Use of isolator technology
The European Pharmacopoeia prescribes special microbiological analytical procedures for testing sterile and non-sterile products.
In our laboratories, we offer testing for bacterial endotoxins, microbiological testing of non-sterile products and sterility testing.
As the only Official Medicines Control Laboratory in Germany, we use the particularly safe isolator technology for sterility testing.
Microbiological Testing offered
In practice, the analysis portfolio of InphA covers the following microbiological tests:
- Bacterial endotoxins (gel-clot and turbidimetric kinetic method according to Ph. Eur. 2.6.14)
- Sterility test (according to Ph. Eur. 2.6.1)
- Microbiological examination of non-sterile products (according to Ph. Eur. 2.6.12 and 2.6.13)
- Microbiological assay (Ph. Eur. 2.7.2)
In principle, the tests can be performed on any pharmaceutical dosage form for which they are specified. Furthermore, the tests can also be performed on certain non-active medical devices.
For all questions regarding microbiological testing, please contact Dr. Annette Burchardt.