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Expert in Cleanroom Design & Operation
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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A significant portion of Expert's career has been in the designing, inventing, operating, teaching, and consulting on all aspects of clean rooms and bio-clean rooms. This experience covers both turbulent flow and laminar flow types encompassing cleanliness levels from Class 500,000 to cleaner than Class 1 per Federal Standard 209E. Expert is one of the original inventors of laminar flow rooms and equipment. He has written seven textbooks on this subject and given seminars for the past 37 years. Expert has spent a significant portion of his career in designing, inventing, operating, teaching, and consulting on all aspects of pharmaceutical bio-clean room, aseptic filling areas, sterile room, bio-tech clean areas, and white rooms using turbulent and laminar flow technology for cleanliness level from Class 500,000 to cleaner than Class 1 per Federal Standard 209E.
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Expert has spent a large amount of his career designing and specifying every conceivable type of equipment for use in clean areas. This includes equipment for processing employees into clean rooms such as shoe cleaner, air showers, garment dressing area equipment, platforms, sinks, and hand dryers and their costs. Expert's son is an employee of Acorn Industries Inc. He is Director of Research and Development and is also the General Manager of the company's Ultra-clean Products Approval Laboratory, a Division of Acorn Industries Inc. This lab is similar to an Underwriters Laboratory (UL) approval operation for the Clean room Industry. Expert is extremely knowledgeable of what materials and products will or won't work in a clean room.
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A significant portion of Expert's career has been devoted to designing, evaluating, and preparing garments and laundry facilities for Class 1, Class 10, Class 100, Class 1000, Class 10,000, and Class 100,000 clean rooms. He has developed the Expert Contamination Index to relate garment type/materials to those activities performed in the clean room and the contamination emissions of personnel. With this index Expert is able to predict how many contaminants a person emits, wearing a specific garment under a certain activity.
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Expert has a great deal of experience in the design and implementation of HEPA and U-LPA type filters for clean rooms and bio-clean rooms for air handling as well as in-plant dust control. This includes the design of fluid filter systems for handling clean fluids in the clean room. These fluids are used for both process needs and component cleaning requirements and include microfiltration using membrane filters, ultrafiltration, water ultrafiltration, and ultra pure-water processes.
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Expert has spent his entire career evaluating and specifying clean materials for the construction of clean rooms and bio-clean rooms per Federal Standard 209. This includes such materials as wall panels, wall systems, coatings, ceiling coverings, ceiling tiles, "T" bar ceilings, floor coatings, floor materials, utility chases, pipes, air ducts, air conditioning, lights, switches, and appointments and their costs.
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A significant portion of Expert's career has been spent designing and specifying heating, ventilating, and air conditioning equipment and systems (sometimes called climate control equipment) for clean rooms, bio-clean rooms, and special function controlled areas where special requirements of temperature, moisture, humidity, pressure, pollutants, contaminants, material out-gassing, vapors, fumes, trace materials, and static charges are needed.
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Expert has experience with the design and operation of aseptic filling areas. This involves the delivery of bottles, containers, and packaging materials to the aseptic filling equipment to prevent inclusion of infection-causing micro-organisms. This includes the application of various sterile packaging processes.
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Expert has spent a significant portion of his career in the detection of contaminants in a clean room or bio-clean room which is causing product failure or low yield rates. He is extremely knowledgeable about the detection of contaminants in a clean room. His evaluation looks at personnel actions, equipment and process operations, work layouts, etc. to discover the cause of the problem. The utilization of light-scattering particle counters and other detection equipment facilitates this micro-detective work. This includes particle-size measurement processes both automatically and manually.
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Expert is one of the few people in the world who can legitimately specify the needed cleanliness for a product using accumulated data and other relevant information. He is skilled at determining the proper airborne, liquid-borne, and vacuum state appropriate as a 3-D environment about the manufacturing site for a specific product. This includes the variations to that environment for a multicomponent assembly. He has almost 40 years experience analyzing product manufacturing environments and yield rates for products. He is able to mathematically and experimentally determine, on a micro scale, how contaminants cause failure and what cleanliness levels are necessary to insure success. This includes hydraulic system contamination control.
