Medical device manufacturers know that Good Manufacturing Processes (GMP) and FDA compliance means that you cannot cut corners ensuring the clinical safety and reliability of medical devices. Thorough testing and application knowledge of medical equipment is required to ensure that each device functions as it is designed to perform.
Medical Equipment Leak Detection System
Unlike off-the-shelf mass-produced leak detectors, InterTech’s patented nondestructive testing instrumentation for FDA-regulated manufacturers is optimized for GMP manufacturing environments. InterTech’s medical equipment leak detection system is proven to be the most cost-effective test technology for a wide range of medical devices and medical products such as catheters, dialysis equipment, medical check valves, syringes, laparoscopic instruments, IV bags, oxygen regulators, implanted medical devices, artificial valves, home care technology, and more.
InterTech’s turnkey test solutions consistently lower medical device, medical product testing costs by 25% or more. To achieve these cost-reductions and maintain GMP standards, InterTech utilizes an encyclopedic knowledge base of test fixture design and a wide array of leak test technology methodologies for medical device manufacturers.
Medical Testing Systems
For medical testing systems, InterTech’s MED75 Leak Detector is designed specifically for the high-speed testing of medical products. The compact instrument is a single channel mass flow leak detector which was engineered for medical device leak testing applications.
Understanding how testing works will help manufacturers design and implement the testing process. It is recommended you work with leak test experts such as InterTech to create a customized testing system so that manufacturers understand how a leak test works, allowing them to design better products and achieve more realistic throughput with leading-edge technology and company know-how.
SLEEP APNEA LEAK TESTER
InterTech’s MED75 model controls leak testing cycle – each test channel is independent in operation with individual flow transducers, pressure regulators, valves, and calibration ports.
OXYGEN DELIVERY SYSTEM
InterTech’s design and implementation of an electronic calibration and testing system enables calibration and functional testing of this medical device in a unique and innovative manner.
VENTILATOR LEAK TESTING
Compared to pressure decay testers, InterTech’s ventilator analyzer decreases test cycle times by 30%+. In many applications with more stringent testing requirements.
CATHETER PRESSURE DECAY LEAK TESTING
InterTech’s experts adopt a systems perspective to develop the best catheter test solution possible through a proven methodology.
DRAINAGE BAG LEAK TESTING
InterTech’s design of the drainage bag leak testing system includes three independent stations cycle at a rate of 40 pph. to leak test bags to 8.5 sccm limit at 6 psig.
BLOOD COLLECTION BAG LEAK TESTER
InterTech understands the many factors that can undermine blood collection bad leak testing integrity via methods such as fail-safe leak testing.
Read industry insights in this article “Experience is Key to Leak Testing” – featured in Assembly Magazine
Intertech Engineers & Accreditation
InterTech’s Applications Engineers are on-call to provide no-cost consultations on your specific medical device leak testing, functional testing, or assembly and test challenge. Contact an applications engineer for help or more information.
ISO 17025 accreditation of InterTech’s Calibration and Applications Laboratory’s quality management system compliments its ISO9001 accreditation ensuring customers and end-users are assured of quality and proven standards at all stages within their supply chains.
View InterTech’s range of Leak & Functional Testing Instruments to find the right instrument for your application.