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Biologic medicines, including vaccines and cell-based therapies, are highly sensitive and expensive to produce. To ensure they remain safe and effective, these products must be stored and delivered in perfectly sealed packaging. Even a tiny, invisible leak can allow air, moisture, or microbes to enter the container, potentially damaging the medicine or making it unsafe for patients.  Therefore, pharma manufacturers have turned to helium leak testing—one of the most accurate ways of verifying container-closure integrity (CCI).

What Is Helium Leak Testing? 

Helium leak testing is a highly sensitive technique used to detect tiny leaks in sealed packages. It involves introducing helium gas into the container or surrounding it, then measuring how much helium escapes.

Why helium? 

• Tiny molecule size: Able to pass through micro-cracks and seal defects 
• Completely inert: Safe, non-reactive, and won’t alter the medication
• Low concentration in air: Enables extremely accurate detection

Using mass spectrometry, helium leak testers can identify leaks as small as 10?¹¹ mbar·L/s, far below what visual inspection or dye tests can detect. 

How Helium Delivers Integrity Assurance at Every Stage

Helium testing plays a critical role from early development through commercial supply:

• R&D + Package Design Understand leak behaviour and component fit
• Process Engineering Optimize sealing parameters before scale-up
• Validation Establish scientifically justified leak limits (USP <1207>)
• Lifecycle Control Monitor risks over time, including supplier or material changes
• Cold-Chain & Cryogenic Systems Detect closure failures at low-temperature material transitions

Protecting High-Value Biologics from Hidden Risks

Biologics are highly vulnerable to environmental exposure. Even tiny leaks can lead to:

Key advantages:

• Potency loss from oxygen exposure
• Moisture-driven degradation
• Sterility failure from microbial ingress
• Seal deformation during cryogenic storage

Helium testing can identify failure mechanisms that other testing methods simply cannot see — before those failures reach patients.

Helium leak testing plays a huge role in keeping high-value biologic packaging secure. It catches even the tiniest leaks. This isn’t just about keeping products from getting contaminated or breaking down. It’s also about meeting strict regulations and making sure patients stay safe.

For manufacturers, using helium leak testing isn’t just another box to tick. It’s a essential safety net that guarantees every dose gets to patients exactly as it should—safe, effective, and reliable. When it comes to biologics, everything’s complicated, and there’s no room for error. Helium leak testing gives manufacturers the confidence they need to trust their packaging.