Why Medical Packaging Testing Matters
Medical packaging that hasn’t been validated creates regulatory exposure and patient safety risk. FDA requirements under 21 CFR Part 820 and ISO 11607 require documented test evidence before a sterile medical device reaches the market.
Packaging Testing & Validation Services
Medical Device Package Testing
Seal strength, accelerated aging, leak detection, and package performance testing for sterile barrier systems under ISO 11607 and FDA requirements.
Environmental Package Testing
Accelerated aging and conditioning testing for shelf life validation and pre-test preparation, supporting medical device packaging validation programs.
A failed FDA submission can be costly
What We Test for Medical Device Companies
Sterile barrier systems for medical devices
ISO 11607 requires that sterile barrier packaging be validated before use with a terminally sterilized device. FDA submissions require documented validation records.
Applicable Standards and Methods
Distribution performance for packaged devices
Medical device packaging must maintain sterile barrier integrity through the distribution environment. Post-distribution seal testing confirms packaging survives shipping hazards.
Applicable Standards and Methods
Accelerated aging for shelf life validation
FDA requires documented evidence that packaging maintains sterile barrier integrity through the claimed shelf life. Accelerated aging compresses real-time aging into a validated test period.
Environmental conditioning before testing
ASTM D4332 and ISO 2233 conditioning establishes consistent material properties before performance testing, a requirement in most medical device packaging validation protocols.
Applicable Standards and Methods
Heat-sealed flexible barrier packaging
Seal integrity is the primary failure mode in sterile medical packaging. Seal strength testing confirms seals meet specifications across the production range.
Leak detection and seal defect inspection
Regulatory submissions require confirmation that seals contain no channels, defects, or leaks at the sterile barrier boundary.
Accreditations That Apply
Our accreditations determine which standards we test to, which regulatory submissions our results support, and which retailer programs our clients can qualify for.
Our Accreditations
ANAB ISO/IEC 17025 Accreditation
DEA Controlled Substance Registration
Frequently Asked Questions
ISO 11607 validation requires that packaging for terminally sterilized medical devices be qualified through testing before use. The validation process covers three main areas: packaging material qualification (confirming that materials meet the standard’s requirements for sterile barrier systems), design validation (confirming that the packaging configuration performs through the intended distribution environment and shelf life), and process validation (confirming that the sealing process produces consistently acceptable seals across the production range). TEN-E performs the seal strength, accelerated aging, leak detection, and performance testing that design validation requires, under ANAB ISO/IEC 17025 accreditation.
FDA submissions for sterile medical devices require documented packaging validation records demonstrating that the sterile barrier system meets ISO 11607 requirements. The documentation typically includes accelerated aging test results demonstrating shelf life performance, seal strength test results across the production range, leak detection results confirming sterile barrier integrity, and distribution performance test results if the device ships through a distribution channel. TEN-E generates test reports under ANAB ISO/IEC 17025 accreditation, providing the documented evidence FDA reviewers require.
Yes. Many medical device packaging validation programs require both sterile barrier testing and distribution performance testing, and TEN-E performs both in a single accredited lab environment. A typical combined program conditions samples, performs baseline seal strength and sterile barrier testing, subjects packaging to ASTM D4169 or ASTM F2825 distribution simulation, and then repeats seal strength and sterile barrier testing post-distribution to confirm integrity is maintained through shipment. Performing both test phases in a single lab maintains chain of custody for test samples and simplifies the validation documentation record.
Accelerated aging testing projects packaging shelf life by subjecting packaging to elevated temperature and humidity conditions over a compressed time period. The method, defined in ASTM F1980, applies the Arrhenius equation to convert the accelerated test duration into an equivalent real-time shelf life period. A product labeled with a five-year shelf life can be supported by accelerated aging data generated in weeks rather than years. Accelerated aging results support expiration date claims and are required documentation for FDA submissions on sterile medical devices.
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