Microbiological Validation Services

Bioburden Testing

Bioburden testing is designed to estimate the number of micro-organisms present on product prior to sterilisation. Using validated methods, in accordance with ISO 11737 bioburden enumeration demonstrates process control and alerts manufacturers if and when a problem arises. Where a validated method does not exist, MVS can develop a technique most suited to your product.

The identification of colonies present can aid in providing insight into where any potential problems may lie and advice on possible solutions is readily available. Further typing of microbiological species is available upon request.

Formal and informal consultancy can be provided to ensure that product is manufactured, cleaned and packaged using best practise at all times, ultimately leading to confidence that product is “fit for purpose”.

Testing single use and reusable medical devices, water and detergents, to include method validation, using various techniques including: Membrane filtration, direct inoculation, tests for specified organisms, TAMC/TYMC (to the harmonised pharmacopeia).

Data interpretation, support and advice.

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