The Parenteral Drug Association (PDA) announced the availability of ANSI/PDA Standard 04-2021 Phage Retention Nomenclature Rating for Small and Large Virus-Retentive Filters. This standard addresses virus-removal filters that retain viruses by a size-exclusion mechanism. The objective is to assist users/manufacturers in selecting the most appropriate filter for their specific application needs.
ANSI/PDA Standard 04-2021 is intended to:
- Provide detailed methods and acceptance criteria for testing bacteriophage (also referred to as phage) retention by large- and small-virus retentive filters,
- Provide methods for preparing and enumerating suitable sized bacteriophage (PP7 and PR772 as models for small and large viruses, respectively) as test items, and
- Guide selection of appropriately rated filters as defined by suppliers in a standardized manner using a risk-based approach.
ANSI/PDA Standard 04-2021 can be purchased at the PDA Bookstore.