STERIS Isomedix Laboratory Services
STERIS AST offers contract sterilization and laboratory testing services, specializing in packaging and shelf-life testing for medical device and pharmaceutical manufacturers.
STERIS Applied Sterilization Technologies provides comprehensive contract sterilization, laboratory testing, and product and packaging testing services tailored for medical device and pharmaceutical manufacturers. They offer global contract sterilization and microbial reduction services utilizing a technology-neutral approach with radiation and gas technologies. Their laboratory testing and validation services encompass microbiological, analytical, and product and package testing. Specifically for packaging testing, STERIS AST simulates accelerated and real-time aging to determine product shelf life, evaluates performance under simulated environmental and distribution conditions, and assesses sterile barrier integrity and seal strength. They can assist manufacturers in extending the expiration dates of medical devices through rigorous testing and documentation. STERIS is a leading global provider focused on infection prevention and patient care support.
About
**Who they are**
STERIS Isomedix Laboratory Services is a global provider of contract sterilization and laboratory testing services, with a focus on supporting medical device and pharmaceutical manufacturers.
**Expertise & scope**
* Specializes in packaging and shelf-life testing.
* Offers accelerated and real-time aging simulations to determine product shelf life.
* Evaluates package performance under simulated environmental and distribution conditions.
* Assesses sterile barrier integrity and seal strength throughout the product lifecycle.
* Provides services to extend the expiration date of medical devices through testing and documentation.
**Reputation / proof points**
* Operates a global network of contract sterilization and testing facilities.
STERIS Isomedix Laboratory Services is a global provider of contract sterilization and laboratory testing services, with a focus on supporting medical device and pharmaceutical manufacturers.
**Expertise & scope**
* Specializes in packaging and shelf-life testing.
* Offers accelerated and real-time aging simulations to determine product shelf life.
* Evaluates package performance under simulated environmental and distribution conditions.
* Assesses sterile barrier integrity and seal strength throughout the product lifecycle.
* Provides services to extend the expiration date of medical devices through testing and documentation.
**Reputation / proof points**
* Operates a global network of contract sterilization and testing facilities.
Additional information
STERIS AST's packaging testing services are designed to simulate real-world conditions that products may encounter. This includes accelerated and real-time aging chambers to establish shelf life, and distribution simulation to evaluate performance under various environmental and transit stresses. They focus on assessing the integrity of sterile barrier systems, which is critical for medical devices. Manufacturers looking to extend product expiration dates can leverage their testing and documentation capabilities.
Key Highlights
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Specializes in packaging and shelf-life testing for medical device and pharmaceutical manufacturers.
Source
“specializing in packaging and shelf-life testing for medical device and pharmaceutical manufacturers.”
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Offers accelerated and real-time aging simulations to determine shelf life.
Source
“Simulates the effects of accelerated and real-time aging to demonstrate the shelf life of a package or product.”
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Evaluates package performance under simulated environmental and distribution conditions.
Source
“Evaluates how a packaged product will perform under simulated environmental and distribution conditions.”
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Assesses sterile barrier integrity and seal strength.
Source
“Assesses the integrity and seal strength of a sterile barrier system maintained throughout its processing, expected shelf life and handling.”
Certifications & Trust Signals
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Global network of contract sterilization and testing facilities.
Source
“Supplying our Customers with a global network of contract sterilization and testing facilities”
Buyer Snapshot
Best for
- Medical device manufacturers requiring packaging and shelf-life validation.
- Pharmaceutical companies seeking to establish or extend product expiration dates.
- Companies needing to simulate distribution and environmental conditions for their products.
How engagement typically works
- Direct engagement for testing services.
- Consultation on shelf-life extension strategies.
Typical deliverables
- Shelf-life study reports (accelerated and real-time).
- Distribution simulation test reports.
- Sterile barrier integrity and seal strength analysis.
- Documentation supporting shelf-life extension.
Good to know
- Best when requiring specialized packaging and shelf-life testing expertise.
HQ:
US
Languages:
English
Timezones:
EST
Status:
listed
Services & Capabilities
Packaging + Shelf-life + Distribution Testing
Countries:
United States, United Kingdom, Germany, Switzerland, China, Canada, France, Italy, Netherlands, Australia, Singapore, Asia
Industries:
Medical Devices
Packaging Tests Offered:
Package integrity, Seal strength
Shelf Life Methods Offered:
Accelerated aging, Real-time aging, Both
Distribution Tests Offered:
Climate, Other
Standards Supported:
ISO 11607, ASTM D4169, ISTA
Has Climate Chambers:
Yes
Has Distribution Simulation:
Yes
Nda Support:
Yes
Additional packaging_shelf_life_testing Details
Packaging Tests Offered
Sterile barrier integrity, Seal strength, Accelerated aging, Real-time aging, Distribution simulation
Standards Supported
ISO 11607, ISO 16775
Shelf Life Methods Offered
Real-time aging, Accelerated aging
Distribution Tests Offered
Vibration, Shock, Drop, Compression, Stacking, Climate
