- Method suitability test
- Sample analysis
Fully equipped lab for microbiological GMP testing and GLP biological studies.
The Ames test is an in vitro assay for the detection of the genotoxic potential of various chemical substances including nitrosamines.
The bacterial reverse mutation test uses amino-acid requiring strains of Salmonella typhimurium and Escherichia coli to detect point mutations, which involve substitution, addition or deletion of one or a few DNA base pairs. Following the OECD 471 Guideline for the Testing of Chemicals, four S. typhimurium strains, TA98, TA100, TA1535, and TA1537, and one E. coli strain, WP2 uvrA, will be used.
Microbiological assay of antibiotics - EP 2.7.2, USP 81
Heparin biological activity
Exposure, contact plates- Incubation and analysis
Sterilizing filtration is the process of removing microorganisms from a fluid stream without adversely affecting product quality. To this end, most filter manufacturers provide results of tests performed according to applicable compendial methods to qualify their filters as suitable for pharmaceutical applications. However, this qualification documentation supports but does not replace, performance qualification as part of process validation conducted by the filter user. Qualimetrix facilitates this task, by undertaking the following tests according to PDA technical report No 26/2008, for which a short description is given:
Optionally and upon request, an adsorption test can also be performed, in order to assess potential product binding to the filter membrane that could affect product composition and concentration.