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Package integrity is actually the capacity of a package to prevent product loss, obstruct the entry of harmful gases or other substances, and block microorganism ingress. This ensures that the product fulfills all relevant safety and quality criteria. Sterility of products is critical to reduce and prevent patient infection when using a product. Therefore, testing for package integrity is essential for regulatory clearance of sterile pharmaceutical products, medical products, and medical devices. Leak testing and seal quality inspection of the packing system are both included in the pharmaceutical package integrity testing process. Foil pouches, vials, prefilled syringes and blister packs are some of the pharmaceutical package formats.

Overview of Foil Pouches

Foil pouches are one of the most common types of flexible packaging used in the pharmaceutical and medical device industries. Pouches provide several packing advantages that cannot be found in other packaging options. In most cases, foil pouches are used as a part of a multi-layered packaging system. Different package integrity test methods can be used for testing foil pouches. Helium leak detection is one such approach.

Evaluating Integrity of Foil Pouches Using SIMS 1915+

Seal Integrity Monitoring System (SIMS) 1915+ is a helium-based leak detection method that has been effectively used in a wide range of pharmaceutical and medical device product packaging systems. Packages may be quantitatively evaluated to levels that exceed those achieved using the vacuum bubble and dye penetration test techniques using helium as the tracer gas. This method may be used with a variety of pharmaceutical and parenteral goods, including vials, syringes, cartridges, and blister cards.

SIMS 1915+ enables testing to be carried out at room temperature as well as cryo storage conditions, providing quantitative analysis of packages at a sensitivity level as low as 1 x 10-10 mbar/L/sec. It gives relevant data sets in place of a simple pass/fail criteria. Each SIMS 1915+ Helium Leak Testing instrument is custom built according to the specifications and package configuration specified by the client. We specialize in creating and developing unique test fixtures that are specifically tailored to the component being tested, ensuring precision and accuracy to fulfill your research objectives, package configurations, and quality monitoring requirements.

SIMS 1915+ Options

• Low-Temperature Add-on Systems LT 80, LT 85 and LT 150 for ultra-cold CCI testing utilizing helium leak detection methods.
• 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.
• Vacuum test fixtures come in a variety of sizes to meet all package types and sizes.

High-barrier pouches are employed in the pharmaceutical and medical industries to transport and store products safely. Foil pouch packaging provides the optimal conditions for storage and transportation for everything from medical samples to pharmaceutical prescriptions. Testing pouches is critical for ensuring the package integrity.

Pharmaceutical product manufacturers use packaging materials that offer optimal protection and safety allowing to extend product shelf life. Cold form blister packs are manufactured by sandwiching aluminum foil between Polyvinyl Chloride and nylon films using dry bond lamination technology. They provide complete barrier to moisture, light, oxygen, and other gasses. Its ability to offer complete product integrity and protection has made it a favourable choice for pharmaceutical industry.

Oral and solid dose manufacturers aim at producing high quality and cost effective alternatives while manufacturing innovative, convenient packs for end-users. Due to its high efficiency rate and the ability to provide extended shelf life, the cold form blister packs are being extensively used in healthcare packaging. Many pharmaceutical products including tablets, capsules, drugs, vials, ampoules, syringes or liquid products are often packaged using cold form blister packaging. Infact, growing requirements of pharmaceutical companies worldwide had led to the production of cold form foils such as push-through, peelable, peel-push, tear-open and child-resistant. However, the growing demand for cold form blister packs have accelerated concerns about integrity of blister packaging. Although the amount of environmental contaminants that can enter a package vary based on leak size, with blister packages, even minute leaks can become a problem. Depending on the pressure, temperature and duration of exposure, contaminants can easily find path in the seal or any other microscopic crack. Therefore, it’s important for manufacturers to conduct appropriate container closure integrity tests that ensure quantitative and reliable leak testing solution.

Helium leak testing is one of the most sensitive container closure integrity test methods, used primarily for evaluating integrity of critical parenteral or injectable products. In simple terms, it can be understood as the act of finding leaks in some type of enclosed or sealed system using helium as a “tracer” gas, and measuring its concentration as it escapes due to leakage. Apart from being an ideal solution for ensuring container closure integrity, the technology is also applicable in package design, monitoring product quality, failure analysis and line set up and validation.

Helium is considered an ideal choice of tracer gas because of multiple reasons. Helium is non-toxic, non flammable, non-condensable and its presence in the atmosphere is not more than 5ppm. The small atomic size of helium makes it easier to pass through leaks. Since helium does not react with other materials, it is relatively safe to use. Additionally, compared to other tracer gases helium is less expensive and is available in multiple cylinder sizes. Under this method, a helium leak detector otherwise known as Mass Spectrometer Leak Detector (MSLD) is used to identify and calculate size of the leak.The test part is first connected to a leak detector and then the tracer gas, helium is introduced. In the presence of a leak, helium escapes from the test parts and this partial pressure?is?measured and results are displayed on the meter

Applications of Helium Leak testing

• Ensuring Container Closure Integrity
• Using sniffer probe to identify sources of the leak
• Selecting closure formulation and configuration
• Seal integrity monitoring during stability studies
• Using proprietary software to predict shelf- life seal integrity