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Sterility Testing

Sterility Testing

Sterility testing is a critical requirement for finished product and raw material quality control of a wide range of pharmaceuticals and medical devices.

Source BioScience offers regulatory compliant sterility testing to European Pharmacopoeia (Ph Eur 2.6.1) and United States Pharmacopeia (USP 24 Microbiological tests).

Testing by membrane filtration and direct inoculation methods are available.

Membrane Filtration Method

Recommended for most finished products, especially those where antimicrobial agents are present in the test material.

The test material is filtered through membranes which retain any microbial contamination, then rinsed prior to addition of sterile growth media and finally incubation for typically 14 days at controlled temperatures specific for growth of aerobic bacteria and yeast or moulds using tryptone soya broth and fluid thioglycollate media.

All manipulations are performed in a sterile isolator in a cleanroom environment.

Environmental monitoring of the test area is assessed during performance of the sterility test, by means of air sampling, settle, and contact plates.

Direct Inoculation Method

Recommended for cell banks/cell lines.

In this method test material is added directly to growth media and incubated as per above above membrane filtration method.

Validation Requirements

In most cases validation of sterility assay is required and would normally be performed once as part of the method transfer process. This validation assay tests for bacteriostasis and any antimicrobial activity in the test material. Validation can be undertaken in conjunction with the sterility assay if required.

 

For further information and prices please contact us or call +44 (0)115 973 9012

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