Pharmaceutical and Medical Device
By consulting with medical device manufacturers for more than five decades, Helium Leak Testing, Inc. (HLT) has gained an invaluable understanding of medical device manufacturing and its critical fabrication requirements necessary to meet FDA regulations. HLT continues to develop innovative and reliable leak testing methods for the medical industry.
Medical Research & Development benefits from HLT’s cutting-edge leak testing techniques and procedures. These techniques are developed through device prototype qualification and implemented into procedures for quality assurance in manufacturing. Such medical devices include: catheters, vials, syringes, insulin pumps, pillow assemblies, pacemakers, earplugs, hermetically-sealed implants, laser-scribed discs, as well as bionic and prosthetic devices.This list continues to grow as our thriving customers enhance their leading-edge product lines.
All of HLT’s leak testing techniques & procedures meet stringent customer specifications and support the validation of packaging process and testing requirements. HLT’s engineers provide Consulting & Design Services for automated leak testing systems which are ideally suited for hermetically-sealed device integrity testing, as well as for the validation of Quality Assurance Management. Based on research & development, HLT’s unique leak testing solutions are designed to meet highly demanding throughput requirements and eliminate production line leak testing bottlenecks. Helium Leak Testing, Inc. provides support and maintenance for state-of-the-art processing equipment, validating the quality control to meet FDA requirements.
Whether used for packaging process quality control, device leak detection, seal permeation or automated testing applications, Helium Leak Testing, Inc. (HLT) provides unique solutions for a myriad of medical devices which require state-of-the art leak testing.