MilliporeSigma Extends Risk Assessment Program

June 28, 2016
Company expands Emprove program to include filtration and single-use products.

MilliporeSigma expands its Emprove risk assessment program to include products for filtration and single-use processing. The program provides documentation and regulatory information on materials used in the manufacture of drug products. The information is designed to enhance transparency and facilitate manufacturers' risk assessment workflows and supplier qualification, according to the company.

The Emprove program now includes Millipore Express filters, Pureflex and Pureflex Plus bags, Viresolve Pro filtration devices and Durapore filters. Customers can access online regulatory and technical information including details on extractables, residual solvents and elemental impurities for these products. In addition, customers will find labeling information, shelf-life data and procedures, sterilization procedures, packaging testing, audit report summaries and management processes for suppliers. Using the Emprove program, manufacturers can download dossiers on material qualification, quality management and operational excellence in one centralized location.

The original Emprove program reportedly includes more than 400 raw materials and active pharmaceutical ingredients used in manufacturing drug products such as excipients, process chemicals and active pharmaceutical ingredients.

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