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> ISTA-certified medical device packaging test lab. Accelerated aging, seal strength, distribution simulation, and complete ISO 11607 validation — from protocol design through audit-ready documentation.

Source: https://lso-inc.com/medical-package-testing/

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# Medical Package Testing

ISTA-certified medical device packaging test lab. Accelerated aging, sterile barrier testing, distribution simulation, and complete ISO 11607 validation — from protocol design through audit-ready documentation.

[Get a Validation Plan Reviewed](https://lso-inc.com/solutions/packaging-validation/#intake-form)

![Medical Package Testing](https://lso-inc.com/api/media/file/Medicalpackagingtestinlabenvironment.webp)

FDA-Registered

Manufacturing Facility

ISO 13485

Certified Quality System

12 Cleanrooms

Class 5–8

125,000+ Sq Ft

Regulated Manufacturing

3 Facilities

CA | NH | Costa Rica

ISO 17025

Accredited Packaging Lab

![LSO MDM OrthopedicCollage 1](https://lso-inc.com/api/media/file/LSO_MDM_OrthopedicCollage-2.png)

Medical Package Testing (MPT) is LSO's ISTA-certified packaging test lab and accredited to ISO 17025.

Our testing and validation services are designed to assure compliance with FDA, ISO, EN, and CE Mark requirements. Whether you're validating a new sterile barrier system, switching packaging materials, or preparing for a regulatory submission, our packaging engineers have the expertise and equipment to get it done right.

## Package Testing & Validation Services

LSO's packaging lab provides the full range of testing required for ISO 11607 compliance and regulatory submission:

-   [Accelerated Aging](https://lso-inc.com/medical-package-testing/services/accelerated-aging/) — ASTM F1980 protocols for shelf life claims
    
-   [Real-Time Aging](https://lso-inc.com/medical-package-testing/services/real-time-aging/) — Long-term stability data to support accelerated aging results
    
-   [Peel (Seal) Strength Testing](https://lso-inc.com/medical-package-testing/services/peel-strength-testing/) — ASTM F88 seal strength measurement
    
-   [Distribution Simulation](https://lso-inc.com/medical-package-testing/services/distribution-simulation-testing/) — ASTM D4169 and ISTA transit testing
    
-   [Dye Penetration Testing](https://lso-inc.com/medical-package-testing/services/dye-penetration-testing/) — ASTM F1929 seal integrity verification
    
-   [Bubble Emission Testing](https://lso-inc.com/medical-package-testing/services/bubble-emission-testing/) — ASTM F2096 gross leak detection
    
-   [Visual Inspection](https://lso-inc.com/medical-package-testing/services/visual-inspection/) — Per ASTM F1886 for package defect detection
    
-   [Environmental Conditioning](https://lso-inc.com/medical-package-testing/services/environmental-conditioning/) — Pre-test conditioning per ASTM D4332
    
-   [Heat Seal Validation](https://lso-inc.com/medical-package-testing/services/heat-seal-validation/) — Process validation for sealing equipment
    
-   [Package Validation Testing](https://lso-inc.com/medical-package-testing/services/package-validation-testing/) — Complete validation test programs
    
-   [Stability Testing](https://lso-inc.com/medical-package-testing/services/stability-testing/) — Ongoing stability monitoring programs
    

## Package Design

Beyond testing, LSO supports packaging development from concept through validated production:

-   [Medical Primary Packaging](https://lso-inc.com/medical-package-testing/package-design/medical-primary-packaging/) — Sterile barrier system design and development
    
-   [Medical Secondary Packaging](https://lso-inc.com/medical-package-testing/package-design/medical-secondary-packaging/) — Protective packaging for distribution
    

## Standards We Test To

Our lab is equipped and certified to perform testing under the major medical device packaging standards:

-   [ISO 11607](https://lso-inc.com/medical-package-testing/standards/iso-11607/) — Packaging for terminally sterilized medical devices
    
-   [ASTM D Standards](https://lso-inc.com/medical-package-testing/standards/astm-d-standards/) — Distribution, compression, vibration, and conditioning tests
    
-   [ASTM F Standards](https://lso-inc.com/medical-package-testing/standards/astm-f-standards/) — Seal strength, aging, leak detection, and integrity tests
    
-   [ISTA Standards](https://lso-inc.com/medical-package-testing/standards/ista/) — Transit testing protocols (1A, 1G, 2A, 3A)
    

## Pre-Validated Packaging Systems

Need to move faster? LSO offers pre-validated pouch and tray packaging systems that can eliminate 8–12 weeks from your validation timeline. If your device fits a pre-validated format, you skip protocol design and testing and go straight to device-specific verification.

## Why LSO for Package Testing

LSO is one of the few contract manufacturers that provides both packaging testing and packaging production under the same roof. When your validation is complete, the same team that tested your packaging can produce it at scale — no transfer to a separate vendor, no re-validation, no lost time.

Our packaging engineers have supported hundreds of regulatory submissions and have direct experience with FDA 510(k), EU MDR, and CE Mark documentation requirements. We don't just hand you test data — we deliver audit-ready reports organized for your submission.

## Ready to get started?

Talk to a specialist about medical package testing.

[Get a Validation Plan Reviewed](https://lso-inc.com/solutions/packaging-validation/#intake-form) [Explore Solutions](https://lso-inc.com/#solutions)

[![Price Match Guarantee badge](https://lso-inc.com/images/price-match-guarantee.png)](https://lso-inc.com/medical-package-testing/price-guarantee/ "We beat qualifying package-testing quotes by 5%")
