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Emprove® Program > Emprove® Filters & Single-use Components > Emprove® Dossiers for Filtration and Single-use
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Emprove® Dossiers for Filtration and Single-use

Easily address your material qualification, risk assessment and process optimization needs

 

Optimized information to fast-track your drug to market

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.

Emprove® Dossier Content

Emprove® Dossier Library for Filters and Single-Use Components

 
Emprove - Material Qualification Dossier

Material Qualification Dossier

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.

  • General information
  • Manufacturing flow chart
  • Product validation and qualification
  • Specifications (design and release criteria)
  • Materials of construction
  • Extractables summary**
  • Regulatory statements (Animal Origin, BPA etc.)

Free of charge*

 
Emprove - Quality Management Dossier

Quality Management Dossier

Answers questions during quality risk assessment. Provides valuable information on how quality variability attributes are controlled.

Demo Dossier

  • Quality Self-assessments
  • Chain of custody
  • Supplier and CMO management
  • Shelf life testing and results
  • Packaging and Sterilization Validation

Free of charge*

 
Emprove - Operational Excellence Dossier

Operational Excellence Dossier

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)).

Demo Dossier

  • Extractables Report**
  • Elemental impurities summary
  • Analytical procedure

* 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.

Learn more about our Learn more about our Emprove® Filters & Single-use Components: Raw Materials and Single-Use Components Portfolios and Dossiers

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