Media Preparation
- Tablet Dissolution Testing Instruments
- Offline Automated Dissolution Systems
- Online Automated Dissolution Systems
- In-Situ Dissolution Testing (Coming Soon)
- Media Preparation
- UV/VIS Spectrometers
Tablet Dissolution Testing Instruments
A dissolution test is a means of identifying and proving the availability of active pharmaceutical ingredient (API) in their delivered form.
Offline Automated Dissolution Systems
The DFC offline semi-automated dissolution testing systems include a dissolution bath, a pump and a fraction collector which collects the sampled dissolution media.
Online Automated Dissolution Systems
Automated dissolution testing in this case means sampling, measuring, and result calculation are automated. The user adds the samples when prompted to do so by the system and takes care of filling and cleaning of the vessels.
Media Preparation
Media preparation and degassing are vital parts of a tablet dissolution test as deaerated media are critical to the reproducibility of dissolution results.
UV/VIS Spectrometers
UV/VIS Spectrometers for Tablet Dissolution Applications
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 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.
- De-aeration and heating of approx. 24 liters of media at the same time
- Pre-heating of media; target temperature adjustable from 30 – 50°C
- Adjustable gravimetric dosing range: 250 – 5,000 g
- 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 3 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
Technical Specifications
| Parameter | Specification |
| Dosing Range | 250 – 5,000g – gravimetric method
250 – 5,000ml – volumetric method |
| Dosing Accuracy | ±0.5% of selected volume – gravimetric method
±0.8% of selected volume – volumetric method |
| Tank Volume | Approx. 24 liter |
| Filling Volume | Not less than min. 10 liter |
| Dispensing Time for 1 Liter | Approx. 45 – 60 seconds |
| De-aeration and Heating Time | 24 liters within approx. 30 – 45 minutes |
| Display | LED backlit LCD, 320×240 pixels, 9″ diagonal, approx. 90x120mm |
| Data Entry | Alpha numerical keypad |
| Method Memory | Store up to 16 methods |
| Printer | Thermo printer, 24 characters |
| Interface | RS232 port |
| Vacuum Level | 0.4 bar absolute |
| Temperature Range | 30.0 – 50.0°C |
| Temperature Accuracy | ±0.5°C |
| Heater Capacity | 900W |
| Calibration | Built-in calibration procedures for digital load cell (weight), digital flow meter (volume) temperature control |
| Height of Dispenser | 130cm from ground floor |
| Space Requirements | 550 x 700 x 900 mm (Length x Width x Height) |
| Packaging Dimensions | Approx. 1070 x 970 x 780cm (Length x Width x Height) |
| Net / Gross weight | Approx. 75 / 110 kg |
| Certification | All components certified to USP / EP requirements |
| CE / EMC Certification | All CE / EMC Certification provided |
| Validation | All IQ & OQ documents included |
Included in the 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
