2023BPSA质量测试矩阵.pdf

1、BPSA Quality Test Matrices2023 UpdateJames Dean Vogel,P.E.Agenda Project Review Changes Path ForwardObjective Update the BPSA Quality Test Matrices(Last updated in 2015)Add new standards and references Remove obsolete standards and references Prioritize tests to:Required Recommended To Be Considered

2、 Complete for rollout with BPSA Summit in July August 2023 Project Gather community input from BPSA members and the industry in general.Survey.Combine information in in 5-6 teams-3-4 online meetings Test Categories and/or Component Categories Present to other teams at a face to face.Refine informati

3、on in 5-6 teams-2-3 online meetings SAB approval Board approval Presentation to Membership-TodayTeam MembersJim Sanford Paul Priebe Dan Nelson Russell Darley Nicole Hunter Charlie Zhang Robert Bob Huffman Janel Wittmayer Joe Figlio Heidi Sinkovich Nick Troise Hernan Parma Joy Xiaohui ChenNasim Mouch

4、a Jen Alejandre Craig Vincze Richard Herpers David RadspinnerGala Johnson James Hathcock Klaus Warmouth Jim Vogel Maureen Eustis Kirsten Strahlendorf Danielle ArcuriEma RajicGala johnsonJeroen Deroover,Kendall Horst Monica Cardona Mrt Sild Russell DarleyTodd AndrewsQTM HistoryPurpose:“help guide use

5、rs when making their selections and(to)facilitate qualification,validation and use of Single-Use products”Most accurate,up-to-date and emergent information QTM History2007-Initial 2015-Last Update2023-Current UpdateTest CategoriesA.PhysicalB.FunctionalC.BiologicalD.ChemicalE.RegulatoryF.Sterilizatio

6、n/SanitizationComponent Categories1.Chromatography2.Connectors,Valves and Retainers3.Containers and Film4.Sensors5.Tubing6.Filters2015Test CategoriesA.PhysicalB.FunctionalC.BiologicalD.ChemicalE.RegulatoryF.Sterilization/SanitizationComponent Categories1.Chromatography2.Connectors,Valves and Retaine