SteriTek
SteriTek, Inc.
SteriTek is a leading contract sterilizer specializing in E-beam and X-ray irradiation for medical devices, biotech, and pharmaceuticals. They offer rapid turnaround and expertise in sensitive materials.
SteriTek is a high-volume E-beam/X-ray contract sterilizer and R&D innovation center established in 2016. They provide on-demand sterilization, microbiology, cross-linking, and expert consultative services tailored to the medical device, biotech, pharmaceutical, and tissue product industries. With facilities in Fremont, CA, and Lewisville, TX, SteriTek offers advanced DualBeam™ technology for high-volume production, ensuring uniform dose without flipping boxes. They specialize in optimizing E-beam/X-ray sterilization for complex products, including drugs, biologics, and allograft tissue, with a proprietary system for sensitive materials. SteriTek is committed to quality and compliance, offering turnkey Sterilization Validation packages per ISO 11137 and providing services that guarantee compliance to ISO 13485. They are known for their fast standard turnaround (2-6 business days) and offer 24-hour and same-day RUSH services, alongside validated cold and freezer temperature-controlled rooms for pre- and post-processing.
About
**Who they are**
SteriTek is a contract sterilizer specializing in E-beam and X-ray irradiation for medical devices, biotech, and pharmaceuticals. They emphasize rapid turnaround and expertise with sensitive materials.
**Expertise & scope**
* E-beam Sterilization
* X-ray Sterilization
* Irradiation of sensitive materials
* Turnkey Sterilization Validation packages, including ISO 11137 VDmax, Method 1, Methods 2a and 2b
* Managed Validation services encompassing production validation, protocol generation, microbiological laboratory management, and final reporting
* Temperature-controlled processing rooms (2C to 8C and -16C to -26C) validated to pharmaceutical standards
* Box processing for configurations up to 76 inches long, 15 inches wide, and stacked up to 48 inches tall
**Reputation / proof points**
* Compliance to ISO 13485 and ISO 11137
* Facilities in Silicon Valley (Fremont, CA) and Dallas (Lewisville, TX)
SteriTek is a contract sterilizer specializing in E-beam and X-ray irradiation for medical devices, biotech, and pharmaceuticals. They emphasize rapid turnaround and expertise with sensitive materials.
**Expertise & scope**
* E-beam Sterilization
* X-ray Sterilization
* Irradiation of sensitive materials
* Turnkey Sterilization Validation packages, including ISO 11137 VDmax, Method 1, Methods 2a and 2b
* Managed Validation services encompassing production validation, protocol generation, microbiological laboratory management, and final reporting
* Temperature-controlled processing rooms (2C to 8C and -16C to -26C) validated to pharmaceutical standards
* Box processing for configurations up to 76 inches long, 15 inches wide, and stacked up to 48 inches tall
**Reputation / proof points**
* Compliance to ISO 13485 and ISO 11137
* Facilities in Silicon Valley (Fremont, CA) and Dallas (Lewisville, TX)
Additional information
SteriTek implements rigorous quality control measures, including weighing, measuring, and labeling all production boxes to ensure conformance to dose maps and maintain lot traceability. Any boxes identified as off-weight or suspect are subject to immediate follow-up with the customer for disposition before processing. Their validated cold and freezer temperature-controlled rooms are equipped with remote sensors and alarms for continuous monitoring, ensuring product integrity throughout the sterilization process. They offer comprehensive Sterilization Validation packages designed to meet pharmaceutical standards and regulatory requirements.
Key Highlights
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Specializes in E-beam and X-ray irradiation for medical devices, biotech, and pharmaceuticals.
Source
“SteriTek is a leading contract sterilizer specializing in E-beam and X-ray irradiation for medical devices, biotech, and pharmaceuticals.”
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Offers turnkey Sterilization Validation packages per ISO 11137 VDmax, Method 1, Methods 2a and 2b.
Source
“SteriTek provides turnkey Sterilization Validation packages (per ISO 11137 VDmax, Method 1, Methods 2a and 2b) for companies that wish to outsource their sterilization validation work.”
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Provides Managed Validation services including protocol generation and microbiological lab management.
Source
“Managed Validation services provide all irradiation services routinely performed for production validation, generation of original validation protocols for your approval, handling and management of needed microbiological laboratory services, completion of the validation protocol, and a final comprehensive report appropriate for the level of regulatory review associated with your product.”
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Operates validated cold (2C to 8C) and freezer (-16C to -26C) temperature-controlled rooms.
Source
“Validated Cold (2C to 8C) and Freezer (-16C to -26C) temperature-controlled rooms with separate doors and areas for pre- and post-processing.”
Certifications & Trust Signals
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Guarantees compliance to ISO 13485 and ISO 11137 for finished products.
Source
“Of your finished products guarantees compliance to ISO 13485 and ISO 11137.”
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Facilities located in Silicon Valley and Dallas.
Source
“SteriTek Silicon Valley48225 Lakeview Blvd.Fremont, CA 94538+1 (510) 933-9700 SteriTek Dallas1206 N Stemmons FwyLewisville, TX 75067+1 (469) 830-9550”
Buyer Snapshot
Best for
- Medical device, biotech, and pharmaceutical companies requiring E-beam or X-ray sterilization
- Companies seeking outsourced sterilization validation services
- Clients needing temperature-controlled processing
How engagement typically works
- Project-based sterilization services
- Managed validation programs
- Consultative approach to validation protocols
Typical deliverables
- Sterilized products via E-beam or X-ray
- Completed Sterilization Validation packages
- Managed microbiological laboratory services
- Final validation reports
Good to know
- Best when requiring irradiation of sensitive materials
- Suitable for large medical shipper box configurations
HQ:
Fremont, US
Languages:
English
Timezones:
America/Los_Angeles, America/Chicago
Status:
listed
Services & Capabilities
Sterilization + Microbiology Validation
Industries:
Medical Devices
Sterilization Methods Supported:
E-Beam, X-Ray
Validation Types Offered:
Full validation (IQ/OQ/PQ), Revalidation, Other
Microbiology Tests Offered:
Bioburden, Sterility, Other
Standards Supported:
ISO 11137 (Radiation), USP <1211>, USP <1229>
GMP Compliant:
Yes
Glp Compliant:
Yes
Has In House Sterilization:
Yes
Has In House Microbiology:
Yes
Lead Time Band:
Start in 2-4 weeks
Quote SLA:
24-48 hours
Rush Available:
Yes
Additional sterilization_microbiology_testing Details
Sterilization Methods Supported
E-Beam, X-Ray
Validation Types Offered
Full validation (IQ/OQ/PQ), Sterilization Validation packages (per ISO 11137 VDmax, Method 1, Methods 2a and 2b)
Microbiology Tests Offered
Microbiological laboratory services (managed)
Lead Time Band
Start in 0-2 weeks
Quote SLA
< 24 hours
Sample Return Policy
Dispose
Minimum Project Size
Custom
Pricing Model
Per project, Fixed package
