Sterile barrier and distribution testing, co-located with sterilization.
Boulder Package Testing is a contract medical device package validation lab executing ISTA-aligned test methods and ISO 17025-aligned protocols. We are the only US package testing lab co-located with EO and chlorine dioxide sterilization — on the same Boulder, Colorado campus.
Test Methods & Standards
Every standard referenced in a typical ISO 11607 validation program.
Our Services
Complete package validation under one roof.
Distribution Simulation
Drop, vibration, compression, and shock per ASTM D4169 and ISTA 3A/2A profiles for medical device packaging.
Accelerated & Real-Time Aging
ASTM F1980 accelerated aging with paired real-time aging to support one-year and multi-year shelf-life claims.
Sterile Barrier Integrity
Dye penetration (F1929), bubble leak (F2096), and visual inspection (F1886) to confirm sterile barrier integrity.
Seal Strength & Burst
Peel testing per ASTM F88 and burst testing per ASTM F1140 to verify sealing process capability.
ISO 11607 Validation Programs
Complete ISO 11607-1 and ISO 11607-2 audit-ready validation programs for sterile barrier systems.
Sterilization-to-Test Workflow
Devices sterilized by Boulder Sterilization (EO or CD) transfer directly into package testing on the same campus.
Why Boulder Package Testing?
Co-located with sterilization
Devices sterilized by Boulder Sterilization (EO or chlorine dioxide) move directly to package testing without leaving the campus.
One protocol, one report, one quality system
Distribution, aging, and integrity testing share documentation, sample IDs, and chain of custody under the Boulder BioMed quality system.
Built for Medical Device Companies Who Need Results, Not Round Trips
Medical device companies across the country have sent packaging samples to California or Minnesota for validation testing. Boulder Package Testing changes that equation. Co-located with EO and chlorine dioxide sterilization on a single Boulder, Colorado campus, we eliminate re-sterilization risk, reduce transit time, and maintain an unbroken chain of custody from sterilization through final validated report.
Backed by the Boulder BioMed family
Engineering and design (Boulder iQ), regulatory and quality (Boulder RA/QA), microbiology (Boulder BioLabs), sterilization, and now package testing.
What Our Clients Say
Anonymized client feedback from medical device companies we have supported.
“
Jim's expertise caught something our internal team had missed entirely. By taking a half-inch off our tray length, we went from needing a large, custom sealing machine to a standard off-the-shelf sealer — and our package shifted to a standard off-the-shelf pouch size. The savings on tooling alone paid for the validation program.
Colorado orthopedic device startup
“
We had budgeted for tray tooling and a full thermoforming qualification. Boulder walked us through why a card-and-pouch configuration would work for our device geometry — and get us to market in half the time at a fraction of the cost. We were shipping product four months sooner than our original plan.
Early-stage surgical device company
“
Before we ran a single test, Boulder reviewed our package design and identified three issues that would have caused us to fail distribution testing. By the time we ran samples, we already knew the design was right. We passed on the first run.
IVD manufacturer
Chain of Custody Workflow
Six steps from sample intake to validated report.
Sample Intake
Receipt, photography, sample ID assignment, conditioning per ASTM D4332.
Sterilization (Optional)
EO or chlorine dioxide via Boulder Sterilization, on the same campus.
Accelerated Aging
ASTM F1980-driven cycles in calibrated temperature/humidity chambers.
Distribution Simulation
ASTM D4169 or ISTA 3A/2A: drop, vibration, compression, shock.
Integrity Verification
Dye penetration (F1929), bubble leak (F2096), seal strength (F88), visual inspection (F1886).
Validated Report
Audit-ready report mapped to ISO 11607-1/-2 and your DHF.
The Boulder BioMed Family
Five companies, one campus, one quality system.
Frequently Asked Questions
What is ISO 11607 and what testing does it require?
ISO 11607 is the global consensus validation standard for terminally sterilized medical device packaging. Part 1 covers requirements for materials, sterile barrier systems, and packaging systems. Part 2 covers validation of forming, sealing, and assembly processes. A typical ISO 11607 program includes package conditioning (ASTM D4332), distribution simulation (ASTM D4169 or an ISTA profile such as 3A), accelerated aging (ASTM F1980), seal strength (ASTM F88), visual inspection of seals (ASTM F1886), dye penetration (ASTM F1929), and bubble or gross leak testing (ASTM F2096).
What is the difference between ISTA 3A and ASTM D4169?
Both are recognized distribution test schemes. ASTM D4169 is a flexible framework where the manufacturer selects assurance levels and hazard sequences. ISTA 3A is a prescriptive profile for packaged products of 150 lb or less shipped through parcel-delivery networks. Both are accepted for ISO 11607 distribution simulation.
What is ASTM F1980 accelerated aging?
ASTM F1980 uses elevated temperature to simulate the effect of time on a sterile barrier system. Using a Q10 of 2.0, one year of real-time shelf life can be simulated in roughly 52 days at 55 degrees C.
How long does a standard packaging validation take?
For a standard one-year shelf life claim using ASTM F1980 accelerated aging at 55 degrees C, end-to-end turnaround is typically 8 to 12 weeks. Each additional year of shelf life adds roughly four weeks.
Is Boulder Package Testing accredited?
Boulder Package Testing operates ISTA-aligned and ISO 17025-aligned protocols under the Boulder BioMed ISO 13485 quality management system. Full ISTA certification and ISO 17025 accreditation are in progress.
What makes you different from other contract labs?
We are the only US package testing lab co-located with EO and chlorine dioxide sterilization. One chain of custody, one quality system, and faster turnaround compared to shipping samples between separate facilities.
Start Your Validation Project
Tell us about your device and packaging. We will propose a test plan within one business day.