www.steri-tek.com

Steri-Tek, based in Fremont, CA, with a new facility in Lewisville, TX is a high-volume E-beam/X-Ray contract sterilizer and R&D innovation center serving the medical device, biotech, pharmaceutical and other industries. Steri-Tek is an ISO 11137 and ISO 13485 certified, FDA registered, DEA licensed as well as State of California Medical Device and Drug Manufacturing licensed facility. The California facility boasts two state-of-the-art 10 MeV, 20 KW linear accelerators. The Texas facility utilizes two state-of-the-art 10 MeV, 30 KW linear accelerators. Both offer 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. Steri-Tek has developed a proprietary system for radiation sensitive materials such as drugs/biologics, combination devices, bioabsorbables, implantables, advanced polymers and other complex products. Steri-Tek offers;

• Turnkey Validation Services (per ISO 11137 VDmax and Method I)
• Rapid Turnaround on Routine Sterilization Processing (48 hours standard with RUSH 24 hour and 4 hour turnaround available)
• DualBeam™ E-beam/X-ray processing (Highest up time in industry)
• Expert Consultation Services to optimize E-beam/X-ray sterilization processing and throughput of complex devices