Steris Isomedix Services
STERIS plc
★★★★★
3.5
/ 5
•
11 reviews
STERIS Isomedix Services is a global leader in infection prevention products and services, specializing in sterilization solutions, sterile processing equipment, and surgical instrument care. They offer comprehensive support for healthcare facilities to ensure patient safety and operational efficien
STERIS Isomedix Services is a premier global provider dedicated to enhancing patient care through advanced infection prevention solutions. Their expertise spans a wide range of critical areas, including sterilization solutions, sterile processing equipment, and surgical instrument cleaning chemistries. They are committed to ensuring sterility assurance and monitoring, offering process improvement for sterile processing, and providing offsite reprocessing center services. With a focus on supporting healthcare facilities, STERIS offers specialized services such as endoscopy device management, endoscope reprocessing, and endoscopy equipment maintenance. They also provide essential surgical device repair and surgical instrument repair services, alongside their SecureCare Services, to maintain the integrity and functionality of vital medical equipment. Their commitment extends to providing comprehensive support, from routine maintenance and calibration to regulatory certifications and emergency repairs, ensuring optimal equipment performance and compliance. STERIS leverages its team of industry-recognized scientists and engineers to offer exceptional expertise in contamination control strategies, process optimization, regulatory compliance, validation support, and quality assurance. They help clients navigate complex regulatory landscapes, reduce operational risks, and accelerate time-to-market for critical healthcare products and services. This includes providing essential documentation like Certificates of Analysis and Safety Data Sheets, and offering technical learning resources.
About
**Who they are**
Steris Isomedix Services is a global leader in infection prevention products and services, with a specialization in sterilization solutions. They offer comprehensive support for healthcare facilities.
**Expertise & scope**
* Packaging Testing
* Accelerated & Real-Time Aging: Simulates aging effects to demonstrate shelf life.
* Distribution Simulation: Evaluates product performance under simulated environmental and distribution conditions.
* Cold Chain Testing
* Sterile Barrier Integrity & Seal Strength: Assesses the integrity and seal strength of sterile barrier systems.
* Shelf-Life Extension: Assists medical device manufacturers in extending expiration dates through testing and documentation.
**Reputation / proof points**
* Global network of contract sterilization and testing facilities.
Steris Isomedix Services is a global leader in infection prevention products and services, with a specialization in sterilization solutions. They offer comprehensive support for healthcare facilities.
**Expertise & scope**
* Packaging Testing
* Accelerated & Real-Time Aging: Simulates aging effects to demonstrate shelf life.
* Distribution Simulation: Evaluates product performance under simulated environmental and distribution conditions.
* Cold Chain Testing
* Sterile Barrier Integrity & Seal Strength: Assesses the integrity and seal strength of sterile barrier systems.
* Shelf-Life Extension: Assists medical device manufacturers in extending expiration dates through testing and documentation.
**Reputation / proof points**
* Global network of contract sterilization and testing facilities.
Additional information
Steris Isomedix Services provides a range of packaging testing services designed to support medical device manufacturers. Their capabilities include simulating environmental and distribution conditions to evaluate product performance and package integrity. They also offer services to assess sterile barrier systems and assist in extending the labeled shelf-life of medical devices through rigorous testing and documentation. Manufacturers can engage Steris Isomedix Services to ensure their packaging meets required standards for product protection and regulatory compliance throughout the product lifecycle.
Key Highlights
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Specializes in packaging testing, including accelerated and real-time aging, distribution simulation, and sterile barrier integrity.
Source
“Simulates the effects of accelerated and real-time aging to demonstrate the shelf life of a package or product.”
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Offers services to assist medical device manufacturers in extending the expiration date of devices through testing and documentation.
Source
“Manufacturers of medical devices whose labelled shelf-life has expired may be able to extend the expiration date of the device by through testing and documentation.”
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Provides distribution simulation to evaluate how packaged products perform under various environmental and shipping conditions.
Source
“Evaluates how a packaged product will perform under simulated environmental and distribution conditions.”
Certifications & Trust Signals
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Global provider of infection prevention products and services.
Source
“STERIS is a leading global provider of products and services that support patient care with an emphasis on infection prevention.”
Buyer Snapshot
Best for
- Medical device manufacturers seeking packaging and shelf-life validation
- Companies needing to extend product expiration dates through testing
How engagement typically works
- Project-based testing engagements
- Consultation on shelf-life extension strategies
Typical deliverables
- Packaging integrity test reports
- Shelf-life validation data
- Distribution simulation reports
- Sterile barrier seal strength analysis
Good to know
- Best when requiring specialized testing for sterile medical devices.
HQ:
Mentor, US
Languages:
English
Timezones:
EST
Status:
listed
Services & Capabilities
Packaging + Shelf-life + Distribution Testing
Industries:
Medical Devices
Pricing model:
Custom pricing
Packaging Tests Offered:
Package integrity, Seal strength, Burst strength, Compression, Vibration, Drop
Shelf Life Methods Offered:
Real-time aging, Accelerated aging
Distribution Tests Offered:
Vibration, Drop, Compression, Climate
Standards Supported:
ISO 11607, ASTM D4169, ISTA
Is Accredited:
No
Has Climate Chambers:
Yes
Has Distribution Simulation:
Yes
Rush Available:
No
Nda Support:
No
Minimum Project Size:
No minimum
Regions Served:
United States, Canada (EN), Canada (FR), Deutschland, Italia, United Kingdom, Europe, Middle East and Africa, Australia, New Zealand, Singapore, Asia-Pacific, Brasil, México, América Latina
Additional packaging_shelf_life_testing Details
Packaging Tests Offered
Package integrity, Seal strength, Accelerated aging, Real-time aging, Distribution simulation, Cold chain testing
Standards Supported
ISO 11607, ASTM D4169, ISTA, ISO 16775
Shelf Life Methods Offered
Real-time aging, Accelerated aging
Distribution Tests Offered
Vibration, Climate, Other
Lead Time Band
Start in 4-8 weeks
Quote SLA
3-5 business days
Sample Return Policy
Return
Minimum Project Size
$25-50k
Pricing Model
Per project
