Microbiology

Many (bio)pharmaceutical raw materials and finished drug products have to meet specific requirements regarding microbiology contamination, as described in pharmacopeia or registration dossiers. In our microbiology and biochemical laboratories, raw materials and products are tested for bioburden and for the absence of specific micro-organisms. Also, we can determine the level of bacterial endotoxins by running LAL tests.

 

(Bio)pharmaceutical products that are intended for systemic use need to be sterile. In our GMP class B cleanrooms, sterility testing is performed in a class A BioSafety Cabinet. For new products

the sterility test needs to be validated. The number of vials required for this validation is critical. PROXY is experienced in designing a cost-effective approach.

 

PROXY is active in the field of environmental monitoring (EM) of (bio)pharmaceutical companies. The EM sampling methods and techniques, as described in the GMP guidelines, can be carried out by our staff on site. Our EM tools are air-borne particle counters, volumetric air samplers, settle plates, contact plates (e.g. Rodac) and swabs. The samples taken on site are analysed in PROXY's microbiology laboratory.