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.

**Expertise & scope**
* ISO 11607 validation, covering sterile barrier system design, sealing, testing, and shelf-life proof.
* Expertise in Part 1 (materials and sterile barrier systems) and Part 2 (process validation, including IQ/OQ/PQ).
* Distribution simulation testing to ensure packages survive real-world hazards.
* Package integrity testing, including dye penetration and bubble leak tests.
* Functional tests such as peel and burst strength testing.
* Accelerated and real-time aging studies to support shelf-life claims.
* Validation of forming, sealing, and assembly processes.

**Reputation / proof points**
* Services align with ISO 11607 standards, which are current through Amd 1:2023 and updated for 2025.

Additional information

LSO's services are designed to ensure medical device packaging meets global standards for sterility and integrity throughout its lifecycle. They focus on providing audit-ready documentation for ISO 11607 compliance. Their testing capabilities include validating packaging materials, sterile barrier systems, and the processes used for forming, sealing, and assembly. This comprehensive approach helps manufacturers demonstrate that their sterile barrier systems protect the device until the point of use and can be opened aseptically. They also conduct distribution and aging studies to confirm package performance under various conditions.

Key Highlights

  • Specializes in ISO 11607 packaging validation for sterile medical devices. Source
    “ISO 11607 defines how your sterile barrier system is designed, sealed, tested, and proven—from first article through shelf life.”
  • Provides validation for sterile barrier systems, including materials and process controls (IQ/OQ/PQ). Source
    “Part 1 defines what “good” looks like for materials and sterile barrier systems... Part 2 proves you can make that performance happen consistently. That means validating your forming, sealing, and assembly with IQ, OQ, and PQ”
  • Offers distribution simulation testing to assess package survivability. Source
    “then confirming the package will survive real-world hazards—distribution and handling”
  • Conducts accelerated and real-time aging studies to support shelf-life claims. Source
    “and aging to support shelf life.”

Certifications & Trust Signals

  • ISO 11607 standards referenced are current through Amd 1:2023 and updated for 2025. Source
    “Last updated: November 2025 (ISO 11607-1/-2 current through Amd 1:2023)”

Buyer Snapshot

Best for
  • Medical device manufacturers requiring ISO 11607 validation
  • Companies needing to prove sterile barrier system integrity
  • Providers seeking distribution and shelf-life testing
How engagement typically works
  • Project-based validation services
  • Testing and documentation support
Typical deliverables
  • ISO 11607 validation reports
  • Distribution simulation test results
  • Accelerated and real-time aging data
  • Seal validation reports
Good to know
  • Best when requiring specialized packaging and shelf-life testing expertise.
HQ: Brea, US
Languages: English
Timezones: America/Los_Angeles
Claim status: Listed

Services & Capabilities

Packaging + Shelf-life + Distribution Testing

Countries: United States, Asia
Industries: Medical Devices
Pricing model: Custom pricing
Packaging Tests Offered: Package integrity, Seal strength, Burst strength, Drop, Other
Shelf Life Methods Offered: Real-time aging, Accelerated aging, Both
Distribution Tests Offered: Vibration, Drop, Compression, Climate, Other
Standards Supported: ISO 11607, ISO 13485, FDA Guidance, ASTM D4169, ISTA
Has Climate Chambers: Yes
Has Distribution Simulation: Yes
Rush Available: No
Nda Support: No
Lead Time Band: Start in 0-2 weeks
Quote SLA: < 24 hours
Sample Return Policy: Dispose
Minimum Project Size: No minimum
Is Accredited: Yes

Additional packaging_shelf_life_testing Details

Packaging Tests Offered
Package integrity, Seal strength, Burst strength, Distribution simulation, Accelerated aging, Real time aging, Environmental conditioning, Visual inspection, Bubble emission testing, Dye penetration testing, Peel strength testing, Stability testing
Standards Supported
ISO 11607, ASTM D3078, ASTM D4169, ASTM D4728, ASTM D999, ASTM F1140, ASTM F1929, ASTM F1980, ASTM F1886, ASTM F88, ASTM F2096, ASTM F3039, ISTA 1A, ISTA 1G, ISTA 2A, ISTA 3A
Shelf Life Methods Offered
Real-time aging, Accelerated aging
Distribution Tests Offered
Vibration, Shock, Drop, Compression, Stacking, Climate
Lead Time Band
Start in 0-2 weeks
Quote SLA
< 24 hours
Sample Return Policy
Return
Minimum Project Size
$25-50k
Pricing Model
Per project
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