International Sterilization Laboratory
STERIS Applied Sterilization Technologies
STERIS AST offers contract sterilization, laboratory testing, and product/packaging testing for medical device and pharmaceutical manufacturers. They provide global services using radiation and gas technologies.
STERIS Applied Sterilization Technologies (STERIS AST) is a leading global provider of contract sterilization, laboratory testing, and product and packaging testing services. They cater to medical device and pharmaceutical manufacturers, offering a technology-neutral approach with radiation and gas technologies for microbial reduction. Their comprehensive laboratory testing and validation services include microbiological, analytical, and product and package testing. STERIS AST also provides integrated sterilization equipment and control systems, such as accelerators, conveyors, and automation. They support sterilization processing with advanced dosimeter technologies for measuring ionizing radiation. With over 60 facilities worldwide, STERIS AST ensures a global reach while maintaining local focus. Their online interactive service, Sterilink, offers real-time visibility into processing facilities. Technical professionals are available to guide customers through complex sterilization and laboratory testing processes. They also offer resources to learn more about their sterilization and testing services.
About
**Who they are**
International Sterilization Laboratory (ISL) provides contract sterilization and laboratory testing services. They specialize in supporting medical device and pharmaceutical manufacturers.
**Expertise & scope**
* Validation support, including product review, cycle development, protocol creation, test method selection, cycle execution, and reporting.
* Ethylene Oxide (ETO) sterilization processing, offering pre-treatment, deep and shallow cycles, and aeration.
* Cold cycles for temperature-sensitive materials.
* Local laboratory services.
* Assistance with custom shipping and distribution to find competitive freight rates.
**Reputation / proof points**
* Experienced Staff
International Sterilization Laboratory (ISL) provides contract sterilization and laboratory testing services. They specialize in supporting medical device and pharmaceutical manufacturers.
**Expertise & scope**
* Validation support, including product review, cycle development, protocol creation, test method selection, cycle execution, and reporting.
* Ethylene Oxide (ETO) sterilization processing, offering pre-treatment, deep and shallow cycles, and aeration.
* Cold cycles for temperature-sensitive materials.
* Local laboratory services.
* Assistance with custom shipping and distribution to find competitive freight rates.
**Reputation / proof points**
* Experienced Staff
Additional information
ISL offers comprehensive validation support, guiding clients from initial product review through to final reporting. Their ETO sterilization capabilities include specialized cycles for various material needs, such as cold cycles for temperature-sensitive items. Beyond processing, they provide local laboratory services and can assist with logistics, helping clients secure competitive shipping rates for product distribution. This integrated approach aims to streamline the sterilization and testing process for manufacturers.
Key Highlights
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Provides 100% ETO sterilization processing with pre-treatment, deep and shallow cycles, and aeration.
Source
“100% ETO sterilization processing using pre-treatment, deep and shallow cycles and aeration.”
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Offers cold cycles for materials sensitive to temperature.
Source
“COLD CYCLES- Cold cycles are available for temperature sensitive materials.”
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Provides comprehensive validation support from product review to reporting.
Source
“VALIDATION- Validation support is provided from product review, through cycle development, validation protocol, test method selection, cycle running and all reporting.”
Certifications & Trust Signals
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Experienced Staff
Source
“Experienced Staff”
Buyer Snapshot
Best for
- Medical device manufacturers requiring sterilization services
- Pharmaceutical companies needing laboratory testing
- Companies seeking ETO sterilization expertise
How engagement typically works
- Collaborative validation support
- End-to-end processing solutions
- Logistics assistance
Typical deliverables
- Validation protocols and reports
- Sterilization processing (ETO)
- Laboratory test results
- Shipping and distribution support
Good to know
- Best when requiring ETO sterilization or validation support.
HQ:
US
Languages:
English
Claim status:
Listed
Services & Capabilities
Sterilization + Microbiology Validation
Industries:
Medical Devices
Pricing model:
Per project
Sterilization Methods Supported:
EtO (Ethylene Oxide), Steam (Moist Heat)
Validation Types Offered:
Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), Full validation (IQ/OQ/PQ), Revalidation
Microbiology Tests Offered:
Bioburden, Sterility, Bacterial Endotoxin (LAL), Environmental monitoring
Standards Supported:
ISO 11135 (EtO), ISO 17665 (Steam), ISO 11737-1 (Bioburden), ISO 11737-2 (Sterility)
GMP Compliant:
Yes
Glp Compliant:
Yes
Has In House Sterilization:
Yes
Has In House Microbiology:
Yes
Regions Served:
Americas, EMEA, APAC
Lead Time Band:
Start in 4-8 weeks
Quote SLA:
3-5 business days
Sample Return Policy:
Dispose
Minimum Project Size:
$25-50k
Is Accredited:
Yes
Accreditation Body:
ANAB
Accreditation Certificate Number:
105778
Rush Available:
Yes
Nda Support:
Yes
Additional sterilization_microbiology_testing Details
Sterilization Methods Supported
EtO (Ethylene Oxide)
Validation Types Offered
Full validation (IQ/OQ/PQ)
Lead Time Band
Start in 0-2 weeks
Quote SLA
3-5 business days
Sample Return Policy
Dispose
Minimum Project Size
No minimum
Pricing Model
Per project
