Description:
The bacteriostasis / fungistasis test must be performed on the product or medical device prior to the sterility test. The purpose of the test is to establish the existing of any interfering / inhibiting factors in the product which may cause a false negative sterility test result. Although it is not a pharmacopoeial requirement, it is good laboratory practice to re-validate under the current experimental conditions every 12 months. (Recommendation on sterility testing, PI012-1, PIC/S, Geneva, 2007)
| Test Code | Description |
| STR-001 | Bacteriostasis / Fungistasis Test (Method Suitability Test, USP ) 3 organisms in SCD, 3 organisms in FTM (USP ) |