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**
* Offers E-beam and X-ray sterilization services.
* Provides sterilization validation packages, including turnkey options and managed validation services.
* Manages necessary microbiological laboratory services as part of validation packages.
* Handles production boxes with checks for conformance to dose maps and lot traceability, including follow-up for off-weight or suspect boxes.
* Operates validated cold (2C to 8C) and freezer (-16C to -26C) temperature-controlled rooms for pre- and post-processing, validated to pharmaceutical standards.
* Able to sterilize medical shipper box configurations up to 76 inches long, 15 inches wide, and stacked up to 48 inches tall.
**Reputation / proof points**
* Guarantees compliance to ISO 13485 and ISO 11137 for finished products.
* Operates facilities in Silicon Valley (Fremont, CA) and Dallas, 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**
* Offers E-beam and X-ray sterilization services.
* Provides sterilization validation packages, including turnkey options and managed validation services.
* Manages necessary microbiological laboratory services as part of validation packages.
* Handles production boxes with checks for conformance to dose maps and lot traceability, including follow-up for off-weight or suspect boxes.
* Operates validated cold (2C to 8C) and freezer (-16C to -26C) temperature-controlled rooms for pre- and post-processing, validated to pharmaceutical standards.
* Able to sterilize medical shipper box configurations up to 76 inches long, 15 inches wide, and stacked up to 48 inches tall.
**Reputation / proof points**
* Guarantees compliance to ISO 13485 and ISO 11137 for finished products.
* Operates facilities in Silicon Valley (Fremont, CA) and Dallas, TX.
Additional information
SteriTek offers comprehensive Sterilization Validation packages, including turnkey solutions and managed services. These packages cover the generation of validation protocols, handling of microbiological laboratory services, protocol completion, and final reporting suitable for regulatory review. They maintain validated cold and freezer temperature-controlled rooms, essential for sensitive materials and pharmaceutical standards. Their process includes rigorous checks on production boxes for dose map conformance and lot traceability, with proactive customer follow-up for any discrepancies prior to processing. SteriTek's capabilities extend to sterilizing large medical shipper box configurations.
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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Provides 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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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.”
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Ensures compliance to ISO 13485 and ISO 11137 for finished products.
Source
“Of your finished products guarantees compliance to ISO 13485 and ISO 11137.”
Certifications & Trust Signals
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Guarantees compliance to ISO 13485 and ISO 11137.
Source
“Of your finished products guarantees compliance to ISO 13485 and ISO 11137.”
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Operates facilities in Silicon Valley and Dallas.
Source
“SteriTek Silicon Valley48225 Lakeview Blvd.Fremont, CA 94538 SteriTek Dallas1206 N Stemmons FwyLewisville, TX 75067”
Buyer Snapshot
Best for
- Medical device, biotech, and pharmaceutical companies requiring contract sterilization.
- Organizations seeking outsourced sterilization validation services.
- Companies needing specialized irradiation for sensitive materials.
How engagement typically works
- Turnkey sterilization validation packages.
- Managed validation services including protocol generation and lab management.
- Direct processing of production boxes with traceability checks.
Typical deliverables
- Sterilized products via E-beam or X-ray irradiation.
- Completed Sterilization Validation packages (per ISO 11137 VDmax, Method 1, Methods 2a and 2b).
- Comprehensive validation reports.
- Managed microbiological laboratory services.
Good to know
- Best when requiring E-beam or X-ray sterilization.
- Suitable for companies needing compliance with ISO 13485 and ISO 11137.
HQ:
Fremont, US
Languages:
English
Timezones:
America/Los_Angeles, America/Chicago
Claim status:
Listed
Services & Capabilities
Sterilization + Microbiology Validation
Industries:
Medical Devices
Pricing model:
Per project
Sterilization Methods Supported:
E-Beam, X-Ray
Validation Types Offered:
Full validation (IQ/OQ/PQ), Revalidation, Other
Microbiology Tests Offered:
Bioburden, Sterility, Environmental monitoring, Other
Standards Supported:
ISO 11137 (Radiation), ISO 11737-1 (Bioburden), ISO 11737-2 (Sterility)
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
Nda Support:
Yes
Sample Return Policy:
Dispose
Additional sterilization_microbiology_testing Details
Sterilization Methods Supported
E-beam, X-ray
Validation Types Offered
Full validation (IQ/OQ/PQ), Revalidation
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
