Expert in Membranes, Filters, Separations, Validation, Extractables, Leachables
Expert ID: 721735 Oregon, USA
Through 14 years of practical membrane experience, Expert has a broad knowledge of membrane materials. He has worked with membranes for medical devices, dialysis, industrial gas and liquid separations, and chemical process plant unit operations. He started a hollow-fiber membrane manufacturing plant using thin film composite polyethersulfone. He has worked with many membrane materials including polysulfones, polyimides, polyamides, cellulosics, PAN, and PTFE.
Expert has worked in separation science for over 20 years. His primary experience is with membranes and filters. However, he has worked in significant depth in many other separation technologies including absorption, adsorption, distillation, liquid-liquid extraction, and liquid chromatography. He offers excellent insight into the applicability of membranes to a particular separation. He has experience with making membranes as well as designing devices that use membranes. He can speak on a practical or theoretical level as is appropriate for a situation.
Expert has set up a laboratory for validating polymeric materials for pharmaceutical uses--both in processing (filters) and end use (containers and closures). In particular, he is expert in determining what extractables and leachables come off out of polymers in actual applications. This involves FDA autidable protocols that allow for the identification and quantification of extractables from solutions that would normally be considered too difficult to analyze. The finished product is a report that can be taken to the FDA.
Expert has a broad and deep background in membranes and filters, including materials, manufacturing methods, and use in specific applications. He has experience with both industrial and medical applications. He is a natural teacher and lecturer and has been asked to give general membrane primers to companies who need to learn more about membranes and filters.
Expert spent seven years developing microporous membranes for industrial gas and liquid separations. He understands solvent-based processes where poreformers are used to create the pore structure. He does not have experience with the hot melt spinning process technique.
Expert spent seven years developing a thin film composite hollow-fiber membrane for industrial gas and liquid separations. He helped develop models to simulate gas separation using counter-current and cross-flow model configurations. He has tested membrane separations including water vapor from air, organics from air, polar organics from non-polar organics, and oxygen from nitrogen.
He has also been involved with gas separation with other technologies, including absorption and adsorption (activated carbon, zeolites) and can discuss the advantages of each for a specific application.
Expert has worked with filters for medical and pharmaceutical use for several years. He has helped customers modify existing filters for a specific application (hydrophobic/hydrophilic self-venting filter). He has worked with many different filter materials and understands their strengths and weaknesses. He is familiar with the requirements of FDA registration and can consult regarding validation.
Expert has broad experience with microfiltration and ultrafiltration in industrial and medical application. He has developed ultrafilters for wastewater clean up. He has performed comparative testing for protein concentration using cross flow (also called tangential flow) cassettes. He has performed chemical treatments to membrane filters for specific affinities.
Expert's filtration background is strongest for pharmaceutical processing and medical devices. He is intimately familiar with filtration products from the major filter suppliers including Pall, Millipore, Whatman and Sartorius. He has performed filtration and cross-flow filtration studies for customers. He can also produce FDA auditable data under GLP conditions.
Expert has worked with major pharmaceutical filter manufacturers to optimize their filters for specific applications. He can perform filterability tests and adsorption studies, and can consult regarding integrity tests and other validation tests.
Expert developed a hydrophobic chemical treatment for a medical syringe filter.He determined a polymer manufacturing process and was the inventor for a competitive gas separation membrane.He performed a market study for a membrane-based medical device. The study included current technology, evaluation of competitors, future trends, and unmet opportunities.He determined if nanofiltration membranes can be used for a medical application.He performed tests to compare tangential-flow filtration cassettes for protein concentration.
