Expert Details

Expert in Sterilization; Food & Drug Product, Packaging & Process Development; HACCP & Validation

Expert ID: 107894 Ohio, USA

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Expert is a nationally recognized expert in aseptic, retort and autoclave, thermal processing and associated packaging of foods and drugs. He is well networked with the FDA food regulatory agency technical staff, academia, other process authorities, and research consortia. He participated in developing national guidelines for FDA filings of retort and aseptic, low-acid liquid and particulate-containing foods.

Expert has experience designing and implementing low-acid food retort sterilization processes. He has expedited process design and development of supporting data for FDA low-acid filings for products being prepared for clinical and in-home trials and test markets. He has used the physical properties of foods and the thermal mechanical properties of polyolefin containers to program sterilizer pressures appropriately in order to maintain a closure integrity and a containers’ aesthetic appearance without the need for extensive trial-and-error tests to identify optimal pressures. These methods enable stacking of polyolefin containers in sterilizer baskets with standard separator sheets between layers and standard rigid container loader-unloaders.

Expert has specified moisture barrier films for unit-serve drink flavoring powders that require a very low O2TR to prevent vitamin degradation and WVTR in order to avoid caking and interference with mixing during a three-year shelflife.

Expert has designed and implemented semirigid polyolefin containers for powdered drink products that require a very low O2TR to prevent vitamin degradation and WVTR in order to avoid caking and interference with mixing during a three-year shelflife shelf life for the global market. Shelf life was estimated using international weather records and product and package physical properties.

Expert designed multiple containers by combining the application of nonlinear finite element analysis with methods of deoptimal experimental design to identify the most optimal designs compatible with the thermal processing environment.

His experience with nonlinear material includes designing and implementing a 1/2-liter prefilled, tube-feeding, retort pouch with an elastomer port and opening feature so the port can be exposed by opening the pouch and pierced with a tube feeding set in much the same manner as are intravenous bags.


Expert designed and implemented semirigid polyolefin-EVAL-copolymer bottles and cups for oxygen sensitive powdered and liquid nutritional drinks. He worked with both high-acid and low-acid drink packaging.

Expert designed a ported retort pouch for tube feeding composed of polyester/high-barrier polyvinylidene chloride/polyolefin laminated film. He worked with gas barrier requirements of 10-cc/100-square inch/year at atmospheric conditions.

Experienced with plastic food packaging, Expert designed and implemented flexible and semirigid packaging with low-WVTR and O2TR for powdered and liquid drinks (low- and high-acid).

He is familiar with the limitations of state-of-the-art technologies, critical leak size and criteria for quantifying the same. He is also knowledgeable of and experienced in destructive and nondestructive test methods and bio-challenges -- aerosol and various immersion methods. He knows of proprietary technologies, some that are patented and others that are patent pending. He is also in a position to broker some patented and patent-pending technologies. Expert is also familiar with pending publications for semirigid containers that will be in the public sector soon. He is directly responsible for funding the latter research at a public university. Lastly, he is familiar with ongoing proprietary research, not in the public sector, but available through membership(s) in various research consortia.


Expert has developed a half dozen, multilayer polyolefin bottles, ranging in size from 90 to 1000 ml, for retort/autoclave sterilized food and drug products. Robust container parameters were quantified for optimal compatibility with the sterilization processes. In addition, optimal sterilizer pressure programming was specified to safeguard closure integrity and aesthetic container shape. Optimal sterilizer pressures were determined as a function of fill-seal and sterilization parameters in conjuction with product thermal properties and container materials' thermal mechanical properties as determined via thermal mechanical analyses. The methods enable stacking of the containers in sterilizer baskets using standard separator sheets between layers and standard rigid container loader-unloaders.


Expert designed sterilization processes and developed supporting data and filing processes for various HTST batch and continuous rotary sterilizers. He developed computerized thermal process calculations for forced convection heating of liquid foods using second order models in support of continuous rotary sterilizer FDA filings. Expert has placed spore strips and performed pharmaceutical-style media runs on aseptic form-fill-seal equipment in Europe and the US.


Expert designed sterilization processes and developed supporting data for FDA food regulatory low-acid food filing of UHTST processes.



