Expert Details

Expert in Membranes, Filters, Separations, Validation, Extractables, Leachables

Expert ID: 721735 Oregon, USA

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Expert was responsible for building a new manufacturing facility for hollow-fiber thin film composite membranes for industrial gas and liquid. He helped design the equipment, created the plant layout, hired staff, and led the trouble-shooting phase. He led the engineering design of several membrane products and helped write technical marketing collateral.

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

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Year Degree Subject Institution
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

Work History

Years Employer Title Department Responsibilities
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.

International Experience

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.

Career Accomplishments

Associations / Societies
Expert is a member of Parenteral Drug Association (PDA).
Publications and Patents Summary
Expert has authored four papers and seven presentations.

Additional Experience

Training / Seminars
Expert has given training on membrane fundamentals, and FDA validation testing for filters.
Vendor Selection
Expert's vendor experience includes membranes, membrane testing equipment, chemical process equipment, analytical instruments, and adhesives.
Marketing Experience
Expert has extensive experience in marketing of membrane products, contract research services, pharmaceutical validation services, and for-license technologies.

Fields of Expertise

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