Validation Guides

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Category Description

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 achieve and maintain a validated state ensuring process and regulatory requirements are met.

Single-Use Bioreactors

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

Single-Use Storage Biocontainers/Mixers/Powder Bags

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

Sterile Connectors/Disconnectors/ Filling Needles

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.

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.