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, laboratory testing, and product/packaging testing services. They serve medical device and pharmaceutical manufacturers globally.

**Expertise & scope**
* **Sterilization Processing:** Offers 100% ETO (Ethylene Oxide) sterilization processing, including pre-treatment, deep and shallow cycles, and aeration. Cold cycles are available for temperature-sensitive materials.
* **Validation Support:** Provides comprehensive validation assistance, covering product review, cycle development, validation protocol creation, test method selection, cycle execution, and reporting.
* **Laboratory Services:** Local laboratory services are available.
* **Shipping & Distribution:** Assists in securing competitive freight rates for shipments.

**Reputation / proof points**
* Experienced Staff

Additional information

International Sterilization Laboratory can assist with custom shipping and distribution needs, helping clients find competitive freight rates for their shipments to end users. Their validation support is thorough, encompassing the entire process from initial product review through to final reporting.

Key Highlights

  • Provides 100% ETO sterilization processing with options for pre-treatment, deep/shallow cycles, and aeration. Source
    “100% ETO sterilization processing using pre-treatment, deep and shallow cycles and aeration.”
  • Offers cold cycles for temperature-sensitive materials. Source
    “COLD CYCLES- Cold cycles are available for temperature sensitive materials.”
  • Comprehensive validation support from product review to reporting. Source
    “Validation support is provided from product review, through cycle development, validation protocol, test method selection, cycle running and all reporting.”
  • Local laboratory services are available. Source
    “LOCAL LABORATORY SERVICES AVAILABLE”

Certifications & Trust Signals

  • Experienced Staff Source
    “Experienced Staff”
  • Focus on Quality System & Regulatory Compliance Source
    “Quality System & Regulatory Compliance”

Buyer Snapshot

Best for
  • Medical device manufacturers requiring sterilization and testing
  • Pharmaceutical companies needing product and packaging validation
How engagement typically works
  • Project-based validation support
  • Contract sterilization processing
Typical deliverables
  • ETO Sterilization Processing
  • Validation Protocols and Reports
  • Laboratory Testing Services
Good to know
  • Best when requiring ETO sterilization or validation services.
HQ: US
Languages: English
Status: listed

Services & Capabilities

Sterilization + Microbiology Validation

Industries: Medical Devices
Sterilization Methods Supported: Gamma Radiation, E-Beam
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
Regions Served: Americas, EMEA, APAC

Additional sterilization_microbiology_testing Details

Sterilization Methods Supported
EtO (Ethylene Oxide)
Validation Types Offered
Full validation (IQ/OQ/PQ)
Lead Time Band
Start in 4-8 weeks
Quote SLA
3-5 business days
Sample Return Policy
Dispose
Minimum Project Size
No minimum
Pricing Model
Per project
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