BOTHELL, Wash., Dec. 23 /PRNewswire-FirstCall/ -- BioLife Solutions, Inc. (OTC Bulletin Board: BLFS), a leading developer, manufacturer, and marketer of biopreservation tools for cells, tissues, and organs, today announced that it has successfully completed audits of its quality systems and GMP production facility in Bothell, Washington by BSI Group and has been issued a certification to ISO 13485:2003, an international standard for quality systems supporting the design, development, and manufacture of medical devices.
Mike Rice, BioLife's chairman and CEO, noted, "This achievement is a strategic quality milestone for BioLife. Our growing clinical customer base expects us to set a high bar for the production of our GMP biopreservation media products, since many customer applications include the use of our products as a combined preservative/injection delivery solution for cell-based therapies used to treat cancer, heart failure, and a host of other diseases. We're continuing to enhance the quality footprint of our proprietary, best-in-class HypoThermosol® and CryoStor(TM) biopreservation media products with this certification and updates to our FDA Master Files. Furthermore, we expect to achieve CE Mark conformity for our products in 2010."
In addition to certification to ISO 13485, BioLife's manufacturing facility and quality systems adhere to 21 CFR Part 820 - Quality System Regulation for Good Manufacturing Practices (GMP) of medical devices, 21 CFR Parts 210 and 211 covering GMP for Aseptic Production, Volume 4, EU Guidelines, Annex 1 for the Manufacture of Sterile Medicinal Products, ISO 13408 for aseptic processing of healthcare products, and ISO 14644 for Clean Rooms and Ass
|SOURCE BioLife Solutions, Inc.|
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