Moist Heat (Steam)
STERIS offers contract steam sterilization services on-site for products such as medical devices, diagnostics, drug delivery systems and components.
Customers utilize our contract steam sterilization services for product release, product compatibility studies and sterilization validation.
Steam sterilization services offered include:
- Qualification studies
- Product compatibility
- R & D testing
- Routine contract steam sterilization
- Validation
In addition, STERIS assists in qualifying steam sterilization cycles to be recommended to healthcare facilities for sterilization of reusable devices or sterilization of products sold non-sterile. Research and development testing for early phase product design and for new materials is also routinely provided.
Steam cycles using prevacuum, purge-pulse, air-cool and gravity can accommodate most packaging designs for Class II and III devices, pharmaceuticals and ophthalmic products. In addition, various programmable cycles provide a wide range of steam cycle process development. The installation of multiple sterilizers with the same cycle design allows for back-up and cross validation capabilities to assure continuous production capacity.
Contract Irradiation and Ethylene Oxide Sterilization Services
Contract gamma, electron beam, and ethylene oxide sterilization services are available through STERIS Applied Sterilization Technologies, as well as X-ray and ion beam.
The irradiation process can effectively sterilize a wide variety of products composed of different materials, with varying densities, configurations and orientations.
A wide variety of materials and components commonly used in the manufacture of disposable healthcare products may undergo ethylene oxide sterilization in their final breathable packaging configuration.
Contract Steam Sterilization Summary
MOIST HEAT (STEAM)
Steam autoclaving is a 3-part high-temperature gas process that includes preconditioning, sterilization, and postconditioning.
Technology Variables
- PROCESSING TIME
- TEMPERATURE
- SUBATMOSPHERIC PRESSURE
- Precondition and postcondition
- SUPERATMOSPHERIC PRESSURE
- Exposure phase
Product Considerations
- LIQUID PRODUCTS
- Can effectively sterilize contained liquids and gels (syringes, vials, bottles, etc.)
- MATERIAL COMPATIBILITY
- Chemically compatible with most materials
Ductility and melting of solids need to be considered due to high temperatures
- Chemically compatible with most materials
- GAS PATHWAY
- Relies on vacuum to remove non-condensable gas (air) to achieve sterilant (steam) contact with internal surfaces
Possible Effects
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Damage to heat-sensitive, pressure-sensitive, or moisture-sensitive equipment
Melting, distortion, and potential corrosion
Water is the only residual / by-product
Exposure Time
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- MINUTES to HOURS
- Time varies based on product temperature limitations and validation approach
Why STERIS AST?
As a global leading sterilization and contamination control specialist, STERIS AST has over 40 years experience in providing safe and effective gamma irradiation sterilization.