Blogs

In the pharmaceutical industry, bottles are used for a wide range of products, like liquids, tablets, and capsules. Depending on the contents within, a bottle may be made of glass or plastic. To ensure the seal integrity of pharmaceutical bottles before shipment, leak testing is necessary. Weak or partial seals can occur during the final sealing stage, hence, a non-destructive leak testing method is required to minimize recalls and reduce costs.

We at CCIT offer a range of non-destructive and deterministic leak testing systems, specially designed to rapidly test for leaks in a wide variety of pharmaceutical and medical device packaging.

SIMS 1915+ for Bottle Leak Testing

PTI Seal Integrity Monitoring System (SIMS) Model 1915+ is a helium based leak detection system specially designed for a variety of pharmaceutical packaging systems, including pharma bottles. Pre-filled syringes, vials, cartridges, combination products and blister cards are other applications of SIMS 1915+. Using helium as a tracer gas, the packages can be quantitatively evaluated to levels much above the vacuum bubble and dye penetration test procedures. This quantitative method supports the entire 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 level as low as 1 x 10-10 mbar/L/sec.

Seal Integrity Monitoring System (SIMS) Model 1915+ helium-based leak testing system is 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 mounting the computer and accessories, 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.

Applications of SIMS 1915+

• Vials
• Pre-filled syringes
• Combination products
• Bottles
• Foil pouches
• Blister packs

SIMS 1915+ Options

• Low-Temperature Add-on Systems LT80 and LT150 for ultra-cold CCI testing utilizing helium leak detection methods.
• Various sizes of Vacuum Test Fixtures to accommodate 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.

The quality of packaging is essential to ensuring drug stability, whether you are a pharmaceutical packaging operator, pharmaceutical manufacturer of blister packs, pharma bottles, sachets, pouches, or medical devices. Any defects can reduce the shelf life and effectiveness of the contents. In order to guarantee patient safety, highly sensitive deterministic leak testing methods are preferred over probabilistic methods.