Medical Package Testing & Validation | ISO 11607
ISO 11607-aligned medical package testing and validation within an ISO 13485-certified quality system. ASTM methods and ISTA-certified lab support.
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.
Frequently Asked Questions
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
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