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A combination product may be defined as 'a product composed of any combination of a drug and a device; a biological product and a device; a drug and a biological product; or a drug, device, and a biological product.' In simple words, a combination product is a combination of at least two product categories such as drug, device and/or biological products. Best-known examples of combination products include prefilled syringes, pen injectors, auto-injectors, inhalers, transdermal pumps and patches, and kits containing drug administration devices or components. Often termed as high-risk medical devices, combination products host various challenges for manufacturers, demanding in-depth testing and evaluation. Read on to know how manufacturers can test the integrity of combination product packages using helium leak detection.

Package Integrity Testing using Helium Leak Testing

Helium leak detection is a highly effective technique for evaluating the integrity of a wide range of complex pharmaceutical and parenteral products. Helium leak detection can be understood as the process of identifying leaks in any closed or sealed system with the help of helium gas and measuring its concentration as it escapes due to leakage. Common applications of helium leak testing include pre-filled syringes, cold form blister packs, foil pouches and many other package formats. This technology can precisely determine integrity between specific primary container closure system components, making it an ideal choice for testing the integrity of pharmaceutical products.

Why is Helium used as a Tracer Gas?

• Helium is used as a tracer gas because of certain unique qualities that make it ideal for leak testing.
• Non-toxic, non-condensable, non-flammable.
• Helium gas is inert, which means it does not interact with the components being tested.
• Since the atomic size of helium is really small, it can easily breach through pathways reliably and easily.
• Compared to other tracer gases, helium is less expensive and readily available.
• Its presence in the atmosphere is not more than ppm.

How Does Helium Leak Detection Technology Work?

The test procedure begins by filling the package with helium, which is then subject to vacuum. Then, the amount of helium escaping from the package is quantitatively measured using a helium leak detector. This is then stated as the leak rate. Apart from leak testing, helium leak detection technology is also suitable for package design, failure analysis, tooling qualification, packaging line setup and validation, and product quality monitoring. Helium leak detection per ASTM F2391, is a well-established method recognized and widely used in the pharma industry.

Applications of Helium Leak Testing

• Ensuring Container Closure Integrity
• Selecting closure formulation and configuration
• Seal integrity monitoring during stability studies
• Extremely valuable in early-stage pharmaceutical product package system development
• Continuous product quality monitoring