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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.

Container Closure Integrity Testing (CCIT) is one of the most effective methods used by manufacturers to ensure that their products are sterile until the point of use. Testing the integrity of container closures determine if they can maintain a sterile barrier against potential contaminants that might impair the quality of the final pharmaceutical and biological products. There are several ways to perform tests on the integrity of container closures, each having advantages and limitations of its own. For instance, methods such as dye ingress and microbiological ingress damage the test samples. Therefore, manufacturers choose deterministic methods such as helium leak detection for package integrity testing.

Helium leak testing is the process of identifying leaks in some type of sealed or enclosed systems by utilizing helium as a "tracer" gas and monitoring the concentration of the gas as it leaves as a result of a leak. In this method, the package is helium-filled and placed under vacuum. A helium leak detector is used to monitor the volume of helium that is leaving the package quantitatively. The result is expressed as leak rate.

Helium Leak Detector

Helium leak detector, commonly referred to as a Mass Spectrometer Leak Detector (MSLD), is used to identify leaks that enter or leave a system or containment device and to measure its size. Helium, the tracer gas, is introduced into a test component that is attached to the leak detector. The system allows the helium that is leaking through the test portion to enter, and this partial pressure is monitored. The results are then displayed on a meter.

For a number of reasons, helium is the ideal tracer gas to locate leaks. It is non-toxic, inert, non-condensable, non-flammable, and just traces of it are often found in the atmosphere (5 ppm). Helium is a gas that quickly passes through leaks due to its tiny atomic size. The only non-inert molecule smaller than helium is hydrogen. It comes in several size cylinders and is also relatively inexpensive.

Explain Various Calibration Standards Offered by PTI's Helium Leak

PTI's Helium Leak offers complete sets of calibrated helium leak standards in addition to instruments and accessories to provide routine usage, daily performance verification or system suitability checks, and scheduled qualifications.

Internal Leak Standards:

An internal helium leak standard is included with every PTI SIMS 1915+ leak detection system. This apparatus is calibrated to discharge a certain amount of helium at a defined leak rate. It is utilized either on demand for a point-of-use auto calibration before analysis or automatically by the instrument on each day of usage.

External Leak Standards:

Every external helium leak standard developed by PTI's Helium Leak releases helium at a known leak rate, much as the internal leak standards. They attach to the test port, much like a sample fixture would be mounted to the system, rather than residing inside the instrument. The external nature of these leaks makes them perfect for routine PV or SS activities as well as qualification activities to assess the accuracy of the system. It is possible to perform an industry-standard, multi-point check across leak rate ranges of interest, since external leak standards are accessible in a variety of leak rates.

With every new instrument purchase, PTI's Helium Leak provides the following Internal and External Leak Standards (with certifications of calibration):

• External Helium Leak Standard E-6 3 x 10 -6.
• Internal Leak Standard - Set at E-7 1 x 10 -7.
• External Helium Leak Standard E-7 3 x 10 -7.
• External Helium Leak Standard E-8 3 x 10 -8.

A certificate of calibration that details the standards to which the leak was tested and the tolerance range for which that leak is certified should be attached to every calibrated helium leak. PTI's Helium Leak provides both external and internal leak standards with certificates of calibration.