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Technical Report No. 65

BethesdaTowers4350 EastWestHighwaySuite200 Bethesda, MD20814 USATel:1 (301)656-5900 Fax:1 Report No. 65 Technology TransferParadigm Change in Manufacturing Technology Transfer Technical Report TeamAuthorsMirko Gabriele, EMPHA, Patheon Italia Spa, (Team Leader)Derek Blaettler, F. Hoffman-LaRoche, Elyath, Genzyme CorporationStephan Krause, , MedImmuneAndrea Morelli, Kedrion BiopharmaChittoor Narahari, GlaxoSmithKlineJamie Rogers, Biogen IdecVictor Sanchez, Pharma-Bio Serv Seymour, Biogen IdecYi Xie, , Eli Lilly and CompanyWayland Rushing, , Analytical Bio-Chemistry Laboratories, Wohlpart, , Merck & content and views expressed in this Technical Report are the result of a consensus achieved by the authoring task force and are not necessarily views of the organizations they TransferTechnical Report No.

Bethesda Towers 4350 East West Highway Suite 200 Bethesda, MD 20814 USA Tel: 1 (301) 656-5900 Fax: 1 (301) 986-0296 E-mail: info@pda.org Web site: www.pda.org

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Transcription of Technical Report No. 65

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MICROBIAL IDENTIFICATION USING THE BIOMÉRIEUX VITEK 2 …

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Optical System A transmittance optical system allows interpretation of test reactions using different wavelengths in the visible spectrum. During incubation, each test reaction is read every 15 minutes to measure either turbidity or colored products of substrate metabolism. In addition, a special algorithm is used to eliminate

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Fundamentals of an Environmental Monitoring Program

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Environmental monitoring is adjunct to a sterility assurance program and is used to evaluate the ef-fectiveness of microbial controls used in the manufacture of sterile pharmaceutical products. PDA first published guidance on environmental monitoring in the form of . Technical Report No. 13 . in 1990, and revised the guidance in 2001.

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Points to Consider for Cleaning Validation

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