PDA/ANSI Standard on Mycoplasma Reduction Filtration Receives Complete Recognition Status by U.S. FDA CBER

The Parenteral Drug Association (PDA) is pleased to announce that PDA/ANSI Standard 05-2021: Consensus Method for Rating Filters for Mycoplasma Reduction has received complete recognition status by the U.S. Food and Drug Administration's Center for Biologics Evaluation and Research (CBER). The standard is now listed in the FDA's database of recognized consensus standards. This recognition affirms the value of the standard in supporting regulatory submissions and manufacturing practices involving mycoplasma-retentive filtration. PDA/ANSI Standard 05-2021 provides a consensus-based method for evaluating and rating filters used to reduce mycoplasma contamination, using standardized test parameters and the organism Acholeplasma laidlawii. The method enables filter manufacturers and users to validate and compare filters under consistent conditions, supporting claims of mycoplasma retention in biopharmaceutical processes. "The inclusion of this standard in FDA's database reflects its alignment with regulatory expectations and its utility in ensuring product safety and quality," said PDA President/CEO Glenn Wright. "This recognition affirms the valuable effort of the many volunteer experts who took time outside their regular careers to develop the standard. I would like to personally thank each of them for this job well done!" FDA's decision marks another milestone in PDA's commitment to advancing science-based standards for the pharmaceutical and biopharmaceutical industries. PDA/ANSI Standard 05-2021 joins other PDA-developed standards recognized by FDA, further solidifying PDA's role as a trusted standards developing organization. For more information or to purchase the standard, visit the PDA Bookstore.

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