Steri-Tek (Smart World LLC dba Steri-Tek) is a US-based high-volume E-beam and X-ray contract sterilizer and R&D innovation center, established in 2016. They provide on-demand sterilization, microbiology, cross-linking, and expert consultative services to the medical device, biotech, pharmaceutical, tissue product, and other industries. They operate facilities in Fremont, California (flagship) and Lewisville/Dallas, Texas (opened April 2023 with two 80kW DualBeam lines). They are FDA registered, DEA licensed (Schedule II+), ISO 11137 and ISO 13485 certified. While they serve pharmaceutical and biotech clients with sterilization services, they are a contract sterilization service provider, not a drug manufacturer or CDMO. Their expertise is particularly strong with sensitive materials including drugs/biologics, allograft/xenograft tissue, and combination devices.
E-beam sterilization, X-ray irradiation sterilization, ISO 11137 validation, controlled substance sterilization (DEA licensed), temperature-controlled processing, tissue/biologics sterilization
1 site worldwide
No reviews available yet.
No documents available.