Product sterility- Cleanroom
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- Cleanroom
Product sterility: Membrane filtration, open funnel or SteriTest (Cleanroom) USP 71, USP 161, USP 797, EP2.6.1, JP14 54
Product sterility: direct transfer method; >1 liter media volume (Cleanroom) USP 71, USP 161, USP 797, EP2.6.1, JP14 54
Product sterility: direct transfer method; <1 liter media volume (Cleanroom) USP 71, USP 161, USP 797, EP2.6.1, JP14 54
Product sterility, cleanroom
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.
Price for membrane filtration depends on the difficulty of filtration, the technician time required, and solvents or special equipment required.
