Expert Details

Expert in Validation of Sterilization Processes and USP/AAMI Microbiology, Cleanroom Practices, Aseptics, etc.

Expert ID: 723699 Colorado, USA

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Expert has years of experience in validating EO sterilization systems per ISO 11135, Gamma sterilization systems per ISO 11137, and Steam sterilization systems per ISO 11134/17665. This would also include troubleshooting and cycle development issues. He has worked with large and small manufacturers, various product types (devices, instruments, sets & kits, pharmaceuticals, biologics, human tissues, implants, sterile surgical disposables, etc), various sterilizer types, and contract & in-house sterilization. Industries include medical device, pharmaceutical, biologicals, and HCTPs. Many questions may be handled on the phone or with a minimal amount of research.

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

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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

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