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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…
Microbiology: Bacteria, Molds/Fungi – Identification, Quality Control, Remediation, Expert Witness
MICROBIOLOGY; BACTERIOLOGY; MYCOLOGY; MICROORGANISM IDENTIFICATION. Expert has expertise in the identification and control of microorganisms including aspects of sterilization, disinfection, and inhibition of microbes. He has extensive background in the application of control mechanisms and chemicals to all environments, including…
Sterilization, Biomaterials, Tissue Banking, Medical Product Development, Polymer Toxicology
Expert K. Expert has spent 30 years in the medical products business, in which he developed sterilization processes such as ethylene oxide, gamma radiation, vapor phase hydrogen peroxide, plasma sterilization, aseptic processing, disinfection with formaldehyde, glutaraldehyde, and steam sterilization. Novel…
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, and packaging systems. His current research includes biological verification…
Blood Wetted Devices and Biomaterials
BLOOD-WETTED BIOMATERIAL; CARDIOVASCULAR PROSTHESES; ARTIFICIAL INTERNAL ORGANS. Expert has been involved in the design, development, and evaluation of extracorporeal and implantable artificial internal organs for many years, first with the artificial kidney (including hemodialyzers and those based upon selective absorption)…
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 products. Expert is proficient in total quality systems requirements…