Test Services

Sterility Test Validation

BACKGROUND
For customers that perform in house sterility testing, it is important that for each compound and/or family of compounds tested, that there be validation testing that proves that the compound does not inhibit the sterility test. This is important for compounds containing preservatives and/or that are inherently antimicrobial (eg. Vancomycin), and especially if direct inoculation testing methodology is employed.

OUR METHODOLOGY
DYNALABS method suitability test is performed in accordance to USP <71> using the customer supplied sterility method and compound, and organisms supplied by DYNALABS. If the test fails the method suitability test, DYNALABS will work with the customer to design a sterility method that will.

FORMS TYPICALLY TESTED

• All forms of sterile medications