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Expert ID: 720664 New Jersey, USA

Expert in Medical Devices, Biotech, Aseptic Processing, Engineering, Facilities, and Sterilization

Expert has extensive expertise in all areas of aseptic processing and terminal sterilization of medical devices, human tissue for transplanation processing, microcontamination and controlled environments. He has been involved in clean room projects for Ethicon, Inc., Osteotech, Inc., Manufacturing Automation…

Expert ID: 734924 California, USA

Expert in Medical Device Engineering

He worked on hazard analysis of medical devices such as biochemical sensors. He worked on packaging processes of medical devices such as implantable catheters. He worked on packaging materials of medical devices such as plastic packaging. He worked on manufacturing…

Expert ID: 731857 Illinois, USA

Expert in Sterile Process Validation, Microbiology, Steam Sterilization, Aseptic Filling, Rapid Micro Methods

Expert has over 25 years experience in various aseptic of sterile process validation. She has worked for Baxter, Fujisawa (now Astellas), Jordan Pharmaceuticals, Vectech Pharmaceutical Consultants and Excellent Pharma Consulting. This encompasses steam sterilization, aseptic filling, process validation, development of…

Expert ID: 730905 Ohio, USA

Expert in Process Engineering in Biotechnology, Pharmaceuticals, Food and Fermentation

Expert has years of engineering experience in the biotechnology, pharmaceutical, food and fermentation industries. Training includes hands-on industrial experience in the laboratory, pilot plant, and plant with extensive scale-up and start-up experience. Expertise in fermentation and recovery of aerobic and…

Expert ID: 730610 Canada

Expert in GMP Compliance EPCMV of BioPharmaceutical Process, Clean Utilities, Systems, Facilities Engineering

He is a Health Canada Expert (in 2007) and a Senior BioProcess Engineer & Project Manager Consultant; He acquired more than 21 years’ experience with various BioPharma Industries & Consulting companies (SNC Lavalin Pharma), where more than 50 projects were…

Expert ID: 723699 Colorado, USA

Expert in Validation of Sterilization Processes and USP/AAMI Microbiology, Cleanroom Practices, Aseptics, etc.

Expert has years of experience in validating EO sterilization systems per ISO 11135, Gamma sterilization systems per ISO 11137, and Steam sterilization systems per ISO 11134/17665. This would also include troubleshooting and cycle development issues. He has worked with large…

Expert ID: 722788 California, USA

Expert in Biotechnological Pharmaceutical Chemical Process Development Design Engineering

Expert has applied his extensive background in chemical engineering in various areas including pharmaceutical process and product development; developing new products for pharmaceutical and consumer industries; process, equipment, and analytical method validation in biotechnology areas; and designing and improving various…

Expert ID: 108050 New Jersey, USA

Expert in Engineering Management

Expert has been involved with the re-engineering of new product development processes, creation of total quality management programs, and organizational structure changes for process engineering and research and development functions for two major medical device manufacturers (i.e. Johnson & Johnson…

Expert ID: 721133 North Carolina, USA

Expert in Medical Polymer Sterilization

MEDICAL POLYMER SELECTION; MEDICAL POLYMER STERILIZATION. With knowledge of material selection for medical devices, Expert has specific expertise in selecting materials based on cost, physical properties, radiation or other forms of sterilization, blood and tissue compatibility, permeability, and aging properties.…

Expert ID: 107894 Ohio, USA

Expert in Sterilization; Food & Drug Product, Packaging & Process Development; HACCP & Validation

Expert is a nationally recognized expert in aseptic, retort and autoclave, thermal processing and associated packaging of foods and drugs. He is well networked with the FDA food regulatory agency technical staff, academia, other process authorities, and research consortia. He…

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