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As the demand for biologic drugs continues to grow, so does the need for robust container closure integrity solutions. These high-value, sensitive products require the highest assurance of package integrity to ensure patient safety and therapeutic efficacy. Even microscopic leaks in a container closure system can compromise sterility, leading to product degradation or contamination.

PTI’s helium leak detection method offers a highly sensitive and reliable solution for detecting leaks in pharmaceutical packaging, especially for biologic drug products. This advanced approach plays a crucial role in enhancing pharmaceutical leak detection standards and ensuring that every dose delivered to the patient is safe and effective.

Limitations of Traditional Leak Testing Methods

Conventional leak testing technologies, such as dye ingress or visual inspection have long been used for integrity testing. While these methods are accessible and straightforward, they come with critical limitations, particularly when testing complex or high-risk drug products.

• Limited Sensitivity: Traditional methods often lack the sensitivity needed to detect tiny leaks that could still allow microbial ingress.
• Subjectivity: Visual-based tests, such as dye ingress, can lead to inconsistent results due to human interpretation.
• Incompatibility with Certain Formats: Some test methods may not be suitable for testing modern container systems such as pre-filled syringes or flexible packaging.
• Slower Throughput: Testing time and lack of repeatability can hinder efficiency, especially in high-volume manufacturing settings.

Helium Leak Detection for Biologic Drugs

PTI's helium leak testing technology addresses the shortcomings of traditional methods by offering a more precise and science-driven approach to pharmaceutical leak detection.

Helium, an inert gas with extremely small molecules, is used as a tracer to detect the smallest of leaks with unmatched accuracy. In PTI’s systems, the test sample is filled with helium and placed in a vacuum chamber. Any helium escaping through leaks is quantitatively measured using a mass spectrometer.

Key Benefits of PTI’s Helium Leak Testing Approach:

• High Sensitivity: Capable of detecting leak rates as low as 1 x 10?¹° mbar·L/s, far exceeding the detection limits of traditional methods.
• Quantitative Results: Provides measurable and reproducible data rather than subjective pass/fail outcomes.
• Versatility: Suitable for a wide range of container types, including vials, syringes, and flexible formats used for biologic products.
• Regulatory Alignment: Aligns with current FDA and USP expectations for deterministic leak testing approaches.

The rise of biologic drugs demands a new standard in container closure integrity testing. Relying on traditional leak detection methods may no longer be sufficient to ensure product safety and regulatory compliance. PTI’s helium leak testing offers a highly sensitive and accurate solution tailored to the unique requirements of biologics, reinforcing confidence in product quality and patient safety.

With a proven track record in pharmaceutical leak detection, PTI continues to lead the way in container integrity assurance, bringing science, precision, and reliability to the forefront of pharmaceutical manufacturing.