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Single-Use Validation Services

Pall Validation Services for Allegro™ Single-use Systems

Providing Comprehensive Validation Services for the Allegro Single-use Platform
The Allegro system platform offers a comprehensive single-use product line to serve all applications from upstream through downstream as well as formulation and filling. Pall can therefore provide the Biopharmaceutical industry with process solutions, technical support and validation for single-use systems.

Pall Validation and Technical services play a key role in providing validated single-use solutions for fluid handling and assisting in the implementation of Allegro single-use processing solutions from drug development to manufacturing operations. Our Allegro single-use system validation program includes thorough documentation of test protocols and issuance of final reports that are ready to support regulatory submissions.

Pall maintains close working relationships with government and industry organizations around the world to ensure that we are up-to-date with the latest GMP1requirements and industry best practices.

Validation Services

  • Extractables and leachables
  • Compatibility testing  
  • Sterilizing filter capsule validation

1Good Manufacturing Practices

A general overview of available validation services focusing on single-use system implementation is listed below:

Allegro Single-use Extractables/Leachables Determination

Extractables/leachables determination are performed following BioProcess Systems Alliance (BPSA) recommendations: (reference: Recommendations for Extractables and Leachables Testing Part 1: Introduction, Regulatory Issues, and Risk Management).
  • Complete data reference library of single-use components evaluated in water and ethanol.
  • Validation studies including:
    • Study design and execution of extraction
    • Pre-treatment and analysis of extracts
    • Characterization of extracts, including:
      • Non-volatile residue (NVR) gravimetric measurement
      • Fourier Transform Infrared (FTIR) spectroscopy
      • TOC, pH and conductivity measurements
      • Headspace and derivatization GC/MS
      • ICP/MS
      • LC/UV and LC/UV/MS
  • All testing can include product/process specific conditions and Pall scientific services recommendations.

Sterilizing Filter Capsule Validation

  • Filter capsule study design as part of the single-use system. Validation test examples include:
    • Viability
    • Bacterial challenge
    • Product specific integrity test value

For all services, Pall assigns a project manager to facilitate the communication and study design procedure. Further, a comprehensive and detailed report is provided upon completion of the study that can be directly incorporated into the process validation documentation for regulatory submissions.

Expertise in Single-use Systems

The validation services offered by Pall are provided by our global Scientific and Laboratory Services (SLS), our Technical Support Group (TSG) specialists, andour global Pall Advanced Separation Systems (PASS) engineering staff. These teams are located around the globe to offer fast local services, as required.

Compatibility Testing

  • Functional testing to evaluate compatibility of the components or materials after autoclave or gamma irradiation.
  • Compatibility testing can be based on either chemical and/or mechanical studies.
  • Validation studies including:
    • Study design and execution
    • Leak testing for all connections in the system
    • Drop performance studies for biocontainers (ASTM D4169-05)
    • Integrity testing for filter capsules
    • Burst testing for connectors
    • Leak testing of connectors (ASTM D4991-94)
  • All testing can include product/process specific conditions and Pall scientific services recommendations.

How to Initiate Allegro Validation Services

To find out how Pall can assist you with implementation of single-use solutions within your processes, please contact your local Pall representative or email Allegro@pall.com.

Pall Global Services



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Description

Pall Validation Services for Allegro™ Single-use Systems

Providing Comprehensive Validation Services for the Allegro Single-use Platform
The Allegro system platform offers a comprehensive single-use product line to serve all applications from upstream through downstream as well as formulation and filling. Pall can therefore provide the Biopharmaceutical industry with process solutions, technical support and validation for single-use systems.

Pall Validation and Technical services play a key role in providing validated single-use solutions for fluid handling and assisting in the implementation of Allegro single-use processing solutions from drug development to manufacturing operations. Our Allegro single-use system validation program includes thorough documentation of test protocols and issuance of final reports that are ready to support regulatory submissions.

Pall maintains close working relationships with government and industry organizations around the world to ensure that we are up-to-date with the latest GMP1requirements and industry best practices.

Validation Services

  • Extractables and leachables
  • Compatibility testing  
  • Sterilizing filter capsule validation

1Good Manufacturing Practices

A general overview of available validation services focusing on single-use system implementation is listed below:

Allegro Single-use Extractables/Leachables Determination

Extractables/leachables determination are performed following BioProcess Systems Alliance (BPSA) recommendations: (reference: Recommendations for Extractables and Leachables Testing Part 1: Introduction, Regulatory Issues, and Risk Management).
  • Complete data reference library of single-use components evaluated in water and ethanol.
  • Validation studies including:
    • Study design and execution of extraction
    • Pre-treatment and analysis of extracts
    • Characterization of extracts, including:
      • Non-volatile residue (NVR) gravimetric measurement
      • Fourier Transform Infrared (FTIR) spectroscopy
      • TOC, pH and conductivity measurements
      • Headspace and derivatization GC/MS
      • ICP/MS
      • LC/UV and LC/UV/MS
  • All testing can include product/process specific conditions and Pall scientific services recommendations.

Sterilizing Filter Capsule Validation

  • Filter capsule study design as part of the single-use system. Validation test examples include:
    • Viability
    • Bacterial challenge
    • Product specific integrity test value

For all services, Pall assigns a project manager to facilitate the communication and study design procedure. Further, a comprehensive and detailed report is provided upon completion of the study that can be directly incorporated into the process validation documentation for regulatory submissions.

Expertise in Single-use Systems

The validation services offered by Pall are provided by our global Scientific and Laboratory Services (SLS), our Technical Support Group (TSG) specialists, andour global Pall Advanced Separation Systems (PASS) engineering staff. These teams are located around the globe to offer fast local services, as required.

Compatibility Testing

  • Functional testing to evaluate compatibility of the components or materials after autoclave or gamma irradiation.
  • Compatibility testing can be based on either chemical and/or mechanical studies.
  • Validation studies including:
    • Study design and execution
    • Leak testing for all connections in the system
    • Drop performance studies for biocontainers (ASTM D4169-05)
    • Integrity testing for filter capsules
    • Burst testing for connectors
    • Leak testing of connectors (ASTM D4991-94)
  • All testing can include product/process specific conditions and Pall scientific services recommendations.

How to Initiate Allegro Validation Services

To find out how Pall can assist you with implementation of single-use solutions within your processes, please contact your local Pall representative or email Allegro@pall.com.

Pall Global Services

Application
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Single-Use Solutions