Sterilization Consulting Services

Ensuring regulatory compliance in a competitive market

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Packaging

Harry Shaffer, Sterilization Consulting Services, has extensive experience in the development and validation of industrial sterilization packaging systems. He has assisted numerous clients to develop and validate their sterile packaging systems in accordance with the AAMI/ISO 14607 series of standards. He will work with contract laboratories to insure that the testing performed meets and exceeds the AAMI/ISO requirements.

packaging

Services provided includes:

  • Preparation of validation protocols
  • Managing the execution of the protocols
    • Sterile Barrier Testing
    • Ship Testing
    • Accelerated aging
  • Review of the data to insure compliance with AAMI/ISO guidelines
  • Writing of the Final report(s)

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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