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1. next sampling interval elapsed time Wake up functionality to start heating at a pre programmed time Ultra fast heating system with excellent temperature stability Water diffuser for even temperature distribution Vibration absorber to avoid vibration transfer into the USP EP vessels Spring loaded pump assembly to eliminate vibration transfer to the frame work MonoShaft system to avoid re adjustment of immersion depth Staggered start feature for convenient manual sampling DQ QC IQ and OQ documents included free of charge Features The main features of the PTWS D610 are Fully USP lt 711 724 gt and EP lt 2 9 3 4 gt compliant 12 stirred positions separate speed control for front and back line stirrers Rigid motorized lift drive to raise and lower the head File up a nearly unlimited number of different test descriptions methods Instrument suitability check prior to start of a test run Staggered start capability Vessel low evaporation sealing covers Drainage tap to empty the bath Method management and user administration User access control password expiry control Built in thermo printer to print a test log at the end of a run Optical and acoustic signals to inform about sampling intervals timer count down Traffic Light optical information on display shows the instrument status by different colors green ready to use yellow preparing to use red error encountered O2. robot which features the capability of sample dilution and media refilling The DSR M offers excellent sampling and refilling accuracy via the fully integrated valve less piston pump module Sampling time and interval control is programed the PTWS D610 while volume dilution ratio and refilling option are set at the DSR M instrument For an online automated system it is possible to use a UV VIS spectrophotometer with a multiple cell changer The spectrophotometer and pump of such a system is controlled by the powerful WinDiss ARGUS dissolution software WinDiss ARGUS features drivers for most commonly available UV VIS spectrometer types like Agilent 8453 Diode Array or conventional UV VIS _ a monochromatic spectrophotometers preferably double beam ana scanning poren such as the Analytic Jena Specord SP200 or the Perkin Elmer Lamda series as well as drivers for many popular types of pumps p THE GERMAN GRUNDLICHKEIT PTAG_30 00350_ PTWS_D610_V2 0E Docx Page 4 of 8 onarmd TEST PTWS D610 USP EP Tablet Dissolution Testing Instrument Advantages Some of the highlights the PTWS D610 offers are 6 front line and 6 back line vessels for easy access in manual operation Separate speed control for front and back line Stirrers Individual 3 point vessel centering Excellent access to all vessels Screen information offers most important information at a glance stirrer speed bath temperature time to
3. Q PQ interval warning with programmable interval Interfaces USB port for to use the memory stick RS232 port for external control I O port for remote control of external instruments in automated applications Heater safety system includes thermo switch thermo fuse and flow sensor Calibration menu for stirrer speed bath temperature pH probe Heater wake up and sleeping mode for less energy consumption THE GERMAN GRUNDLICHKEIT PTAG_30 00350 PIWS_D610_V2 0E Docx Page 5 of 8 onarmd TEST PTWS D610 USP EP Tablet Dissolution Testing Instrument Standard Scope of Supply The PTWS D610 comes ready to use with the following standard scope of supply One set of stainless steel paddles One set of 1000mI Borosilicate glass vessels One set of depth adjustment balls One bottle of ALGEX water preservative Comprehensive documentation folder including User manual DQ QC instrument compliance test certificate Q documentation OQ documentation Instrument logbook Compliance certificates for vessels and stirring tools Options In addition to the standard scope of supply Pharma Test offers a broad range of accessories and options including Direct control of peripheral instruments via I O port such as PTFC 16 fraction collector or DSR M Sampling Robot Amber colored vessels for UV sensitive test materials Full range of MonoShaft stirring tools available Full range of certified validation t
