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> ISO 11607-aligned medical package testing and validation within an ISO 13485-certified quality system. ASTM methods and ISTA-certified lab support.

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

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# Medical Package Testing & Validation | ISO 11607

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

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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

## ISO 11607-Aligned Validation Designed for Regulatory Submission

Your packaging validation will be reviewed in detail during FDA submission, audit, or technical file assessment.

-   Seal integrity.
-   Accelerated aging.
-   Transit simulation.
-   Sterile barrier system performance.

One gap in protocol design or documentation can delay approval.

LSO provides ISO 11607-compliant medical package testing and validation within an ISO 13485-certified quality system. Testing strategy, documentation structure, and distribution simulation are supported by ASTM methodologies and ISTA-certified laboratory capabilities.

## ISO 11607 Expertise at the Core

Packaging validation for terminally sterilized medical devices must align with ISO 11607 requirements.

This includes:

-   Sterile barrier system validation
-   Process validation support
-   Seal strength justification
-   Aging studies
-   Distribution simulation
-   Documentation traceability

LSO structures validation programs around ISO 11607 as a framework — not simply as a checklist of tests.

## Comprehensive Package Testing Capabilities

LSO supports:

-   ASTM F88 — Seal Strength
-   ASTM F1929 — Dye Penetration
-   ASTM F2096 — Bubble Leak
-   ASTM F1140 / F2054 — Burst Testing
-   ASTM F1980 — Accelerated Aging
-   ASTM D4169 — Distribution Simulation
-   ISTA Transit Testing Protocols

Testing plans are developed within the context of sterile barrier system performance and regulatory submission expectations.

## Validation Structured for Audit Defense

Regulatory reviewers evaluate:

-   Protocol completeness
-   Sampling rationale
-   Acceptance criteria justification
-   Test method selection
-   Documentation alignment

Testing alone is insufficient without structured validation logic.

LSO approaches package validation as a documented system, executed within an ISO 13485:2016-certified quality framework in FDA-registered facilities.

## Integrated Sterilization & Microbiology Support

Packaging performance cannot be separated from sterilization method or microbial barrier performance.

LSO supports validation with:

-   In-house microbiology expertise
-   Certified sterilization engineers (CISS-EO, CISS-RAD, CISS-MH)
-   Coordination with sterilization modality requirements
-   Alignment between packaging configuration and sterility assurance

Validation planning reflects full lifecycle manufacturing considerations.

## Designed for Critical Regulatory Moments

Organizations engage LSO when:

-   Preparing FDA submissions
-   Responding to audit findings
-   Addressing seal integrity failures
-   Conducting sterile barrier investigations
-   Supporting commercial scale-up

Validation documentation is structured to support regulatory review and long-term compliance stability.

## Ready to get started?

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