Medical Package Testing
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.
Medical Package Testing (MPT) is LSO's ISTA-certified packaging test lab (ID Number ST-2339). We provide validation, testing, and design of medical device packaging under ISO 11607, ASTM, and ISTA standards — from protocol design through audit-ready documentation.
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 — ASTM F1980 protocols for shelf life claims
Real-Time Aging — Long-term stability data to support accelerated aging results
Peel (Seal) Strength Testing — ASTM F88 seal strength measurement
Distribution Simulation — ASTM D4169 and ISTA transit testing
Dye Penetration Testing — ASTM F1929 seal integrity verification
Bubble Emission Testing — ASTM F2096 gross leak detection
Visual Inspection — Per ASTM F1886 for package defect detection
Environmental Conditioning — Pre-test conditioning per ASTM D4332
Heat Seal Validation — Process validation for sealing equipment
Package Validation Testing — Complete validation test programs
Stability Testing — Ongoing stability monitoring programs
Package Design
Beyond testing, LSO supports packaging development from concept through validated production:
Medical Primary Packaging — Sterile barrier system design and development
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 — Packaging for terminally sterilized medical devices
ASTM D Standards — Distribution, compression, vibration, and conditioning tests
ASTM F Standards — Seal strength, aging, leak detection, and integrity tests
ISTA Standards — 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.
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
Ready to get started?
Talk to a specialist about medical package testing.