Comprehensive Medical Device Sterilization Services
QTS offers comprehensive medical device sterilization services. 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 Services
Contract sterilization services vary 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:
- Ethylene oxide
- Gamma irradiation
- Electron beam irradiation
- Other methods for unique needs (we can work with you to develop processes for other methods per your request)
- Sterilization validations
- Dose audits (gamma and electron beam)
- Annual revalidations (ethylene oxide)
- Production-cycle coordination
Laboratory Testing Coordination:
- Bioburden testing
- Microbial identification
- Product sterility testing
- BI sterility testing
- Ethylene oxide residuals testing
- Endotoxin testing
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.
- Radiation sterilization dose setting
- Ethylene oxide sterilization validations