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Product Inoculations

A Product Inoculation test provides inoculated samples or carriers with specific test organisms that are used to test the ability to sterilize a device to a given sterilization cycle. This study is useful for R&D and process development of different methods of sterilization including ethylene oxide, steam, dry heat, vaporized hydrogen peroxide, and other methods. Inoculation is performed with different BI configurations such as commercially prepared spore suspensions, paper strips, discs, and sutures with 106 spores per location; other populations can be used as well. The products can be used in validation cycles, comparative resistance cycles (to determine the most resistant product location), or product D-value studies.

Applicable Standards

  • ANSI/AAMI/ISO 11135
  • ISO 17665

Testing Locations

  • Salt Lake City, UT, USA
  • Itasca, IL, USA
  • Ontario, California, USA
  • Mexico City, Mexico
  • Shanghai, China
  • Petit-Rechain, Belgium
  • Somercotes, England
  • Rantigny, France
  • Wiesbaden, Germany
  • Espergaerde, Denmark

Study Outline

The Product Inoculation study involves placing spores of the appropriate indicator organism in varying locations on the device, including those judged most difficult to sterilize. Inoculating the actual product in its most resistant location is the only definitive way to determine the resistance to sterilization. All types of products or components can be inoculated and then exposed to sterilization to determine the ability to sterilize the device. Different test organisms and different populations can also be used if requested.

All sterilization standards using the overkill method require the manufacturer to demonstrate kill of the device when inoculated in the most difficult-to-sterilize location with the appropriate indicator organism. For ethylene oxide and dry heat, the correct organism is Bacillus atrophaeus, and for steam and vaporized hydrogen peroxide, the indicator organism is Geobacillus stearothermophilus.

Nelson Labs has extensive experience in product inoculation and can use your samples for further sterilization testing at the lab, or we can ship them back to the client or directly to the contract sterilizer for validation studies.

Please include the desired BI type and population when submitting samples.

If you have additional questions about Product Inoculation test services, or would like to consult with the experts at Nelson Labs, just send us a request or call us at (801) 290-7500.