Medical Device Package Testing
What Is Medical Device Package Testing?
Medical device package testing validates that the packaging protecting a sterile medical device maintains its integrity from production through distribution and storage to the point of use. The sterile barrier is the sealed enclosure that keeps a device sterile until opened, and it must prove it can survive real-world handling, shipping conditions, and the duration of the product’s intended shelf life.
Testing covers seal strength and seal defect detection, accelerated aging to project shelf life, leak detection, and distribution performance simulation. The output is a documented test record that supports FDA submissions and demonstrates compliance with ISO 11607, the international standard governing sterile barrier systems for terminally sterilized medical devices.
Why Does Medical Device Package Testing Matter?
FDA requirements for medical device packaging are defined under 21 CFR Part 820 and reinforced by ISO 11607, which specifies validation requirements for sterile barrier systems. Packaging that reaches the market without documented test data creates regulatory exposure and, in failure, carries direct patient safety consequences.
Validated test reports give manufacturers the documented evidence that packaging performs to spec before a device reaches a patient. Accelerated aging data supports shelf life claims on product labeling. Seal strength and leak detection results demonstrate sterile barrier integrity across the full production range. TEN-E’s ANAB ISO/IEC 17025 accreditation means those results carry the standing FDA reviewers and regulatory submissions required.
Who Is Medical Device Package Testing For?
Medical Device
Medical device manufacturers validate sterile barrier packaging to ISO 11607 so devices reach the point of use sterile and intact.
Pharmaceutical
Pharmaceutical companies packaging sterile products rely on the same sterile barrier and accelerated aging tests to support FDA submissions.
Accreditations That Apply
Every medical device testing program is built from recognized procedures, run on calibrated equipment, and backed by laboratory accreditation.
Our Accreditations
ANAB ISO/IEC 17025 Accreditation
ISTA Certified Laboratory
Medical Device Testing Methods & Standards
Testing Standards
ASTM Package Testing
Testing Methods
Frequently Asked Questions
A sterile barrier system is the minimum packaging configuration that prevents microorganism entry and allows aseptic presentation of a sterile medical device at the point of use. ISO 11607 requires that sterile barrier systems be validated through testing before they can be used with a medical device intended for sterile use. Testing confirms that the seal integrity, material performance, and packaging configuration hold up through the product’s intended distribution path and shelf life.
Accelerated aging testing projects a packaging system’s shelf life by subjecting it to elevated temperature and humidity conditions over a compressed time period. The method, defined in ASTM F1980, allows manufacturers to demonstrate that packaging maintains its sterile barrier integrity through the intended shelf life without waiting in real time for that period to elapse. Accelerated aging results support the expiration date printed on the product label and are required documentation for FDA submissions on sterile medical devices.
Seal strength testing (ASTM F88, ASTM F2203) measures the force required to separate a heat seal, confirming the seal is strong enough to maintain sterile barrier integrity through handling and distribution. Leak detection methods (ASTM F1929, ASTM F2096) test whether the barrier is actually intact: dye penetration identifies any channels or defects at the seal boundary, and bubble emission testing confirms the package holds pressure without leaking. Both test types address sterile barrier performance from different angles, and most validation programs require both.
Yes. Many medical device packaging validation programs require both sterile barrier testing and distribution performance testing. TEN-E tests to ASTM D4169 and ASTM F2825 for distribution performance, confirming that packaging survives vibration, drop, compression, and the other hazards of the distribution environment, and then retests seal integrity and sterile barrier performance after distribution simulation. Combined testing in a single lab reduces project coordination and maintains chain of custody for test samples throughout the validation process.
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