Microbial limits testing based on USP, EP, JP |
Sterility test validation (bacteriostasis/fungistasis) |
LAL validation (inhibition/enhancement) |
Closure integrity testing (microbial challenge and dye immersion method) |
Sterilization validations (steam, EO, gamma radiation, chemical) |
Bioburden recovery |
Method development and validation |
Environmental monitoring |
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