Steam sterilisation is a widely used method of sterilisation for medical devices in hospitals, pharmaceutical companies and device companies. Steam sterilisation works by placing products in a machine called an autoclave and exposing them to pressurised steam at high temperatures in order to destroy viable microorganisms. The process components of steam sterilisation provide the benefit of being non-toxic which reduces the bio-compatibility issues of steam sterilised products in comparison to those using ethylene oxide sterilisation. Additionally, the process is fast and delivers a high-level of sterility assurance.
Andersen Caledonia can offer fully integrated steam sterilisation services to companies and hospitals that require support to steam sterilise their medical devices. All steam sterilisation is undertaken at our accredited Bellshill facility which conforms to ISO13485 and has USA FDA and Japanese MOH registration. Our facility has 2 large steam autoclaves with over 1 cubic metre capacity and run 3 industry standard cycles at 121°, 132° and 134°. Our expertise in steam sterilisation means we are also able to develop steam cycles tailored to individual customer requirements.
Our microbiological laboratory are able to run sterility tests and biological indicator enumerations and our Validation Engineering Team offer validations of steam cycles including shelf life and packaging to meet regulatory standards and to provide additional assurance.
Many gels and liquids are sterilised with steam to avoid product damage from radiation or reactions with Ethylene Oxide Gas. Andersen Caledonia has considerable experience in developing and running contained fluid cycles which use an overpressure cycle to adjust for the different expansion rates of air and liquids, and avoid package deformation.
Many reusable and single use medical devices require steam sterilisation or development and validation of a suitable cycle. Our team has considerable knowledge in this area and we have developed cycles for a variety of products including drug coated catheters, specialist laboratory equipment, instrument trays and respirator bellows.
Implant manufacturers specify cycle times that can vary significantly often with long steam dwell times, to destroy TSE material, and a variety of temperatures. Our 10 years of experience sterilising implants for hospitals includes identifying, labelling and packing each implant individually as well as running exact parameters set by manufacturers.
For products that are sensitive to heat or moisture Ethylene Oxide Sterilisation may be preferable.