4. are inserted into the instrument support framework Each vessel is correctly centered against the stirring tool while this position is secured even when the vessels are removed for cleaning and placed back afterwards The access points for sampling as well as the openings for the tools are contained in an auxiliary low evaporation vessel cover Lift Mechanism The upper drive is motorized and electronically controlled it offers eight programmable positions an upper cleaning position and lower working positions are programmable depending on the type of Stirring tool used The upper position offers ideal access to the stirring tools and vessels for a change of tools and cleaning steps between the dissolution tests The rigid design of the electronically driven lift mechanism ensures that the whole lift drive mechanism is positioned in a way so that the tool shafts are always kept parallel and at a 90 angle to the vessel walls when in the working position w WE GERMAN GRUNDLICHKEIT PTAG_30 00350_ PTWS_D610_V2 0E Docx Page 2 of 8 r onarmd TEST Heating System PTWS D610 USP EP Tablet Dissolution Testing Instrument x The ultra fast heating system is contained in a easy to remove platform within the stainless steel housing _ Access to pump heater and all safety sensor system is possible without to move the bath from its qualified position The connections between the heater and the bath are made by qui
5. blet Dissolution Testing Instrument common sampling time points and so on The test method memory capacity is almost limitless As soon as the test is started the display shows the most important information so that this information remains visible even at time when the operator is not standing directly in front of the instrument The user access administration of the filing system protects the system from unauthorized actions The traffic light information center clearly shows the operator the status of the instrument running well green light slight problem yellow or out of specification red All this is automatically logged the log file can be printed any time using the built in thermo printer Stirring Tools The PTWS D610 uses the Pharma Test MonoShaft design Tools consist of the main shaft plus interchangeable tool heads adapters The main shaft remains in place in the instrument regardless of the tool head being used The clearance of each tool from the vessel base will always be correct once the main tool shaft has been installed and fixed in its position PRDPRPRREPPRRES lt 1 iii iti isi ists ed A wide variety of different stirring tools is available while the standard configuration includes USP EP App 2 Paddle stirrers The PTWS D610 features a three point individual centering system for each dissolution vessel picture shows view from below The vessels are held in position by three adjustable noses and
6. bly Built in calibration procedures for speed temperature control OQ PQ interval programmable including alarm indicator 112 x 58 cm 137 x 88 x 78 cm W x Dx H All components certified to USP EP requirements All CE EMC Certification provided All IQ amp OQ documents included We reserve the right to make technical changes without any prior notice PTAG_30 00350 PIWS_D610_V2 0E Docx THE GERMAN GRUNDLICHKEIT Page 8 of 8 a
7. ck connect fittings for easy connection and disconnection Water is pumped through _ the system using a powerful yet quiet circulation pump The pump itself is spring mounted to limit vibration transmission and the flow through heater is protected from overloading overheating in case of control electronics failure via a thermal fuse as well as a thermo switch for added security With service and maintenance in mind access to the compact pump and heater section is easily achieved without having to move the main body of the instrument Water Bath The U shaped water bath rests on vibration absorbers to avoid any vibration transfer from either inside the instrument or even from external equipment placed on the same bench surface The bath cover can also be easily unscrewed for cleaning The water bath contains a water diffuser for faster heating and to ensure that heated water is evenly distributed throughout the whole bath A tap allows emptying the bath if this should be required Motorized Sampling System EPE 1210 which lowers and rises the sampling ferrules into the media and after sampling back out again 10 different sampling positions can be programmed ITM 1210 Media Temperature Monitoring system which is attached to the EPE 1210 will read and report the media temperature while sampling And a manual or motorized Tablet Dropping Magazine _ TM TMA 1210 with its attached low evaporation vessel sealing covers complete
8. h keys Programmable acoustic signal for operator information Programmable sampling times wake up and sleeping mode operation time information and timer count down mode 8 Programmable stirrer immersion positions paddle over disk transdermal cylinder etc Unlimited number of different test descriptions can be file Dual Level access control password expiry date control Programmable time periods to remind on QO or PQ testing Built in thermo printer 12 6 6 arrangement 1 liter USP EP Borosilicate glass vessel each individually coded 25 250 RPM 2 of set speed typically lt 1 Better than 0 2 mm total run out MonoShaft stirrer design USP EP apparatus 1 2 5 6 tool adapter cream cell transdermal patch tools each tool and vessel individually coded Pump for water circulation and 1400W heater for fast heating up lt THE GERMAN GRUNDLICHKEIT Page 7 of 8 a onarmdl TEST Heater Range Heater Accuracy Heat Up Process Water Circulation Vibration Elimination Calibration Bench Space Requirement Packaging Certification CE EMC Certification Validation PTWS D610 USP EP Tablet Dissolution Testing Instrument 25 450 0 2 inside the water bath Energy saving programmable wake up heater function and sleep mode Water circulated from external heating system through special diffuser inside the water bath Water bath rests on vibration absorbers spring loaded pump assem
