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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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Depth Filters
Depth Filters
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Palltronic Instrumentation
Palltronic Instrumentation
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Sterilizing Grade Liquid Filters/Air Filters
Sterilizing Grade Liquid Filters/Air Filters
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Membrane Chromatography
Membrane Chromatography
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Sterile Connectors/Disconnectors/ Filling Needles
Sterile Connectors/Disconnectors/ Filling Needles
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Single-Use Storage Biocontainers/Mixers/Powder Bags
Single-Use Storage Biocontainers/Mixers/Powder Bags
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Tangential Flow Filtration (TFF)
Tangential Flow Filtration (TFF)
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Virus Filters
Virus Filters
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