Issue link: https://www.e-digitaleditions.com/i/1351840
NOW AVAILABLE New ANSI/PDA Standard PDA, a Standards Developing Organization accredited by the American National Standards Institute (ANSI), is pleased to announce the release of its second standard, ANSI/PDA Standard 04-2021 Phage Retention Nomenclature Rating for Small- and Large-Virus Retentive Filters. This standard addresses the use of virus-removal filters that retain viruses by a size-exclusion mechanism. It should be considered as a guide intended to provide filter suppliers with an approach to standardizing methodology and nomenclature for large- and small-virus retentive filters using bacteriophage as a model. The objective is to assist users/manufacturers in selecting the most appropriate filter for their specific application needs. This new American National Standard (ANS) 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 • Guide selection of appropriately rated filters as defined by suppliers in a standardized manner using a risk-based approach. This Standard is intended to expand on the requirements already defined under FDA regulations and should be viewed only as recommendations. Digital Item No: 60001 PRICE Member: $180 | Non-member: $325 For more information or to purchase, visit go.pda.org/Standard04 As an ANSI accredited Standards Developer, PDA has met the guidelines set forth in the ANSI Essential Requirements: Due process requirements for American National Standards that include openness, consensus vote, due process, lack of dominance, balance, public review/consideration of view and objections, an appeals process, and compliance with the ANSI policies and administrative procedures. Visit pda.org/bookstore to see all of the technical books and resources PDA has to offer. go.pda.org/Standard04 © 2021 PDA ® . All rights reserved PDA Standard 04-2021 Phage Retention Nomenclature Rating for Small- and Large-Virus Retentive Filters