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Biotech Regulatory Support

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

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Gamma-Irradiation: Sterilization Validation Approach for Allegro™ Single-Use Systems with Sterile Claim

FAQ: How are the principles of Sterility Assurance Levels (SAL) applied to the sterilization of liquids by filtration?

Approach to sterility

Is there a regulatory requirement to perform process-specific bacterial retention studies on pre-filters?

Bacterial retention studies

Change Management

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What are the Main Elements of an Effective Biotechnology Supplier Change Management Process?

Continuous Processing

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Definition of Batch and Lot in Continuous Bioprocessing

Process Characterization Approach for Continuous Downstream Bioprocessing

Extractables and Leachables

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List of Available Extractables Reports for Pall-Manufactured Components

Ready for USP 665?

Extractables and Leachables

BPOG/ USP <665> Sample Extractables Report

Impurities Risk Assessment Calculator

Industry Interest Sterility

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Is Pall Biotech Actively Involved with Industry Interest Groups?

What is the BPSA? Is Pall Biotech Involved with the BPSA?

What is BPOG? Is Pall Biotech Involved with BPOG?

Integrity of Single-Use Systems

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What are The Current Practices for Assurance of Integrity of Single-Use Systems (SUS)?

Test Methods to Check a Single-Use System (SUS) for Leaks

New ASTM Standard: E3251- 20 Standard Test Method for Microbial Ingress Testing on Single-Use Systems.

Integrity Testing

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New ASTM Standard Practice for Integrity Assurance and Testing of Single-Use Systems

Best Practices For Successful Filter Integrity Testing Using The Water Intrusion Test (WIT) Method

Best Practices For Successful Filter Integrity Testing Using The Water Intrusion Test (WIT) Method

Wetting and Flushing of Pall Microbially-Rated Filter Cartridges and Capsules

Wetting and Flushing of Pall Microbially-Rated Filter Cartridges and Capsules

Pre-Use Post Sterilization Integrity Test - PUPSIT

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What is the Position of the Regulatory Authorities on PUPSIT?

What is the Pall’s Position on PUPSIT?

Particle Management in Single Use Systems

New BPSA 2020 Particulates Guide Particle Management in Single-Use Systems

Sterile Filter Validation

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Should a Pre-Filtration Bioburden Be Determined Prior to Sterile Filtering a Solution?

Application of Pall’s Sterility Optimization by Assessment of Risk (SOAR) Program

When Should Filter Validation Be Performed?

During Filter Validation, Can Pall Perform One Set of Testing to Cover Both Gamma and Steam Sterilization?

Sterile Filter Validation

Evaluation of Monodispersion in Brevundimonas Diminuta Suspensions