PT-DDS4 Media Preparation and Degassing System
Contents
1. Adjustable volumetric dosing range 250 5 000ml optional Online buffer mixing adjustable buffer dosing range 100 5 000g optional LC display and keypad to show and enter data like product information batch no media density etc Live information about the remaining tank volume minimum 1 liter File up to 16 de aeration procedures methods Built in adjustment and calibration program for the digital load cell and flow meter Built in thermo printer to report the dosed media weight or volume and to document of adjustment and calibration results Standard Scope of Supply The PT DDS4 comes ready to use with the following standard scope of supply Gravimetrical dosing set up Electro polished stainless steel tank max capacity approx 24 liters Stainless Steel dosing dish to hold dissolution vessels Comprehensive documentation folder including User manual DQ QC instrument compliance test certificate Q documentation OQ documentation Instrument logbook Options In addition to the standard scope of supply Pharma Test offers a broad range of accessories and options including Volumetric dosing system pH buffer dosing system Upgrade kit for foaming media Support stand to take up to 6 USP vessels Full range of certified validation tools including DO tester to read the amount of de aeration available Pharma Test Apparatebau AG P 49 6182 9532 600 Siemensstr 5 F 49 6182 9532 650 63512 H2. The curved inlet tube directs the medium against the barrel wall where it can gently flow down the tank thus preventing an excessive foam build up The inlet tubes can be changed freely by the user The inlets are secured by a knurled head screw An upgrade kit for existing PT DDS4 instruments is available as well P 49 6182 9532 600 F 49 6182 9532 650 info pharma test de www pharma test com Page 4 of 10 onarmd TEST PT DDS4 Media Preparation and Degasing System Gravimetric Dosing is the Most Accurate Method of Liquid Dispensing In this mode the medium is directly dispensed into the dissolution vessel which is placed safely in its stand during filling The dosing volume can be adjusted within a range of 250 to 5 000g with an accuracy of 0 5 max 1ml This accuracy is much better than what any current Pharmacopoeia requires Enter the media density to correct the dosing The temperature can be adjusted as well within a range of 30 0 to 50 0 with an accuracy of 0 5 The media is constantly circulating while the vacuum level is kept constant Inlet P 10 ley 11 H 12 Bo SL 13 TB 7 op evacuation t breather P drain D44 circulation Figure 3 Operating Principle Gravimetric Dosage Legend 1 Medium Reservoir 2 Circulation Pump 3 Temp Control Sensor 4 Heater 5 Temp Security Sensor 6 Decompression Valve 7 Vacuum Switch 8 Vacuum Pump 9
3. Dosage Valve 10 USP Vessel 11 Load Cell 12 Inlet Valve 13 Inlet Flow Sensor 14 Drain Valve 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_38 31200_PT Page 5 of 10 DDS4_V2 3e Docx onarmdl TEST PT DDS4 Media Preparation and Degasing System Volumetric Dosage is Selectable As Well This mode of dosage is very convenient and time effective for the end user Here the de aerated medium is filled directly into the dissolution vessels which are installed in the dissolution bath The design of the filling arm ensures a slow filling along the side of the vessels to avoid oxygen saturation while filling ip 6 Ht 7 circulation evacuation breather oP Y arate D14 Figure 4 Operating Principle Volumetric Dosage Legend 1 Medium Reservoir 2 Circulation Pump 3 Temp Control Sensor 4 Heater 5 Temp Security Sensor 6 Decompression Valve 7 Vacuum Switch 8 Vacuum Pump 9 Dosage Valve 10 USP Vessel 11 Load Cell 12 Inlet Valve 13 Inlet Flow Sensor 14 Drain Valve 18 Dosage Low Flow Sensor 19 Dosage Check Valve 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_38 31200_PT Page 6 of 10 DDS4_V2 3e Docx onarmdl TEST PT DDS4 Media Preparation and Degasing System Online Buffer
4. Mixing Using the Built in Electronic Load Cell Balance is Available as Well Simply enter the amount and density of the buffer range from 100g to 5 000g to be filled into the pre filled storage tank buffer LAG dosage gy oi 11 o L a dosage me i een a pricey 10 7 X ect 11 E 6 La 7 circulation O i a evacuation breather drain VA D14 Figure 5 Operation Principle Buffer Preparation Station Legend 1 Medium Reservoir 2 Circulation Pump 3 Temp Control Sensor 4 Heater 5 Temp Security Sensor 6 Decompression Valve 7 Vacuum Switch 8 Vacuum Pump 9 Dosage Valve 10 USP Vessel 11 Load Cell 12 Inlet Valve 13 Inlet Flow Sensor 14 Drain Valve 15 Buffer Beaker 16 Check Valve 17 Buffer Dosage Valve 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_38 31200_PT Page 7 of 10 DDS4 V2 3e Docx onanmdd TEST PT DDS4 Media Preparation and Degasing System a Figure 6 Directly Filling a Vessel using the Volumetric Dosing Option Advantages Some of the highlights the PT DDS4 offers are De aerates to approx 35 of rest gas content residual oxygen less than 5 ppm inside PT DDS4 container Pre heats your media to save time during start up of dissolution tests Fill up program under pressure connect directly to factory de min water supply Fill up prog
5. ainburg Germany info pharma test de www pharma test com PTAG_38 31200 PT Page 9 of 10 DDS4_V2 3e Docx onan TeST PT DDS4 Media Preparation and Degasing System Technical Data Parameter Dosing Range Dosing Accuracy Tank Volume Dispensing Time for 1 Liter De aeration and Heating Time Display Data Entry Method Memory Printer Interface Vacuum Level Temperature Range Temperature Accuracy Heater Capacity Calibration Space Requirements Height of Dispenser Net Weight Gross Weight Packaging Dimensions Certification CE EMC Certification Validation Specification 250 5 000g gravimetric method 250 5 000mI volumetric method 0 5 of selected volume gravimetric method 0 8 of selected volume volumetric method Approx 24 liters Approx 45 60 seconds 24 liters within approx 30 45 minutes LC Display 320x240 pixels 8 x 8cm screen Alpha numerical keypad Store up to 16 methods Thermo printer 24 characters RS232 port 0 4 bar absolute 30 0 50 08 0 5 900W Built in calibration procedures for digital load cell weight digital flow meter volume temperature control 55 x 70 x 90cm W D H 130cm from ground floor Approx 75 kg Approx 110 kg 107 x 97 x 78cm W D 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 pri
