Bacteriostasis and Fungistasis test
This test is performed on a sterile product to determine if any inhibiting factors exist in the product which would invalidate a test for sterility. A sterility test is technically not valid unless this test has been performed on the product.
Optional Tests for Bacteriostasis and Fungistasis test
Bacteriostasis and fungistasis, special requests USP 71, USP 161, USP 797, EP2.6.1, JP14 54
Bacteriostasis and Fungistasis Validation: Radiation, One medium, three organisms (AAMI)
This test is performed on a sterile product to determine if any inhibiting factors exist in the product which would invalidate a test for sterility. A sterility test is technically not valid unless this test has been performed on the product.
Although bacteriostasis/fungistasis testing is only required once for the life of the product, we recommend that a revalidation be done annually. This is substantiated by a recently published guideline which recommends this testing to be repeated every 12 months in case of product reformulation, manufacturing changes, or experimental condition changes. (Recommendation on sterility testing, PI012-1" PIC/S, Geneva, Switzerland, 01 November 2002.)
Bacteriostasis and Fungistasis Validation: Two medias, six organisms (USP/EP/JP) - Isolator USP 71, USP 161, USP 797, EP2.6.1, JP14 54
This test is performed on a sterile product to determine if any inhibiting factors exist in the product which would invalidate a test for sterility. A sterility test is technically not valid unless this test has been performed on the product.
Although bacteriostasis/fungistasis testing is only required once for the life of the product, we recommend that a revalidation be done annually. This is substantiated by a recently published guideline which recommends this testing to be repeated every 12 months in case of product reformulation, manufacturing changes, or experimental condition changes. (Recommendation on sterility testing, PI012-1" PIC/S, Geneva, Switzerland, 01 November 2002.)
Bacteriostasis and Fungistasis Validation: Two medias, six organisms (USP/EP/JP) - Cleanroom USP 71, USP 161, USP 797, EP2.6.1, JP14 54
This test is performed on a sterile product to determine if any inhibiting factors exist in the product which would invalidate a test for sterility. A sterility test is technically not valid unless this test has been performed on the product.
Although bacteriostasis/fungistasis testing is only required once for the life of the product, we recommend that a revalidation be done annually. This is substantiated by a recently published guideline which recommends this testing to be repeated every 12 months in case of product reformulation, manufacturing changes, or experimental condition changes. (Recommendation on sterility testing, PI012-1" PIC/S, Geneva, Switzerland, 01 November 2002.)
