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 solutions and managed validation services.
* Manages necessary microbiological laboratory services as part of validation packages.
* Accommodates medical shipper box configurations up to 76 inches long, 15 inches wide, and stacked up to 48 inches tall.
* Operates validated cold (2°C to 8°C) and freezer (-16°C to -26°C) temperature-controlled rooms for pre- and post-processing, validated to pharmaceutical standards.
* Ensures lot traceability and conformance to dose maps through box weighing, measuring, and labeling, with follow-up for any discrepancies.
**Reputation / proof points**
* Guarantees compliance to ISO 13485 and ISO 11137 for finished products.
* Follows ISO 11137 VDmax, Method 1, Methods 2a and 2b for sterilization validation packages.
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 solutions and managed validation services.
* Manages necessary microbiological laboratory services as part of validation packages.
* Accommodates medical shipper box configurations up to 76 inches long, 15 inches wide, and stacked up to 48 inches tall.
* Operates validated cold (2°C to 8°C) and freezer (-16°C to -26°C) temperature-controlled rooms for pre- and post-processing, validated to pharmaceutical standards.
* Ensures lot traceability and conformance to dose maps through box weighing, measuring, and labeling, with follow-up for any discrepancies.
**Reputation / proof points**
* Guarantees compliance to ISO 13485 and ISO 11137 for finished products.
* Follows ISO 11137 VDmax, Method 1, Methods 2a and 2b for sterilization validation packages.
Additional information
SteriTek offers comprehensive sterilization validation services, including the generation of validation protocols, management of microbiological testing, and final reporting suitable for regulatory review. Their process includes rigorous checks on production boxes to ensure lot traceability and dose map conformance before processing. They maintain validated cold and freezer storage areas, critical for sensitive materials and pharmaceutical standards. Buyers can engage SteriTek for outsourced sterilization validation work, benefiting from their expertise in sensitive materials and adherence to key industry standards like ISO 13485 and ISO 11137.
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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Offers 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 (2°C to 8°C) and freezer (-16°C to -26°C) 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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Provides sterilization validation packages per ISO 11137 standards.
Source
“SteriTek provides turnkey Sterilization Validation packages (per ISO 11137 VDmax, Method 1, Methods 2a and 2b)”
Buyer Snapshot
Best for
- Medical device, biotech, and pharmaceutical companies requiring contract sterilization.
- Organizations seeking outsourced sterilization validation services.
- Companies needing expertise in handling sensitive materials during irradiation.
How engagement typically works
- Turnkey sterilization validation packages.
- Managed validation services including protocol generation and lab management.
- Direct processing for E-beam and X-ray irradiation.
Typical deliverables
- Sterilized products via E-beam or X-ray.
- Completed sterilization validation protocols.
- Comprehensive validation reports.
- Managed microbiological laboratory services.
Good to know
- Best when requiring adherence to ISO 13485 and ISO 11137 standards.
- Suitable for products requiring validated cold or freezer storage conditions post-processing.
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 (as part of validation)
Lead Time Band
Start in 0-2 weeks
Quote SLA
< 24 hours
Sample Return Policy
Dispose
Minimum Project Size
Custom
Pricing Model
Per project
