Sterilization Validation Services
Radiation/EO Sterilization & Process Validation
STERIS Laboratories assists Customers at all levels of sterilization validation for ISO11135 (ethylene oxide) and ISO11137 (radiation sterilization) technologies.
Working in coordination with the STERIS Applied Sterilization Technologies TechTeam®, we provide technical support in all phases of the radiation and ethylene oxide sterilization design process, including product development, materials testing, protocol generation and sterilization validation.
We perform and coordinate studies such as:
- Sterilization (EO, radiation, steam, dry heat)Packaging
- Cleanroom certification
- Reusable device qualification
- Other process operations
Our sterilization validation team conducts studies as a single validation or as part of a facility startup or technology transfer either onsite or at STERIS Laboratories. As part of your complete radiation or ethylene oxide validation program, we will develop a protocol, assemble all data, summarize results and make recommendations in a succinct and comprehensive format.
Steam validation and sterilization of medical products is also provided at our Minneapolis, Minnesota, USA facility for diagnostics, drug delivery combination products, liquids and gel products.
Validation services provided include:
- Engineering studies
- Materials selection
- Dose validation/setting
- Dose mapping
- New product qualification
- Process optimization studies
- BI incubation time reduction
- Residual (hold time) reduction
- Installation qualifications
- Operations qualifications
- Performance qualifications
STERIS Laboratories offers:
- A complete service package including initial microbiological method development, verification dose and final sterility testing. The complete sterilization validation is detailed in one report along with the irradiation certificate.
- A range of expertise covering the microbiological testing as well as the process sterilization, ensuring our Customers achieve a tailored product/device sterilization solution
- Experience providing sterilization validations for complex or unique products
- Experience and guidance for products that are sensitive to irradiation and may require lower irradiation doses
- Controlled testing documentation issued to Customers for every sterilization validation completed, ensuring consistency in sterilization dose audit testing throughout product/device life span
- Testing lead times available to suit product submission timelines
- Continuous support, consultancy and updates within the sterilization validation process
Sterilization validations are performed for:
CE marked products
Products with a sterility claim