Life Science Outsourcing is the largest contract steam sterilization provider on the West Coast. Get started on your project today.
Achieve unparalleled efficiency and reliability with LSO’s in-house steam sterilization services, the largest contract offering on the West Coast. Ideal for high-heat-compatible devices, our solutions combine cutting-edge autoclaves with flexible cycle programming to meet your unique requirements. With capabilities to sterilize liquid containers, surgical instruments, and more, we ensure compliance with ISO 17665 and other industry standards. Benefit from the shortest lead times, in-house biological indicator testing, and expert validation protocols to safeguard product integrity and patient safety. Partner with LSO for end-to-end support and unmatched precision in steam sterilization.
Steam sterilization is a simple yet very effective decontamination method. Sterilization is typically achieved by exposing products to saturated steam at high temperatures (121°C to 134°C).
The steam sterilization process is not appropriate for many materials due to the high temperatures involved. Some quarantine/down time is required once products have been sterilized. Sterilized packages may need to dry before being removed from the autoclave to prevent contamination. Once removed, they will cool to ambient temperatures, which may take several hours. Biological indicators, if used, can take about a week to test.
Steam sterilization is commonly used by OEMs and medical device manufacturers for their high-heat compatible devices both for terminal sterilization and sterilization of reusable devices during reprocessing. Some examples include:
Devices or products are placed in an autoclave and heated through pressurized steam to kill all microorganisms, including spores. The device’s exposure time to steam would be anywhere between 3 to 60 minutes, depending on the heat required.
For effective sterilization it is critical that the steam covers all surfaces of the device. To ensure optimal conditions, many autoclaves have built-in meters that display temperature and pressure conditions with respect to time. Color-changing test packs and biological indicators are also used to gauge the performance of the autoclave. If the pack is the correct color, it shows that the autoclave is mechanically functional. If the biological indicator shows that sufficient spores were destroyed, the sterilization process was effective.
ISO 17665 specifies requirements for the development, validation and routine control of a moist heat sterilization process for medical devices. Moist heat sterilization processes covered by ISO 17665include but are not limited to:
LSO provides contract steam sterilization services for any product capable of withstanding high-temperature sterilization. We can program cycle parameters to duplicate an existing sterilization cycle or develop a cycle for specialized requirements.
Sterilization validations are performed according to ANSI/AAMI/ISO guidelines. Our staff will prepare the protocol, perform all required sterilization cycles, conduct all testing, and generate a final report. Customers review and approve the protocol before the validation process begins.
Life Science Outsourcing maintains validated autoclaves of various sizes and capabilities. Unique among these chambers is our CDER-registered 74 ft³ GMP autoclave with air-over-pressure capabilities for sterilizing liquid containers such as flexible bags, syringes, and vials.
Steam sterilization validations can be performed to various standards, including ISO 17665, ISO 17664, AAMI ST79, etc. At LSO, gravity and pre-vacuum cycles are performed at temperatures up to 135°C. LSO also performs biological indicator sterility testing in-house and offers the shortest lead times in the industry.
Comprehensive packages for regulatory compliance.
From fractional to full cycles with EtO residual testing.
Secure with 2X qualification.
Tailored to your sterilization needs.
Life Science Outsourcing is an FDA registered and ISO 13485 certified full service Medical Device Contract Manufacturer.
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These standards are crucial for effective sterilization of medical devices, which in turn ensures patient safety and regulatory compliance. Depending on your geographic location and markets you operate in, additional standards may be enforced by local regulatory organizations and authorities. It’s important to thoroughly research all applicable standards or consult with an industry professional experienced in the regulatory landscape. Their expertise can provide valuable insights and guidance in following specific requirements relevant to your region and verify that your sterilization processes meet industry standards.
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