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Journal article: Validation of Milliflex quantum for bioburden testing of pharmaceutical products

Posted: 27 June 2019 | | No comments yet

Pharmaceutical drug products must fulfill specified quality criteria regarding their microbial content in order to ensure patient safety. Drugs that are delivered into the body via injection, infusion, or implantation must be sterile (i.e., devoid of living microorganisms).

Bioburden testing measures the levels of microbes present in the bulk solution of a drug before sterilization, and thus it provides important information for manufacturing a safe product. In general, bioburden testing has to be performed using the methods described in the pharmacopoeias (membrane filtration or plate count). These methods are well established and validated regarding their effectiveness; however, the incubation time required to visually identify microbial colonies is long.

Register below to read the full article published in the PDA Journal of Pharmaceutical Science and Technology to learn from a leading pharma company about their validation methods and results.

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