Sterility
The sterility of cell lines, media, in process material and final products is critical to the manufacturing process of reliable biotechnology products. Testing by direct inoculation and membrane filtration procedures to the main regulatory guidelines are offered (ie United States Pharmacopeia [USP], European Pharmacopeia [EP] and US Code of Federal Regulations [CFR]).

Direct Inoculation Method
The test material is added directly to growth media and incubated. Direct inoculation assays are offered in a variety of formats:

• The full test which includes qualification of the sterility assay (to test for
  bacteriostasis and antimicrobial substances),plus the sterility assay itself
• A stand alone qualification assay
• The sterility assay alone

The full assay would be recommended for one-off testing, this allows the qualification of a substance to be run in conjunction with the sterility assay itself. The stand alone qualification assay would normally be run once at the start of a production or process run and, providing that there has been no change in the process, would not require to be run again.

The sterility assay alone can be run where a previous qualification assay has been carried out to show that there are no antimicrobial components in the test article. If there are any changes to materials or production processes the qualification assay must be run again.

Membrane filtration method
The test material is filtered through membranes which will retain microbial contamination then rinsed to remove any inherent antimicrobial material, sterile growth media is then added and the test material is incubated.

Regulatory compliance
All our sterility assays at a minimum meet the required regulatory standards and in most cases exceed the requirements.

• European Pharmacopeia (EP)
• United States Pharmacopeia (USP)
• US Code of Federal regulations (CRF)

Click here for literature references.