Comprehensive Medical Device Sterilization Management
QTS offers sterilization management for medical devices. Certified staff microbiologists and sterilization specialists oversee the process, and we provide complete validation services including creating protocols, sample preparation, coordinating third-party laboratory testing, and submitting a final report to our clients. Contact us to learn more about our medical device sterilization services.
Contract Sterilization Managment
Contract sterilization management varies depending on the compatibility of the medical device with the sterilization method and regulatory requirements for the device to be certified sterile. Depending on a combination of factors, we may recommend one or more of the following services:
Sterilization Methods:
- Ethylene oxide
- Gamma irradiation
- Electron beam irradiation
- Steam
- Other methods for unique needs (we can work with you to develop processes for other methods per your request)
Sterilization Validations:
- Sterilization validations
- Dose audits (gamma and electron beam)
- Annual revalidations (ethylene oxide)
Sterilization Coordination:
- Production-cycle coordination
Laboratory Testing Coordination:
- Bioburden testing
- Microbial identification
- Product sterility testing
- BI sterility testing
- Ethylene oxide residuals testing
- Endotoxin testing
New! QSTERILE™ Pre-Validated EO Cycle
QTS offers a QTS-owned, pre-validated EO cycle for customers to adopt into, saving them time and money by not having to complete their own full EO sterilization validation. Normally a full EO cycle validation encompasses multiple half cycle and full cycle testing incorporating biological indicators and temperature/humidity mapping, along with product-specific testing of microbial resistance and product EO residuals. When utilizing the QSTERILE™ pre-validated EO cycle, cycle testing is already completed in accordance with ISO11135 requirements, and customers are only required to perform product-specific testing to adopt into the cycle.
If your medical device requires sterilization, contact us to discuss your next project.
Attention to Detail to Manage and Mitigate Your Risk
Often it’s the attention to detail that makes all the difference. We track and inform you when a dose audit or annual revalidation is required. By managing the details, we also manage and mitigate your risk, helping to keep your projects on time, on budget, on task, and compliant. Call us today to learn more about our services.
Establishing Product Families
Product families are often established so that a representative product can be chosen to represent an entire product family. This can considerably reduce the costs associated with a validation.
The experienced microbiologists on staff at QTS can also assist our customers in establishing product families for validation and routine monitoring purposes. By establishing product families, QTS can help you to minimize your testing costs. Our staff can help you through the process of justifying your product family groupings, as well as selecting product family representatives.
Product Families:
- Radiation sterilization dose setting
- Ethylene oxide sterilization validations
