Medical Device Packaging Validation

Q: What ISTA procedures does gh Testing run for medical device packaging?

gh Testing runs ISTA 2A, 2B, 3A, 3B, 7D, and 7E for medical device packaging programs. ISTA 3A is the most commonly specified procedure for medical device distribution validation. The right procedure depends on your distribution channel, product weight, and regulatory requirement.

Q: Does gh Testing produce documentation for FDA regulatory submissions?

gh Testing produces ISO 17025 accredited test reports with photographic documentation and measurement uncertainty data formatted to support regulatory submissions. gh Testing does not submit to FDA on your behalf -- your regulatory affairs team handles submission using the accredited data we produce.

Q: Does gh Testing run cold chain validation for medical devices?

gh Testing runs ISTA 7D and 7E for temperature-sensitive devices and diagnostic products, with environmental conditioning from -20F to 140F. Accelerated aging is available at the Phoenix, Arizona facility.

ISO 17025 Accredited (Fairfield, OH)

Medical Device Packaging Testing Lab

gh Testing runs ISTA and ASTM distribution validation programs for medical device, diagnostic device, and healthcare packaging manufacturers. We produce documentation your packaging and regulatory teams need before your product ships.

Test Programs

ISTA 2A / 2B – Partial simulation for products with defined distribution requirements. Common where a full 3-series program exceeds scope.
ISTA 3A / 3B – General simulation performance testing. The most widely specified ISTA program for medical device distribution validation. Covers parcel, LTL, and air distribution legs with atmospheric conditioning before each mechanical sequence.
ISTA 7D / 7E – Thermal and temperature-controlled distribution testing for temperature-sensitive devices and diagnostic reagents requiring cold chain validation.
ASTM D4169 – Distribution cycle testing at Assurance Levels I, II, and III across all 18 defined distribution cycles. Specified when your regulatory pathway, quality system, or OEM requirement calls for a fully method-documented distribution validation.
Environmental Conditioning & Accelerated Aging – Temperature and humidity conditioning from -20°F to 140°F across eight standard profiles plus user-defined cycles. Accelerated aging programs simulate long-term storage effects in a compressed timeframe – used to validate shelf life claims and packaging performance before commercial launch. Available at both Ohio and Arizona locations.
Individual test elements – Drop, vibration, shock, incline impact, and compression testing run standalone or sequenced within a complete program.
See all testing capabilities.

Medical Device Packaging Distribution Testing showing compression and vibration testing of medical device packaging in a laboratory environment

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A technician loads a pallet of packaged boxes into a temperature controlled environmental chamber in a clean industrial lab during packaging validation testing.

Why Choose gh Testing?

Two Lab Locations – Two Lab Locations – Fairfield, Ohio serving the Midwest and East Coast, ISO 17025 accredited. Phoenix, Arizona serving the Southwest and West Coast, running the same testing programs. Accelerated aging capacity available in Phoenix
No Submission Guesswork – gh Testing’s Fairfield, Ohio lab produces the data. Your regulatory affairs team handles submission. You receive exactly what your FDA or regulatory review requires – nothing more, nothing less.

Frequently Asked Questions

What ISTA procedures does gh Testing run for medical device packaging?

ISTA 2A, 2B, 3A, 3B, 7D, and 7E. ISTA 3A is the most commonly specified for medical device distribution validation. The right procedure depends on your distribution channel, product weight, and regulatory requirement. Contact gh Testing to confirm which applies to your program.

Does gh Testing produce documentation for FDA regulatory submissions?

gh Testing’s Fairfield, Ohio lab produces ISO 17025 accredited test reports with photographic documentation and measurement uncertainty data formatted to support regulatory submissions. gh Testing does not submit to FDA on your behalf – your regulatory affairs team handles submission using the accredited data we produce.

What is the difference between ISTA 2A and ISTA 3A for medical devices?

ISTA 2A is a partial simulation combining conditioning, drop, vibration, and compression. ISTA 3A is a general simulation that more closely replicates complex real-world distribution and is the more commonly required program. Contact gh Testing to confirm which applies.

Does gh Testing run cold chain validation for medical devices?

Yes. ISTA 7D and 7E for temperature-sensitive devices and diagnostic products, with environmental conditioning from -20°F to 140°F. Accelerated aging available in Phoenix, Arizona.