The company was founded in 1979 by Franz J. Fähler. Today, Pharma Test offers a wide range in two product categories, “Galenic Instruments” and “Dissolution Testing”. Dissolution testing systems in pharmaceutical tests are used to test the quality of solid dosage forms such as tablets, capsules, suppositories, ampoules and bulk materials. The Galenic range contains all the instruments used to test the physical parameters of solid dosage formats and powders and granules.
Tablet disintegration testing instruments
Tablet disintegration testing instruments are widely used in the pharmaceutical industry to evaluate the disintegration characteristics of formulations and to control the quality of various dosage forms. All Pharma Test tablet and capsule disintegrants are fully compliant with the current USP and EP pharmacopoeia and also support Type A and B baskets for regular or larger samples. They have a stainless steel housing, which is GMP compliant with colored housing designs. Pharma Test disintegration instruments are available with several levels of automation:
Fully automated decomposition test: PTZ AUTO EZ
Semi-automated decomposition test: PTZ AUTO
Manual decomposition test: PTZ-S, DIST-3
The addition of the PT-ODF decay basket is a unique device for testing the decay time of orodispersible films.
Suppository Testing Instruments
The European Pharmacopeia describes methods to test the disintegration time and softening time of suppositories. Disintegration time is measured by placing the samples into rotating baskets inside a heated water bath. The softening time is the time for which the suppository melts at a certain temperature. This is an indication for the hardness of the base. This range of instruments to test the quality of suppositories, pessaries and creams includes disintegration and penetration testers.
Ampoule Testing Instruments
Many liquid drugs are delivered in ampoules. Quality control of this glassware is important to ensure that no glass particles enter the drug solution when the ampoule is opened. We offer a fully DIN / ISO 9187 compliant solution to test the hardness of empty ampoules at line during production.
Tablet friability testing instruments
The friability test is used to test the durability of tablets during the packaging and transit process. This involves successively dispensing a tablet sample over a period of time, using a rotating barrier drum. The result is examined for broken tablets and the percentage by weight of the tablet lost through chipping. All Pharma Test fragility is fully compliant with the current USP, EP and JP pharmacopoeia and is ready for use with the fragility drums (“Roche”) included in the standard scope of delivery. Abrasion drums are available as an option, as well as fragile drums with antistatic coating.
Powders are used in many industries today and the bulk properties of a powder are dependent upon the preparation, treatment, and storage of a sample. Since small disturbances of bulk powders result in a changed bulk density, it is often very difficult to measure with good reproducibility. The Pharma Test powder testing product portfolio includes instruments to not only measure bulk density but also tap density and ﬂowability. We also offer added benefits by combining ﬂowability measurement with NIR (near-infrared) spectroscopy to give as much in-depth information about your powders as possible.
Leak testing instruments
The leak tester is used in the pharmaceutical industry to check the integrity of tablet strips, blisters and small vials. It also finds application in the food industry where it can be used effectively to check the impermeability of sweet packets, ready-to-eat ready-to-eat foods, confectionery packaging, noodle packaging, sauces.
Tablet dissolution testing instruments
The dissolution test is a means of identifying and proving the availability of an active pharmaceutical ingredient (API) in the supplied form. The dissolution test reflects the availability of the active substance and allows the prediction of the time for complete release of the material from the dosage form. All Pharma Test tablet dissolution testing instruments are fully compliant with USP and EP. They use our MonoShaft tool system and include a full set of containers and 2 USP blades. A full range of dissolving additives is also available.
Offline Automated Tablet 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. The DSR-M systems can offer online dilution in addition to the sampling. Automated refilling of the collected media back into the testing vessels is possible for both the DFC and DSR-M systems.
What Does Semi-Automated Tablet Dissolution Testing Mean?
Semi-automated in this case means automated sampling for a dissolution test instrument at pre-programmed times. Automating this step alone eases the dissolution job a lot. After all samples have been dropped, the dissolution test proceeds automatically and all samples are simultaneously removed from each connected vessel. The sample is delivered into a connected fraction collector by either a PT-SP syringe pump, a peristaltic pump, or a valve-less piston pump. These systems do not require any external PC software to control them (the WinDiss ARGUS dissolution software package can be used optionally). Sampling information is entered directly at the connected Pharma Test dissolution testing instrument.
Automatic online dissolution testing
Automated dissolution testing in this case means that sampling, measurement and calculation of results are automated. The user adds samples when prompted by the system and takes care of filling and cleaning the containers. Network ADS-L systems are so-called “closed loop” dissolution systems. The basic units of ADS-L automated network dissolution systems are a dissolution test instrument type PTWS 120, PTWS 820, PTWS 620, PTWS 1220 or PTWS D620, TIDAS L diode array UV / VIS spectrophotometer with multicellular inverter, peristaltic sample transfer pump and WinDiss ARGUS software package.
Unlike the off-line systems where samples are removed from the dissolution vessels and stored either for transfer to a measurement system or for further preparation (e.g. dilution), the samples here are circulated in a closed loop. This means there is no sample volume loss over the time of the dissolution test. At programmed time points the sample circulation is stopped and either a single point absorbance reading or a full UV spectrum of each vessel is collected.
Preparation of dissolution media
Medium preparation and degassing are vital parts of the tablet dissolution test, as aerated media are crucial for the reproducibility of dissolution results.
UV / VIS Spectrometers for Tablet Dissolution Applications
The TIDAS® L by J&M of Pharma test group is the perfect spectrometer for dissolution online tests:
Very fast measurements of the complete spectra. Six cuvettes are measured in about 8 seconds.
More information due to the availability of the complete spectral data results in a higher robustness. Other wavelengths and wavelength ranges can be used to perform scattering and turbidity corrections.
Multicomponent analysis can be performed easily with a Diode Array spectrometer. Interval times remain very short.