Sterilization Consulting Services

Ensuring regulatory compliance in a competitive market

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Sterilization validation

Harry Shaffer, Sterilization Consulting Services, is a leader in the development of the sterilization standards and sterilization validation for the industry. He has been a member of AAMI for more than 30 years.  His extensive experience in the development and validation of industrial sterilization processes, has assisted numerous clients to initiate, maintain and improve the sterilization process, both in terms of regulatory compliance and cost.

sterilization

Sterilization technologies:

  • Ethylene Oxide
  • Radiation
    • Gamma
    • Electron Beam
    • X-ray

Services provided include:

  • Preparation of validation protocols
  • Managing the execution of the protocols
  • Review of the data to insure compliance with AAMI/ISO guidelines
  • Writing of the Final report(s)
  • Implementation of the Sterilization Release process, including the necessary Procedures for cycle review.
  • Developing the Procedures for Sterilization deviations and product adoptions
  • Establishment of Sterilization Processing Categories
  • Determination of EO residuals
  • Evaluation of Sterile Packaging systems

Harry Shaffer

Harry Shaffer

Harry Shaffer is the president of Sterilization Consulting Services, based out of Denver, Colorado.

Qualifications

Qualifications

Experience: 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 … Read More

Applicable Standards

AAMI/ISO standards detail the requirements and guidance used throughout the industry. These standards are consensus voluntary standards which are the minimum requirements for the manufacturing and sterilization of Medical Products. With a combination of these standards and the … Read More

Connect

Sterilization Consulting Services
Harry Shaffer
10051 Oak Leaf Way
Highlands Ranch, CO 80129
(303) 929-3808


hshaffer@sterilizationconsulting.com

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