SIMS 1915+ for Testing Leakage of Bottles

As a result of the vast range of applications in the medical field, bottles exist in a variety of sizes and forms. They usually include a screw top closure that is threaded onto the bottle mouth, but the sealing capabilities vary from elastomeric liners to?O-rings?to induction seals and rely on plastic-to-plastic contact and compression. The transport of sterile medicinal products and the necessity to evaluate them are becoming more common as the industry continues to move toward outsourcing or even insourcing through a network of suppliers or locations. These containers are notoriously difficult to test. However, helium leak detection can be used to qualify them before use or as a proof of concept.?

Helium leak detection?is one of the highly sensitive container closure integrity testing methods offered by LDA to detect the presence and location of leaks in an enclosed or sealed system. The quantity of helium that escapes from the package is quantitatively measured and expressed as a leak rate.?

Why Choose SIMS 1915+ for Bottle Integrity Testing??

Helium leak detection using Seal Integrity Monitoring System (SIMS) 1915+ is an optimal solution for testing the integrity of pharmaceutical bottles. Packages may be quantitatively tested using helium as the tracer gas, which offers better levels of accuracy compared to traditional vacuum bubble and dye penetration test procedures. This method enables for a comparison of various packaging materials and shapes, as well as production line settings and stability storage conditions, throughout the lifetime. LDA SIMS 1915+ is a proven and effective method for a variety of package types, including cold form blister cards, foil pouches, parenteral vials, syringes, bottles, pre-filled syringes, and unique medical devices, and can be used for package design, tooling qualification, production line setup, and on-going product quality monitoring.??

Technology Overview?

The Seal Integrity Monitoring System (SIMS) Model 1915+ is a helium-based leak testing device with an oil-free pump, detector, and integrated power system built specifically for the pharmaceutical and medical device industries. It allows for quantitative analysis of packaging systems at room temperature with sensitivity levels as low as 1 x 10 -10 mbar L/s. Instead of simple pass/fail criteria, SIMS 1915+ offers relevant data sets. The Helium Leak Detector Module (HLDM), the most important component, is built within a Console Frame Assembly with a stainless-steel working surface and an optional Dual Test Port Manifold. The freestanding?consoles have a locking wheel and articulating arm system for attaching the computer and peripherals, making them convenient?to operate and transport.?

Standard components of SIMS 1915+?

• Helium Leak Detector Module?
• External Calibrated Helium Leak Standard?
• Headspace Analyzer Module (HSAM)?
• Dual Test Port Manifold?
• Vacuum Test Fixture Model (VTFM)?

LDA is one of the world’s?leading?manufacturers of?helium leak testing?for package systems including pharmaceuticals as well as medical devices. We also provide entire sets of calibrated helium leak standards to support everyday usage, daily performance verification or system suitability?checks, and scheduled qualifications, in addition to instruments and accessories. We have developed technologies to evaluate package class, assisting clients in optimizing torque assembly, as well as sealing design, selection, and application parameters.?Custom fixtures for helium leak detection, like most other applications, provide for a variety of test modes depending on the client's research goals and logistical constraints.?