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Sterility Testing

The sterility of cell lines, media, in-process material and final products must be demonstrated during the manufacture of biopharmaceuticals.  Moredun Scientific offers regulatory compliant testing to a high standard.  Testing is carried out by the Direct Inoculation Method, the test material is added directly to growth media and incubated.

Assay duration: generally 14 days up to a maximum of 21 days depending on the sample type.

The assays are offered in a variety of formats:

Assay Format

Application

Qualification assay

Tests for bacteriostasis and antimicrobial substances.

This test would normally be undertaken once at the start of a production or process run and would not require to be performed again (unless there have been changes in the production process).

Sterility Assay

The sterility assay can be performed when a previous qualification assay has been carried out to show that there are no antimicrobial components in the test article.

Full test: Qualification assay and sterility assay

Recommended for one-off testing. This allows the qualification of a substance to be run in conjunction with the sterility assay itself.

 

Regulatory compliance

All our sterility assays at a minimum meet the required regulatory standards.

  • European Pharmacopeia (EP 2.6.1),
  • United States Pharmacopeia (USP 24 Microbiological Tests),
  • US Code of Federal regulations (21 CFR 610.12)

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Printed from http://www.moredun.org.uk/moredun-scientific-homepage/biosafety-testing/microbiology-services/sterility-testing on 26/06/17 01:09:16 AM

Moredun is committed to promoting animal health and welfare through research and education and is recognized worldwide for its contribution to research into infectious diseases of farmed livestock.