Sterilization Validation Consulting

Meeting Your Sterilization Needs

iuvo BioScience brings over 40 years of experience to the design and validation of sterilization processes.  Our experience includes extensive work on validation of ethylene oxide cycles (including products with temperature, moisture and ethylene oxide sensitivity) as well as validation of radiation, steam and reusable device cleaning validations..

Our knowledgeable, experienced personnel are available to discuss the intended use, design and material composition of your product to assist in determining the extent of processing required.

Members of our team sit on many of the standards setting boards, so we are always on the cutting edge of changes in regulations, helping to provide you the best advice to ensure that you are never unprepared for changing regulations.

Validation Studies

  • Performed according to the following standards:
    • Ethylene Oxide – ANSI/AAMI/ISO 11135
    • Gamma – ANSI/AAMI/ISO 11137
    • Steam – ANSI/AAMI/ISO 17665
  • Microbiology testing performed at our in house Microbiology laboratory