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Varian 400-DS Op Man 70-9051 Rev A
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1. FIGURE 12 Browse Dissolution Servers screen Jissolution Servers amp SHELDON SHIPPING1 SHIPPING2 SLADEC SMOORE SMOUTHON SOFTENG2 SNFTFNG WIN K v cnc Step 4 The default server port is 8787 but may be changed to any other port Coordinate the selection of a port number with your I T department to satisfy any port restriction requirements they may have Varian Inc Revision A 05 07 Varian 400 DS Automated Apparatus 7 Page 43 P N 70 9051 Operator s Manual Installation and Setup Step 5 Click OK Step 6 Click Logon on the Logon screen Step 7 After successfully logging onto the software click Tools gt Options The Configuration Dialog screen displays see Figure 13 Configuration Dialog screen on page 43 Configuring the Application Adding Users Note aE In order to configure the application it is necessary to be logged on as an administrator FIGURE 13 Configuration Dialog screen Configuration Dialog User secunty is enabled by adding users to the following user groups Group l Description S amp VkDisscAuthorizer Allows the user to sign final acceptance of the results BS VkDissoRunMetho Allows the user to run any method on any system BA ViDissoDiagnostics Allows the uses to change system configuration settings or to add new s B VkDissoSystemCo Allows the user to run diagnostic utiities on configured system S
2. Permissions Use this option to view permissions assigned to the current user and the descriptions of the corresponding privileges Click Permissions The User Group Membership screen displays Status Click one of the pie shaped graphics under status to view the status of the corresponding dissolution system Varian Inc Page 50 Varian 400 DS Automated Apparatus 7 Revision A 05 07 Operation Operator s Manual P N 70 9051 Configuring Your System It is necessary to configure the components that will be used for automated sample collection Systems can be added modified and removed from the database All system configuration activity is recorded in the system audit log The dissolution software allows the configuration of multiple systems A maximum of four systems can be running methods at one time System configuration entails selecting the appropriate equipment and setting the communication and other physical properties of the system Serial numbers are stored for each system to allow tracking of physical system changes Step 1 From the navigation bar click Configuration The System Configuration screen displays FIGURE 18 System Configuration screen System Configuration T Module Ver t Module Desc Laboratory Time Step 2 Click Create The System Editor screen displays see Figure 19 System Editor screen on page 51 Varian Inc Revision A 05 0
3. FIGURE 2 Accessory Tray 2 Varian Inc chapter3 Installation and Setup Unpacking Your Equipment The Varian 400 DS is shipped in one crate The crate contains the apparatus and accessories Step 1 Open the crate and check the contents for damage which may have occurred during shipping Shipping damage rarely occurs but if it does contact both the carrier who delivered the instruments and the Dissolution Systems Service Department Though claims for damage should be filed with the carrier we can help you file a claim Step 2 Remove the top of the crate Step 3 Remove one side of the crate and lift the accessories box out of the crate Step 4 Disassemble the other three sides of the crate Varian Inc Page 26 Varian 400 DS Automated Apparatus 7 Revision A 05 07 Installation and Setup Operator s Manual P N 70 9051 Step 5 Remove any cushioning material and tape If any item is missing contact the Dissolution Systems Service Department or your local representative for replacements Step 6 Carefully remove the apparatus from the base of the shipping crate Warning Because of its heavy weight two people should lift the apparatus Lift by holding underneath the base of the unit on each side Support feet are located at each corner of the unit Hands should be positioned between the support feet to ensure they are not trapped when lowering Step 7 Place the apparatus on a clean
4. Varian Inc Page 38 Varian 400 DS Automated Apparatus 7 Installation and Setup Operator s Manual Revision A 05 07 P N 70 9051 FIGURE 8 Tools menu DissoService Manager File CEJ View Help Syste Stop Service Restart Service Configure Instruments Server USCARW000533 8787 R 10 16 27 AM DissoService Manager File BEES View Help AM Onters Start Service Configure Instruments Server USCARW000533 8787 Stopped _ 10 17 38 AM DAR aaa Step 3 On the toolbar click Tools gt Options The DissoService Options screen displays see Figure 9 DissoService Options screen on page 39 Varian Inc Revision A 05 07 Varian 400 DS Automated Apparatus 7 Page 39 P N 70 9051 Operator s Manual Installation and Setup FIGURE 9 DissoService Options screen DissoService Options e Database Email DissoServer Port 9787 24 Step 4 Configure the SMTP server address Note The e mail alert software assumes the use of an SMTP server Op E which does not require authentication for sending Most e mail servers only require authentication for receiving POP3 but allow sending from any system on the same domain without the use of a password If your corporate server does not require passwords provide the address of the corporate SMTP server in order for Dissolution Server to send e mail Enter the SMTP server address as either a name for exampl
5. on page 85 CeOCOCOCEOCOO OOO ECCCECECERCCEE SCECCECOCCEE ECL Soh ot of iy ot oo ot od OM ot ot eeecceeccecece ececcececceccc COCCCCCCCE CECE CECCOCEFECCECES gids adagdgddday ol st of of of of ot of uf of oS Sh eh ot of Gt Of Of of so of Ghat oF Cececececceece COCR SCRE Ei Varian Inc Revision A 05 07 Varian 400 DS Automated Apparatus 7 Page 85 P N 70 9051 Operator s Manual Operation FIGURE 33 Method Start Options screen Method Start Options Sample Information Product Name 72 Hour Test 10mL System Notes Notes Lot Batch Group Active Channels 1 3 4 Time Delayed Start amp 7 2007 MS 3 25 12 PM eg Following is a description of the Method Start Options screen options Screen Section Parameter Description Sample Product Name Enter the product name Information Notes Enter any appropriate notation Label 1 Enter the appropriate information based on the Label 2 user defined labels see User Defined Labels on page 72 Label 3 Active Channels Enter the number of active heating channels Note Heating channels are counted from left to right Varian Inc Page 86 Varian 400 DS Automated Apparatus 7 Revision A 05 07 Operation Operator s Manual P N 70 9051 Screen Section Parameter Description Injection Control Enable Injections N A Inject Only No Sampling Temperature Vessel Temperature N A
6. Label 2 Batch Label 3 Group Sampling Parameters Sample Vome E mL Samples Fter f Prime Volume E mL Replacement Volume 7 mL Purge Volume mL WasteDropVol D ml Dip While Sampling I Dual Sample x Eror Tolerance Profile Interval Temperature 0 5 C Speed 2 00 00 HH MM Change Management 9 I Restrict method editing rights to the method owner Owner Everyone Varian Inc Page 72 Varian 400 DS Automated Apparatus 7 Revision A 05 07 Operation Operator s Manual P N 70 9051 Step 3 Select the Parameters tab Following is a description of the Parameters tab options Option Description Sample Product Name Enter the name of the product Information Notes Enter any relevant notes regarding the sample User Defined Labels The fields in this area have default values of LOT Label 1 BATCH and GROUP These fields are Label 2 customizable enter the information that best Label 3 serves the needs of the method parameters Error Tolerance Temperature Enter the desired temperature fluctuation limit If the tube temperature goes over or under the set temperature see Verifying the Cell Temperature on page 67 by the amount of this tolerance an error is recorded as part of the results Speed Enter the desired speed fluctuation limit If the RPM goes over or under the set speed see Reciprocation on page 68 by the amount of this tolerance an error is recorded as pa
7. The System Editor screen displays see Figure 19 System Editor screen on page 51 Note Alternately you can double click the desired system configuration or right click the desired system configuration and select Properties The System Editor screen displays as a result of any of these actions Step 4 Select the appropriate tabs and change the relevant information in the same manner that the system was created Step 5 Close the System Configuration screen Show Audit Trail To display the audit trail for a system configuration complete the following steps Step 1 From the navigation bar click Configuration The System Configuration screen displays see Figure 18 System Configuration screen on page 50 Step 2 Select the system configuration and click Show Audit Trail The System Audit Trail screen displays Note IL Alternately you can right click the desired system configuration and select Show Audit Trail The System Audit Trail screen displays as a result of either of these actions Step 3 Select two or more versions and click Differences in the navigation bar A change report displays The report can be printed or exported Varian Inc Varian 400 DS Automated Apparatus 7 Revision A 05 07 Page 58 Operator s Manual P N 70 9051 Operation Verify Integrity To verify that the system configuration has not been changed outside of the 400 DS Work
8. dry and level section of the bench Warning The electrical connection at the back of the apparatus is the primary disconnect for the instrument The apparatus should be positioned to allow accessibility to the power cords and circuit breaker switch for easy disconnection Leveling Your Apparatus Step 1 Place the level provided in the accessory kit on the vessel table Step 2 Check the level of the instrument in the front and rear center of the unit as well as the left and right sides Step 3 The apparatus has adjustable feet under each corner These may be screwed in or out to raise or lower each leg Adjust the feet so the bubble inside the level is within the circle at all four points Varian Inc Revision A 05 07 Varian 400 DS Automated Apparatus 7 Page 27 P N 70 9051 Operator s Manual Installation and Setup Electrical Connection Warning Ensure the apparatus is configured for the voltage available in your laboratory Check the serial number tag on the rear panel of the instrument to confirm the voltage requirement The electrical connection at the back of the apparatus is the primary disconnect for the instrument Step 1 Verify the Varian 400 DS is off Step 2 Connect the power cord between the receptacle on the drive unit rear panel and an outlet of the appropriate voltage FIGURE 3 Diagram of the electrical connection Power Receptacle Varian Inc Page 28 Varian
9. reader comment form 101 report toolbar 88 run method 82 S safety features 20 safety practices 11 sample information 72 screen options automated apparatus 7 workstation method start options screen 85 system editor 51 security 49 select method step 2 of 2 screen 83 select system step 1 of 2 screen 82 selecting dissolution server 41 serial numbers 55 service 93 setting up your pc 28 show audit trail 57 79 starting dissolution workstation 40 status 49 system configuration report 56 system configuration screen 50 system editing rights 52 system editor screen 51 system status screen 84 t tab options method editor Parameters tab 72 test report selection screen 87 test reports 87 u user administration 47 usp physical parameters 20 v verify integrity 58 80 Varian Inc Index Index w warranty 93 warranty limitations 94 windows security alert screen 40 Varian Inc Index This page was intentionally left blank except for this message Varian Inc Tell Us How We Are Doing We listen to our customers We work hard to make our technical documentation user friendly and to make the information in our manuals easy to retrieve and use We d like you to tell us the kinds of additional information you d find helpful in our documentation Your feedback will be carefully considered when we prepare future editions of this manual This manual should contain the following additional informa
