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)
Contact Moredun Scientific
For all enquiries please contact us:
- Tel: +44 (0)131 445 6206
- Email: info@moredun-scientific.com