Steam sterilisation is a widely accepted and heavily used method to sterilise medical devices not only in hospitals for reprocessed instrument trays but also in the pharmaceutical industry for solutions and in the device industry for devices such as gels and drug coated catheters. The process components of steam sterilisation are non-toxic and this reduces the bio-compatibility issues with steam sterilized product. In addition the process is fast and delivers a high level of sterility assurance.

The use of steam sterilisation however has been constrained by the potential damage to the product and packaging from the process and the complexity of the validation process. Small changes in key parameters such as temperature of chamber have a large impact on delivered lethality. The trapping of air within the product or packaging can lead to sterilisation skips or deformation of packaging.

Steam Sterilisation at Andersen Caledonia

Andersen Caledonia has built up a fully integrated service to support companies and hospitals that require support to steam sterilise their medical device. Our on site capabilities at our Glasgow site include:

  • 2 Large Steam autoclaves with over 1 cubic metre capacity
  • Microbiological Laboratory able to run sterility tests and biological indicator enumerations
  • Packaging Test Laboratory able to run seal tests and shelf life studies
  • Validation Engineering Team with many years of experience
  • ISO13485 quality system with scope covering steam sterilisation that also has USA FDA and Japanese MOH registration

Our services include

  • Contract Steam Sterilisation / Sterilization
  • Steam Cycle Development
  • Validation of steam cycles including shelf life and packaging

Steam Sterilisation of Gels and Liquids

Many gels and liquids are sterilised with steam to avoid product damage from radiation or reactions with ethylene oxide. The process requires the use of an overpressure cycle to adjust for the different expansion rates of air and liquids and avoid package deformation or bottles losing their caps. Andersen Caledonia has considerable experience in developing and running contained fluid cycles.

Steam Sterilisation of Instruments / Devices

Many medical devices both reusable and single use require steam sterilisation or development and validation of a suitable cycle. Our team has considerable knowledge in this area and we have the equipment and expertise to offer a fully integrated service. We have developed cycles for a wide variety of products including drug coated catheters, specialist laboratory equipment, instrument trays and respirator bellows.

Steam Sterilisation of Orthopaedic Implants

Many orthopaedic implants are steam sterilised prior to surgery. The cycles specified by the manufacturer of the implants can vary with long steam dwell times to destroy TSE material and a variety of temperatures. Many hospitals lack the capability to run the cycles required. Andersen Caledonia has been sterilising implants for Scottish and other UK hospitals for almost 10 years. Our service includes identifying, labelling and packing each implant individually as well as running the exact parameters set by the implant manufacturer.