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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.

In an industry where the stakes are exceptionally high, the integrity of packaging components is a top priority for pharmaceutical manufacturers. A defect in a vial, syringe, or ampoule can have serious repercussions, including contamination and reduced effectiveness of life-saving drugs. To ensure that packaging remains airtight and secure, helium leak testing has become a widely embraced method for assessing the integrity of various pharmaceutical components.

This testing approach leverages the unique properties of helium, a small, inert gas, to identify even the tiniest leaks that could jeopardize product quality. The sensitivity of helium leak testing not only provides assurance of sterility but also supports compliance with stringent regulatory standards. As a result, manufacturers can maintain high quality and safety standards throughout their production processes, ultimately safeguarding patient health and well-being.

Reasons to Choose Helium for Leak Testing in Pharmaceutical Industry

Helium leak testing stands out as one of the most effective methods for validating packaging integrity. Here are some reasons why helium is the go-to choice for leak testing in the pharmaceutical industry:

• Exceptional Leak Detection Sensitivity: Helium’s ability to detect incredibly small leaks makes it ideal for pharmaceutical applications where precision is paramount. The sensitivity of helium leak testing allows for the identification of micro-leaks down to 10^-10 mbar L/s, ensuring packaging maintains its sterility.
• Safe for Sensitive Drug Products: Helium is an inert, non-reactive gas, meaning it won’t compromise sensitive pharmaceutical products during testing. This is particularly important for high-value drugs, biologicals, and vaccines that require sterile packaging and must remain unaffected by external substances.
• Fast and Efficient Process: The speed of helium leak detection offers a significant advantage in production settings. Testing cycles are rapid, allowing manufacturers to maintain high throughput without sacrificing accuracy or quality control—critical in an industry where meeting tight production schedules is essential.
• Reliable Detection in Diverse Packaging Types: From glass vials and ampoules to flexible pouches and pre-filled syringes, helium leak testing can be applied across a wide range of pharmaceutical packaging formats. This versatility ensures a robust testing solution, regardless of packaging material or design.
• Testing products at ultra-cold storage temperatures: Complex drug and biologic formulations have resulted in a continuous drive toward deeper cold storage in an effort to maintain product quality attributes. In an effort to maintain product quality attributes of increasingly complex and delicate formulations, life science companies continue to drive toward deeper cold storage. These products, often cell or gene therapies, or proteinaceous in nature, often require storage at temperatures below -20°C, and are involved in storage and distribution environments at times down to -160 C. While the products demanding such intense cold storage may be complex, oftentimes, the package systems in which the products are placed are rather traditional in nature, such as a screw or crimp top vial. However, at these temperatures, many of the materials used in these package systems and responsible for maintaining package integrity are not typically assessed at these temperatures.
• Compliance with Regulatory Guidelines: The pharmaceutical industry must adhere to strict regulatory standards, such as those set by the FDA and USP for container closure integrity (CCI). Helium leak testing is widely recognized and accepted as a validated method for achieving compliance, making it a reliable choice for manufacturers aiming to meet industry regulations.
• Ability to Detect Hard-to-Find Leaks: Due to the small atomic size of helium, the gas can penetrate even the tiniest leaks that might go undetected by other testing methods. This makes helium an invaluable tool for ensuring the integrity of sterile products and safeguarding against contamination risks.
• Trusted Across High-Risk Applications: Helium leak detection is trusted by pharmaceutical companies for products that demand the highest level of quality assurance, such as injectables, vaccines, biologics, and other sterile drugs. This trust is built on helium's proven reliability and consistency in leak detection.

By using helium for leak testing, pharmaceutical companies ensure their products are safe, sterile, and fully compliant with industry standards—ultimately protecting both their brand reputation and patient health.

As regulatory standards become increasingly stringent, the reliance on robust testing methods like helium leak detection will only intensify. This method not only facilitates compliance but also enhances overall product quality and safety, reinforcing the commitment to patient well-being. In a landscape where trust is paramount, helium leak testing serves as a cornerstone for delivering reliable, safe, and effective pharmaceutical products to the market.