pall,颇尔,Single-Use Validation Services,

产品名称:
Single-Use Validation Services
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产品介绍

pall,颇尔,Single-Use Validation Services,
pall,颇尔,Single-Use Validation Services

一次性验证

颇尔 Validation Services for Allegro™ Single-use Systems

为 Allegro 一次性平台提供全面验证服务
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.颇尔 can therefore provide the Biopharmaceutical industry with process solutions, technical support and validation for single-use systems.

 

颇尔 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.

 

颇尔 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.

 

验证服务

  • 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
      • 傅立叶变换红外 (FTIR) 光谱分析
      • 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 颇尔 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, 颇尔 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 颇尔 are provided by our global Scientific and Laboratory Services (SLS), our Technical Support Group (TSG) specialists, andour global 颇尔 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 颇尔 scientific services recommendations.

 

How to Initiate Allegro Validation Services

To find out how 颇尔 can assist you with implementation of single-use solutions within your processes.

 

颇尔 全球服务项目

 


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