Steri-Tek


SteriTek is a high-volume E-beam/X-ray contract sterilizer and R&D innovation center that provides on-demand sterilization, microbiology, cross-linking, and expert consultative services to the medical device, biotech, pharmaceutical, tissue product, and other industries. Established in 2016, it has become a trusted partner for startups and global companies, with facilities in Silicon Valley and Dallas, offering proprietary systems for optimizing sterilization of sensitive materials and complex products.

Industries

Biotechnology
Medical Device
Pharmaceutical
Medical Equipment Manufacturing

Nr. of Employees

medium (51-250)

Steri-Tek

Fremont, California, United States


Products

E-Beam

High volume E-beam and X-ray contract sterilization, cross-linking, and R&D innovation center providing on-demand sterilization and expert consultative services for medical device, biotech, and pharmaceutical industries.

E-Beam Sterilization and Irradiation Services

High quality E-beam irradiation services providing rapid processing and superior business, technical, operational and regulatory support from R&D and testing to validation and production.

Sensitive Materials E-beam/X-ray Sterilization

Proprietary system and processing service for optimizing E-beam and X-ray sterilization of drugs, biologics, allograft/xenograft tissue products, combination devices, and other complex or temperature-sensitive products.

Packaging configuration sterilization simulation

A service offered in partnership with Triple Ring Technologies that allows customers to simulate packaging configuration sterilization to help get products to market faster and optimize sterilization methods.

DualBeam

An innovative e-beam sterilization process combining two independent, horizontally opposed LINACs with unique product totes for simultaneous beam processing and uniform dose delivery.

Validated Routine Processing

Routine processing service for validated medical devices and products following established product processing specifications to prove sterility.

View All Products

Services

Facility-based terminal sterilization using electron-beam processing for medical devices, pharmaceuticals, biologics, tissues and packaged products with configurable doses and expedited options.

Facility-based X-ray sterilization for products requiring deeper penetration or alternative beam modalities; integrated with accelerator-based operations.

Process development and R&D to identify irradiation conditions that achieve sterility while preserving functional and biomechanical properties of sensitive products.

Simulation of dose distribution for packaging configurations to guide packaging design and sterilization method selection, reducing need for iterative prototyping.

Validation testing, QA/QC processes, and documentation aligned with relevant ISO standards and SAL requirements to support production release and regulatory compliance.

Microbiological testing to support sterilization development and polymer cross-linking processing for material modification or stabilization.

View All Services

Expertise Areas

  • Radiation sterilization (E-beam and X-ray)
  • Contract sterilization services for medical devices and biologics
  • Sterilization development for sensitive materials and combination products
  • Dosimetry and irradiation process validation
  • Show More (3)

Key Technologies

  • Electron-beam irradiation
  • X-ray irradiation
  • Linear accelerator (LINAC) processing
  • Dose mapping and dosimetry
  • Show More (3)

News & Updates

View All News

Similar organizations

Browse all ORGANIZATIONS

JOIN OUR MAILING LIST

Stay Connected with MTEC

Keep up with active and upcoming solicitations, MTEC news and other valuable information.