial No Fose7 y Serial No G7ety y Br Ceres Sampler Data Current Setup Print Setup PHA gt A XMin 4 Type Liquid Model HALD 400CE Syringe Size fig mL I Auto Print On XMax 77 Calibration Mode Single Serial No Fo6211 Operating Parameters Calibration Date 2000 06 26 Calibration Due 2003 12 12 Modify Field Names 3 i Parameters View Volume 2 85 Roe AL AM feo i Sample Volume mL 5 Channel Size um porn 35 7 10 imit fa m Calibration Data En E 35 Dilution Factor Fr Tare Volume mL fr Multi stroke Tare mL jor IT Discard First Run his screen at the beginning of HIAC Cancel Print Help Fig 6 1 Hardware Settings Dialog This dialog is organized into multiple sections Each section is explained below To setup a new system the first step is to configure or Add Sensor s Counter s and the Sampler s The next step is to define the current setup components by selecting the Sensor Counter and the Sampler used in the system and the communication parameters such as the Port number and the Baud rate Then you need to set the Operating Parameters User Guide 50 of 136 System Configuration PharmSpec 2 a Configure Current Test Set up A user can have an inventory of more than one Sensor C
104. valid the Procedure Loader dialog will appear on the screen that will list the procedure updates which are licensed to the user The Master Procedure s list contains the licensed procedure updates HIAC User Guide 122 of 136 User Guide Procedure Loader PharmSpec 2 Procedure Loader x Master Procedure s List Selected Procedure s List E Upload Kea Close Procedure Fig 16 5 Procedure Selection Dialog Select the required procedures one by one from this list selected procedure will be highlighted and click the gt button so that it is moved to the Selected Procedure s List From Selected procedure list a procedure can be moved back to the Master procedures list by selecting it and clicking on the lt button Once the all required procedures are moved to the Selected procedures List user has to click the Upload Procedure button to upload the procedure updates to the PharmSpec database On successful uploading of the procedure updates a confirmation message will be shown Click the Close button to close this message box click the Close button from main dialog to exit from the Procedure Loader application HIAC Edition 3 2006 KSS Marct KSS March 2006 Edition 3 PharmSpec 2 PharmSpec Admin Tool 123 of 136 17 PharmSpec Admin Tool The PharmSpec Admin tool is used to reset the PharmSpec system configuration This application is not installed in your system during PharmSpec inst
105. y the parameters Calibration data in most cases of an existing sensor For this user has to select the radio button corresponding to Modify The user has to first select the Model and then the Serial No of the sensor and then modify the details User will not be allowed to modify the type model and serial number Instead of adding a new sensor using the Add option and by entering the sensor data the user can import sensor data from a file For this the sensor data should be available in a predefined format in a file This sensor details file shall have an extension sen To import the sensor data select the radio button corresponding to import following which the Import From control is enabled The user is then allowed to select the path and file from which the user has to import the sensor An Open File dialog is displayed from which the user can select the path and file User can import it and modify the details if required excluding type model and serial number You can remove a sensor from the system The currently selected sensor is deleted by clicking on the Remove button The caption of the Save when the Remove radio button is selected User Guide 54 of 136 User Guide System Configuration PharmSpec 2 Modify Sensor xi Import From C Add amp Modify Remove Import EA Sensor Details Type Liquid Z Model HRLD400CE Calibration Mode Singe gt Serial No roen y
106. ystem was installed with HIGH security then any valid user other than the USER ID that caused the LOCKOUT will be able to access the software with a proper login Note The installation program automatically creates a PharmSpec program group and a shortcut on your Windows desktop HIAC PharmSpec 2 Setting up the System 13 of 136 2 Setting up the System HIAC Once you have installed the PharmSpec software you need to configure the system for use with your equipment This configuration includes providing information concerning channel settings sensor calibration and run parameters as well as information on your specific hardware configuration PharmSpec acquires data according to the setup parameters that you specify and will save this data in database Data analysis will be based on the particle distribution and on the pass fail classifications of the test procedures The following chapters will guide you through the system configuration and the user administration steps Note Before starting the software verify the following settings in the Windows Operating System OS Display Settings are set for Small Fonts 46 97 oy Decimal Separator typically either the decimal or comma character is set correctly for your use User Guide 14 0f 136 User Guide Setting up the System PharmSpec 2 HIAC KSS March 2006 Edition 3 Edition 3 PharmSpec 2 System Configuration 15 of 136

PharmSpec 2.1 Software User Guide

Contents

Download Pdf Manuals

Related Search

Related Contents