Only DEA Approved E-beam facility in the US
R&D Consulting for E-beam/X-ray Sterilization - FDA Approved
Only X-Ray sterilization facility in the US
After years of planning, the new Steri-Tek facility opened April 18, 2016!
Steri-Tek is an ISO 11137 and ISO 13485 certified, FDA registered, DEA registered as well as State of California Medical Device and Drug Manufacturing licensed facility serving the medtech, biotech, pharmaceutical and other industries.
The facility boasts two state-of-the-art 10 MeV, 20 KW linear accelerators, using simultaneous beam processing that allows for high volume production, providing uniform dose to the product without having to rotate the customer’s boxes. This DualBeam™ configuration significantly increases efficiencies, expands product options, and serves as an effective back-up for the accelerators. The facility will provide the most 10 MeV sterilization capacity, the most comprehensive product options, and the highest uptime availability than any other facility in North America.
Steri-Tek offers a seamless dose map validation of customer’s product from any other contract irradiator. Our staff of validation engineers will provide expert consultation for setting up any products to be dose mapped. We also offer turnkey sterilization validations for any new products to be introduced into the market at some of the most competitive rates.
Call us to learn more about how Steri-Tek can help you with your medical devices, pharmaceuticals, material modification, and food safety.
Completed in early 2016, our leading technological facility contains the most advanced accelerators for high volume E-beam/X-ray sterilization. Our service provides you with fully validated sterilized product without a costly delivery delay. Our process, our facility and quality system ensures your goal of optimal E-beam/X-ray sterilization processing.
For more information, contact us at firstname.lastname@example.org today!
1. Fastest standard turnaround in the industry for all R&D, batch, and routine production: 48-hours for E-beam; our standard turnaround beats the industry average of up to one week. We also offer several expedite options.
2. Prices that are among the lowest in the industry, even with premium services included. Our 100% customer-driven culture and operationally efficient business model allows us to offer this level of exceptional value to our customers.
3. Use of our R&D Innovation Center – utilize our E-beam in Silicon Valley to design, test, and innovate to help ensure your products give you a competitive advantage.
4. Ability to schedule our sterilization experts to help with R&D, compliance, design, test, packaging, protocols, validation, and production.
5. Ability to utilize any of Steri-Tek’s proprietary optimization methods specifically for your products to reduce costly product re-designs, save money, and get your product to market faster.
6. Protection and elimination of sterility risks for your entire product life cycle from concept through production; receive turnkey sterilization and validation to ensure you meet – or exceed – all ISO 11137 and SAL protocol requirements… guaranteed.