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sterile product aseptic manufacture




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Sterile Product Aseptic Manufacture Experts

The following experts are available as sterile product aseptic manufacture consultants and sterile product aseptic manufacture expert witnesses.  ORC experts are peer-recommended authorities who have been carefully selected and rigorously screened.
    Definition:  Sterile Product Aseptic Manufacture - The manufacture of a sterile product by means of sterile processing.

Synonyms:  sterile product aseptic manufacturing

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Sterile Product Aseptic Manufacture Experts
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Expert in Parenteral/Sterile Product Formulation Development; Protein Peptide Formulation; Drug Delivery
Former Director, Formulation Research, Hoffmann-La Roche Inc.- primarily parenteral formulation and drug delivery systems Extensive experience in the areas of formulation, drug delivery and clinical manufacturing - Member of Global Formulation ... See full profile

New Jersey (NJ), USA

Expert in QC/QA, Sterility Assurance, Aseptic, Pharmaceutical, Biotech, Device Manufacturing & Testing
Environmental Monitoring Operations, EM Trends Reports, EM Remediation and Investigation. Cleanroom Contamination Control Practices, Behaviors, Personnel, Gowning, Cleanroom Traffic Guidelines, Process/Personnel and Product Flows. See full profile

California (CA), USA

Expert in Pharmaceutical Technology, Manufacturing, Quality Systems and Regulations; GMPs and GLPs
Expert specializes in the field of pharmaceutical technology with particular emphasis on the development, manufacture, quality control and quality assurance of pharmaceuticals and medical devices. As a professional consultant to the healthcare ... See full profile

Illinois (IL), 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. See full profile

Colorado (CO), USA

Expert in Aseptic Processing, Aseptic Packaging
Expert has over 35 years of experience in the food-packaging field. His particular expertise is in aseptic packaging. He has consulted with the largest food processors in the world, technically advising on many aspects of aseptic processing and packaging ... See full profile

California (CA), USA

Expert in Food Processing and Packaging
During the past 14 years, Expert has had an active research program in aseptic processing and packaging. This program has included university and industry research into package/product interactions, aseptic processing equipment, ... See full profile

Virginia (VA), USA

Expert in Package Engineering, Products Liability-Foods, Pharmaceuticals, Medical Devices
Expert has had approximately 30 years of experience in the area of child-resistant (C-R) packaging. He has worked in this area for Monsanto Company, Allan Drug Company, and his own company. His consulting clients have had him work on C-R components, C-R ... See full profile

Missouri (MO), USA

Expert in Medical Product Design and Development
I have nearly 20 years professional experience with product development and manufacturing. This is ignoring the extensive experience I gained in my own time beginning at a very young age. For example, by age 10 I was experimenting with lasers and ... See full profile

California (CA), USA

Expert in Medical Device Design Control and Software Validation
Expert has extensive medical device engineering development and regulatory experience. He is a certified Lloyds of London ISO 9000 Lead Auditor and a member of the Westlaw Roundtable Expert Witness Network. His regulatory experience is primarily in product ... See full profile

New Jersey (NJ), USA

Expert in Cleanroom Technology
Expert has applied his background in the clean room industry to help those clients who are considering the use of clean rooms for their manufacturing process. He can assist with material alternatives and equipment selection that best fits into a ... See full profile

New York (NY), USA

Expert in Medical Technology
A significant portion of Expert's current activities include maintaining awareness and working knowledge of regulations that impact medical device manufacturers. She has specific experience with new medical device submissions, including combination ... See full profile

Minnesota (MN), USA

Expert in Peracetic Acid Manufacture, Chlorine Dioxide Generation, Infection Control, and Disinfectants
Expert has extensive experience with developing cleaning and sanitizing products and techniques for use in the North American dairy, food processing, beverage, and brewery industries. He transferred European technology for state-of-the-art gel ... See full profile

Ontario, Canada

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, ... See full profile

Ohio (OH), USA

Expert in Medical Device Product Development
Expert has designed, invented, and developed a wide range of single-use medical devices, including wound dressings, absorbent-hygienic products, compression garments, first aid products, and drapes and gowns. See full profile

North Carolina (NC), USA


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