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.
**Expertise & scope**
* Offers E-beam and X-ray sterilization services.
* Specializes in handling sensitive materials.
* Provides turnkey Sterilization Validation packages, including ISO 11137 VDmax, Method 1, Methods 2a and 2b.
* Offers Managed Validation services encompassing irradiation, protocol generation, microbiological laboratory coordination, and final reporting.
* Operates validated cold (2C to 8C) and freezer (-16C to -26C) temperature-controlled rooms.
* Ensures lot traceability and conformance to dose maps through box weighing, measuring, and labeling.
* Capable of sterilizing 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.
**Expertise & scope**
* Offers E-beam and X-ray sterilization services.
* Specializes in handling sensitive materials.
* Provides turnkey Sterilization Validation packages, including ISO 11137 VDmax, Method 1, Methods 2a and 2b.
* Offers Managed Validation services encompassing irradiation, protocol generation, microbiological laboratory coordination, and final reporting.
* Operates validated cold (2C to 8C) and freezer (-16C to -26C) temperature-controlled rooms.
* Ensures lot traceability and conformance to dose maps through box weighing, measuring, and labeling.
* Capable of sterilizing 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 emphasizes rigorous quality control throughout their sterilization process, including weighing and measuring all production boxes to ensure conformance to the original dose map and maintain lot traceability. Any boxes identified as off-weight or suspect are subject to a customer disposition call before processing. Their temperature-controlled rooms for cold and freezer storage are validated to pharmaceutical standards and monitored with remote sensors and alarms, ensuring product integrity throughout pre- and post-processing stages. For companies looking to outsource validation, SteriTek provides comprehensive packages that manage the entire process, from protocol generation to final reporting, suitable for various regulatory review levels.
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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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 lot traceability and dose map conformance through box weighing and measurement.
Source
“At SteriTek all production boxes are weighed, measured, and labeled as a check of conformance to the original dose map and to ensure lot traceability.”
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.”
Buyer Snapshot
Best for
- Medical device companies requiring E-beam or X-ray sterilization.
- Biotech and pharmaceutical firms needing specialized irradiation services.
- Companies seeking outsourced sterilization validation packages.
How engagement typically works
- Turnkey validation services.
- Managed validation process.
- Direct processing for production batches.
Typical deliverables
- Sterilized products via E-beam or X-ray.
- Sterilization validation protocols and reports.
- Managed microbiological laboratory services.
- Temperature-controlled storage (cold and freezer).
Good to know
- Best when requiring compliance with ISO 11137 and ISO 13485 standards.
- Suitable for products requiring sensitive material handling.
- Box configurations up to 76" L x 15" W x 48" H are supported.
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, 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
Nda Support:
Yes
Sample Return Policy:
Both options
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
Lead Time Band
Start in 0-2 weeks
Quote SLA
< 24 hours
Sample Return Policy
Dispose
Minimum Project Size
Custom
Pricing Model
Per project
