Blogs

Testing a pre-filled syringe is critical when it comes to developing and releasing safe injectables to the market. Pre-Filled syringes are becoming increasingly popular due to their efficiency and simplicity. In addition, they provide a more dependable and safe option for patients as they contain the exact dose. Container closure integrity test techniques can be utilized to satisfy the regulatory, quality, and safety demands of sterile drug products. During development, qualification, and stability testing, the FDA encourages sterile pharmaceutical manufacturers to employ established and deterministic methodologies to confirm CCI.

Ensuring Pre-Filled Syringes Integrity using SIMS 1915+

Seal Integrity Monitoring System (SIMS) Model 1915+ is a helium-based leak testing system specially designed for a variety of pharmaceutical and medical device product package systems. A pre-filled syringe is one of its applications. Vials, cartridges, and blister cards are other applications. Packages may be quantitatively evaluated to levels much above the vacuum bubble and dye penetration test procedures using helium as the tracer gas. This quantitative method supports the full lifespan by allowing direct comparison across multiple packing materials and formats, production line settings, and stability storage conditions. SIMS 1915+ allows for quantitative analysis of packages with a sensitivity as low as 1 x 10-10 mbar/L/sec and will offer meaningful data sets instead of simple pass/fail criteria.

Seal Integrity Monitoring System (SIMS) model 1915+ helium-based leak testing system from PTI includes an oil-free pump, detector, and integrated power system built for the pharmaceutical and medical device industries. The most important component is the Helium Leak Detector Module (HLDM), built into a console frame assembly with a stainless steel working surface and an optional dual test port manifold. The freestanding units are equipped with a locking wheel and an articulating arm system for attaching the computer and peripherals, making them easy to operate and move. Each SIMS 1915+ helium leak testing device is manufactured to the specifications and package configurations of the individual customer.

SIMS 1915+ Options

• Low-Temperature Add-on Systems LT 80 and LT 150 for ultra-cold CCI testing utilizing helium leak detection methods.
• Vacuum test fixtures come in a variety of sizes to meet all package types and sizes.
• Helium leak testing for non-vacuum chamber applications with custom test fixtures.
• External helium leak standards in a variety of leak rate ranges.
• Helium Sniffer Probe - for determining leak sites on a site-by-site basis.
• Vacuum clamps, O-ring seals, chamber gaskets, and other components.

Pre-filled syringes benefit the manufacturer as well as the patient. They help in reducing medication mistakes since they have fewer steps and are easier to use than empty syringes. SIMS 1915+, developed by Leak Detection Associates, is an effective technique for testing leaks in pre-filled syringes. End-users may utilize the technology to ensure that manufacturing and packaging processes are efficient and productive while still satisfying safety requirements, international regulations, and market quality standards.