sterilisationbyvhp过氧化氢灭菌技术.doc

ISOLATOR TECHNOLOGY MANUFACTURING Design…Qualification…Experience Complimentary WEBINAR Wednesday, December 12, 2007 This webinar presents the methods used at Baxter’s Halle, Germany facility for the design and validation/qualification of isolators used for the aseptic production of sterile drug products. Featured Speakers: Frank Generotzky Corinna Schneider Speakers Frank Generotzky Corinna Schneider Director of Technology and Engineering QA Specialist GMP Compliance Mr. Frank Generotzky is recognized as an expert in the field of aseptic manufacturing of parenteral products, and is a frequent presenter at several European Conferences and ISPE Meetings for Sterile Drug Manufacturing. He earned his Diploma for Pharmaceutical Engineering from the University of Applied Science Lippe / H?xter in Germany. Since 1996 Frank has designed and installed several production-lines in standard Cleanroom Technology as well as in Isolator Technology at Baxter’s facility in Halle, Germany. Starting in 2001 Frank headed the production department for sterile cytotoxic drugs (liquid, powders and lyophilisates). In his present role, Frank is responsible for the strategic development of Pharmaceutical Technology in Halle. He is leading a team of 13 engineers, who design, plan and realize the investment projects in Halle according to customer and market requirements. Ms. Corinna Schneider, is recognized as an expert in the field of sterile drug products produced by aseptic processing. She developed and implemented a complex VHP sterilization process for isolators and equipment parts in Halle/Germany and presented this method at pharmaceutical conferences and workshops in Europe and in the US. She trained local regulatory inspectors in VHP cycle development and presented her concept several times to the FDA. Ms. Schneider earned her Diploma for Pharmaceutical Engineering from the University of Applied Science Lippe / H?xter in Germany. From 1995 to 2000 she headed the Micro