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Expert in Membranes, Filters, Separations, Validation, Extractables, Leachables
Available for your Consulting and Expert Witness Needs
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Summary of Expertise:
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Listed with other top experts in: |
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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.
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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.
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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.
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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.
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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.
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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.
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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 as 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.
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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.
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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.
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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.
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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.
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Show Secondary and Basic Areas of Expertise | Localities:
Expert may consult nationally and internationally, and is also local to the following cities: Portland, Oregon;
Eugene, Oregon;
Salem, Oregon;
Springfield, Oregon;
and Bend, Oregon.
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Degree |
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Subject |
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Institution |
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1988
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MBA
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Finance and International Business
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New York University
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1982
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MS
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Chemical Engineering
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University of Washington
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1980
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BS
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Chemical Engineering
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Clarkson University
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Title |
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Responsibilities |
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2001 to
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(Undisclosed)
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President
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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.
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1997 to 2001
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Chemica Technologies, Inc.
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Vice President
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Expert was Director of Technology Transfer and Commercialization.
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1995 to 1997
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GTC Technology Corp
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Manager
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Expert was responsible for technical development and marketing of chemical processes for world-wide chemical market.
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1994 to 1995
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AquaAir, Inc. (subsidiary of Bend Research, Inc.)
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Director of Sales/Marketing
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He was responsible for sales and marketing for membrane products.
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1993 to 1994
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Bend Research, Inc.
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Project Manager
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He was involved with the development of hollow-fiber membrane technology.
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1991 to 1994
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AquaAir, Inc. (subsidiary of Bend Research, Inc.)
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Director of Engineering
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Expert set up a hollow-fiber membrane production line. He designed and engineered prodcuts based on membrane technology.
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1989 to 1991
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Bend Research, Inc.
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Senior Engineer
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He developed hollow-fiber membrane technology.
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1982 to 1989
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Union Carbide
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Senior Engineer
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He was involved in process engineering, process development, and sales support for Union Carbide's technology licensing division.
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Associations/Societies
Expert is a member of Parenteral Drug Association (PDA).
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Publications and Patents Summary
Expert has authored four papers and seven presentations.
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Selected Publications and Publishers
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- PDA Journal
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| Selected Consulting Examples: |
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Expert developed a hydrophobic chemical treatment for a medical syringe filter.
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He determined a polymer manufacturing process and was the inventor for a competitive gas separation membrane.
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He performed a market study for a membrane-based medical device. The study included current technology, evaluation of competitors, future trends, and unmet opportunities.
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He determined if nanofiltration membranes can be used for a medical application.
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He performed tests to compare tangential-flow filtration cassettes for protein concentration.
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Recent Client Requests:
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Expert to consult in nanoparticle isolation and purification,.
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Expert in Membranes for Life Science and Pharmaceutical Applications.
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Polymer material expert for consulting on a technology priority assessment for a startup.
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Expert in water treatment for consulting on residential and commercial/industrial water treatment technology and market conditions .
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Expert in RO membrane manufacturing.
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"Hollow fiber" manufacturing potting expert for consulting on Development of Static Potting Method for Hollow Fiber based Single-Use Product.
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Sound wave expert for consulting on sonar signal processing.
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Expert for consulting on Hydrophobic Materials.
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Expert in RO membrane casting machine for consulting on membrane filtration.
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Click the green button above to contact
Expert for a free initial screening call regarding your expert consulting needs.
Expert is available for consulting to corporate, legal and government clients.
Remember, your initial screening call to speak with
Expert is free.
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Recent Litigation Client Requests:
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Biomedical engineer expert witness for consulting on Use of pre-filled diluent syringes in the Autoject device by an MS patient. The syringe broke when using the Autoject and caused injuries to our client.
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Water treatment, filtration and reverse osmosis expert for consulting on on patent litigation in Malaysia.
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Expert in hemodialysis machines for consulting on home use of hemodialysis machines.
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Click the green button above to contact
Expert for a free initial screening call regarding expert testimony,
litigation consulting and support, forensic services, or any related expert witness services.
A few litigation needs include product liability, personal injury, economic loss, intellectual property
(patent, trademark, trade secret, copyright), and insurance matters. Remember, your initial screening
call to speak with
Expert is free.
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| International Experience: |
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Summary |
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1997 to 2002
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Germany
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Expert consulted for a German pharmaceutical products processing company regarding product testing, development, and marketing.
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1995 to 1997
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South Korea/Asia
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He licensed technology to the chemical process market. He traveled extensively, and attended plant commisionings.
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1982 to 1989
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Europe
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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.
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1989 to 1995
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Europe
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He worked with a membrane technology company in The Netherlands to commericalize new gas separation membranes.
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Expert has extensive experience in marketing of membrane products, contract research services, pharmaceutical validation services, and for-license technologies.
Click the green button above to contact
Expert for a free initial screening call regarding your marketing research, industry research, and company
research needs. For research needs involving multiple experts or secondary research,
a Research Director can be assigned to coordinate the work into a custom report for you as a potentially quicker
and more cost effective alternative to doing this work yourself or hiring a boutique consultancy.
Remember, your initial screening call to speak with
Expert is free.
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| Additional Skills and Services: |
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Training/Seminars
Expert has given training on membrane fundamentals, and FDA validation testing for filters.
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Supplier and Vendor Location and Selection Expert's vendor experience includes membranes, membrane testing equipment, chemical process equipment, analytical instruments, and adhesives.
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Education
