Genencor International Launches Enzyme Technology for Prion Decontamination
Genencor International, Inc. announced a European Notified Body has assessed and certified the first enzyme technology designed specifically as a prion disinfectant for medical devices. Developed jointly with the United Kingdom's Health Protection Agency (HPA) and independently certified for use by a European Community Notified Body, Prionzyme(TM) carries the CE mark (Conformité Européenne). The product can be used to disinfect medical instruments utilized in invasive surgeries, such as procedures related to the central nervous system, eyes and tonsils, where prions have been shown to accumulate in the body. Genencor plans to further develop its Prionzyme line of products targeted for disinfecting general instruments and for sanitizing equipment for the meat processing industry.
Prionzyme M, the first enzyme from the new line of products, carries the CE mark indicating that the protease conforms with the essential requirements established by the European Medical Device Directive 93/42/EEC. Genencor plans for its additional Prionzyme products to also carry the CE designation. Genencor also recently received the ISO 13485:2003 registration at its Cedar Rapids, Iowa production site, where the Prionzyme products are manufactured. Following an extensive audit of the site's quality systems, Lloyd's Register Quality Assurance, a International Standards Organization (ISO) registrar and European Community Notified Body, awarded the ISO 13485 certificate of registration.
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