9. onan TeST PTWS D610 USP EP Tablet Dissolution Testing Instrument PTWS D610 USP EP Tablet Dissolution Testing Instrument The PTWS D610 is Dual Drive 6 6 stirred position tablet dissolution testing instrument for solid dosage forms as described in USP chapter lt 711 724 gt and EP section lt 2 9 3 4 gt as well as the DAB BP and Japanese Pharmacopeia section lt 15 gt having 2 extra beakers to take media refilling and reference standard media The PTWS D610 is the ideal choice for Bio Waiver studies and Dissolution Method Development User Interface In keeping with our cutting edge design a large LC Display informs of the various mechanical features of the instrument such as the tool stirring speed for front and back line stirrers common lift drive and heater The instrument control is menu driven Visual signals on the display inform the user of the status of critical instrument parameters e g bath target temperature stirring speed etc If certain operational parameters form a regular feature of the daily routine then these can be incorporated into a test method for faster set up These parameters can be tool speed for front and back line stirrers common target bath temperature Pharma Test Apparatebau AG P 49 6182 9532 600 Siemensstr 5 F 49 6182 9532 650 63512 Hainburg Germany info pharma test de www pharma test com PTAG_30 Page 1 of 8 00350 PIWS_D610_V2 0E Docx onarmd TEST PTWS D610 USP EP Ta
10. ools available EPE 1210 motorized sampling system ITM 1210 media temperature monitoring system TM 1210 manual tablet drop magazine TMA 1210 automated tablet drop magazine o THE GERMAN GRUNDLICHKEIT PTAG_30 00350 PIWS_D610_V2 0E Docx Page 6 of 8 a onaamd TEST PTWS D610 USP EP Tablet Dissolution Testing Instrument Example Runtime Report PTA DISSOLUTION TEST INSTRUMENT TYP PTWS300 S N 10710 Product Muster Start Test 04 19 2002 15 48 Nom Speed 50 rpm PH Meter not activated Operator PT Info Test wait for Corr Par 1 Start rpm 50 Temp 37 0 2 Interval m rpm 50 Temp 36 9 5 TS 36 2 2 T6 36 4 4 Tvs 37 0 0 TS 36 3 3 Interval 2 rp 50 Temp 37 0 Ti 36 8 T2 36 2 T3 36 7 T4 37 2 End Runtime Report ERRORS 2 Batch OO7 Test End 04 19 2002 15 54 Nom Bath Temperatur Test Start Condition all correc t 04 19 2002 15 48 04 19 2002 15 48 2min 04 19 2002 15 49 ec 2min 04 19 2002 15 51 2c Technical Data Standard Version Parameter Display Data Entry Acoustic Signal Timer Stirrer Position Testing Method Descriptions User Access Control OQ PQ control Printer Number of Stirred Vessels Standard Vessels Speed Control Speed Accuracy stirrer Shaft Wobble System Tools Heating System PTAG_30 00350 PTWS_D610_V2 0E Docx Specification 6 320 240 Pixel LCD illuminated in monochrome Alpha numerical and functional touc
11. the set of useful accessories for automation w THE GERMAN GRUNDLICHKEIT PTAG_30 00350_ PTWS_D610_V2 0E Docx Page 3 of 8 r onarmdl TEST PTWS D610 USP EP Tablet Dissolution Testing Instrument Offline Sampling and Sample Preparation For offline automation with fraction collection the PTFC 16 fraction collector as well as either a IPC 12 channel peristaltic pump two PT SP8 multiple syringe pumps or a CAT piston pump can be added to the PTWS D610 Using the PTWS D610 within an automated system offers the operator full access to the vessels before and at the end of a run as the complete drive head is lifted electronically Sampling sequence timing is programmed using the menu system of the PTWS D610 instrument a while sampling volume and the optional media refilling process is programmed at either the PTFC 16 or DSR M No external software is necessary in this system The motorized sampling system EPE 1210 is used to lower the sampling ferrules while sampling into the dissolution vessels When sampling is finished the sampling ferrules are raised out of the media and the system waits for the next cycle Each sampling ferrule holds a 5 or 10u PP sinter filter When the tablets have been dropped into the dissolution vessels the automated sampling process starts If the refilling option is used media refilling will start automatically after a sample has been withdrawn It is also possible to use the DSR M dissolution sampling
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