10. 12 Reciprocation Hazard 13 Other 13 Warning 13 General 15 WEEE Directive 17 Introduction 19 Conventions Used in this Manual 20 USP Physical Parameters 20 Specifications 21 Environmental Specifications 21 Engineering Specifications 21 Accessories 23 Varian Inc Table of Contents Chapter 3 Chapter 4 Installation and Setup 25 Unpacking Your Equipment 25 Leveling Your Apparatus 26 Electrical Connection 27 Setting up YourPC 28 Setting up YourPC 28 Cable Connections 29 Single System Setup 29 Multiple System Setup 29 Setting Up the Varian 400 DS 30 Initial Power Up 32 Software Installation 32 Attaching the Database 33 Local Security Policy 35 E mail Notification Configuration Optional 37 Starting 400 DS Workstation 40 Dissolution Server Selection 41 Configuring the Application Adding Users 43 Operation 47 Log on to the Varian 400 DS Workstation 47 Configuring Your System 50 Copying a System Configuration 54 Deleting a System Configuration 54 Serial Numbers 55 System Configuration Report 56 Editing an Existing System Configuration 56 Import Export XML File 58 System Calibration 60 Cell Calibration Temperatures 62 Manual Control Diagnostics 64 Varian Inc Table of Contents Chapter 5 Chapter 6 Verifying Sample Tray Control 65 Media Control 66 Verifying the Cell Temperature 67 Reciprocation 68 Controlling the Evaporation Cover 69 Method Editor 69 Creating a Method 70 Copying
11. 400 DS Automated Apparatus 7 Revision A 05 07 Installation and Setup Operator s Manual P N 70 9051 Setting up Your PC The 400 DS Workstation software requires Microsoft Windows 2000 or Windows XP to be installed on your computer For instructions on installing the operating system refer to the documentation supplied with Windows Minimum PC Configuration e Windows 2000 SP6 or e 256 MB RAM Windows XP SP1 1024 x 768 pixel display resolution e 10 GB free hard disk drive space e 2x USB port optional If the PC is not equipped with a standard serial port a USB to serial converter must be purchased If Varian is installing the 400 DS Workstation software for you note that the installation of a Windows operating system is not included as part of the standard instrument installation Setting up Your PC The monitor keyboard mouse and printer plotter are connected to the PC via cables which plug into the back of the PC Consult your monitor and printer manuals for details of their individual cabling requirements Varian Inc Revision A 05 07 Varian 400 DS Automated Apparatus 7 Page 29 P N 70 9051 Operator s Manual Installation and Setup Cable Connections FIGURE 4 Diagram of cable connections ETHERNET sp Caution The Varian 400 DS can be connected to the PC using an RS232 USB or Ethernet cable Do not connect more than one type of cable Communication errors may occur Single
12. Configuration To delete a system configuration complete the following steps Step 1 From the navigation bar click Configuration The System Configuration screen displays see Figure 18 System Configuration screen on page 50 Step 2 Select the desired system configuration Step 3 Click Delete Varian Inc Revision A 05 07 Varian 400 DS Automated Apparatus 7 Page 55 P N 70 9051 Operator s Manual Operation Step 4 Click Yes Step 5 Close the System Configuration screen Note IIE The system configuration is never physically deleted It is marked as deleted in the database Serial Numbers To review or add serial numbers to the system configuration complete the following steps Step 1 From the navigation bar click Configuration The System Configuration screen displays see Figure 18 System Configuration screen on page 50 Step 2 Select the desired system configuration Step 3 Click Serial Numbers The Serial Number Editor screen displays Note Alternately you can double click the desired system E configuration and double click Next until the Serial Numbers section of the System Editor displays or right click the desired system configuration and select Serial Numbers Serial numbers can be added or deleted as a result of any of these actions Step 4 Enter the serial number for the sample cells sample holders etc and click Add Step
13. DS Automated Apparatus 7 Page 63 P N 70 9051 Operator s Manual Operation Step 5 In the Cell Heat box set the cell temperature to an appropriate temperature 9g Step 6 Click stn DO THE SAMPLE CELLS CONTAIN LIQUID displays Step 7 Click Yes The temperatures display in the Cell Temperature box Step 8 Set the reciprocation rate and click Run Step 9 Allow the media to equilibrate to the set temperature Step 10 In the Evaporation Cover box click the up arrow to raise the evaporation cover Up Step 11 Remove the two thumb screws from the evaporation cover and remove the evaporation cover Step 12 Remove the sample holder for cell 1 and replace with the modified temperature probe Step 13 Allow 3 5 minutes for the temperature to stabilize Step 14 Note the temperatures for use at step 23 Step 15 Repeat steps 12 14 for each additional cell Step 16 Replace the sample holders and the evaporation cover Step 17 Stop reciprocation and cell heating Step 18 Under the Media Control box click Purge The media in all cells purges Varian Inc Page 64 Varian 400 DS Automated Apparatus 7 Revision A 05 07 Operation Operator s Manual P N 70 9051 Step 19 Close the Diagnostics screen Step 20 From the navigation bar click Configuration The System Configuration screen displays see Figure 18 System Configuration screen on page 50 Step 21 Select the appropriate system and click Next Step 22 Enter th
14. Methods 77 Deleting Methods 77 Editing an Existing Method 78 Method Report 78 Audit Trail 79 Import Export XML File 80 Running the Method 82 Test Reports 87 Electronic Signatures 88 Clean System 88 Maintenance 89 Routine Maintenance to be Performed Between Each Dissolution Method 90 Sample Holders 90 Non Routine Maintenance to be Performed at Pre Determined Intervals 91 Service and Warranty 93 Exclusions and Limitations 94 Obtaining Warranty Service 94 Warranty Limitations 94 Exclusive Remedies 95 Index 97 Tell Us How We Are Doing 101 Varian Inc Table of Contents This page was intentionally left blank except for this message Varian Inc List of Figures FIGURE 1 FIGURE 2 FIGURE 3 FIGURE 4 FIGURE 5 FIGURE 6 FIGURE 7 FIGURE 8 FIGURE 9 FIGURE 10 Accessory Tray 1 24 Accessory Tray 2 24 Diagram of the electrical connection 27 Diagram of cable connections 29 License dongle 33 MSDE Manager screen 34 DissoService Manager screen 37 Tools menu 38 DissoService Options screen 39 Logon screen 41 Varian Inc List of Figures FIGURE 11 FIGURE 12 FIGURE 13 FIGURE 14 FIGURE 15 FIGURE 16 FIGURE 17 FIGURE 18 FIGURE 19 FIGURE 20 FIGURE 21 FIGURE 22 FIGURE 23 FIGURE 24 FIGURE 25 FIGURE 26 FIGURE 27 FIGURE 28 FIGURE 29 Add New Dissolution Server screen 42 Browse Dissolution Servers screen 42 Confi
15. P N 70 9051 Operator s Manual Maintenance Non Routine Maintenance to be Performed at Pre Determined Intervals It is recommended that the following procedures be performed by a properly trained service technician Remove and inspect all sample cells for signs of damage Replace as necessary Clean the sample cells thoroughly especially the area that typically covers the seal Clean the entire external surface of the instrument including top cover and syringe pump window Inspect and clean the air filter s Replace if necessary Inspect all sample cell holder seals Re grease the o rings if necessary using a pre approved lubricant e g Krytox Replace any o rings that appear dried or cracked Inspect all external media lines Replace if necessary Check the magnet plate for free play Check the evaporation mechanism for free play Inspect the evaporation cover seals Remove inspect and clean the needles Place them in an ultrasonic bath for a few minutes if necessary Verify the following limit switch alarm operations home position top cover open close front door and sample tray lift empty sample row See Verifying Sample Tray Control on page 65 Verify proper operation of all LEDs 4 total Open the front door sample tray compartment of the Varian 400 DS Lubricate reciprocation slide rail using a pre approved lubricant Using the Diagnostics portion of the software Manual Control Diagno
16. Varian Inc Page 16 Varian 400 DS Automated Apparatus 7 Revision A 05 07 Safety Practices and Hazards Operator s Manual P N 70 9051 Varian Inc has confirmed that each product complies with the relevant directives by testing a prototype against the prescribed European Norm EN standards Proof that a product complies with the directives is indicated by e the CE marking appearing on the rear of the product e the documentation package that accompanies the product containing a copy of the declaration of conformity This declaration is the legal declaration by Varian Inc that the product complies with the directives and also shows the EN standards to which the product was tested to demonstrate compliance The declaration of conformity is signed by the representative of the manufacturing plant cTUVus U S and Canadian Product Approvals The Varian 400 DS Automated Apparatus 7 has been designed to comply with North American safety requirements This product has been tested and certified for the North American market by TUV Rheinland of North America Inc The TUVus mark signifies that this product has been tested to U S standards and certified for the U S market The cTUV mark signifies that this product has been tested to Canadian standards and certified for the Canadian market When the two marks are coupled the cTUVus mark signifies that this product has been tested to standards and certified for both markets Varia
17. and select Export The Version Selection screen displays as a result of either of these actions Step 4 If applicable indicate which version to export and click OK The Export System to XML File screen displays Note gt Each time a system configuration is saved a new version is created To export a version other than the most recently saved indicate the appropriate version number on the Version Selection screen Step 5 Indicate the directory and file name and click Save The code is saved as an XML file To import the XML file at another 400 DS Workstation complete the following steps Step 1 From the navigation bar click Configuration The System Configuration screen displays see Figure 18 System Configuration screen on page 50 Step 2 Click Import The Import System from XML File screen displays Note Op KC Alternately you can right click the desired system configuration and select Import The Import System from XML File screen displays as a result of either of these actions Step 3 Select the appropriate directory and file name and click Open The system configuration displays on the System Configuration screen Step 4 Close the System Configuration screen Varian Inc Page 60 Operation Varian 400 DS Automated Apparatus 7 Revision A 05 07 Operator s Manual P N 70 9051 System Calibration Step 1 Step 2 Step 3 St
