Life Science Outsourcing, Inc.
LSO provides comprehensive medical device packaging and testing services, including ISO 11607 validation, accelerated aging, and distribution simulation to ensure product safety and market readiness.
Life Science Outsourcing (LSO) is an FDA-registered and ISO 13485-certified provider specializing in medical device packaging and testing. They offer end-to-end solutions designed to accelerate time-to-market and reduce costs for OEMs and startups. Key services include ISO 11607 packaging validation (Parts 1 & 2), accelerated aging studies (ASTM F1980), and distribution simulation testing (ISTA, ASTM D4169). LSO ensures sterile barrier systems are designed, sealed, tested, and proven to protect devices through their shelf life and open aseptically at the point of use. Their expertise extends to cleanroom assembly, kitting, sterilization (EtO, steam, gamma, ebeam), and supply chain management. LSO acts as a single-source partner, streamlining processes from initial planning to final reporting, ensuring compliance with global standards and audit-readiness.
About
**Who they are**
Life Science Outsourcing, Inc. (LSO) provides comprehensive medical device packaging and testing services, designed to accelerate product time-to-market and reduce costs through in-house expertise and end-to-end solutions.
**Expertise & scope**
* Integrating assembly, kitting, packaging, and quick-turn sterilization under one roof.
* Offering pre-validated packaging solutions and validation services.
* Performing packaging validation, testing, and design to meet regulatory requirements.
* Providing contract sterilization services for single-use and reusable products.
* Specializing in accelerated aging testing (ASTM F1980) to simulate long-term shelf life.
* Conducting ISO 11607 packaging validation (Parts 1 & 2) for sterile barrier systems.
* Executing distribution simulation testing.
**Reputation / proof points**
* Possesses in-depth understanding of regulatory processes and relevant certifications.
Life Science Outsourcing, Inc. (LSO) provides comprehensive medical device packaging and testing services, designed to accelerate product time-to-market and reduce costs through in-house expertise and end-to-end solutions.
**Expertise & scope**
* Integrating assembly, kitting, packaging, and quick-turn sterilization under one roof.
* Offering pre-validated packaging solutions and validation services.
* Performing packaging validation, testing, and design to meet regulatory requirements.
* Providing contract sterilization services for single-use and reusable products.
* Specializing in accelerated aging testing (ASTM F1980) to simulate long-term shelf life.
* Conducting ISO 11607 packaging validation (Parts 1 & 2) for sterile barrier systems.
* Executing distribution simulation testing.
**Reputation / proof points**
* Possesses in-depth understanding of regulatory processes and relevant certifications.
Additional information
LSO emphasizes a partnership approach, adapting to evolving customer needs to serve specialized markets. Their services integrate assembly, kitting, packaging, and sterilization, aiming for efficiency and cost reduction. Clients benefit from access to pre-validated packaging and validation services. The company highlights its in-house expertise and state-of-the-art manufacturing equipment. They also offer accelerated aging testing, which uses elevated temperatures to simulate shelf life according to ASTM F1980, recognized by regulatory bodies as a conservative estimate until real-time data is available.
Key Highlights
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Provides comprehensive medical device packaging and testing services, including assembly, kitting, packaging, and sterilization.
Source
“comprehensive end-to-end solutions such as integrating assembly, kitting, packaging, and quick-turn sterilization”
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Specializes in accelerated aging testing following ASTM F1980 to simulate product shelf life.
Source
“Accelerated aging is a standardized method that uses elevated temperatures to simulate the long-term shelf life”
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Offers ISO 11607 packaging validation (Parts 1 & 2) for sterile barrier systems.
Source
“ISO 11607 defines how your sterile barrier system is designed, sealed, tested, and proven”
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Conducts distribution simulation testing to ensure package integrity during transit.
Source
“confirming the package will survive real-world hazards—distribution and handling”
Certifications & Trust Signals
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Possesses an in-depth understanding of regulatory processes and holds relevant certifications.
Source
“We have all relevant certifications and an in-depth understanding of regulatory processes.”
Buyer Snapshot
Best for
- Medical device manufacturers seeking integrated packaging and testing solutions.
- Companies needing ISO 11607 and ASTM F1980 validation services.
- Providers requiring end-to-end support from assembly to distribution.
How engagement typically works
- Partnership-focused approach.
- Adaptable to client needs.
- Emphasis on in-house expertise.
Typical deliverables
- Validated sterile barrier systems.
- Accelerated aging test reports.
- Distribution simulation test results.
- Packaging design and testing services.
- Sterilization services.
Good to know
- Best when requiring comprehensive, integrated packaging and testing services.
HQ:
Brea, US
Languages:
English
Timezones:
America/Los_Angeles
Status:
listed
Services & Capabilities
Packaging + Shelf-life + Distribution Testing
Countries:
United States, Asia
Industries:
Medical Devices
Pricing model:
Custom pricing
Packaging Tests Offered:
Seal strength, Burst strength, Package integrity
Shelf Life Methods Offered:
Real-time aging, Accelerated aging, Both
Distribution Tests Offered:
Other
Standards Supported:
ISO 11607, ISO 13485, FDA Guidance, ASTM D4169
Has Climate Chambers:
No
Has Distribution Simulation:
Yes
Rush Available:
Yes
Nda Support:
Yes
Additional packaging_shelf_life_testing Details
Packaging Tests Offered
Package integrity, Seal strength, Burst strength, Accelerated aging, Distribution simulation, Visual inspection, Bubble emission testing, Dye penetration testing, Peel strength testing, Stability testing
Standards Supported
ISO 11607, ASTM D4169, ISTA, ASTM F1980
Shelf Life Methods Offered
Accelerated aging, Real time aging
Distribution Tests Offered
Vibration, Drop, Compression, Climate
Lead Time Band
Start in 0-2 weeks
Quote SLA
< 24 hours
Sample Return Policy
Dispose
Minimum Project Size
Custom
Pricing Model
Custom
