PT-DDS4 Media Preparation and Degassing System Media degassing or “de-aeration”, pre-heating to a temperature of 37°C 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 degassing 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. Pharma Test Apparatebau AG Siemensstr. 5 63512 HAINBURG GERMANY T: +49 6182 9532-600 F: +49 6182 9532-650 [email protected] www.pharma-test.com THE PHARMA TEST GROUP

PT-DDS4 - Media Preparation and Degassing System Test Procedure 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....

PT-DDS4 - Media Preparation and Degassing System Easy Access 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 Factors affecting the PQ results Type Temperature Speed Vibration Centricity Dissolved Gas Media pH Media Contamination Sampling Position Rating not...

PT-DDS4 - Media Preparation and Degassing System Handling of Foaming Media with PT-DDS4 To improve the degassing and dosing of foaming media, like SDS 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. 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...

PT-DDS4 - Media Preparation and Degassing 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. Operating Principle Volumetric Dosage 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...

PT-DDS4 - Media Preparation and Degassing System Advantages » 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 program 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)...

PT-DDS4 - Media Preparation and Degassing System 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 » IQ 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:...

PT-DDS4 - Media Preparation and Degassing System Technical Specifications Parameter Dosing Range 250 – 5,000g - gravimetric method 250 – 5,000ml - volumetric method ±0.5% of selected volume - gravimetric method ±0.8% of selected volume - volumetric method Approx. 24 liter Approx. 45 - 60 seconds 24 liters within approx. 30 - 45 minutes LED backlit LCD, 320x240 pixels, 9" diagonal, approx. 90x120mm Alpha numerical keypad Store up to 16 methods Thermo printer, 24 characters RS232 port 0.4 bar absolute 30.0 – 50.0°C ±0.5°C 900W Built-in calibration procedures for digital load cell (weight), digital...