Medical Packaging & Sterile Barrier Testing Equipment
Medical Packaging & Sterile Barrier Testing | ISO 11607 & ASTM F2096 Compliance
Medical packaging and sterile barrier testing equipment measures the mechanical strength, seal integrity, and pressure performance that keep a sterile barrier system intact from manufacturing through clinical use. Torontech's range covers universal mechanical testers built to ISO 7864, ISO 7886, and related needle and syringe packaging standards, a dedicated gross leak and burst tester built to ASTM F2096 and ISO 11607, and instruments that verify the sealing and flow performance of the medical device inside the package. Manufacturers, quality control labs, and contract test facilities use these instruments to confirm packaging holds a seal, survives handling, and protects device performance.
The range spans large and compact mechanical packaging testers, a pneumatic gross leak and burst tester, and general-purpose pressure and flow rate testers for the medical devices themselves, so a lab can validate both the package and the device it protects.
Why Choose Torontech for Your Medical Packaging & Sterile Barrier Testing
Torontech supplies testing and measurement equipment to laboratories and manufacturers across North America and worldwide, backed by responsive technical support and calibration service. The Medical Packaging & Sterile Barrier Testing range is built for reliable, standards-driven results, so you can standardize on one supplier as your testing needs grow. Our team helps you match the right configuration to your samples, applicable standards, and throughput, then supports you through installation and beyond.
Request a Quote
Tell us which packaging format or device you need to test and the standards your program follows, and we will recommend the right instrument from this range. Contact the Torontech team for pricing and lead times.
Applications
Medical packaging and sterile barrier testing supports manufacturers and labs across pharmaceutical and medical device packaging.
- Sterile Barrier System Validation: confirms seal strength, peel strength, and heat-seal integrity of pouches, blister packs, and foil laminates against ISO 11607.
- Packaging Component Testing: validates break force, puncture force, and opening force of ampoule bottles, butyl stoppers, and composite caps per ISO 7864 and ISO 7886.
- Packaging Integrity QC: performs gross leak, burst pressure, and creep-to-failure testing on flexible and rigid packaging per ASTM F2096 and related standards.
- Device Seal and Flow Verification: checks the pressure sealing and flow performance of the needles, catheters, and infusion devices contained within the package.
Medical Packaging & Sterile Barrier Testing Range
The range covers five instruments spanning mechanical packaging properties, pneumatic leak and burst testing, and device sealing and flow performance.
Tester | Key Standard | What It Measures |
ISO 7864, ISO 7886, ISO 9626, ISO 8537, ISO 23908 | Break force, puncture force, sliding force, tensile strength, heat-seal strength, and peel strength across ampoules, caps, films, and syringe packaging. | |
ISO 7864, ISO 7886, ISO 8871-5, USP <381> | The same mechanical packaging test methods on a compact platform for benchtop and lower-throughput labs. | |
ASTM F2096, ASTM F2054, ASTM F1140, ISO 11607-1, ISO 11607-2 | Gross leaks, burst pressure, creep, and creep-to-failure of sterile barrier packaging using positive pressure and bubble test methods. | |
Positive and negative pressure test method | Sealing integrity and leakage resistance of infusion sets, syringes, and sterile catheters under positive and negative pressure. | |
ISO 7864 | Flow rate, pressure resistance, and sealing reliability of syringe needles, infusion needles, and catheters. |
How to Choose the Right Medical Packaging & Sterile Barrier Tester
- For full-range mechanical packaging testing: choose the medical packaging tester for high-capacity tensile, compression, puncture, and peel testing.
- For compact or lower-volume labs: choose the small medical packaging tester for the same test methods on a benchtop footprint.
- For sterile barrier integrity: choose the gross leak tester to detect gross leaks and evaluate burst and creep performance.
- For device-level sealing inside the package: choose the positive and negative pressure tester to validate infusion set, syringe, and catheter seal integrity.
- For device flow performance: choose the medical device flow rate tester for needle and catheter patency and flow validation.
