USP 51

USP 51

ANTIMICROBIAL PRESERVATIVE EFFECTIVENESS TEST (PET)

Bioscience Labs uses the US Pharmacopeia conventional test to verify the effectiveness of an antimicrobial preservative.  The purpose of the Preservative Effectiveness Test is to focus on activity of the preservative product to protect against inadvertent contamination during manufacturing, process, storage, and use of the product.

To test the effectiveness of a preservative, five standard challenge organisms are each individually inoculated into the Test Product and incubated for appropriate intervals.  After incubation, the Test Product is evaluated visually and enumerated by the plate count method to determine: no increase in cfu per mL, log reduction cfu per mL, or increase in cfu per mL as compared to the initial population.  Examples of test articles include but not limited to: parenteral, otic, nasal, ophthalmic, oral, and topical products.

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In-Vitro Laboratory

Scientists in our In-Vitro testing labs are well trained on ASTM, AATCC, AOAC, CLSI, and EN standard methods. The efficacy testing services of this laboratory include MIC/MBC, biofilm prevention and removal, time-kill kinetics, clean room disinfectant validation, zone of inhibition and custom efficacy studies for disinfectants, antimicrobials and other products requiring EPA registrations and FDA 510(k) submissions. Studies in…

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