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 provider of contract sterilization and laboratory testing services, with a specialization in packaging and shelf-life testing for medical device and pharmaceutical manufacturers.
**Expertise & scope**
* Packaging and shelf-life testing
* Accelerated and real-time aging simulations to determine product shelf life
* Distribution simulation to evaluate package performance under environmental and distribution conditions
* Cold chain testing
* Sterile barrier integrity and seal strength assessment
* Shelf-life extension testing and documentation for medical devices
**Reputation / proof points**
* Global network of contract sterilization and testing facilities
STERIS Isomedix Laboratory Services is a provider of contract sterilization and laboratory testing services, with a specialization in packaging and shelf-life testing for medical device and pharmaceutical manufacturers.
**Expertise & scope**
* Packaging and shelf-life testing
* Accelerated and real-time aging simulations to determine product shelf life
* Distribution simulation to evaluate package performance under environmental and distribution conditions
* Cold chain testing
* Sterile barrier integrity and seal strength assessment
* Shelf-life extension testing and documentation for medical devices
**Reputation / proof points**
* Global network of contract sterilization and testing facilities
Additional information
STERIS AST's packaging testing services are designed to simulate various real-world conditions that a product might encounter. This includes accelerated and real-time aging to establish shelf life, and distribution simulation using climatic/environmental chambers to mimic shipping stresses. They also focus on assessing the integrity and seal strength of sterile barrier systems throughout the product lifecycle. For medical device manufacturers facing expired shelf-life labels, their testing can provide the necessary data for extension.
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 to demonstrate 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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Operates a 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 testing
- Pharmaceutical companies needing to validate product packaging
How engagement typically works
- Consultative approach to testing needs
- Data-driven validation for shelf-life extension
Typical deliverables
- Shelf-life study reports
- Distribution simulation test results
- Sterile barrier integrity reports
- Documentation for shelf-life extension
Good to know
- Best when requiring specialized packaging and shelf-life validation for medical and pharmaceutical products.
HQ:
US
Languages:
English
Timezones:
EST
Claim 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, Distribution simulation, Accelerated aging, Real-time aging, Cold chain testing
Standards Supported
ISO 11607, ISO 16775
Shelf Life Methods Offered
Real-time aging, Accelerated aging
Distribution Tests Offered
Distribution simulation, Climate testing