18. best site to repair the unit either onsite or returned to Varian Inc Any onsite warranty services are provided only at the initial installation point Installation and onsite warranty services are available only in Dissolution Systems service travel areas Varian Inc Page 94 Varian 400 DS Automated Apparatus 7 Revision A 05 07 Service and Warranty Operator s Manual P N 70 9051 Exclusions and Limitations Excluded from this warranty are expendable or consumable items such as but not limited to paddles baskets vessels and acrylic water baths Also excluded are defects from improper or inadequate maintenance by the customer user induced chemical action or contamination unauthorized modification or misuse and improper site preparation and maintenance Operation of software is not warranted to be uninterrupted or error free Obtaining Warranty Service To obtain warranty service in the United States contact the Dissolution Systems Service Department at 800 229 1108 to obtain authorization to return units for repair At the option of the customer onsite warranty service is available but travel charges may be incurred The customer should prepay all shipping charges for products returned to the Dissolution Systems Service Department unless otherwise authorized and Varian Inc will pay all charges for return to the customer Warranty Limitations Varian Inc makes no other warranty either express or implied with re
19. from the tube Caution Do not click Fill more than one time without purging in between The media will overflow the cells Varian Inc Page 68 Varian 400 DS Automated Apparatus 7 Revision A 05 07 Operation Operator s Manual P N 70 9051 Reciprocation To set the dips per minute complete the following steps Step 1 Click any vessel position corresponding to the desired row in the Sample Tray Control box see Figure 23 Sample Tray Control box on page 65 The drive unit moves to the indicated row Step 2 In the Reciprocation box use the up and down arrows in the box that corresponds to DPM to set the dips per minute to 15 and click Dipping begins FIGURE 24 Reciprocation box Reciprocation x 30 0 2 DPM Start Stop Step 3 Click The dipping stops Step 4 Click a under the Sample Tray Control box The drive unit returns to the home position Varian Inc Revision A 05 07 Varian 400 DS Automated Apparatus 7 Page 69 P N 70 9051 Operator s Manual Operation Controlling the Evaporation Cover To raise the evaporation cover click Up in the Evaporation Cover box To lower the evaporation cover click a4 in the Evaporation Cover box own Method Editor All test parameters are entered via the Method Editor screen Function Procedure Create a new method See Creating a Method on page 70 Copy a method See Copy
20. the up and down arrows to indicate appropriate volume based on your vial size Dissolution Volume mL Use the up and down arrows to indicate appropriate volume based on your cell size Varian Inc Page 74 Varian 400 DS Automated Apparatus 7 Revision A 05 07 Operation Operator s Manual P N 70 9051 Option Description Cell Temperature Enter the desired tube temperature in degrees Celsius This can be entered for the first timepoint Hold Time mmi ss Enter the desired duration for the dip to remain at the bottom of the stroke in mm ss format Dip Speed DPM Use the up and down arrows to indicate the desired dips per minute DPM for each applicable row of the 400 DS Dip Interval hhh mm ss Enter the desired duration for dipping in hhh mm ss format Step 5 Select the Automated App7 Options tab FIGURE 28 Automated App7 Options tab Method Editor Parameters Automated App7 Sequence Automated App7 Options Notifications Media Description MediaA Media MedaB MediaB MediaC Media MediaD Media D MediaE Media E Rinse Media Rinse Media Syringe Properties Aspirate Flow Rate ml s Dispense Flow Rate ml s Aspirate Dwell Time s Prime Volume mf Syringe Clean Cycles Sample Cell Clean Cycles Needles Clean Cycles Varian Inc Revision A 05 07 P N 70 9051 Varian 400 DS Automated Apparatus 7 Operator s M
21. 005 6 56 34 AM Everyone No Restriction nx Tjenq7BGgt5 Apparatus3 Lb 8 02 2005 9 06 13 AM Everyone No Restriction oYkkqdMy 7H 2 Apparatus3 Validation 8 02 2005 11 21 19 AM Everyone No Restriction wRBleGMGoIrn 2 wawo Validation Lab 8 02 2005 9 01 04 AM VARLANNC thompso No Restriction CEN AWS VAQ 2 WBO20wipp Vaidsionlab 14 01 2005 12 47 15 PM Everyone No Restriction Teuvo 2 W00 wisp ValidstionLab 14 01 2005 2 50 40 PM VARIANNCItthompso NoRestrcton ydWGnB4Vio7 2 wao Validation Lab 27 01 2005 9 07 59AM_ Everyone NoRestrition TIVZHAS94rL4 Step 2 Select the desired system to run the method and click Next The Select Method Step 2 of 2 screen displays Varian Inc Revision A 05 07 Varian 400 DS Automated Apparatus 7 Page 83 P N 70 9051 Operator s Manual Operation FIGURE 31 Select Method Step 2 of 2 screen Select Method Step 2 of 2 Select the method to be run U Method Version Product Nome Notes Time Oner Document Ic 2 7010 USB Converter 14 02 2005 12 40 31 PM_ Everyone J6vQgcr0 ve 1S E7025 wipo USB Converter 14 02 2005 9 03 08 AM Everyone OMINCHgwt S VK7025 wisp USB Converter 19 01 2005 1 23 01 PM Everyone EIMA 4 VE7O25 wispt USB Converter 16 02 2005 1 22 35 PM VARIANNC tthompso RipSzbELy 2 Copy of VK7025S w po 107 13 USB Converter 26 01 2005 6 30 39AM Everyone JSpmiOUSuh Step 3 Select the desired method to run and click Finish The system status screen displays Va
22. 5 Click OK The Serial Number Editor screen closes Varian Inc Page 56 Varian 400 DS Automated Apparatus 7 Revision A 05 07 Operation Operator s Manual P N 70 9051 System Configuration Report To display a report of the system configuration complete the following steps Step 1 From the navigation bar click Configuration The System Configuration screen displays see Figure 18 System Configuration screen on page 50 Step 2 Select the desired system configuration Step 3 Click Report By default the most recent report version displays Note E z Alternately you can right click the desired system configuration and select Report The Version Selection screen displays as a result of either of these actions Step 4 Use the up and down arrows to indicate the desired report version and click OK Step 5 The system report displays The report can be printed exported searched or verified Editing an Existing System Configuration To display and edit the properties of an existing system configuration complete the following steps Step 1 From the navigation bar click Configuration The System Configuration screen displays see Figure 18 System Configuration screen on page 50 Step 2 Select the desired system configuration Varian Inc Revision A 05 07 Varian 400 DS Automated Apparatus 7 Page 57 P N 70 9051 Operator s Manual Operation Step 3 Click Properties
23. 6 characters Password Must Meet Complexity Requirements Enabled Step 3 Click Security Settings gt Account Policies gt Account Lockout Policy and set the following configuration Policy Security Setting Account lockout duration 0 minutes infinite Account lockout threshold 3 invalid login attempts Reset account lockout counter 99999 minutes Step 4 Click Security Settings gt Local Policies gt Audit Policy and set the following configuration Policy Security Setting Audit account logon events Success Failure Audit account management Success Failure Audit logon events Success Failure Audit policy change Success Failure Step 5 Close the Local Security Settings Management screen Varian Inc Revision A 05 07 Varian 400 DS Automated Apparatus 7 Page 37 P N 70 9051 Operator s Manual Installation and Setup E mail Notification Configuration Optional Step 1 On the computer which is hosting the DissoService click Start gt All Programs gt Varian gt Dissolution gt Service Manager The DissoService Manager screen displays FIGURE 7 DissoService Manager screen DissoService Manager File Tools View Help System ID and Description Owner Server SOFTENG2 8787 Running 6 13 55 PM Step 2 On the toolbar click Tools and select Stop Service The Options item on the Tools menu enables after the service stops see Figure 8 Tools menu on page 38
24. 7 Varian 400 DS Automated Apparatus 7 Page 51 P N 70 9051 Operator s Manual Operation FIGURE 19 System Editor screen System Editor System Configuration System System Name Laboratory Dissolution Setup Restrict Execution To Specified Server 3 No Restriction B NoRestriction Change Management Restrict system editing rights to the system owner Q 4 Owner Everyone Following is a description of the System Editor screen options Screen Section Parameter Description System System Enter a name for your system Name Laboratory Enter a laboratory name Varian Inc Page 52 Operation Varian 400 DS Automated Apparatus 7 Revision A 05 07 Operator s Manual P N 70 9051 Screen Section Restrict Execution To Specified Server Change Management Step 3 Parameter Description Click 8 to display the name of the workstation or enter the name of the workstation connected to the system Click No Restriction to allow the system to be run from any workstation Note The system must be physically connected If applicable select the box under Change Management in order to restrict the system editing rights to the current user Note This option prevents system configuration modification by anyone other than the system owner or a user with VkModifyOthersSystems privilege Click Next The 400 DS Workstation
25. Delayed Start Start Bath Temperature Start Time Delayed Start Step 5 Step 6 Step 7 Use this option to program a delayed start Enter the desired date and time to start the method Click OK The Method Sample Information screen displays Method Sample Information 2 3 4 5 6 7 8 EN re ay EA OUPO Enter the sample information if applicable When the method is complete click Test Report The test report displays The report can be printed exported searched verified and or signed Varian Inc Revision A 05 07 Varian 400 DS Automated Apparatus 7 Page 87 P N 70 9051 Operator s Manual Operation Test Reports To display a report of the completed method complete the following steps Step 1 From the navigation bar click Test Reports The Test Report Selection screen displays FIGURE 34 Test Report Selection screen Actions Date And System Fite Test ID Fite I Show Repot Start Date 12 1 2008 X Moo D Rerieve Rocceds Fiter Date And System Erd Date 2 18 2005 xj ETAD E Veily Integy K ba ad Export lo He Test ID Product Name System Desc I Tester Serial UserID BB Expert to Excel 183640 Engineeting 7010 Engineering 7010 Engineering 7010 Engineering 7010 006200000 Engineering 7010 Engineaing 7010 0062000009 Engineering 7010 Engineering 7010 00620 0000 5 Enginesring 7010 Enginesting 7010 006200009 Engnesing 7010 Engineeing 7010 0 0620 0000 Engin
26. E ViDissoMethodM Allows access to Method Creation and modification functions BE VkModfyOthersM Allows modification of methods owned by other users SE ViModlyOthersSy Allows modification of systems owned by other users Ary uter that is not a member of one of these groups will have minimal access to reporting functions through membership of the Everyone group User Administration Varian Inc Page 44 Installation and Setup Varian 400 DS Automated Apparatus 7 Operator s Manual Revision A 05 07 P N 70 9051 Step 1 To add a user to a group select the Security tab on the Configuration Dialog screen Note CES Only an administrator can add users Step 2 Click User Administration at the bottom of the screen The Local Users and Groups screen displays FIGURE 14 Local Users and Groups screen Local Users and Groups fie Acton View tiep e Olm xXxvr7B EQ Local Users and Groups Local Nome Description _ a Power Users Power Users possess most acmristr Remate Desktop Users Members in this group are granted t Replicator Supports file repication in a domain Users Users are prevented from making ac ChemStation anagers Chenstation Managers Group ChemStationOperators ChemStation Operators Group Debugger Users Debugoe users can debug processe HelpServiesGroup Group for the Help and Support Center SheredChem Managers Shared ChemSzation Manager Log
