The Parenteral Drug Association (PDA) today announced the availability of industry standard, ANSI/PDA Standard 05-2021 Consensus Method for Rating Filters for Mycoplasma, available now for purchase in the PDA Bookstore.
This new standard describes a filter challenge test for standardizing test parameters across laboratories using 47 mm discs and using A. laidlawii as the test organism.
While this standard is primarily to educate users and filter manufacturers about best practices for mycoplasma reduction filtration, this test is also to be used by the filter manufacturers to validate a mycoplasma-retentive filter within a manufacturing process and to qualify a filter for a mycoplasma retentive claim.
This is the third ANSI/PDA Standard released by PDA since it was accredited by the American National Standards Institute (ANSI) as a Standards Developing Organization in 2017. The others are:
- ANSI/ PDA Standard 001-2020:, Enhanced Purchasing Controls to Support the Bio-Pharmaceutical, Pharmaceutical, Medical Devices and Combination Products Industries
- ANSI/PDA Standard 04-2021, Phage Retention Nomenclature Rating for Small and Large Virus Retentive Filters
More information about PDA’s role in standards development and current standards under development can be found here: https://www.pda.org/scientific-and-regulatory-affairs/pda-ansi.