Biotech Regulatory SME Corner
Check this page to learn more about our position on regulatory and industry changes or our involvement with industry interest groups. For further information consult our ‘Resources’ page.
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Approach to Sterility
Pall’s approaches to sterility testing of single-use systems to assure compliance with standards and equipment safety.
Application of processes, tools, and techniques to effectively manage change and support our customers.
Extractables and Leachables
Pall’s approach to extractables and leachable from available product data to regulatory requirements.
Industry Interest Groups
Topics on Pall’s involvement with industry interest groups where Pall influence, advance, and promote single-use technologies.
Integrity of Single-Use Systems
Regulatory views on the application of integrity testing to single-use systems and Pall’s position to ensure product integrity.
Pre-Use Post Sterilization Integrity Test - PUPSIT
Pre-Use Post Sterilization Integrity Test (PUPSIT) regulatory overview and Pall’s recommendation.
Pall’s approach to particles- data for regulatory requirements, including the BPSA industry guide to particle management.
Sterile Filter Validation
Overview of sterile filter validation requirements, regulations, applications, and support Pall offers customers.