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Accelerator℠ Documentation Center

Validation Guides

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Find all available validation guides for Pall Biotech products. For more detailed information on the products visit our Accelerator Regulatory Dossier.

 

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Single-Use Bioreactors

Data applicable data to single-use bioreactors that demonstrate their suitability for cell culture applications

Depth Filters

Validation data sets for depth filters to support their suitability for biotechnology and pharmaceuticals applications

Membrane Chromatography

Design, applications, and qualification testing that ensures membrane chromatography devices are suitable for downstream bioprocessing applications

Palltronic™ Instrumentation

Guidance to enable end users to achieve and maintain a validated state through qualification testing, ensuring process and regulatory requirements are met

Sterile Connectors/Disconnectors/ Filling Needles

Applicable methodologies and data supporting shelf life studies and suitability for use in biopharmaceutical applications

Sterilizing Grade Liquid Filters/Air Filters

Comprehensive validation data and information regarding tests conducted to validate the performance of filter cartridges and capsules

Single-Use Storage Biocontainers/Mixers/Powder Bags

Validation data for single-use biocontainers to demonstrate their suitability for biotech and biopharmaceuticals applications

Tangential Flow Filtration (TFF)

Validation support information containing test data on safety, compatibility, performance, and usage conditions for tangential flow filtration

Virus Filters

Comprehensive validation data to support the qualification and validation of virus retentive filters

Single-Use Bioreactors
Single-Use Bioreactors
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  • Allegro™ XRS 25 Biocontainer

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  • iCELLis® 500+ Generation R Bioreactors

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Depth Filters
Depth Filters
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  • Stax™ Capsule System

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  • SUPRAdisc™ HP Depth Filter Media

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  • Seitz® P-Series Depth Filter Media

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  • Activated Carbon Filters Incorporating Seitz® AKS Filter Media (Grade AKSJ)

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  • Activated Carbon AKS Depth Filter Media

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  • Preflow™ Filter Cartridges

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Palltronic Instrumentation
Palltronic Instrumentation
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  • Palltronic® Flowstar and AquaWIT Integrity Test Instruments

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  • Palltronic® Flowstar IV Integrity Test Instrument

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    • Tonga
    • Trinidad and Tobago
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Sterilizing Grade Liquid Filters/Air Filters
Sterilizing Grade Liquid Filters/Air Filters
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  • 0.45 μm-Rated Filter Cartridges and Filter Capsules with Fluorodyne® II Grade DBL Membrane

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    Country
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    • South Africa
    • Spain
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    • St Kitts and Nevis
    • St Lucia
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    • Sweden
    • Switzerland
    • Taiwan
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    • Togo
    • Tonga
    • Trinidad and Tobago
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  • 0.1 μm-Rated Fluorodyne® II DJL Filters

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  • 0.2 µm-rated Filter Cartridges and Filter Capsules with Fluorodyne® II Grade DFL Membrane
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  • Special Purpose Fluorodyne® II Grade DFL Filter Cartridges

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    Country
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