27. GH oH ot Ov Gg i Gi BS SF Ot GH OF OF Bt Qt Ge Gr o Hh SS We at Ot a KE ot m amp BB OF BH Oe OF oe ae am Gr OG PS SD o amp BO w oO amp Y St OS a Br Bt BI Qo Gr gr ar oe PD OF Gt SH SF Ot OF DF DPY BH SD BF OP BY GH Ot Se Or a onmnn nnkt wn an SA A ai w N O Click a under the Sample Tray Control box The drive unit returns to the home position Click ed to stop the movement to eject or retract the sample tray Click e to raise the evaporation cover Varian Inc Page 66 Operation Varian 400 DS Automated Apparatus 7 Operator s Manual Revision A 05 07 P N 70 9051 Step 6 Click ee to lower the evaporation cover Step 7 Click to turn off any audible alarm Media Control Step 1 Under the Media Control box set the following parameters Option Aspirate Flow Rate mL s Description Use the up and down arrows to indicate the rate at which the media is pulled into the syringe Dispense Flow Rate mL s Use the up and down arrows to indicate the rate at which the media is dispensed from the syringe Aspirate Dwell Time S Use the up and down arrows to indicate the duration of time the plunger holds at the top of the stroke before dispensing Note The time specified is for full syringe volume For smaller syringe volumes it is calculated proportionately Needle Clean Cycles Use the up and down arrows to indicate the number of times the u
28. System Setup Step 1 Connect a cable between COM1 on the PC and the left serial port IN COM A on the rear of the Varian 400 DS Automated Apparatus 7 Step 2 Ensure the loop back switch located to the right of the right serial port is switched to the left ON Multiple System Setup Step 1 Connect a cable between COM1 on the PC and the left serial port IN COM A on the rear of the Varian 400 DS Automated Apparatus 7 Step 2 Ensure the loop back switch located to the right of the right serial port is switched to the right OFF Varian Inc Page 30 Varian 400 DS Automated Apparatus 7 Revision A 05 07 Installation and Setup Operator s Manual P N 70 9051 Step 3 Connect a 6 pin mini DIN cable between the right serial port OUT COM B of the first apparatus and the left serial port of the second apparatus Step 4 If this is the final Varian 400 DS Automated Apparatus 7 in the series ensure the loop back switch located to the right of the right serial port is switched to the left ON If this is not the final Varian 400 DS Automated Apparatus 7 in the series ensure the loop back switch located to the right of the right serial port is switched to the right OFF Step 5 Repeat steps 3 and 4 for each additional apparatus Setting Up the Varian 400 DS Step 1 Step 2 Step 3 Step 4 Step 5 Step 6 Step 7 Locate the 1 5 mm Allen wrench to install the sample heater jackets Install the fi
29. Variable Specification Temperature Measurement 0 2 C Accuracy Communications RS232 USB and Ethernet Sampling Automated sampling driven through PC software Sample Holder Material PEEK and titanium Status Indicator LEDs Dimensions Height 24 00 inches 60 9 cm Width 20 00 inches 50 8 cm Depth 22 00 inches 55 8 cm Weight 130 3 Ibs 59 1 kg Varian Inc Revision A 05 07 P N 70 9051 Varian 400 DS Automated Apparatus 7 Operator s Manual Page 23 Introduction Accessories Following is a list of accessories that ship with the Varian 400 DS the protective foam packaging on the following page All items are pictured in Label Item Quantity Varian 400 DS 1 AC power cord 1 Sample cells 13 Cell heater jackets 13 Sample holders 13 25 roll of tubing k Sample tray with 12 rows Additional sample tray row for calibration Magnetic plate Evaporation cover 1 5 mm Allen wrench 9 64 Allen wrench Modified temperature probe Sample vials 12x32 Qty 100 Sample vials 15x35 Qty 100 Level Sample holder extraction tools RS232 cable FOVCEEOEEGEDEEODE User manual CD lt m a a NI l A oo Varian Inc Revision A 05 07 Page 24 Varian 400 DS Automated Apparatus 7 P N 70 9051 Introduction Operator s Manual FIGURE 1 Accessory Tray 1
30. anual Page 75 Operation Following is a description of the Automated App7 Options tab options Screen Section Parameter Description Media Media A Enter descriptions as appropriate for the different Description Media B medias Media C Media D Media E Rinse Media Syringe Aspirate Flow Rate Use the up and down arrows to indicate the rate at Properties mL s which the media is pulled into the syringe Dispense Flow Use the up and down arrows to indicate the rate at Rate mL s which the media is dispensed from the syringe Aspirate Dwell Use the up and down arrows to indicate the duration Time s of time the plunger holds at the top of the stroke before dispensing Note The time specified is for full syringe volume For smaller syringe volumes it is calculated proportionately Prime Volume mL Use the up and down arrows to indicate the volume to be pulled before taking measurement Syringe Clean Use the up and down arrows to indicate the number of Cycles times to rinse the syringe between samples Sample Cell Clean Use the up and down arrows to indicate the number of Cycles times to rinse the sample cell between samples Needles Clean Use the up and down arrows to indicate the number of Cycles times to rinse the needles between samples Step 6 Select the Notifications tab see Figure 29 Notifications tab on page 76 Varian Inc Page 76 Varian 400 DS Automated Appara
31. arian 400 DS Automated Apparatus 7 P N 70 9051 Page 78 Operator s Manual Operation Editing an Existing Method To edit a method already entered on the 400 DS Workstation complete the following steps From the navigation bar click Editor The Methods screen displays see Step 1 Figure 25 Methods screen on page 70 Step 2 Click the desired method Click Properties on the navigation bar The Method Editor screen Step 3 displays see Figure 26 Method Editor screen on page 71 Note Ez Alternately you can double click the desired method or right click the desired method and select Properties The Method Editor screen displays as a result of any of these actions Step 4 Select the appropriate tabs and change the relevant information in the same manner that the method was created Method Report To display a report of the method parameters complete the following steps From the navigation bar click Editor The Methods screen displays see Step 1 Figure 25 Methods screen on page 70 Step 2 Select the desired system configuration Step 3 Click Report The Version Selection screen displays Varian Inc Revision A 05 07 Varian 400 DS Automated Apparatus 7 Page 79 P N 70 9051 Operator s Manual Operation Step 4 If applicable indicate which version and click OK Note Op Each time a method is saved a new version is created To create a rep
32. ave TAY Varian 400 DS Automated Apparatus 7 Operator s Manual P N 70 9051 May 2007 sl le evision A Limitation of Liability The information in this document is subject to change without notice Varian Inc makes no warranty of any kind with regard to this material including but not limited to the implied warranties or merchantability and fitness for a particular purpose Varian Inc shall not be liable for errors contained herein or for incidental consequential damages in connection with the furnishing performance or use of this material All rights are reserved Reproduction adaptation or translation without prior written permission is prohibited except as allowed under copyright laws First Edition May 2007 Varian 400 DS Automated Apparatus 7 Operator s Manual Part Number 70 9051 Revision A Printed in the United States of America The following terms are trademarks of Varian Inc Benchsaver e Practical Solutions BIO DIS III QA and QAII e Enhancer Cell e TruCenter Full Flow Filters VanKel e Peak Vessel VK All other trademarks are property of their respective owners Varian Inc 13000 Weston Parkway Cary North Carolina 27513 2250 800 229 1108 919 677 1108 Fax 919 677 1138 www varianinc com ap m8 VARIAN Copyright c 2007 by Varian Inc Table of Contents Chapter 1 Chapter 2 Safety Practices and Hazards 11 Electrical Hazards
33. creen 42 c cable connections multiple system 29 single system 29 change management 72 change user 49 clean system 88 configuration dialog screen miscellaneous tab 45 security tab 43 configuring automated apparatus 7 workstation 50 configuring the application 43 conventions 20 copying a system configuration 54 copying methods 77 creating a method 70 d database attaching 33 deleting a system configuration 54 deleting methods 77 diagnostics 64 dissolution server selection 41 dissoservice manager screen 37 tools menu 38 dissoservice options screen 39 e editing an existing method 78 editing an existing system configuration 56 electronic signatures 88 Varian Inc Index e mail notification configuration 37 error tolerance 72 exclusions 94 exclusive remedies 95 export xml file 58 80 h hazards 11 i import xml file 58 80 initial power up 32 introduction 19 l limitations 94 local security policy 35 local users and groups screen 44 lock application 49 logon 47 logon screen 41 47 m maintenance 89 manual control 64 method editor 69 method editor screen 71 method report 78 method start options screen 85 methods screen 70 minimum pc configuration 28 msde manager screen 34 o obtaining warranty service 94 p pc requirements minimum 28 pc setting up 28 periodic maintenance 89 permissions 49 physical parameters usp 20 power up 32 profile interval 72 r
34. ctices and Hazards Operator s Manual P N 70 9051 The meaning of the symbols that appear alongside warnings in this manual are as follows Electrical shock Pinch point Caution Refer to accompanying documents Read all warnings and cautions carefully and observe them at all times Caution A Caution message appears in the manual when failure to observe instructions could result in damage to equipment Varian supplied and or other associated equipment Varian Inc Revision A 05 07 Varian 400 DS Automated Apparatus 7 Page 15 P N 70 9051 Operator s Manual Safety Practices and Hazards A Note appears in the manual to give advice or information C gt Information Symbols Switches main power on Switches main power off Indicates single phase alternating current Indicates the product complies with the requirements of one or more European Union EU directives Indicates specific equipment meets consensus based standards of safety to provide assurance required by OSHA that these products are safe for use in the workplace for North America Indicates that this product must not be disposed of as unsorted municipal waste see WEEE Directive on page 17 General CE Compliant Products The Varian 400 DS Automated Apparatus 7 has been designed to comply with the requirements of the Electro magnetic Compatibility EMC Directive and the Low Voltage Directive LVD of the EU
35. e server domain com or as an IP address for example 192 168 1 1 If your corporate SMTP server requires passwords consider installing Microsoft Internet Information Server IIS to a server on your intranet through which other Dissolution Servers could send e mails IIS includes a SMTP server which allows unrestricted e mail sending Varian Inc Page 40 Varian 400 DS Automated Apparatus 7 Revision A 05 07 Installation and Setup Operator s Manual P N 70 9051 Step 5 Once you have configured the SMTP server address click OK to save the settings Step 6 On the toolbar click Tools and select Start Service Starting 400 DS Workstation Step 1 Double click the 400 DS Workstation icon on the Windows desktop to start the software Step 2 If your system has Windows Firewall installed the following displays Windows Security Alert To help protect your computer Windows Firewall has blocked some features of this program Do you want to keep blocking this program U Name 400 DS Workstation Publisher Marian Inc Windows Firewall has blocked this program from accepting connections from the Internet or a network If you recognize the pogram or trust the publisher you can unblock it When should unblock a program Click Unblock to enable the program Varian Inc Revision A 05 07 Varian 400 DS Automated Apparatus 7 Page 41 P N 70 9051 Operator s Manual Installation and Setup Disso
