Precision leak testing connectors for medical devices and life science products. FDA-approved seal materials, controlled-environment production, and application-specific designs for the delicate, geometrically complex components that define this industry.
Medical device and life science manufacturers operate under testing requirements that are among the most demanding in any industry. Components are often extremely small, fragile, and geometrically complex. Leak test pressures are typically low, but sensitivity requirements are high—a leak that would be acceptable in an industrial application can be a critical defect in a catheter, infusion set, or sterile barrier package. Effective medical device testing depends on repeatable, highly accurate connections, and the consequences of a missed defect can directly affect patient safety.
FasTest designs leak testing connectors specifically for this environment. Our medical connectors seal onto luer fittings, catheter hubs, syringe barrels, filter housings, tube sets, and custom device geometries without damaging the component or compromising test integrity. Every medical connector is produced with FDA-approved seal materials, clean anodized aluminum or stainless steel housings, and controlled-environment manufacturing processes—so the test tooling meets the same standards as the products it’s testing.
Whether you’re testing angioplasty catheters, insulin pump assemblies, dialysis filters, chest drains, IV sets, or sealed electronic medical devices, FasTest has the standard and custom medical connectors to improve your medical device leak testing accuracy, reduce scrap, and increase throughput for medical device testing and life science testing applications.
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Angioplasty Catheter | Battery Packs | Needle/Syringe | Luer Testing | Dialysis Filters | Specialty Tools | and More
Medical device leak testing is fundamentally different from industrial leak testing. Standard connectors designed for automotive or HVAC applications are too aggressive, too large, or too imprecise for the delicate components and tight tolerances of medical manufacturing. Here’s what makes this industry unique:
Connectors for Automation or Hand-Operation. A perfect seal to any type of medical testing application.
Designed for high volume production testing with test pressures up to 500 psi (34 bar).
Reduce product scrap with application specific tools. Easy-to-use Connector operation
Ergonomic designs reduce stress injuries and improve productivity.
We transform connection tools into tailor-made solutions to fit your exact requirements. Our Team of engineers will work with you to identify and design the optimal Connection Tool for your testing needs. Having difficulty sealing a unique port? Issues with clearance? Work with our dedicated team of Custom Experts to build your perfect solution.
Can't find what you need? We either have it or can make it.
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| Device / Component | FasTest Connection Approach |
|---|---|
| Angioplasty Catheters | Precision connectors for catheter hub and shaft leak testing. Seal onto luer hubs and custom catheter geometries without damaging the catheter shaft or balloon. Pressure decay and flow testing configurations. |
| Drug Delivery Systems | Connectors for insulin pump components, infusion sets, autoinjectors, pen injectors, and drug-eluting device assemblies. Sealing to luer fittings, tubing connections, and custom fluid pathway ports for leak integrity and flow verification. |
| Dialysis Filters & Devices | Connectors for dialyzer housing leak testing, blood and dialysate port sealing, and filter membrane integrity testing. Designed for the specific port configurations of hemodialysis and peritoneal dialysis devices. |
| Syringes & Needles | Connectors for syringe barrel leak testing, needle hub sealing, and plunger-seal integrity verification. Application-specific tools that grip and seal without damaging glass or plastic syringe barrels. |
| Luer Fittings (Male & Female) | Dedicated luer connectors for leak testing any device with standard male or female luer connections—IV sets, stopcocks, manifolds, extension sets, and custom luer-based devices. Seal onto luer tapers consistently without over-tightening or cross-threading. |
| Stents & Implantable Devices | Connectors for stent delivery system testing, implantable device housing seal verification, and catheter-deployed device assembly testing. Custom designs for the extremely small and delicate geometries of implantable devices. |
| IV & Infusion Sets | Connectors for IV tubing set leak testing, drip chamber sealing, Y-site and port verification, and flow rate testing. Sealing to luer, spike, and custom IV set connection points. |
| Chest Drains & Wound Care | Connectors for chest drain assembly testing, wound VAC system component testing, and drainage device seal verification. Custom solutions for the non-standard port geometries common in drainage devices. |
| Respiratory Devices | Connectors for ventilator circuit testing, oxygen mask and cannula assembly verification, nebulizer component testing, and respiratory filter integrity. Sealing to standard and custom respiratory connection points. |
| Sterile Barrier Packaging | Connectors for package seal integrity testing (ASTM F2095, F2391). Sealing to package test ports for whole-package leak testing and seal strength verification of pouches, trays, and lidded containers. |
| Battery Packs (Medical Devices) | Connectors for sealed battery compartment leak testing in implantable and portable medical electronics. Sealing to housing ports and cable glands for environmental integrity verification. |
| Laboratory & Diagnostic Equipment | Connectors for leak testing fluid pathways in analyzers, sample handling systems, reagent delivery assemblies, and microfluidic devices. Custom solutions for the small-bore, low-volume connections typical of diagnostic equipment. |
FasTest medical connectors are not standard industrial products repackaged for medical use. They are designed, manufactured, and delivered to the standards that medical device manufacturers require.
