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 focus on supporting medical device and pharmaceutical manufacturers.

**Expertise & scope**
* ETO sterilization processing, including pre-treatment, deep and shallow cycles, and aeration.
* Cold cycles available for temperature-sensitive materials.
* Validation support encompassing product review, cycle development, protocol creation, test method selection, cycle running, and reporting.
* Local laboratory services.
* Assistance with custom shipping and distribution, including finding 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 processing capabilities include 100% ETO sterilization, with specialized cold cycles for materials requiring lower temperatures. Beyond core sterilization, they provide local laboratory services and can assist with logistics, helping clients secure favorable shipping rates for distribution to end-users. This integrated approach aims to streamline the sterilization and testing process for manufacturers.

Key Highlights

  • Offers 100% ETO sterilization processing. Source
    “PROCESSING- 100% ETO sterilization processing using pre-treatment, deep and shallow cycles and aeration.”
  • Provides 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.”
  • Specialized cold cycles for temperature-sensitive materials. Source
    “COLD CYCLES- Cold cycles are available for temperature sensitive materials.”
  • Assists with custom shipping and distribution. Source
    “CUSTOM SHIPPING AND DISTRIBUTION- ISL can assist in finding competitive freight rates for shipments to the end user.”

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
  • Pharmaceutical manufacturers
  • Companies requiring ETO sterilization
  • Clients needing validation support
How engagement typically works
  • Project-based validation support
  • Contract sterilization processing
  • Laboratory testing services
Typical deliverables
  • Sterilization validation reports
  • Processed sterilized product
  • Laboratory test results
  • Shipping and distribution assistance
Good to know
  • Best when requiring ETO sterilization or specialized validation services.
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
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