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Expert is one of the inventors of the laminar flow technology as used in cleanrooms and bio-cleanrooms worldwide. He is one of the original 1960 developers of Vertical and Horizontal Laminar Flow Cleanrooms and Clean Benches. He is a U.S. Patent holder on various laminar flow clean benches. He wrote the first standards and specifications on this subject in 1961. Expert prepared and then published the first textbook on laminar flow cleanrooms and clean Benches starting in 1962. This textbook has been continually updated and has been expanded into seven textbooks, the latest being the year 2000, 3rd revision of The Encyclopedia of Cleanrooms, Bio-cleanrooms and Aseptic Areas.
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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: Detroit, Michigan;
Warren, Michigan;
Flint, Michigan;
Sterling Heights, Michigan;
Lansing, Michigan;
Ann Arbor, Michigan;
Livonia, Michigan;
Dearborn, Michigan;
Cleveland, Ohio;
and Toledo, Ohio.
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Degree |
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Subject |
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Institution |
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1967
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Ph.D.
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Engineering Science
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University of Stuttgart
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1965
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M.S.
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Aerospace Engineering
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California Institute of Technology
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1959
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B.A.E.
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Aeronautical Engineering
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University of Detroit
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Employer |
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Title |
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1967 to
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(Undisclosed)
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President/Chief Engineer
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1961 to 1967
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United States Air Force
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Chief Engineer for Clean Rooms
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Associations/Societies
Expert is a member of IES and ISPE.
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Awards/Recognition
He received the USAF Commendation Medal for saving USAF $15,000,000 in construction and operating costs.
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| Publications: |
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Publications and Patents Summary
Expert has authored the world's first textbooks on cleanrooms: Encyclopedia of Cleanrooms, Bio-Cleanrooms and Aseptic Areas; Design and Operation of Pharmaceutical Bio-Cleanrooms and Aseptic Areas; Design and Operation of Bio-Cleanrooms for Medical Devices; Encyclopedia of Cleanrooms/White Rooms/Sterile Rooms; Design and Operation of Clean Rooms; and Expert's Clean Rooms of the World. He has written over 100 cleanroom technical papers and reports and has acted as Consulting Editor to four trade journals.
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Selected Publications and Publishers
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- Contamination Control Seminars
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Recent Client Requests:
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Clean room expert for consulting on design of a clean room and document clean room assembly procedures.
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Stainless steel expert for consulting on stainless steel.
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Expert in Clean Room -Aseptic Packaging of Beer.
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Aseptic expert for consulting on contamination issues within clean rooms.
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Expert in class 1000 aseptic clean room for consulting on installation of a class 100 aseptic clean room facility.
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FDA expert for consultation to provide pre approval and post approval support to ensure approval of a NADA with a minimum of time spent in the review cycle of T-Pro.
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Expert in Air Filtration.
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Expert in GE Healthcare (Electric Avenue), Milwaukee, WI - Cleanroom & NVR Testing Consultation.
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Class 100 clean room expert for consulting on Class 100 cleanroom.
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FDA sterile medical device regulatory expert for consulting on sterile package integrity validation.
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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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Clean room testing expert for consulting on contamination issue.
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Expert on clean room design and construction to review design of facility.
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Clean room expert for consulting on requirements.
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Clean room expert for consulting on patent infringement.
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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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| Additional Skills and Services: |
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Supplier and Vendor Location and Selection Expert has experience locating vendors of: components for clean rooms; manufacturers of clean rooms; laminar flow benches; vertical flow modules; particle counters; clean room garments; all types of filters; architects, engineering firms, and testing organizations; costs for cleanrooms; and, equipment. He also has access to the following resources: product literature; textbooks; mailing lists; and, buyers' guide information.
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Education