| Specification | Detail |
|---|---|
| Housing Material | Clear bright-dipped anodized aluminum as standard. Stainless steel available as an option for applications requiring higher corrosion resistance, chemical compatibility, or autoclavability. |
| Seal Materials | White FDA-approved Neoprene, Silicone, or Fluorocarbon (FKM) main seals. Material selection is matched to your test media, pressure, temperature, and cleanliness requirements. Additional elastomer options available for specialty applications. |
| Production Environment | All FasTest medical-grade connectors are produced in FasTest’s controlled environment and double-bagged for cleanliness. Contact the factory for specific environmental specifications and documentation. |
| Pressure Range | Medical connectors are designed for the low-pressure, high-sensitivity test requirements typical of medical device testing and medical device leak testing—up to 500 psi (34 bar) depending on series. |
| Custom Capability | FasTest’s custom engineering team designs connectors for non-standard medical device geometries, including extremely small ports, irregular shapes, and multi-lumen configurations. Prototyping and validation testing included. |
A: FasTest provides leak testing connectors for angioplasty catheters, drug delivery systems (insulin pumps, infusion sets, autoinjectors), dialysis filters, syringes and needles, luer-based devices, stents and delivery systems, IV sets, chest drains, respiratory devices, sterile barrier packaging, battery packs for medical electronics, and laboratory/diagnostic equipment.
A: FasTest medical connectors use white FDA-approved Neoprene, Silicone, or Fluorocarbon (FKM) main seals. The specific seal material is selected based on your test media, pressure, temperature, and cleanliness requirements. Additional specialty elastomer options are available.
A: Yes. All FasTest medical-grade connectors are produced in FasTest’s controlled environment and delivered double-bagged. Contact the factory for specific environmental specifications and documentation to support your cleanroom and regulatory requirements.
A: FasTest medical connectors support test pressures up to 500 psi (34 bar) depending on the series. Most medical device leak tests operate at significantly lower pressures. Our engineering team will recommend the right connector for your specific pressure and sensitivity requirements.
A: Yes. Custom connector design is one of FasTest’s core strengths in the medical industry. Many medical devices have non-standard port shapes, extremely small dimensions, or multi-lumen configurations that require purpose-built connectors. Submit an Application Evaluation with your device drawings and specifications for a custom recommendation.
A: FasTest medical connectors are designed to seal without damaging the device under test. Controlled clamping forces, smooth contact surfaces, and application-specific geometries prevent the crushing, scratching, and deformation that cause scrap when testing with poorly designed tooling. SURE SEAL™ confirmation also eliminates false failures, ensuring that test rejects represent actual defects rather than tooling problems.
A: Yes. Stainless steel housing is available as an option for applications requiring higher corrosion resistance, chemical compatibility, or autoclavability. Standard housing is clear bright-dipped anodized aluminum.
A: Yes. FasTest medical connectors are available in both manual and automated configurations, including pneumatically operated models for high-volume production. ICON™ technology provides the digital seal confirmation and PLC integration needed for automated medical device test systems.
A: FasTest medical connectors are purpose-designed for medical device testing with FDA-approved seal materials, clean anodized or stainless steel housings, controlled-environment production, gentle sealing forces appropriate for delicate components, and precision geometries for small medical ports. Standard industrial connectors are too aggressive, too imprecise, or made from incompatible materials for medical applications.
A: FasTest connectors support manufacturers operating under ISO 13485 and FDA quality frameworks. Controlled-environment production, documented material specifications, and ICON™ traceability data all contribute to the process documentation and validation that regulated manufacturers require.