Sterilization Consulting Services

Ensuring regulatory compliance in a competitive market

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Medical device microbiology

The production and sterilization of a sterile medical device requires the application of validated microbiological testing. Sterilization Consulting Services has the experience and expertise in medical device microbiology to assist in all of the required testing. We will work with either in-house or a contract laboratory to insure that the testing performed meets and exceeds the AAMI/ISO requirements. In addition, we will provide guidance in the establishment of product families to reduce the overall costs of the testing.

Medical device microbiology

Services provided include the management of:

  • Biological indicator / BI testing
  • Test of Sterility
  • Bacteriostasis/Fungistasis (B/F)
  • Bioburden testing
    • Bioburden Validation
    • Establishment of Bioburden Families
  • Manufacturing Environment Test Programs
  • Sterile Media production
  • Growth Promotion

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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