How Emprove® Dossiers for Filters and Single-use Components can support you
Three Levels of Information for Qualification and
Similar to our dossiers for our Emprove® chemicals, our Emprove® dossier library for filters and single-use components is organized into three types of dossiers. Each dossier’s name indicates where it can be used to help facilitate your qualification, risk assessment and process optimization efforts.
- The Material Qualification Dossier supports qualification and speeds up drug filing preparation. It includes content on the manufacturing process, product specifications and various qualification criteria (product validation data), regulatory statements, stability summary, and more.
- The Quality Management Dossier supports your risk assessment needs through useful information of how we control quality variability attributes such as site quality self-assessment, product family shelf life information, sterilization dose, and product packaging validation.
- The Operational Excellence Dossier supports process optimization objectives. It contains extractables profiles including information on elemental impurities that can be utilized to perform a leachables risk assessment for the product with in the process conditions.
For filters, the dossiers are grouped according to product families with the same materials of construction, production processes, and packaging components. The test methodology in the Operational Excellence Dossier involves a “worst case” approach.
For single-use components, dossiers are made available for components starting with those most commonly used. An assembly level information can be developed by the end user from the individual dossiers available for the components forming the part of the assembly.
Emprove® Dossier Library for Filtration and Single-use
*The Material Qualification Dossier is 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.
|Dossier Name||Purpose of Dossier||Price||Content|
|Material Qualification Dossier
||Information to start a material qualification
||Free of charge*
- General information
- Manufacturing flow chart
- Product characterization and qualification
- Specification, release criteria
- Materials of construction
- Extractables summary**
- Residual solvents statement
- Regulatory statements (Animal origin, allergens…)
|Quality Management Dossier
||Answers questions during risk assessment
- Quality self assessment
- Supplier and CMO management
- Shelf life testing and results
- Packaging and sterility validation
|Operational Excellence Dossier
||Supports process optimization
- Extractables Report**
- Elemental impurities summary
- Analytical procedure
|Subscribe to Emprove® Suite
||Full Access to All Dossiers of the Emprove® Library
- One time registration
- Access for 2 years
- Includes 5 email addresses per company
- Additional accesses can be purchased
**Standardized Extractables Protocol, BPOG, published in Pharmaceutical Engineering 11.2014 & USP draft chapter <665>, published 05.2017.
To learn more about our dossiers for raw and starting materials please click here.