Expert may consult nationally and internationally, and is also local to the following cities: Portland, Oregon - Eugene, Oregon - Salem, Oregon - Springfield, Oregon - Bend, Oregon
|Year: 1988||Degree: MBA||Subject: Finance and International Business||Institution: New York University|
|Year: 1982||Degree: MS||Subject: Chemical Engineering||Institution: University of Washington|
|Year: 1980||Degree: BS||Subject: Chemical Engineering||Institution: Clarkson University|
|Years: 2001 to Present||Employer: Undisclosed||Title: President||Department:||Responsibilities: Expert is the founder of Validation Resources that offers services including validation testing of extractables from polymeric materials for use in the pharmaceutical industry. Services also include separation testing for membranes and filters, consulting, and technical writing.|
|Years: 1997 to 2001||Employer: Chemica Technologies, Inc||Title: Vice President||Department: Technology Transfer and Commercialization||Responsibilities: Expert was Director of Technology Transfer and Commercialization.|
|Years: 1995 to 1997||Employer: GTC Technology Corp||Title: Manager||Department: Technical Development||Responsibilities: Expert was responsible for technical development and marketing of chemical processes for world-wide chemical market.|
|Years: 1994 to 1995||Employer: AquaAir, Inc. (subsidiary of Bend Research, Inc.)||Title: Director of Sales/Marketing||Department: Membrane Products||Responsibilities: He was responsible for sales and marketing for membrane products.|
|Years: 1993 to 1994||Employer: Bend Research, Inc.||Title: Project Manager||Department: Membrane Technology||Responsibilities: He was involved with the development of hollow-fiber membrane technology.|
|Years: 1991 to 1994||Employer: AquaAir, Inc. (subsidiary of Bend Research, Inc.)||Title: Director of Engineering||Department: Membrane Technology||Responsibilities: Expert set up a hollow-fiber membrane production line. He designed and engineered prodcuts based on membrane technology.|
|Years: 1989 to 1991||Employer: Bend Research, Inc.||Title: Senior Engineer||Department: Membrane Technology||Responsibilities: He developed hollow-fiber membrane technology.|
|Years: 1982 to 1989||Employer: Union Carbide||Title: Senior Engineer||Department: Technology Licensing||Responsibilities: He was involved in process engineering, process development, and sales support for Union Carbide's technology licensing division.|
|Years||Country / Region||Summary|
|Years: 1997 to 2002||Country / Region: Germany||Summary: Expert consulted for a German pharmaceutical products processing company regarding product testing, development, and marketing.|
|Years: 1995 to 1997||Country / Region: South Korea/Asia||Summary: He licensed technology to the chemical process market. He traveled extensively, and attended plant commisionings.|
|Years: 1982 to 1989||Country / Region: Europe||Summary: He worked with an internation technology licensing organization. He performed start-ups of a chemical plant, made sales calls, and follow-up technical service visits.|
|Years: 1989 to 1995||Country / Region: Europe||Summary: He worked with a membrane technology company in The Netherlands to commericalize new gas separation membranes.|
|Associations / Societies|
|Expert is a member of Parenteral Drug Association (PDA).|
|Publications and Patents Summary|
|Expert has authored four papers and seven presentations.|
|Training / Seminars|
|Expert has given training on membrane fundamentals, and FDA validation testing for filters.|
|Expert's vendor experience includes membranes, membrane testing equipment, chemical process equipment, analytical instruments, and adhesives.|
|Expert has extensive experience in marketing of membrane products, contract research services, pharmaceutical validation services, and for-license technologies.|
Fields of Expertise
membrane manufacturing, membrane material, biomedical membrane, membrane separation, membrane processing, membrane process, membrane permeation, nanofiltration, Food and Drug Administration validation, drug validation, membrane process technology training, microporous membrane, gas-permeable membrane, gas permeable, medical filter, membrane filtration, membrane filter, filtration, microfiltration, ultrafiltration, water ultrafiltration, pharmaceutical filtration, pharmaceutical filter, industrial gas manufacturing, point-of-use filtration, cellulose chemistry, biocompatibility testing, aqueous filtration, dialyzer membrane, particle filtration, plastic medical device, ionic membrane, air-permeable film, membrane oxygenator, oxygenator, air filtration, perfluorocarbon, perfluorosulfonic acid membrane, diafiltration, cellulose nitrate membrane, polymer surface chemistry, cellulose nitrate, fuel cell material, Food and Drug Administration drug packaging regulation, renal dialysis, drinking water treatment, biofiltration, plastic film, gas-permeable contact lens, biomedical device, activated carbon, Food and Drug Administration regulation, process validation, liquid phase membrane, water purification, surface chemistry, reverse osmosis water treatment, pressure filtration, FDA medical device regulation, ion-exchange membrane, gas separation