MSL Solution Providers - Microbiological Testing

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Microbiological Testing

The following is a summary of tests that can be required to satisfy EU regulatory compliance:

Quality Control testing
Batch release testing to ensure the microbiological suitability of a product. Microbial limit testing ensures no contamination during manufacture, this must be undertaken for each batch of product.

New Product Development testing

Can include some or all of the below:-

  • Microbial limits – microbiological assessment of a product for presence and growth of specific organisms. Required by EU cosmetic regulation, GMP and SCCS for batch release for cosmetic products.
  • Claims support – various testing methods used to support product marketing claims.
  • Stability and Compatibility – assessment of a product and its packaging under various representative (and accelerated) conditions to ascertain whether any recognisable adverse effects likely to occur to chemical stability of product or appearance/functionality of the packaging. This testing is required by EU cosmetic regulation to support the claimed shelf life of a product.
  • PAO (Period After Opening) – additional (Challenge) testing that can be undertaken after being stored in accelerated conditions to support claimed period after opening of a product (i.e. support a claim that a product will not experience microbiological spoiling for a particular time period).
  • Chemical and heavy metal analysis – testing that is sometimes required/recommended to confirm the absence of heavy metals within particular types of products that may be susceptible to the presence of these ingredients.
  • Challenge/PET – testing required to support the safety assessment of products and confirm the robustness of the product against microbiological contamination.