Your packaging validation will be reviewed in detail during FDA submission, audit, or technical file assessment.
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.
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.
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.
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.
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.
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.
Yes. Validation planning and testing align with ISO 11607 requirements for terminally sterilized medical devices.
Yes. ASTM D4169 and ISTA transit testing protocols are supported.
Yes. Accelerated aging is performed in accordance with ASTM F1980.
Yes. LSO performs ASTM F88, F1929, F2096, F1140, and F2054 testing.
Yes. All package testing and validation services operate within an ISO 13485:2016-certified quality system in FDA-registered facilities.
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