Assurance that bacteria and fungi have been removed during manufacturing process. Serum filtered through 0.1um pore sized integrity tested filters, will remove bacteria and fungi and provide a product suitable for cell culture applications.
| Reference | Title | Description |
|---|---|---|
| EP 2.6.1 | Biologicals Tests-Sterility | Satisfactory result indicating that no contaminating micro-organism has been found. |
| USP <71> | Sterility Tests | If no evidence of microbial growth is found, the product to be examined complies with the test for sterility. |
| 21CFR 610.12 | General Biological Product Standards – Sterility | Verified to demonstrate that the test method can consistently detect the presence of viable contaminating micro-organisms |
| 9CFR 113.26 | Detection of viable bacteria and fungi except in live vaccine | No extraneous growth found |
| JP 4.06 | General Test – Sterility Test | No evidence of microbial growth found, product tested meets the requirement of the Sterility Test. |
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