A Custom Helium Leak Detector For A Regulated Environment
Leak Detection Associates’ most current model, the Seal Integrity Monitoring System (SIMS) 1284+, is the ideal choice for your helium based leak detection system. Using helium as the tracer gas, packages can be quantitatively tested to levels far exceeding the vacuum bubble and dye penetration test methods. This Quantitative approach allows direct comparison across various packaging materials and forms, production line settings and stability storage conditions. The LDA SIMS 1284+ is a proven and effective tool for package design, tooling qualification, production line setup and on-going product quality monitoring of a variety of package types including cold form blister cards, foil pouches, parenteral vials, syringes, pre-filled syringes and unique medical devices.
Each SIMS 1284+ Helium Leak Testing instrument manufactured by Leak Detection Associates is custom built to client-specific standards. Key factors that determine instrument build specifications include:
- What type of package(s) will you be testing with this instrument – Vials, Blister Cards, Syringes, Cartridge System or Medical Device? Size and closure type should be included and whenever possible a schematic of the package or device can be helpful in optimizing the test system.
- Projected amount of use the instrument will see?
- Country where the instrument will be installed?
Leak Detection Associates Seal Integrity Monitoring System (SIMS) Model 1284+ helium-based leak testing system features an oil-free detector and integrated power system that is designed for the needs of the pharmaceutical and medical device industries, enabling the client to quantitatively analyze package system at a sensitivity level as low as 1 x 10 -10 cc/s at room temperature. The most critical component, the Helium Leak Detector Module (HLDM), is engineered into a Console Frame Assembly that features a Stainless Steel working surface and Dual Test Port Manifold. The console has a locking wheel and will be fitted with an articulating arm system for mounting of the computer, monitor, key board and direct access printer, making the freestanding unit easy to use and maneuver.