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Validation data sets for depth filters to support their suitability for biotechnology and pharmaceuticals applications.
Design, applications, and qualification testing that ensures membrane chromatography devices are suitable for downstream bioprocessing applications.
Guidance to achieve and maintain a validated state ensuring process and regulatory requirements are met.
Data applicable to single-use bioreactors that demonstrate their suitability for cell culture applications.
Validation data for single-use biocontainers to demonstrate their suitability for biotech and biopharmaceuticals.
Methodologies and data supporting shelf-life studies and suitability for use in biopharmaceutical applications.
Comprehensive validation data and information regarding tests conducted to validate the performance of filter cartridges and capsules.
Validation support information containing test data on safety, compatibility, performance, and usage conditions for tangential flow filtration.
Comprehensive validation data to support the qualification and validation of virus retentive filters.