Emprove® Dossiers for Filters are grouped according to product families with the same materials of construction, production processes, and packaging components.
Emprove® Dossiers for Single-Use Components are available beginning with the most commonly used components in the process. Assembly level information can be developed from the individual dossiers available for components forming the part of the single use assemblies.
Supports product qualification and speeds up regulatory filing preparation. Includes content on the manufacturing process, product specifications and various qualification criteria (product validation data), regulatory statements, and more.
Free of charge*
Answers questions during quality risk assessment. Provides valuable information on how quality variability attributes are controlled.
Free of charge*
Support process optimization and safety risk assessment with detailed extractables profile (BPOG extractables protocol and USP <665> draft chapters and information on elemental impurities (ICH Q3D)).
* The Material Qualification Dossier and the Quality Management Dossier are free of charge and available on the specific product detail pages of our website after log-in. It can also be downloaded through the Emprove® Suite.
** Extractables testing of polymeric single-use components used in biopharmaceutical manufacturing, BioPhorum, published April 2020 & USP <665> draft, Plastic Components and Systems Used to Manufacture Pharmaceutical Drug Products and Biopharmaceutical Drug Substances and Products, published Sep 2020.
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