Expert Details
Expert in Validation of Sterilization Processes and USP/AAMI Microbiology, Cleanroom Practices, Aseptics, etc.
Expert ID: 723699
Colorado, USA
He also has considerable experience in the performance and validation of USP / AAMI microbiology test methods (bioburden, sterility test, LAL gel-clot, biological indicators, B/F, disinfectant testing, etc.). Other area of expertise include cleanroom practices/aseptic techniques, biological monitoring of purified water systems, environmental monitoring practices, and the validation of cleaning/reuse processes for the reuse and resterilization of surgical instruments and instrument sets/kits.
Numerous clients in medical device and HCTP industries. EO, steam, Sterrad, gamma, and various microbiology validation projects.
Expert may consult nationally and internationally, and is also local to the following cities: Denver, Colorado - Colorado Springs, Colorado - Aurora, Colorado - Fort Collins, Colorado - Arvada, Colorado - Pueblo, Colorado - Westminster, Colorado - Boulder, Colorado - Greeley, Colorado - Longmont, Colorado
Education
| Year | Degree | Subject | Institution |
|---|---|---|---|
| Year: 1983 | Degree: M. S. | Subject: Microbiology | Institution: South Dakota State University |
| Year: 1980 | Degree: B. S. | Subject: Microbiology | Institution: SDSU |
Work History
| Years | Employer | Title | Department | Responsibilities |
|---|---|---|---|---|
| Years: 1999 to 2001 | Employer: Synthes (Synthes-Stratec) USA | Title: Sterility Assurance Specialist | Department: Corporate | Responsibilities: Responsible for all sterilization programs, validation, and activities (gamma, EO, steam, Sterrad) for one of the largest device & instrument manufacturers (permanent surgical implants, instruments, and sets) in the US. Pivotal in establishing sterilization requirements for new product development/introductions. Also in charge of environmental monitoring, monitoring of purified water systems, cleanroom monitoring, testing for bioburden, LAL-endotoxin, biological indicators, etc. |
| Years: 1998 to 1999 | Employer: Bayer Pharmaceutical | Title: Microbiology QA Supervisor | Department: Allergy Products (Parenteral & Injectables) | Responsibilities: |
| Years: 1995 to 1998 | Employer: Baxter Healthcare | Title: Sterilization Engineer / Senior Microbiologist | Department: Surgical Products Division(s) | Responsibilities: |
| Years: 1992 to 1994 | Employer: ProCyte Corp | Title: Senior Associate | Department: Therapeutics | Responsibilities: |
| Years: 1986 to 1992 | Employer: ZymoGenetics | Title: Research Associate III | Department: Division of NovoNordisk | Responsibilities: |
| Years: 1982 to 1986 | Employer: Becton Dickinson | Title: QA/Sterilization Microbiologist | Department: Labware | Responsibilities: |
Fields of Expertise
ethylene oxide sterilization, gamma-ray sterilization, gas sterilization, irradiation sterilization, steam sterilization, steam sterilizer, sterilization, clean room microbiology, biologic (product), cobalt-60 sterilization, vapor phase hydrogen peroxide sterilization, terminal sterilization, cleaning product, biological sterilization indicator, bacterial spore, sterile product aseptic manufacture, cold liquid sterilant, sterilant, sterilizer, autoclave, sterilization engineering, gamma radiation, medical sterilization, industrial sterilization, ethylene oxide, electron beam, disinfection, cleaning, clean room, bactericide