Tablet disintegration testing instruments are widely used in the pharmaceutical industry to evaluate the disintegration characteristics of formulations and the quality control of different dosage forms.
This range of instruments to test the quality of suppositories, pessaries and creams includes disintegration and penetration testers.
Tablet hardness testing is used to test the breaking point and structural integrity of a tablet prior to storage, transportation, and handling before usage.
Many liquid drugs are delivered in ampoules.We offer a fully DIN/ISO 9187 compliant solution to test the hardness of empty ampoules at line during production.
Friability testing is used to test the durability of tablets during packing processes and transit. This involves repeatedly dropping a sample of tablets over a fixed time, using a rotating drum with a baffle.
The Pharma Test powder testing product portfolio includes instruments to not only measure bulk density but also tap density and flowability.
The leak test apparatus is used in the pharmaceutical industry to check the integrity of tablet strips, blister packs and small bottles.
Ampoule Breakpoint Tester
The PTBA 211E ampoule breakpoint tester is designed and manufactured in compliance to the DIN EN ISO <9187-1/2:2010> standard. According to this standard the break point of ampoules has to be tested to control the quality during production of empty ampoules and prior to the filling process.
Ampoule Testing Instruments
The PTBA 211E by Pharma Test is an ampoule hardness (or breakpoint) testing instrument. Ampoules with a volume of 1 to 30ml may be tested and up to 250 tests per series for statistical evaluation are possible. The results may be printed which include a batch code and a date and time stamp.
Easy calibration and validation possible with full calibration report. Stainless steel design, easy to operate features.
>Dual force mode instrument with linear speed increase and linear force increase modes
>Multiple point validation procedure built-in
>Programmable print-out of force increase curve
>Breakpoint testing of empty ampoules in compliance with the DIN EN ISO <9187-1/2:2010>
>Force standard setting: linear speed increase 10mm/min. (adjustable)
>Automatic re-start facility to speed up the testing sequence
>Entry of time and date
>Enter a 12 digit batch number
>Documentation of all results using a separate PCL5 or dot-matrix printer
>Programmable print-out of force increase curve
>Data transfer via RS-232 interface
>Validation and calibration program for the measurement station
>Dual point adjustment of the load cell for the hardness test station
>Multiple point validation (calibration)
| Parameter | Specification |
| Display | LED Display showing number of tests and breakpoint result |
| Data Entry | Numerical and Functional keys |
| Standard Force Range | 5.0 to approximately 300N (optional 500N) |
| Accuracy | < 1N |
| Resolution | 0.074N (300N model) – 0.1482N (500N model) |
| Force Settings | Linear speed or linear force increase (standard setting: linear speed 10mm/Min) |
| Selectable Range | 4.0 – 200 Millimeter/Minute or 5.0 – 200 N/Second |
| Accuracy | < 2% force or < 0.1% speed |
| Printer | Parallel Interface to connect Dot-Matrix or PCL 5 Printer |
| Interface | RS232 COM port |
| Calibrations | Multiple point for load cell precision using certified weights (PT-CAL15/30 and PT-CAL 50) |
| Calibration Guidance | Built-in calibration procedures the digital load cell |
| Adjustments | Two point adjustment – zero and 10kg |
| Force Detection Reproducibility | PT-MT3 Magnetic Tablet and suitable support |
| Instrument Housing | Stainless Steel (312) to meet GLP requirements |
| Bench Space Requirement | L 30cm x W 30cm x H 48cm (without external printer ) |
| Certification | All components certified to DIN EN ISO requirements |
| CE / EMC Certification | All CE / EMC Certification provided |
| Validation | All IQ & OQ documents included |
Included in the Standard Scope of Supply
>Standard Jaw set to allow breakpoint test of all size of ampoules up to 30ml
>Broken Sample collector and protection shield
>Comprehensive documentation folder including:
>>User manual
>>QC/DQ testing certificate
>>IQ documentation
>>OQ documentation
>>Conformity Declaration
>>CE/EMC Declaration
>>Instrument logbook
