EUROLABoffers unparalleled expertise in product sterilization verifications across a wide range of technologies. EUROLAB With our combined resources and expertise, our understanding of material compatibility, sterilization science, validation approaches and cycle optimization ensures customers have a reliable and defensible validation strategy.
Ethylene Oxide (EO) Sterilization Validation is designed to help develop a sterilization process that provides the manufacturer with the appropriate level of sterility assurance and ensures repeatability for each product type developed. Any product, whether sterilized in-house or with a contract sterilizer, must be certified to ensure compliance with national and international standards.
The requirements for an EO Sterilization Validation are outlined in ANSI/AAMI/ISO 11135. Various AAMI TIRs also provide guidance on meeting the requirements of the sterilization standard. EUROLAB, specializes in Ethylene Oxide Sterilization Validations and we can partner with you and many contract sterilization facilities throughout the entire process, from protocol production to final report completion.
EUROLABoffers full package testing and services in compliance with global legal requirements. A radiation sterilization validation determines the appropriate radiation sterilization dose for a product that requires a sterile label claim. Bioburden testing includes a bioburden recovery efficiency test, a sublethal radiation dose (confirmation dose), sterility testing, and bacteriostasis/fungistasis testing.
For process monitoring EUROLABprovides quarterly dose audit (QDA) coordination services that include dosing, testing, consulting and summary reports.
If a sterile label claim is required and the sterilization method will be radiation, a validation is required to determine the appropriate sterilization dose. EUROLABhas extensive experience providing validation for complex or unique products or products that cannot handle high doses of radiation. The test complies with radiation sterilization standard ANSI/AAMI/ISO 11137 and technical specification ANSI/AAMI/ISO 13004.
Clinical Reprocessing Sterilization Validations and Functionality Studies
Sterilization validation testing confirms the appropriate Sterility Assurance Level (SAL) of the medical device. The test determines relevant sterilization parameters for healthcare reprocessing instructions. Based on the data obtained by the tests, the manufacturer will be able to provide approved sterilization parameters to healthcare institutions. EUROLAB can validate using steam (gravity or pre-vacuum), ethylene oxide (EO), STERRAD® or dry heat. For reusable instruments, liquid chemical or thermal disinfection are acceptable alternatives.
In addition, manufacturers must certify end-of-life for reusable or reprocessed medical devices to demonstrate functionality through repeated exposure and clinical simulations. EUROLABcan assist in conducting study design and functionality and repeat use studies.
Clinical batch release studies may be performed on a limited basis for new devices and products that require sterilization before obtaining marketing approval.
ANSI/ASMI ST79, ANSI/AAMI ST77, and AAMI TIR12 are guidelines for testing reusable medical devices. EUROLABhas the equipment and qualified personnel to guide you through the process. Our experts will provide individualized advice and are here to help simplify complex regulatory and standards recommendations.
Process monitoring is an important part of any sterilization validation and routine cycle verification. EUROLABoffers a range of Process Testing Devices (PCD), Biological Indicator (BI) spore strips and disks to monitor comparative resistance or ongoing cycle activity. We also offer product inoculation services to verify worst-case cycle effectiveness.
For pharmaceutical and liquid products requiring sterile processing EUROLABoffers filter validation services to evaluate a filter's ability to remove chemicals or microbial organisms of various sizes. This test allows manufacturers to determine membrane pore sizes and is an excellent lot release test in compliance with both ASTM F838-05 and HIMA guidance documents.
EUROLAB, with its highly expert team and internationally accredited laboratories, Sterilization Validation Analysis It performs all test, analysis, measurement, evaluation and report generation services completely and reliably.
To get an appointment, to get more detailed information or to request an evaluation, you can ask us to fill in our form and reach you.