36. e minutes before the application is automatically locked 15 Minutes Step 10 Click OK The application has been configured Varian Inc Page 46 Varian 400 DS Automated Apparatus 7 Revision A 05 07 Installation and Setup Operator s Manual P N 70 9051 This page was intentionally left blank except for this message Varian Inc chapter4 Operation Log on to the Varian 400 DS Workstation Step 1 Double click the Varian 400 DS Workstation icon on your desktop The Logon screen displays FIGURE 16 Logon screen User ID amp amp Password Doman VARIANINC Dissolution Server USCARWO00532 8787 This software i intended for use by authorized personnel ony Varian Inc Page 48 Varian 400 DS Automated Apparatus 7 Revision A 05 07 Operation Operator s Manual P N 70 9051 Step 2 Enter your user identification and password Verify the domain is correct and click Logon The 400 DS Workstation screen displays FIGURE 17 400 DS Workstation screen Method B Edta Run Method Text Reports Security B Change User Lock Application Bs Audt Trail BS Permissions 400 DS Workstation Copyright Varian Inc 2005 2007 Varian Inc Revision A 05 07 Varian 400 DS Automated Apparatus 7 Page 49 P N 70 9051 Operator s Manual Operation Following is a description of the screen options listed on the navigation bar of the 400 DS Workstation sc
37. e set point temperature as appropriate based on the cell calibration temperatures Step 23 Enter the temperature values for each cell as noted in step 14 into the cell calibration field Step 24 Click Finish The Reason for Change screen displays Step 25 Enter a reason code and change description and click OK Step 26 Close the System Configuration screen Manual Control Diagnostics To check the diagnostics of a dissolution apparatus complete the procedures on the following pages These procedures are performed on one system at a time Repeat the procedures as applicable for each additional system Step 1 Step 2 From the navigation bar click Diagnostics The Select Item screen displays Select the desired system and click OK The System Diagnostics screen displays see Figure 22 System Diagnostics screen on page 62 Varian Inc Revision A 05 07 P N 70 9051 Varian 400 DS Automated Apparatus 7 Page 65 Operator s Manual Operation Verifying Sample Tray Control Step 1 Click any vessel position corresponding to the desired row in the Sample Tray Control box The tray moves and the indicated row raises FIGURE 23 Sample Tray Control box Step 2 Step 3 Step 4 Step 5 Sample Tray Control PLM SS amp w So o a amp amp PISS CHF OK SKK SY GD St Qe DP OP BP Gr Ee ot a OF Hh OS OF GF Be Ot OF OF oF amp ay ar oF Ge Gt ot Gt GH ge ae Ge Or oF Sh Bh Se Gt Be OF OF GH
38. ed Apparatus 7 fills and dispenses media automatically without operator intervention A report can be generated to provide hard copy documentation of the testing progress and conditions All parameters are controlled via the PC Up to 4 units can be pre programmed to withdraw samples at designated timepoints Samples can be collected in pre capped HPLC vials for direct transfer to an HPLC system Septa are pierced using the exclusive needle manifold which lowers and raises at each sample point Sample trays are available in 1 5 mL and 4 mL sizes Caution Panels or covers that are retained by fasteners which require the use of a tool for removal may be opened only by Varian trained Varian qualified or Varian authorized service engineers Varian Inc Page 20 Varian 400 DS Automated Apparatus 7 Revision A 05 07 Introduction Operator s Manual P N 70 9051 Conventions Used in this Manual e Items you are asked to press are in bold For example press H on the keypad e Key sequences you are asked to press appear like this MENU gt 0 gt 8 Note Remember to return the warranty card supplied with this manual Completing and returning the card ensures your right to O protection under the terms and conditions of your warranty It also enables us to better assist you in the event of any problems Additionally it guarantees you will be informed of any issues that arise concerning your equipment such as upgrad
39. een displays see Figure 25 Methods screen on page 70 Step 2 Select the method and click Verify Integrity Either the data is verified successfully or the user is directed to contact their system administrator Note a Alternately you can right click the desired method and select Verify Integrity The integrity of the method is checked as a result of either of these actions Import Export XML File To use an existing method from one 400 DS Workstation on a different 400 DS Workstation you can export and import the method as an XML file To export the method complete the following steps Step 1 From the navigation bar click Editor The Methods screen displays see Figure 25 Methods screen on page 70 Step 2 Select the desired method Step 3 Click Export The Version Selection screen displays Note Cp Alternately you can right click the desired method and select Export The Version Selection screen displays as a result of either of these actions Varian Inc Revision A 05 07 Varian 400 DS Automated Apparatus 7 Page 81 P N 70 9051 Operator s Manual Operation Step 4 If applicable indicate which version to export and click OK The Export Method to XML File screen displays Note p Each time a method is saved a new version is created To export a version other than the most recently saved indicate the appropriate version number on the Version Selecti
40. eering 7010 Engineeing 7010 00620 0000 Expout List Note By default the test report dialog only shows tests done in the previous week To view tests completed earlier than the previous week click the Start Date and or End Date drop down arrows to indicate date range QE fora test report selection and click Filter Date and System Additionally you can select a system name from the System combo box to restrict the selection to a particular system To restrict the selection to a particular test identification enter the value in the Test ID Filter box and click Filter Test ID Step 2 Click a test in the list to select it Step 3 From the navigation bar in the Test Report Selection dialog click Show Report The report for the selected test displays Varian Inc Page 88 Varian 400 DS Automated Apparatus 7 Revision A 05 07 Operation Operator s Manual P N 70 9051 Step 4 Using the buttons on the report toolbar you can do the following Kd rn AShH amp a Qrverty Z sion y Sin the report first skip to a specific page by number page previous page next last page page Electronic Signatures When the user is satisfied with the results the results can be electronically signed The software allows multiple electronic signings of a set of results Each signing is accomplished using the signature dialog box shown The user authenticity is determined by testing the user identification and passwo
41. ep 4 Place the Media A tube into a suitable container with deionized water From the navigation bar click Configuration Select desired configuration Click Calibration The System Calibration screen displays FIGURE 21 System Calibration screen Step 5 Step 6 System Calibration System 33 Gamma3 Label 26 empty sample vials 13 x 4ml and 13 x 1 5ml with 10s Row 1 Vial 1 Row 2 Vial 13 Weigh each of the vials and record their empty masses in the assigned cells in the table below Place the sample vials in rows 1 and 2 of the sample tray Click on the Fill Calibration Volumes button to fill the vials in the first row with with 4ml and the second row with iml of DH20 After the fill process is complete weigh each of the vials and record their filled masses in the table below Balance Calibration Details Mondoctser E Model Name N A Caraion Date 472572007 Serial Number NA Calteation Due Date 4 5 2007 v EA Caltnation Vokmes LreyEject System Serisi Number To 10 Empty Viel Mass 9 Filed Vial Mass 9 Vial Volume mil Row 1 Vial 1 52882 9 1832 3307 Row 1 Vial 2 52993 92170 Row 1 Vial 3 53294 9 2230 Row 1 Vial 4 63157 9 2290 Row 1 Vial 5 52654 91555 Row 1 Vial 6 5 2651 9 1889 Row 1 Vial 7 523m2 91612 Row 1 Vial 8 52452 91556 Row 1 Vial 9 52300 9 1904 Row 1 Vial 10 5 3083 9 1820 Row 1 Vial 17 5 2868 91712 Row 1 Vial 12 52916 9 1941 Row 1 Vial 13 5 2671 9 1485 Row 2 Vial 1 24660 34326 Row 2 V
42. es retrofits or regulatory changes USP Physical Parameters In addition to the apparatus suitability test you must monitor several physical parameters such as stroke distance dip speed and temperature A Certificate of Compliance is included with your Varian 400 DS Contact the Laboratory Services Department for more information on USP physical parameters Varian Inc Revision A 05 07 Varian 400 DS Automated Apparatus 7 Page 21 P N 70 9051 Operator s Manual Introduction Specifications Your tester is designed for indoor use It is suitable for the categories stated below Environmental Specifications Temperature 15 40 C Humidity RH non condensing not more than 80 Physical site clean dry level bench Support weight 150 Ib 68 kg min Engineering Specifications Variable Specification Voltage Requirements 115 VAC 60 Hz 230 VAC 50 Hz Current Requirements 115 VAC 8 0 AMP 230 VAC 8 0 AMP Circuit Breaker 115 VAC 8 0 AMP 250 VAC 50 60 Hz 230 VAC 8 0 AMP 250 VAC 50 60 Hz Power Consumption Max 600 W Loaded Reciprocation 5 35 DPM Reciprocation Accuracy 0 5 Reciprocation Resolution 0 1 DPM Speed Selection Via PC software Temperature Range Ambient to 50 C Varian Inc Page 22 Varian 400 DS Automated Apparatus 7 Revision A 05 07 Introduction Operator s Manual P N 70 9051
43. guration Dialog screen 43 Local Users and Groups screen 44 Miscellaneous tab 45 Logon screen 47 400 DS Workstation screen 48 System Configuration screen 50 System Editor screen 51 400 DS Workstation screen 52 System Calibration screen 60 System Diagnostics screen 62 Sample Tray Control box 65 Reciprocation box 68 Methods screen 70 Method Editor screen 71 Automated App7 Sequence tab 73 Automated App7 Options tab 74 Notifications tab 76 Varian Inc List of Figures FIGURE 30 Select System Step 1 of 2screen 82 FIGURE 31 Select Method Step 2 of 2 screen 83 FIGURE 32 System status screen 84 FIGURE 33 Method Start Options screen 85 FIGURE 34 Test Report Selection screen 87 Varian Inc List of Figures This page was intentionally left blank except for this message Varian Inc chapter1 Safety Practices and Hazards The Varian 400 DS Automated Apparatus 7 has been carefully designed so that when used properly you have an accurate fast flexible and safe instrument If the equipment is used in a manner not specified by the manufacturer the protection provided by the equipment may be impaired Operation of a Varian 400 DS Automated Apparatus 7 involves the use of solid dosage forms and aqueous liquids Unskilled improper or careless use of this instrument can create shock hazards fire hazards or other hazards which can cause death serious injury to personnel or severe damage to equip
