Product sterility- Isolator
Samples are tested for sterility by placing them in growth media, incubating them for a minimum of fourteen days and checking them for evidence of microbial contamination. Samples are placed into the media using direct transfer or membrane filtration. To optimize aseptic transfer of samples into the test media, all testing is performed in a state of the art ISO class 5 cleanroom. Sterility tests must be validated by performing a Bacteriostasis/Fungistasis test.
Optional Tests for Product sterility- Isolator
Package validation (isolator) USP 71, USP 161, USP 797, EP2.6.1, JP14 54
The isolator unit at Nelson Laboratories provides you with a unique environment for sterility testing. The isolator system protects your test articles from contamination by eliminating direct contact between the analyst and the test articles. The isolator interior is sterilized by a hydrogen peroxide vapor generator. The decontamination system allows rapid sterilization at a low temperature. The sterilant is highly sporicidal even in low concentrations.
Samples are tested for sterility by placing them in growth media, incubating them for a minimum of fourteen days and checking them for evidence of microbial contamination. Samples are placed into the media using direct transfer or membrane filtration. Sterility tests must be validated by performing a Bacteriostasis/Fungistasis test.
Product sterility: direct transfer method (Isolator) USP 71, USP 161, USP 797, EP2.6.1, JP14 54
