Smart World LLC
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
Nr. of Employees
medium (51-250)
Smart World LLC
Fremont, California, United States, North America
Products
E-beam Sterilization
A sterilization method using high-energy electrons to break up the RNA/DNA of bioburden, suitable for terminal sterilization of various products.
X-ray Sterilization
A sterilization technique with deeper penetration than E-beam, suitable for products and packaging configurations that E-beam cannot handle, including metals, liquids, and high-density materials.
R&D Innovation Center
A facility providing design, testing, and innovation services for product development, including E-beam and X-ray optimization.
Microbiology Services
Services related to the study and control of microorganisms in the sterilization process.
Cross-linking Services
Services that involve the use of irradiation to create chemical bonds between polymer chains, enhancing material properties.
Consultative Services
Expert advice and support for compliance, design, testing, packaging, protocols, validation, and production.
E-beam Sterilization
A sterilization method using high-energy electrons to break up the RNA/DNA of bioburden, suitable for terminal sterilization of various products.
X-ray Sterilization
A sterilization technique with deeper penetration than E-beam, suitable for products and packaging configurations that E-beam cannot handle, including metals, liquids, and high-density materials.
R&D Innovation Center
A facility providing design, testing, and innovation services for product development, including E-beam and X-ray optimization.
Microbiology Services
Services related to the study and control of microorganisms in the sterilization process.
Cross-linking Services
Services that involve the use of irradiation to create chemical bonds between polymer chains, enhancing material properties.
Consultative Services
Expert advice and support for compliance, design, testing, packaging, protocols, validation, and production.
Services
E-beam irradiation sterilization service
Facility-based terminal sterilization using electron-beam processing for medical devices, pharmaceuticals, biologics, tissues and packaged products with configurable doses and expedited options.
X-ray irradiation sterilization service
Facility-based X-ray sterilization for products requiring deeper penetration or alternative beam modalities; integrated with accelerator-based operations.
Sterilization optimization for sensitive materials and combination products
Process development and R&D to identify irradiation conditions that achieve sterility while preserving functional and biomechanical properties of sensitive products.
Packaging sterilization simulation and testing
Simulation of dose distribution for packaging configurations to guide packaging design and sterilization method selection, reducing need for iterative prototyping.
Validation and QA/QC services for sterilization
Validation testing, QA/QC processes, and documentation aligned with relevant ISO standards and SAL requirements to support production release and regulatory compliance.
Microbiology analysis and cross-linking services
Microbiological testing to support sterilization development and polymer cross-linking processing for material modification or stabilization.
E-beam irradiation sterilization service
Facility-based terminal sterilization using electron-beam processing for medical devices, pharmaceuticals, biologics, tissues and packaged products with configurable doses and expedited options.
X-ray irradiation sterilization service
Facility-based X-ray sterilization for products requiring deeper penetration or alternative beam modalities; integrated with accelerator-based operations.
Sterilization optimization for sensitive materials and combination products
Process development and R&D to identify irradiation conditions that achieve sterility while preserving functional and biomechanical properties of sensitive products.
Packaging sterilization simulation and testing
Simulation of dose distribution for packaging configurations to guide packaging design and sterilization method selection, reducing need for iterative prototyping.
Validation and QA/QC services for sterilization
Validation testing, QA/QC processes, and documentation aligned with relevant ISO standards and SAL requirements to support production release and regulatory compliance.
Microbiology analysis and cross-linking services
Microbiological testing to support sterilization development and polymer cross-linking processing for material modification or stabilization.
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
Key Technologies
- Electron-beam irradiation
- X-ray irradiation
- Linear accelerator (LINAC) processing
- Dose mapping and dosimetry