Harry Shaffer has over 33+ years experience in the sterilization and manufacturing of medical devices. In addition to expertise with radiation, EO and steam sterilization, Harry has also developed and validated sterilization cycles and procedures. Sterilization Consulting services has personally managed multiple microbiological laboratories, as well as built and validated various sterilization systems. SCS can additionally help manage quality assurance with medical device manufacturing, as well as perform quality and microbiological audits within various manufacturing environments.
- Abilene Christian University, Abilene, TX – B.S. Biology 1978
- Abilene Christian University, Abilene, TX – M.S. Microbiology 1980
- 1994 – 2002 Vice President/General Manager, Titan Scan Technologies, San Diego, CA
- 1984 – 1994 Director of Quality Assurance/Sterility Assurance, Baxter Healthcare, El Paso, TX
- 1980 – 1984 Sterility Assurance Supervisor, Ethicon, Inc., San Angelo, TX
Member– ISO Committee on Microbiology for Sterilization
Member – ISO Radiation Sterilization Committee
Member – AAMI/ANSI Committee for Radiation Processing
Member-AAMI/ANSI Committee for EO Processing
Member – AAMI/ANSI Committee on Microbiological Methods
Member- AAMI/ANSI Committee on General Sterilization
“A Guide to revised AAMI Methods for Radiation Sterilization,” Medical
Device and Diagnostic Industry, (January 1993), 108 – 120, co-author.
“Investigating AAMI Radiation Audit Results.” Medical Device and Diagnostic
Industry, (May 1994), 218 – 222, co-author.
“A Dosimetry Calibration Method for High Energy Electron Beam Sterilization
Facilities”, Titan Scan Technologies, (October 1995), 1 – 3, co-author;
“Electron-Beam Systems for Medical Device Sterilization,” Medical Plastics
and Biomaterials, (August 1997), 26 – 31, co-author.
“The Practical Application of Parametric Release in Radiation Processing”,
(March 1999), 1 – 6, co-author.
“Sterilization and Preservation by Radiation Sterilization”, (2001), 729-746,
co-author. Disinfection, Sterilization, and Preservation, S. Block ed.