6. ee TeST PT DDS4 Media Preparation and Degasing System PT DDS4 Media Preparation and Degassing System Media degasing or de aeration pre heating to a temperature of 37 and absolutely precise gravimetric dispensing according to the recommendations and demanded for dissolution testing from the US FDA authorities are standard for the Pharma Test PT DDS4 media preparation and degasing system De aeration is generally recommended to prevent the formation of bubbles on the dosage form surface which may cause a variation in active dissolution rates by virtue of surface obscuration 7 THE GERMAN GRUNDLICHKEIT PTAG_38 31200 PT DDS4_V2 3e Docx Page 1 of 10 Se onarmdl TEST PT DDS4 Media Preparation and Degasing System Effective media de aeration is one of the most important requirements for a successful tablet dissolution test USP reference standard tablets RST for PVT tests in particular react very sensitive to ineffectively de aerated media Often the test fails to arrive at the required results for the release even if all technical parameters of the dissolution bath in use have been checked and passed the tests A save and efficient way of media de aeration of un dissolved oxygen O2 is offered by the techniques the PT DDS4 is using The prepared media buffer is filled by means of vacuum or manually into the storage and heating tank of the instrument While the media is heated it is being constantly circ
7. or notice THE GERMAN GRUNDLICHKEIT PTAG_38 31200 PT DDS4_V2 3e Docx Page 10 of 10
8. pharma test de www pharma test com Page 2 of 10 T N TEST PT DDS4 Media Preparation and Degasing System Factors affecting the PQ results Type Rating Influence degree Speed significant oso significant sso significant soas The influence of air inside the media on Tablet Dissolution Test results Non de aerated media have a definite impact on the results of a tablet dissolution test For example non de aerated media can increase Prednisone release rate up to 50 compared to the release rate using properly de aerated media Figure 1 Prednisone Test after 10 Min using De Aerated Media No Floating Particles 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_38 31200_PT Page 3 of 10 DDS4_V2 3e Docx onarmdd TEST PT DDS4 Media Preparation and Degasing System Figure 2 Prednisone Test after 10 Min using Non De Aerated Media Increased Release Rate because of floating particles lower tablet cone Handling of Foaming Media with PT DDS4 Pharma Test Apparatebau AG Siemensstr 5 63512 Hainburg Germany PTAG_38 31200 PT DDS4_V2 3e Docx To improve the degassing and dosing of foaming media like SPS with the Pharma Test PT DDS4 media preparation system a new alternative inlet tube system is available now A curved inlet tube can be used as an alternative to the standard diffuser inlet
9. ram under vacuum prime from any external container Can be upgraded to de aerate and dispense SPS foaming media Can be used to directly dose into any vessel arrangement inside the dissolution bath Special adapter to handle foaming media available optional The instrument is movable and fits underneath most laboratory benches Includes a balance load cell and all accessories for gravimetrical dosing Good access to the media tank easy to control the cleaning and test procedure The only instrument which offers a software supported calibration program to validate and calibrate dosing accuracy using a certified 1 kg weight Dosing performance test possible using built in strain gauge Correct dosing accuracy by entering density of media changes because of temperature or solvent used Maximum of 2 liters waste when media change has to be done Noise protected max noise level approx 55dB lIQ OQ documents included free of charge 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_38 31200_PT Page 8 of 10 DDS4_V2 3e Docx onarmd TEST PT DDS4 Media Preparation and Degasing System Features The main features of the PT DDS4 are De aeration and heating of approx 24 liters of media at the same time Pre heating of media target temperature adjustable from 30 50 Adjustable gravimetric dosing range 250 5 000g
10. ulated under vacuum within the tank Because of this way of operating the PT DDS4 provides fully de Pharma Test Apparatebau AG Siemensstr 5 63512 Hainburg Germany PTAG_38 31200 PT DDS4_V2 3e Docx aerated and preheated media ready to be dispensed into the USP dissolution vessels Therefore another huge advantage of media preparation in this way is the time saved during the startup of subsequent dissolution runs because the media is already at the required testing temperature of 370 PT DDS4 is more effective than other available instruments because the de aeration process can be maintained for as long as required as opposed to instruments which only de aerate during the actual dispensing PT DDS4 features a large back lit LCD screen The user menu offers the possibility to program the dispensing weight volume the temperature to pre heat the media and the total de aeration time All information including dosed weight volume and statistics can be printed via the built in thermo printer The portable nature PT DDS4 instrument offers the user easy servicing of many dissolution baths The built in pre heating tank is easily removable for cleaning Open the drainage valve and empty the tank of any medium left Flush the tank again and repeat the software assisted process When the media has to be changed a tube flushing run is automatically done previous to any dispensing P 49 6182 9532 600 F 49 6182 9532 650 info
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