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 Expert  721735

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


Available for your Consulting and Expert Witness Needs

Oregon (OR)
USA
Education Work History Career AccomplishmentsPublicationsConsulting Services Expert Witness Market Research

Summary of Expertise: Listed with other top experts in: 
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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membrane manufacturing

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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membrane material

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biomedical membrane

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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membrane separation

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membrane processing

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membrane process

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membrane permeation

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nanofiltration

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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Food and Drug Administration validation

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drug validation

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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membrane process technology training

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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microporous membrane

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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gas-permeable membrane

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gas permeable

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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medical filter

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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membrane filtration

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membrane filter

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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filtration

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microfiltration

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ultrafiltration

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water ultrafiltration

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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pharmaceutical filtration

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pharmaceutical filter


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.

Often requested
with this expert:

Membrane Filtration
Membrane Purification Processes, Separation Processes
Membrane Separation Processes, Water Purification, Waste...
Fluid Filtration

Education:
Year   Degree   Subject   Institution  
1988   MBA   Finance and International Business   New York University  
1982   MS   Chemical Engineering   University of Washington  
1980   BS   Chemical Engineering   Clarkson University  

Work History:
Years   Employer   Title   Responsibilities

2001 to

 

(Undisclosed)

 

President

 

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.

1997 to 2001

 

Chemica Technologies, Inc.

 

Vice President

 

Expert was Director of Technology Transfer and Commercialization.

1995 to 1997

 

GTC Technology Corp

 

Manager

 

Expert was responsible for technical development and marketing of chemical processes for world-wide chemical market.

1994 to 1995

 

AquaAir, Inc. (subsidiary of Bend Research, Inc.)

 

Director of Sales/Marketing

 

He was responsible for sales and marketing for membrane products.

1993 to 1994

 

Bend Research, Inc.

 

Project Manager

 

He was involved with the development of hollow-fiber membrane technology.

1991 to 1994

 

AquaAir, Inc. (subsidiary of Bend Research, Inc.)

 

Director of Engineering

 

Expert set up a hollow-fiber membrane production line. He designed and engineered prodcuts based on membrane technology.

1989 to 1991

 

Bend Research, Inc.

 

Senior Engineer

 

He developed hollow-fiber membrane technology.

1982 to 1989

 

Union Carbide

 

Senior Engineer

 

He was involved in process engineering, process development, and sales support for Union Carbide's technology licensing division.


Career Accomplishments:
Associations/Societies

Expert is a member of Parenteral Drug Association (PDA).


Publications:
Publications and Patents Summary

Expert has authored four papers and seven presentations.

Selected Publications and Publishers  
 - PDA Journal  

Consulting Services:
Selected Consulting Examples:
  • 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.
Recent Client Requests:
  • Expert to consult in nanoparticle isolation and purification,.
  • Expert for consulting on Blood separation/filtration for in-vitro diagnostics application.
  • Expert in Membranes for Life Science and Pharmaceutical Applications.
  • Polymer material expert for consulting on a technology priority assessment for a startup.
  • Expert in water treatment for consulting on residential and commercial/industrial water treatment technology and market conditions .
  • Expert in RO membrane manufacturing.
  • Sound wave expert for consulting on sonar signal processing.
  • Expert for consulting on Hydrophobic Materials.
  • Expert in RO membrane casting machine for consulting on membrane filtration.
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.

Expert Witness:
Recent Litigation Client Requests:
  • 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.
  • Water treatment, filtration and reverse osmosis expert for consulting on on patent litigation in Malaysia.
  • Expert in hemodialysis machines for consulting on home use of hemodialysis machines.
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.

International Experience:
Years   Country / Region   Summary
1997 to 2002   Germany   Expert consulted for a German pharmaceutical products processing company regarding product testing, development, and marketing.
1995 to 1997   South Korea/Asia   He licensed technology to the chemical process market. He traveled extensively, and attended plant commisionings.
1982 to 1989   Europe   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.
1989 to 1995   Europe   He worked with a membrane technology company in The Netherlands to commericalize new gas separation membranes.

Market Research:
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.

Additional Skills and Services:
Training/Seminars

Expert has given training on membrane fundamentals, and FDA validation testing for filters.

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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