Accelerating Leak Detection with the Bombing Methode

The Role of the Bombing Method in Headspace Analysis with NEO HSX

The Bombing Method leverages controlled environmental conditioning to accelerate the detection of gas concentration changes in a test sample. Using a specialized bombing station, the method allows for the introduction of compressed air, carbon dioxide, or other gases under defined pressure cycles. This creates a controlled exchange of gases within the sample, even when the headspace is unmodified, significantly reducing the time required to detect leaks.

With its ability to condition test samples quickly and deterministically, the Bombing Method unlocks the full potential of Headspace Analysis (HSA) for pharmaceutical packaging materials such as vials, syringes, and ampoules.

The Challenge of Leak Detection in Liquid-Filled or lyophilized Containers

Detecting leaks in liquid-filled pharmaceutical containers is particularly difficult when the packaging is sealed without a vacuum. In such cases, the oxygen or gas content within the headspace changes at a very slow rate, making traditional HSA methods impractical due to extended waiting times. This challenge applies to many common packaging types, including parenteral containers filled with liquid, freeze-dried, or powdered products.

The Bombing Method resolves this challenge by artificially creating a measurable change in the gas composition, enabling the precise and non-destructive detection of leaks.

How the Bombing Method Works

The Bombing Method enhances the effectiveness of HSA by manipulating the gas composition in the test sample through cycles of overpressure and negative pressure. This process involves:

Environmental Conditioning: The headspace environment of the test sample is altered using controlled changes in ambient conditions, such as pressure or gas concentration.
Accelerated Gas Exchange: In the event of a leak, the gas composition within the sample changes quickly, allowing for rapid detection.
HSA Detection: The altered gas composition is measured using the NEO HSX Headspace Analyzer, which can identify trace gases like oxygen (O₂) and carbon dioxide (CO₂) with high sensitivity.

This deterministic testing approach complies with USP <1207> standards and provides a reliable alternative to traditional destructive methods like the blue bath test.

Advantages of the Bombing Method

Faster Leak Detection: Reduces waiting times for gas concentration changes, making HSA viable for real-time leak testing.
Larger quantities: A large number of containers can be placed together in the chamber, resulting in time efficiency.
Versatile Applications: Supports various packaging types, including those without vacuum in the headspace, and can handle products with alcohol, liquid, or oil-based compositions.
High Sensitivity: Detects leak rates as low as 6.6 × 10⁻⁶ mbar × l/s, equivalent to a leak size of 0.2 µm.
Deterministic Testing: Provides a robust, reproducible, and preferred method in compliance with USP <1207>.
Scalable for Production: Operates at high throughput, with capabilities of up to 600 tests per minute.

NEO HSX with a Bombing Station: A Complete Solution for Lab Testing

The Bombing Method integrates seamlessly with the NEO HSX system for efficient and precise headspace analysis. Through programmable pressure profiles, intuitive controls, and a robust design, the bombing station ensures reliable performance in both laboratory and production environments. Key features include:

Programmable Pressure Profiles: Up to 12 pressure changes for flexible testing cycles.
Integrated Venting and Extraction: For rapid and controlled gas exchange.
Compact and Mobile Design: Suitable for lab and production use, with robust stainless steel construction.
Auxiliary Device Compatibility: Includes flanges for heating, cooling, or additional monitoring equipment.

Is the Bombing Method the right solution for your project?

With over a decade of experience in developing bombing processes, we offer unmatched expertise and proven reliability in leak testing for pharmaceutical packaging. To ensure optimal performance, our team works closely with our customers to analyze production processes, assess packaging materials, and develop a customized bombing and testing strategy. Our in-house laboratory is equipped with an automated, high-precision bombing chamber for testing cycle development and method validation. Combined with our broad portfolio of HSA devices, this approach guarantees a tailored solution for every application.

Accelerating Leak Detection with Bombing