44. ial 2 24644 3 4545 Row 2 Vial 3 25074 3 4943 Row 2 Vial 4 25470 35368 Row 2 Vial 5 24732 34233 Row 2 Vial 6 24812 4463 Row2Vial 7 25271 35112 Row 2 Vial 8 24801 3 4566 Row 2 Vial 3 24743 3 4549 Row 2Vial 10 24676 Row 2 Vial 11 24789 Row 2 Vial 12 28011 Row 2 Vial 13 2 4603 Label 13 empty 4 mL sample vials Row 1 Vial 1 Row 1 Vial 13 Label 13 empty 1 5 mL sample vials Row 2 Vial 1 Row 2 Vial 13 Varian Inc Revision A 05 07 Varian 400 DS Automated Apparatus 7 Page 61 P N 70 9051 Operator s Manual Operation Step 7 Weigh each of the vials and record the empty masses in the assigned cells in the table Step 8 Place the sample vials in row 1 4 mL and row 2 1 5 mL of the sample tray Step 9 Click Fill Calibration Volumes to fill the vials in the first row with 4 mL and the second row with 1 mL of deionized water Step 10 After the fill process is complete weigh each of the vials and record their filled masses in the table The vial volume calculates and displays in the table automatically Step 11 Click OK The Reason for Change screen displays Note The software performs a Least Squares Fit analysis The volume Qa deviation from the curve is 1 5 of the vial volume An automated error message is generated if the calibration fails Step 12 Step 13 Step 14 Step 15 Step 16 Step 17 Enter a reason code and change description and click OK Highlight the ap
45. ing Methods on page 77 Delete a method See Deleting Methods on page 77 Edit an existing method See Editing an Existing Method on page 78 Run a report of the method setup See Method Report on page 78 View the method audit trail See Show Audit Trail on page 79 Verify the integrity of a method See Verify Integrity on page 80 Import or export the method between See Import Export XML File on two 400 DS Workstations page 80 Varian Inc Page 70 Varian 400 DS Automated Apparatus 7 Revision A 05 07 Operation Operator s Manual P N 70 9051 Creating a Method To create a new method complete the following steps Step 1 From the navigation bar click Editor The Methods screen displays FIGURE 25 Methods screen Methods Actions Method Version Product Name Notes 3 13 2007 3 14 54 PM L New Method RY Copy Method ia X Delete A Report FA Properties Audit Trail By Show AuditTrail Verity Integrity XML File 1 0 2 Import E Export Step 2 Click New Method The Method Editor screen displays Varian Inc Revision A 05 07 Varian 400 DS Automated Apparatus 7 Page 71 P N 70 9051 Operator s Manual Operation FIGURE 26 Method Editor screen Method Editor Parameters Automated App7 Sequence Automated App7 Options Notifications Sample Information Product Name Product Name Notes Notes User Defined Labels Label 1 Lot
46. ins SharedchemOperators Shared ChemSation Operator Logins HiVidissoAuthorizer Allows the user to sign final accepts gS VidissoDiagnostics Alias the user to change system co Gvictscottethedtent Alans access to Method Creston an GvidicecRurttethods Alans the user to run any methed o BviciccoSystemTontig Alas the user to run degnostic util GBvittedtyOthersMethed Allows modification of methods ovme G VittedfyQthersSystems Alows modification of systems oana Svs Cevekpers Visual Sudo developers can author Step 3 Double click the Groups folder to expand the list of groups Step 4 Click Add to add users to the group The Select Users Computers or Groups screen displays Step 5 Enter the names of the users to add to the group and click OK Step 6 Repeat steps 3 5 as appropriate for each group that requires new users Varian Inc Revision A 05 07 Varian 400 DS Automated Apparatus 7 Page 45 P N 70 9051 Operator s Manual Installation and Setup Step 7 Close the window Step 8 Select the Miscellaneous tab see Figure 15 Miscellaneous tab on page 45 To run the software without physically connecting instruments check the Use Simulated Instruments box The system operates in simulation mode Step 9 Enter an appropriate length of time in minutes the application can be idle before locking FIGURE 15 Miscellaneous tab Security Miscellaneous Use Simulated Instruments Number of idl
47. le cells over the O ring seals as damage can occur Ensure the cell and seal are properly aligned before applying pressure Step 15 With the magnet at the top insert the sample holder into the sample cell Step 16 Repeat steps 12 15 to install the remaining sample cells and holders Step 17 Replace the evaporation cover and tighten the two thumb screws Varian Inc Page 32 Varian 400 DS Automated Apparatus 7 Revision A 05 07 Installation and Setup Operator s Manual P N 70 9051 Initial Power Up Step 1 Step 2 Step 3 Step 4 Ensure the circuit breaker on the rear of the instrument is on Turn on the power switch on the front panel and ensure the integrated red LED illuminates Repeat steps 1 and 2 for each Varian 400 DS Automated Apparatus 7 Turn on the PC monitor and printer Verify the PC power light illuminates and the Microsoft Windows XP or Windows 2000 initializes Software Installation Note To complete the installation of the 400 DS Workstation software you must log on to the PC as an administrator Attaching the ME Database and Local Security Policy are included as part of the software installation procedures The CD contains all of the requirements for an installation To install the software complete the following steps Step 1 Step 2 Step 3 Step 4 Install the 400 DS Workstation CD and access the files Execute the file setup exe and fol
48. low the on screen prompts When asked if you want to install the Microsoft Net Framework V1 1 you must click Yes After the installation has successfully completed install the license dongle by plugging it into an open USB port Varian Inc Revision A 05 07 Varian 400 DS Automated Apparatus 7 Page 33 P N 70 9051 Operator s Manual Installation and Setup FIGURE 5 License dongle Attaching the Database Note k_ K gt This section is only required when upgrading an existing installation Once the basic installation is complete complete the following steps to attach the database files Step 1 Click Start gt All Programs gt Varian gt Dissolution gt MSDE Manager The MSDE Manager screen displays Varian Inc Page 34 Varian 400 DS Automated Apparatus 7 Revision A 05 07 Installation and Setup Operator s Manual P N 70 9051 FIGURE 6 MSDE Manager screen Step 2 Step 3 MSDE Manager Available Servers SCARW005003 VarianDisso z Backup Attach Restore Backup Name Description Database Name Destination Enter Backup Fiename gt i itti s SCS S ea Select a machine name from the list of available servers When connecting to a database installation on a local machine the encrypted password is automatically entered in the password box When connecting to a remote database your system administrator may have to pro
49. lution Server Selection Note I gt A dissolution server must be selected when logging into a server for the first time The same user ID and password that was used to log on to Windows should be used to log on to the 400 DS Workstation software Step 1 From the logon screen enter a domain user identification and password Step 2 Click the drop down arrow corresponding to Dissolution server and select Add New The Add New Dissolution Server screen displays see Figure 11 Add New Dissolution Server screen on page 42 FIGURE 10 Logon screen Logon ap AK VARIAN 400 DS Workstation User ID amp Password Domain VARIANINC Dissolution Server SRE This software is intended for use by authorized personnel only Varian Inc Page 42 Varian 400 DS Automated Apparatus 7 Revision A 05 07 Installation and Setup Operator s Manual P N 70 9051 FIGURE 11 Add New Dissolution Server screen ServerName SOFTENG Port 787 Step 3 If you know the domain name of the computer on which the Dissolution Server is installed enter the name in the Server Name box Alternately click the network browse button to select a server from a list of computers on your network see Figure 12 Browse Dissolution Servers screen below Note I gt lf your network has a large number of systems connected browsing the network may take several minutes
50. ment and property Information on safety practices is provided with your instrument and operation manuals Before using your instrument or accessories you must thoroughly read these safety practices Observe all relevant safety practices at all times Varian Inc Page 12 Varian 400 DS Automated Apparatus 7 Revision A 05 07 Safety Practices and Hazards Operator s Manual P N 70 9051 Electrical Hazards Warning The tester contains electrical circuits devices and components operating at dangerous voltages Contact with these circuits devices and components can cause death serious injury or painful electric shock conducting cleaning or maintenance Warning GN The apparatus should be disconnected from AC power before Panels or covers that are retained by fasteners which require the use of a tool for removal may be opened only by Varian trained Varian qualified or Varian authorized service engineers Consult the manuals or product labels supplied with the instrument to determine which parts are operator accessible Application of the wrong supply voltage connection of the instrument to an incorrectly wired supply outlet or lack of proper electrical grounding can create a fire hazard ora potentially serious shock hazard and could seriously damage the instrument and any attached ancillary equipment Always use a three wire outlet with ground connection which is adequately rated for the load The i
51. n Inc Revision A 05 07 Varian 400 DS Automated Apparatus 7 Page 17 P N 70 9051 Operator s Manual Safety Practices and Hazards WEEE Directive All Varian products that are subject to the WEEE directive shipped after August 13 2005 are compliant with the WEEE marking requirements Such products are marked with the crossed out wheelie bin WEEE symbol shown on page 15 in accordance with European Standard EN 50419 This symbol on the product or on its packaging indicates that this product must not be disposed of as unsorted municipal waste The separate collection and recycling of your waste equipment at the time of disposal will help to conserve natural resources and ensure that it is recycled in a manner that protects human health and the environment For more information on collection reuse and recycling systems please contact your local regional waste administration your local distributor or Varian Inc Varian Inc Page 18 Varian 400 DS Automated Apparatus 7 Revision A 05 07 Safety Practices and Hazards Operator s Manual P N 70 9051 This page was intentionally left blank except for this message Varian Inc chapter2 Introduction The patented Varian 400 DS Automated Apparatus 7 is ideal for extended release products or any dosage form requiring release profiling at multiple pH levels The 13 test samples traverse the two rows of corresponding cells filled with media The Varian 400 DS Automat
52. nit performs the cleaning cycle Prime Volume mL Use the up and down arrows to indicate the volume to be pulled before taking measurement Media Source Use the drop down arrow to indicate the source of the media Media Volume Use the up and down arrows to indicate the desired volume of the media Step 2 Under the Media Control box click Prime Step 3 Under the Cells box click Fill The media moves into the cells Step 4 Under the Sample Vials box use the up and down arrows to indicate the desired row number to sample into and the desired volume Varian Inc Revision A 05 07 Varian 400 DS Automated Apparatus 7 Page 67 P N 70 9051 Operator s Manual Operation Step 5 Under the Sample Vials box click Fill Row The media moves from the cell into the sample vial Step 6 Under the Waste Pump box click On to turn on the waste pump Step 7 Under the Waste Pump box click Off to turn off the waste pump Verifying the Cell Temperature Step 1 Step 2 Step 3 Step 4 Step 5 In the Cell Heat box use the up and down arrows to set the media cell temperature to an appropriate temperature see the sample screen below Cell Heat X 9 EE Start Stop WS X Click stan DO THE SAMPLE CELLS CONTAIN LIQUID displays Click Yes The temperatures display in the Cell Temperature box As applicable click stop Under the Cells box click Purge to purge the remaining media
