Dear Microbiologist or QA Manager:
I have a emulsion product intended for sterile injection, but no preservative is added in the formulation.
The FDA wants us to do microbial challenge test which is somewhat different than the AET for preserved
injectable or product inherently antimicrobial. Do you know how to proceed with the "Microbial Challenge
Test?" Questions like inoculation, microorganism selection, incubation time, etc.
Best,
Ed Lin
VP Quality and Compliance
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Ed Lin
United Biomedical Inc
Hauppauge NY
United States
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