Microbiological Testing

• Pharmaceuticals Efficacy Testing
• Microbiological Assays
• Bioburden Testing
• Disinfectant Testing

Our laboratories at Ely have specialised facilities for handling pharmaceutical testing, including:

	sterility testing of products, medical devices and waters for pharmaceutical use.
	undesirable micro-organisms, bio-burden testing , pathogens and spoilage organisms
	assays of antibiotics and vitamins
	preservative efficacy to EP guidelines
	purified waters
	BS/EN disinfectant testing

Pharmaceutical Preservative Efficacy Testing

Pharmaceutical preparations with inadequate intrinsic anti-microbial activity are likely to have anti-microbial preservatives added. These additives are designed to prevent proliferation or limit contamination by micro-organisms. The preservative qualities of the preparation are checked during development by performance of an Efficacy of Anti-microbial Preservation Test.

During the development of pharmaceutical preparations, it is necessary to prove that the anti-microbial activity of the preparation is adequate to prevent the problems that could occur from microbial contamination or proliferation during storage.

The BP, EP and USP detail guidance on the performance and interpretation of preservative efficacy testing.

Our in-house method, which is UKAS accredited, has been developed according to the EP. We can, however, perform testing according to the BP or USP.

The types of preparations for testing range from powders through to liquids and include topical creams, oral syrups and parenteral solutions.

Microbiological Assays

Bioassays are used for the analysis of certain antibiotics and vitamins by either turbidimetric or agar diffusion techniques.

The turbidimetric assays have largely been developed in-house for vitamin analysis and are applicable to a wide range of matrices, containing either supplemented or natural forms. Products tested include foods, soft drinks, multi-vitamin tablets and pharmaceutical preparations.

The agar diffusion technique is primarily for certain antibiotics used within the animal health industry, although other standard procedures, listed within the various pharmacopoeias, can be performed.