53. nstallation must comply with local state and federal safety regulations Do not connect the instrument to the main power supply until you have made sure that the operating voltage is correctly set for the main power supply in the specific outlet in your laboratory to which the equipment will be connected Varian Inc Revision A 05 07 Varian 400 DS Automated Apparatus 7 Page 13 P N 70 9051 Operator s Manual Safety Practices and Hazards Reciprocation Hazard The Varian 400 DS Automated Apparatus 7 contains a magnetic plate that reciprocates up and down during operation Trapping an appendage between the evaporation cover and this plate could cause injury Other Other specific warnings and cautions appear in the manuals where appropriate These notifications detail the specific hazard describe how to avoid it and specify the possible consequences of not heeding the warning or caution Warning A Warning message appears in the manual when failure to observe instructions or precautions could result in death or injury Symbols depicting the nature of the specific hazard are also placed alongside warnings These symbols may be used on warning labels attached to the instrument When you see one of these symbols you must refer to the relevant operation or service manual for the correct procedure referred to by that warning label Varian Inc Page 14 Varian 400 DS Automated Apparatus 7 Revision A 05 07 Safety Pra
54. on screen Step 5 Indicate the directory and file name and click Save The code is saved as an XML file which displays in Notepad Step 6 Close the Notepad file To import the XML file at another 400 DS Workstation complete the following steps Step 1 From the navigation bar click Editor The Methods screen displays see Figure 25 Methods screen on page 70 Step 2 Click Import The Import Method from XML File screen displays Note p Alternately you can right click the desired method and select Import The Import Method from XML File screen displays as a result of either of these actions Step 3 Select the appropriate directory and file name and click Open The method displays on the Method screen Varian Inc Page 82 Varian 400 DS Automated Apparatus 7 Revision A 05 07 Operation Operator s Manual P N 70 9051 Running the Method Step 1 From the navigation bar click Run Method The Select System Step 1 of 2 screen displays see Figure 30 Select System Step 1 of 2 screen on page 82 FIGURE 30 Select System Step 1 of 2 screen Select System Step 1 of 2 Select the system to run the method System Desc Laboratory Time Owner Restricted wian Document 10 waos Validation Lab 19 01 2005 11 30 11 AM Everyone NoRestricton MKDIO GYP iat 9 w7010 Validation Lab 8 02 2005 8 57 36 AM Everyone esne IRVGSITGEQI 2 WOS wipp ValdationLab 14 02 2
55. ort of a version other than the most recently saved indicate the appropriate version number on the Version Selection screen Step 5 The method report displays The report can be printed exported searched verified and or signed Audit Trail Once a method has completed the results are available for review audited modification and electronic signature The software maintains complete history for all runs executed on the system Results can be previewed and printed Show Audit Trail To display the audit trail for a method complete the following steps Step 1 From the navigation bar click Editor The Methods screen displays see Figure 25 Methods screen on page 70 Step 2 Select the method and click Show Audit Trail The Method Audit Trail screen displays Note no Alternately you can right click the desired method and select Show Audit Trail The Method Audit Trail screen displays as a result of either of these actions Step 3 Select two or more versions and click Differences in the navigation bar A change report displays The report can be printed or exported Varian Inc Page 80 Varian 400 DS Automated Apparatus 7 Revision A 05 07 Operation Operator s Manual P N 70 9051 Verify Integrity To verify that the method has not been changed outside of the application complete the following steps Step 1 From the navigation bar click Editor The Methods scr
56. propriate system Click Properties Click Next and ensure the Volume Calibration Coefficients are visible Click Finish Close the System Configuration screen Varian Inc Page 62 Varian 400 DS Automated Apparatus 7 Revision A 05 07 Operation Operator s Manual P N 70 9051 Cell Calibration Temperatures Step 1 Place the rinse media line into a suitable container holding deionized water Step 2 From the navigation bar click Diagnostics The Select Item screen displays Step 3 Select the desired system and click OK The System Diagnostics screen displays FIGURE 22 System Diagnostics screen System Diagnostics Gamma3 Firmware Ver Automated Appaatis 7 Sample Tray Control COCCCOOCCOOCOOC FBP BS PO BF BE OF Ge Oe sae oe AY CCCCCCCCCCCCC Dispense Flow Rate 050 4 m s EEPE GE Gee ae ah YET AS Aspirate Dwell Time 10 3 cee es Ce ek ee SEA Needle Clean Cycles 13 ceeececececce Of Prime Voh 500 m E DRE A ee E E Y PLEKSO a ww oF gw Dig St wh Bt OE OF OF ae Be a gy ae ot oC CRRA RAK AS Aspirate Flow Rate 0504 m s Media Source MedaA v Media Volume 500 4 m Waste Pump Cols ee ee ee ee oe Fil Purge On olf ceeceecccececc ee ae ee ee ek 12345678 9 10111213 Tube C Cel Heat Reciprocation T s KE L 9 300 21 OPM if ad Status a Step 4 In the Cells box under Media Control click Fill Media moves into the cells Varian Inc Revision A 05 07 Varian 400
57. rd against the Windows security database Electronic signatures are permanently linked to the results The software always requires the signature to be executed using all the signature components Any attempts to sign a set of results using an invalid user identification password or any combination thereof that is incorrect is automatically recorded to the system audit trail Clean System From the system status screen click 2 All instruments initialize Media is pulled from the Rinse Media Container and cells are filled and expelled through the valves The cells are aspirated and purged Varian Inc Chapter 5 Maintenance Periodic Maintenance Warning The tester contains electrical circuits devices and components operating at dangerous voltages Contact with these circuits devices and components can cause death serious injury or painful electric shock Warning The apparatus should be disconnected from AC power before conducting cleaning or maintenance Periodic maintenance intervals may vary depending on frequency of instrument usage Varian Inc Page 90 Varian 400 DS Automated Apparatus 7 Revision A 05 07 Maintenance Operator s Manual P N 70 9051 Routine Maintenance to be Performed Between Each Dissolution Method All parts of the 400 DS exposed to the dissolution medium should be cleaned after each use Parts made from stainless steel are particularly susceptible to
58. reen Option Description System Configuration Use this option to configure the system See Configuring Your System on page 50 Diagnostics Use this option to check the diagnostics of a dissolution apparatus or accessory within the system See Manual Control Diagnostics on page 64 Method Editor Use this option to create a method change or delete method parameters run a report of the method setup view the method audit trail and verify the integrity of the method See Method Editor on page 69 Run Method Use this option to run a method See Running the Method on page 82 Test Reports Use this option to run a report of the completed method See Test Reports on page 87 Security Change User To change the user click Change User The Logon screen displays Enter the appropriate user identification and password and click Logon Lock To lock the 400 DS Workstation screen click Lock Application Application The 400 DS Workstation Locked screen displays Click the lock or the link to unlock the screen The Logon screen displays Enter the appropriate user identification and password as applicable and click Logon Audit Trail Click Audit Trail The Security Audit Trail screen displays Click Show Report to display the report Change the start date end date and or user identification as desired and click Retrieve Records to change the parameters for the information displayed
59. rian Inc Page 84 Operation Varian 400 DS Automated Apparatus 7 Operator s Manual Revision A 05 07 P N 70 9051 FIGURE 32 System status screen l dle 0 jse scarrndlab BEBEER BEF 12345676 011 1213 Cot Status Activty Log Sample Status 1 1321 Gamma J Noacway Step 4 Test Properties Method ID Method Version Tester Serial Product Name Lot Batch Group Profile Interval Temperature Tolerance Speed Tolerance Dual Sample Dip While Sampling Programmed Timepoints Semple Samp ileVol 01 200 oz 200 03 300 04 400 os 61 1 999 0000 0013 Sample volume Accuracy test Lot Batch Group 00 00 HH MM 0 5 2 0 False False MediaType MediaVol FullRep Nediaa 05 000 Yes Mediad 95 000 Yeo Media 05 000 Yes Mediat 05 000 Yes Mediat 05 000 Yes MNediaa 05 000 Yes Nediad 05 000 Yes Medias 05 000 Yes Mediat 05 000 Yes Medias 05 000 Yes Medias 05 000 Yes Nediaa 95 000 Yes HoldTime 00 00 00 000 00 00 00 00 00 000 00 00 00 00 00 000 00 00 000 00 00 000 00 00 000 00 00 000 00 00 000 00 00 000 00700 a DipInterval DPN 00 30 00 00 30 00 00 30 00 000 30 00 00 30 00 000 30 00 000 30 00 000 30 00 00 30 00 000 30 00 900 30 00 30 30 30 30 30 30 30 30 30 30 8 30 20st gt Click Start The Method Start Options screen displays see Figure 33 Method Start Options screen
60. rst cell heater by placing it over the thermistor at the desired cell position of the Varian 400 DS While holding the jacket in place use the Allen wrench to tighten the screw Insert the 2 pin plug for the heater in the appropriate location on the sample heater jacket Repeat steps 2 4 to install the sample heater jackets for the remaining cell positions Install the magnetic plate on the reciprocation guide rod which is the shorter rod in the middle of the 3 rods on the Varian 400 DS Tighten the bolt on each end of the magnetic plate using the 9 64 Allen wrench Varian Inc Revision A 05 07 Varian 400 DS Automated Apparatus 7 Page 31 P N 70 9051 Operator s Manual Installation and Setup Step 8 Install the guide rod stabilizers on top of the magnetic plate using the two longer guide rods for alignment Step 9 Tighten the two bolts on each stabilizer plate using the 9 64 Allen wrench Step 10 Locate the sample cells and sample holders provided with your instrument Step 11 Remove the sample cells and holders from the packing material to ensure no damage occurred during shipment Step 12 To install a sample cell in the heater jacket slide one end through the magnetic lift plate Step 13 Use the finger tabs on the heater jacket to spread it open Step 14 Continue to lower the sample cell until it is secure and completely covers the bottom cell seal Caution Be careful when sliding the samp
61. rt of the results Profile Interval Enter the timepoint in hh mm format at which the temperature and speed settings are recorded Note Profile measurements are optional Values are always recorded at sample timepoints independent of this setting Change Management If applicable select the box under Change Management in order to restrict the method editing rights to the current user or any user with VkModifyOthersMethod Step 4 Select the Automated App7 Sequence tab see Figure 27 Automated App7 Sequence tab on page 73 Varian Inc Revision A 05 07 P N 70 9051 Varian 400 DS Automated Apparatus 7 Page 73 Operator s Manual Operation FIGURE 27 Automated App7 Sequence tab Method Editor Sample Row 1 2 Sampled Volume 1 00 2 mL Media MediaA v Dissolution Volume 10 00 2 mL Full Replace y Cell Temperature 37 0 c Hold Time 00 00 MM SS DipSpeed 20 2 DPM Dip Interval 001 00 00 HHH MM SS Segt Sample Sample Vol Media Type Media Vol Full Replace Tut Following is a description of the Automated App7 Sequence tab options Option Description Sample Row Use the up and down arrows to indicate the row number for which the parameters are being set After clicking Add to List use the up and down arrows to indicate the next row Media Use the drop down arrows to indicate Media A Media B Media C Media D or Media E Sampled Volume mL Use
