Emprove^® Filters and Single-Use Components

Emprove^® Dossiers for Filters and Single-use Components

All our high-quality portfolio products feature Emprove^® Dossiers, providing the optimized information you need to fast track your drug to market. These include:

Emprove^® Filtration and Single-use Component Product Groups*

For an overview of our portfolio products and dossier availability, select any product family below. 

*Status as per Q1 2023, constantly updated.

Fast track your extractables risk assessment

All polymeric components, such as the filters and single-use systems used in biopharmaceutical manufacturing, must be assessed for safety through an evaluation of extractables and potential leachables. Extractables are compounds that can be extracted from these materials, while leachables are compounds that leach from the materials into the process stream. An understanding of extractables is essential as it can help identify the leachables that may enter a process stream.

With our Emprove^® Program, developing an extractables profile for filters and single-use systems no longer requires a time- and resource-intensive compilation of a vast amount of data. Instead, our Emprove^® Operational Excellence Dossiers provide you with reliable extractables data based on industry standards and guidelines established by the BioPhorum Operations Group's (BPOG) standardized testing protocol and USP <665> chapters. The datasets generated facilitate your safety risk assessment, accelerating your ability to identify potential leachables and calculate patient exposure based on process conditions, total surface area in contact with the product, batch size and final drug product maximum daily dose.

A full spectrum of services for extractables and leachables risk assessment

Together with our BioReliance^® Validation Services experts, we provide a higher level of confidence in safety risk assessment through careful selection of well-characterized materials, experience in identifying and analyzing potential leachables (or process-specific extractables) data, and expertise in the design and execution of need-based leachables studies. Because every product and process is unique, we tailor our approach to deliver best-in-class services and robust results that meet global industry standards, even as the standards continue to evolve.

EMPROVE^® Advanced Qualification Dossier and Component Extractables Reports

For Mobius Assemblies that contain multiple components, the Advanced Qualification Dossier includes assembly and component information to support the qualification and patient safety.  Included are the extractable datasets that are individually available through the Operational Excellence Dossiers (film, connectors, and filters) and Third-Party component Extractables Reports.  To evaluate your specific product and process, further support through consultation and services from  Validation Services are available. The Advanced Qualification Dossier or individual component Extractable reports can be obtained from the links below. 

Emprove^® Operational Excellence Dossiers by Product Family

A thorough interpretation of the extractables datasets from our Operational Excellence Dossiers to your specific product and process can further be supported through consultation and services from Bioreliance^® Validation Services. For an overview of available Operational Excellence Dossiers, select any product family below.

* P/N stands for part number. The indicated part numbers are generic for the family. Please replace your specific part numbers as applicable.

Related Product Resources

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