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Pharmaceutical products are often stored and transported in vials, particularly high-potency medications that need strict protection. Vials—both glass and, increasingly, polymeric vials represent one of the most frequently examined package systems in the field of helium leak detection. The elastomeric closure and land seal of a vial, which are physically forced together by a folded aluminium seal, form the main sealing interface of a conventional vial system.

Package integrity testing of vials using SIMS 1915+

The Seal Integrity Monitoring System (SIMS) 1915+, a helium-based leak detection system, is a most effective option. Using helium as the tracer gas, packages can be quantitatively assessed to levels significantly higher than the vacuum bubble and dye penetration test procedures. By enabling direct comparison across various packing materials and forms, production line settings, and stable storage conditions, this quantitative approach enables the whole lifespan. SIMS 1915+ can be used for manufacturing line setup, tooling qualification, package design, and continuous product quality monitoring.

Every SIMS 1915+ helium leak testing equipment is tailored to the client's requirements. The medical device and pharmaceutical sectors are the target market for the Seal Integrity Monitoring equipment (SIMS) Model 1915+ helium-based leak testing equipment. Its integrated system and detector enable quantitative examination of package systems at ambient temperature with sensitivity levels as low as 1 x 10 -10 mbar L/s. The simplest part is the Helium Leak Detector Module (HLDM), which is contained in a Console Frame Assembly with an optional Dual Test Port Manifold and a stainless steel worktable. Convenient features of the standalone consoles include an articulating arm system and a locking wheel for connecting the computer and peripherals.

Advantages of using SIMS 1915+

• Cryogenic Testing: Accurate leak detection down to -150°C.
• Enhanced Integrity: Identifies leaks not visible at room temperature.
• Improved Quality & Safety: Ensures product integrity at storage temperatures.
• Versatility: Customizable to meet specific needs.
• High Sensitivity: Detects even the smallest leaks./li>

SIMS 1915+ helium leak detection system emerges as the preferred choice for assessing the package integrity of vials, particularly in the context of the growing cell and gene therapy market. Its ability to perform sensitive leak detection at cryogenic temperatures, coupled with its versatility and data integrity features, makes it an invaluable tool for ensuring the quality, safety, and efficacy of these critical therapies.