X 射线灭菌：BPSA更新.pdf

1、2023 Bio-Process Systems Alliance|bpsalliance.orgX X-ray ray SterilizationSterilization UpdateUpdateWednesday July 12,11:15-12:152023 Bio-Process Systems Alliance|bpsalliance.orgAgenda Part II White Paper Related Industry Activities Implementation Timelines Regulatory Perceptions&Feedback Leveraging

2、 Prior Knowledge,Physics Language,Communication Workshop Feedback Q&A2023 Bio-Process Systems Alliance|bpsalliance.orgX-Ray:Representative Qualification Data Part II X-ray paper now available Authors and Reviewers bpsalliance.org/resources/technical-guides/Please share the link,not the guide2023 Bio

3、-Process Systems Alliance|bpsalliance.orgX-Ray:Representative Qualification DataTemperature and ActivationAssessment(45 polymer formulations)Component Test Data&AssessmentMaterial Test Data&AssessmentsAssembly IntegrityNext Steps2023 Bio-Process Systems Alliance|bpsalliance.org https:/doi.org/10.101

4、6/B978-1-4831-9776-0.50007-3(1960!)Arthur Charlesbyhttps:/doi.org/10.1016/j.radphyschem.2022.110702(2023)Fermilab2023 Bio-Process Systems Alliance|bpsalliance.orgASTM E55/E61 Irradiation Workshop The objective of this workshop is to enhance the knowledge and understanding of the radiation process an

5、d critical requirements needed for the sterilization of components and finished products using radiation technologies Radiation Processing for the Pharmaceutical and BioPharmaceutical Industries Training Workshop()This workshop is powered by the ASTM E61 International Workshop on Radiation Processin

6、g but focused on and tailored for the individuals supporting the pharmaceutical and biopharmaceutical industriesRadiation Processing for the Pharmaceutical and BioPharmaceutical Industries Training Workshop,May 8-9,20232023 Bio-Process Systems Alliance|bpsalliance.orgBioPhorum Activities Physical,ch