Expert stacked semirigid containers in batch retorts and autoclaves by using optimal pressure programming. He programmed optimal sterilizer pressures in order to maintain semirigid containers' aesthetic apprearance and closure integrity without the need for extensive trial-and-error testing. Expert accomplished this by using heat penetration data, the physical properties of foods and the thermal mechanical properties of polyolefin containers. These methods enabled stacking of polyolefin containers in sterilizer baskets with standard separator sheets between layers and standard rigid container loader-unloaders. Expert expedited FDA thermal process filing and retort pressure programming for an in-home test product. In less than 100 days he expedited delivery of a low-acid beverage in a 180 ml, innovative, very-thin-walled, deep-draw, thermal formed cup for in-home use studies. He designed and implemented container carriers and racking, developed heat distribution and penetration data, filed FDA low-acid food thermal processes and programmed sterilizer pressures. The finished product was delivered. Expert used the product's physical properties and the thermal-mechanical properties of polyolefin containers to set batch sterilizer pressure programming to assure the containers' aesthetic appearance and closure integrity without running trial-and-error tests to identify optimal pressures. Expert safeguarded full-panel-pull, closure integrity in sterilmatic retorts. Expert used heat penetration data to determine required container buckle and panel strengths. This information was used to specify container performance and fill-seal and sterilizer parameters to safeguard full panel pull, FPO, closure integrity. Expert specified vessel pressures for semirigid containers for STERILMATIC (TM) retorts. He used the physical properties of foods and the thermal-mechanical properties of polyolefin containers to set STERILMATIC (TM) sterilizer vessel pressures. In addition, Expert recommended a number of manufacturing line modifications to assure adequate control of critical fill parameters. Optimal vessel pressures were recommended to assure semirigid containers' aesthetic appearance and closure integrity without the need for extensive trial-and error testing. Expert designed semirigid containers for STERILMATIC (TM) retorts. He designed multiple containers by combining the application of nonlinear finite element analyses with methods of deoptimal experimental design to identify the most optimal designs compatible with STERILMATIC (TM)retorts. He was able to find an optimum desgn that could not be found either by intuitive search or response surfaces and many localized optimums that are dependent of initial starting points. Expert used finite element analyses and innotative test methods to identify lowest wieght sheet stocks that could be used for metal cans and lids in STERILMATIC (TM) retorts. Expert tested aseptic fillers at vendors'sites in Europe and the US. He designed portable process equipment, wrote and executed test protocols for testing aseptic filler on equipment vendor's site.

Expert may consult nationally and internationally, and is also local to the following cities: Columbus, Ohio - Cincinnati, Ohio - Akron, Ohio - Dayton, Ohio - Canton, Ohio - Lorain, Ohio - Springfield, Ohio - Hamilton, Ohio - Elyria, Ohio - Middletown, Ohio

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Education

Year Degree Subject Institution
Year: 1986 Degree: MBA Subject: Strategic Management of Technology Institution: University of Dayton
Year: 1978 Degree: PhD Subject: Food, Agriculture, and Biological Engineering Institution: Michigan State University
Year: 1970 Degree: MS Subject: Food, Agriculture, and Biological Engineering Institution: Michigan State University
Year: 1969 Degree: BS Subject: Mechanical Engineering Institution: University of Wisconsin
Year: 1969 Degree: BS Subject: Agriculture Institution: University of Wisconsin

Work History

Years Employer Title Department Responsibilities
Years: 1997 to Present Employer: Undisclosed Title: Principle Consultant & Engineer Department: Responsibilities: He is involved in aseptic, retort, and autoclave sterilization engineering, process & packaging experimental design optimization & troubleshooting, process and packaging equipment selection and vendor relations, primary & secondary packaging vendor relations, high-headspace semirigid retort container design technologies, HACCP, and validation.
Years: 1978 to 1998 Employer: Abbott Laboratories, Ross Products Division Title: Research Scientist, then Senior Research Scientist and later, Associate Research Fellow Department: Package Development, Product R&D, Process/Package Development Responsibilities: He was involved in sterilization engineering,
process and packaging experimental design, optimization and troubleshooting,
process and packaging equipment selection and vendor relations,
primary & secondary packaging vendor relations,
high-headspace semirigid retort container design technologies,
HACCP, and
validation.
Years: 1975 to 1978 Employer: The Pillsbury Company Title: Senior Packaging Scientist Department: Responsibilities: His responsibilities included refrigerated frozen & microwave packaging,
refrigerated & frozen distribution, environment definition and shelf life prediction.
Years: 1970 to 1975 Employer: Michigan State University Title: Research and Teaching Assistant Department: Agricultural Engineering Responsibilities:
Years: 1969 to 1970 Employer: International Harvester Title: Design Engineer Department: Responsibilities:
Years: 1968 to 1968 Employer: Deere and Company Title: (Summer) Test Engineer Department: Responsibilities:

International Experience

Years Country / Region Summary
Years: 1980 to 1980 Country / Region: France Summary: Expert designed portable process equipment, wrote and executed test protocols for testing aseptic filler on equipment vendor's site.
Years: 1997 to 1998 Country / Region: Europe Summary: Expert developed a 1/2 liter, multilayer polyolefin bottle for retort/autoclave sterilized food and drug products. Robust container parameters were quantified for optimal compatibility with the sterilization processes. In addition, optimal sterilizer pressure programming was specified to safeguard closure integrity and aesthetic container shape. Fill-seal and sterilization parameters were used in conjunction with product thermal properties and container materials' thermal mechanical properties determined via thermal mechanical analyses. These methods enabled stacking of the containers in sterilizer baskets with separator sheets between layers and standard rigid container loader-unloaders.

Career Accomplishments

Associations / Societies
Expert is a member of the American Society of Agricultural Engineers, the American Institute of Chemical Engineers, the Institute of Food Technologists, the Institute of Packaging Professionals, the Institute for Thermal Processing Specialists, and the Parental Drug Association.

Professional Appointments
Expert was the Chairman of the Ross Products Division Scientific Advisory Board. He has served six years on the Industry and Professional Advisory Board for the Ohio State University Department of Food, Agricultural and Biological Engineering. He was a Member-at-Large for two years on the Institute of Food Technologists, Food Engineering Division Board.
Awards / Recognition
Expert was named the Abbott Outstanding Researche and was once runner-up. He also received the Abbott Chairman's Award.
Publications and Patents Summary
Expert has four patents, four publications, has delivered seven speeches, and has 50-plus proprietary Ross/Abbott technical publications.

Fields of Expertise

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