62. screen displays FIGURE 20 400 DS Workstation screen System Editor Automated Apparatus 7 Serial Number N A re Cell Size 10m hd Vial Size 1 5m z Syringe Size 10r X Moisture Sensor Control Stop On Intemal Moisture Detection V Cell Calitvation Temperatures Manufacturer N A Model Name N A Serial Number N A Setpoint Temperature C 37 0 Varian Inc Revision A 05 07 P N 70 9051 Varian 400 DS Automated Apparatus 7 Operator s Manual Page 53 Operation Following is a description of the 400 DS Workstation screen options Screen Section Parameter Response Varian 400 DS Automated Apparatus 7 Serial Number Click to display the serial numbers of all connected instruments Highlight the appropriate serial number and click Select Moisture Sensor Control Cell Size Click the drop down arrow to indicate the appropriate cell size Vial Size Click the drop down arrow to indicate the appropriate vial size Syringe Size Click the drop down arrow to indicate the appropriate syringe size Cell Calibration Manufacturer Enter the manufacturer of the calibrated Temperatures temperature probe Model Name Enter the model name of the calibrated temperature probe Serial Number Enter the serial number of the calibrated temperature probe Set Point Temperature C Stop On Internal Moisture Detection Enter the set point for the cell temperature En
63. spect to this product Specifically disclaimed are any implied warranties of merchantability and fitness for a particular use In no event will Varian Inc be liable for any indirect incidental or consequential damages arising from the use of this product This warranty gives you specific legal rights which may vary from state to state or province to province so you may have other rights and some of these exclusions may not apply to you Varian Inc Revision A 05 07 Varian 400 DS Autoamted Apparatus 7 Page 95 P N 70 9051 Operator s Manual Service and Warranty Exclusive Remedies The remedies provided herein are the customer s sole and exclusive remedies In no event shall Varian Inc or its representatives be liable for any direct indirect special incidental or consequential damages whether based on contract tort or any other legal theory Some states or provinces do not allow the exclusion or limitation of incidental or consequential damages so the above limitation or exclusion may not apply to you Varian Inc Page 96 Varian 400 DS Automated Apparatus 7 Revision A 05 07 Service and Warranty Operator s Manual P N 70 9051 This page was intentionally left blank except for this message Varian Inc Index a accessories 23 add new dissolution server screen 42 application configuring 43 audit trail 49 79 automated apparatus 7 workstation screen 48 b browse dissolution servers s
64. station program complete the following steps Step 1 From the navigation bar click Configuration The System Configuration screen displays see Figure 18 System Configuration screen on page 50 Step 2 Select the system configuration and click Verify Integrity Either the data is verified successfully or the user is directed to contact their system administrator Note Op Alternately you can right click the desired system configuration and select Verify Integrity The integrity of the system configuration is checked as a result of either of these actions Step 3 Click OK to close the Data Verification screen Step 4 Close the System Configuration screen Import Export XML File To use an existing system configuration from one 400 DS Workstation computer on a different 400 DS Workstation computer you can export and import the system configuration as an XML file To export the system configuration complete the following steps Step 1 From the navigation bar click Configuration The System Configuration screen displays see Figure 18 System Configuration screen on page 50 Step 2 Select the desired system configuration Varian Inc Revision A 05 07 Varian 400 DS Automated Apparatus 7 Page 59 P N 70 9051 Operator s Manual Operation Step 3 Click Export The Version Selection screen displays Note Alternately you can right click the desired system configuration
65. stics on page 64 move the sample tray from row to row to work in the lubricant Inspect the front door bumper Inspect waste line front view Varian Inc Page 92 Varian 400 DS Automated Apparatus 7 Revision A 05 07 Maintenance Operator s Manual P N 70 9051 Power OFF the 400 DS and disconnect the power cord Remove the back cover of the 400 DS to perform the following Lubricate the ball screw on syringe pump Lubricate all moving pieces of syringe pump Inspect the main drive belt Inspect clean the waste row Inspect clean the waste tubing Inspect all internal stainless steel components for signs of discoloration Lightly wipe the surface with a soft cloth to remove if necessary Lubricate the main rails Inspect the waste line rear view Check lift blocks for free play Varian Inc Chapter 6 Service and Warranty The warranty is provided by Varian Inc or one of its authorized representatives Service and Warranty Information Varian dissolution products carry a one year warranty on parts and labor The Dissolution Systems Service Department or one of its representatives will at its option either repair or replace any mechanical and electrical components in your instrument which prove to be defective During the first year of warranty coverage there is no charge for the labor to repair your unit The Dissolution Systems Service Department or one of its representatives will determine the
66. surface corrosion if not cleaned immediately after use If any stainless steel parts show signs of surface discoloration lightly wipe the surface with a soft cloth or nonabrasive pad to remove it Execute the Clean System cycle using the 400 DS Workstation software Clean System on page 88 Ensure an appropriate cleaning solution is in place to thoroughly rinse the media lines and sample cells If an alternate cleaning solution is used it is recommended that all the media lines are rinsed with deionized water at the end of the cleaning procedure Sample Holders Clean sample holders thoroughly after each use and place them in an ultrasonic bath for a few minutes if necessary When using corrosive materials such as hydrochloric acid or medium containing salts be sure to rinse the holders with deionized water immediately after use Dry completely with a soft towel or cloth preferably lint free Do not clean the sample holders with abrasive cleansers or cloths Use deionized water whenever possible If you must use cleanser or solvent be sure that it is as mild as possible non abrasive and fully compatible with fluorocarbons and stainless steel before use It is suggested that the sample holders are cleaned by hand Use of a laboratory dishwasher is NOT recommended Handle with care at all times Store the sample holders properly between each use Varian Inc Revision A 05 07 Varian 400 DS Automated Apparatus 7 Page 91
67. ter the temperature for each cell as determined from the diagnostic see Cell Calibration Temperatures on page 62 Check this option to shut down the system when moisture is detected Note Enabling this option is recommended Volume Calibration Offset The current offset displays in this area Coefficient Slope The current slope displays in this area Step 4 Click Next The Serial Numbers screen displays Step 5 Enter the serial number for the sample cells sample holders etc and click Add Step 6 Click Finish Varian Inc Page 54 Varian 400 DS Automated Apparatus 7 Revision A 05 07 Operation Operator s Manual P N 70 9051 Step 7 Repeat all the sections under Configuring Your System on page 50 for each additional system Step 8 Close the System Configuration screen Copying a System Configuration To copy a system configuration complete the following steps Step 1 From the navigation bar click Configuration The System Configuration screen displays see Figure 18 System Configuration screen on page 50 Step 2 Select the desired system configuration Step 3 Click Copy Step 4 Click Paste A new system configuration displays The description of the new system configuration is Copy of Step 5 Close the System Configuration screen Step 6 To edit the system configuration see Editing an Existing System Configuration on page 56 Deleting a System
68. tion The most useful thing about this book is This manual would be more helpful if My general impressions of this book are May we contact you regarding your comments YES NO If yes please write your name address and telephone number here Please return this form via mail to Technical Writing Dissolution Systems Varian Inc 13000 Weston Parkway Cary North Carolina 27513 2250 USA Optionally you can return this form via fax at 1 919 677 1550 Always feel free to telephone us to discuss your comments at 1 800 229 1108 Varian 400 DS Automated Apparatus 7 Operator s Manual P N 70 9051 Revision A
69. tus 7 Revision A 05 07 Operation Operator s Manual P N 70 9051 FIGURE 29 Notifications tab Method Editor Parameters Automated App Sequence Automated App7 Options L Email Addresses Notification Options M Eros V Wamings M Status V Timepoint Enter semicolon delimited email addresses Step 7 Enter appropriate e mail address es to receive notification of system operation Step 8 Indicate which options would require notification Step 9 Click OK to close the Method Editor screen Step 10 Close the Methods screen Varian Inc Revision A 05 07 Varian 400 DS Automated Apparatus 7 Page 77 P N 70 9051 Operator s Manual Operation Copying Methods To copy a method complete the following steps Step 1 From the navigation bar click Editor The Methods screen displays see Figure 25 Methods screen on page 70 Step 2 Select the desired method Step 3 Click Copy Method Step 4 Click Paste A new method displays The description of the new method is Copy of Step 5 To change any of the parameters of the method see Editing an Existing Method on page 78 Deleting Methods To delete a method complete the following steps Step 1 From the navigation bar click Editor The Methods screen displays see Figure 25 Methods screen on page 70 Step 2 Select the desired method Step 3 Click Delete Step 4 Click Yes Varian Inc Revision A 05 07 V
70. vide you with a password Click Connect to connect to the server or local PC Varian Inc Revision A 05 07 Varian 400 DS Automated Apparatus 7 Page 35 P N 70 9051 Operator s Manual Installation and Setup Step 4 Select the Attach tab on the MSDE Manager screen and attach the database by clicking Attach Leave all the values at their default settings After successful attachment the Database Attach screen displays Database Attach J P Attached C Program Files Microsoft SQL Serveri MSSQL VARIANDISSO Dataltest_data mdf Step 5 Click OK Step 6 Close the MSDE Manager screen Local Security Policy For 21 CFR Part 11 compliance purposes you must ensure that the following minimum requirements are met by your system s security policy Note I It may be necessary to coordinate the following configurations with the domain administrator Step 1 Click Start gt Run to run the Local Security Settings Manager Type secpol msc and press Enter The Local Security Settings manager displays Varian Inc Page 36 Varian 400 DS Automated Apparatus 7 Revision A 05 07 Installation and Setup Operator s Manual P N 70 9051 Step 2 Click Security Settings gt Account Policies gt Password Policy and set the following security policy configuration Policy Security Setting Enforce Password History 3 passwords remembered Maximum password age 30 days Minimum password length
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