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23
Apr 2025

How Helium Leak Detection Outperforms Dye Ingress in Ensuring Package Integrity

How-Helium-Leak-Detection-Outperforms-Dye-Ingress-in-Ensuring-Package-Integrity

In the pharmaceutical and medical device industries, ensuring the integrity of product packaging is critical to maintaining sterility, efficacy, and patient safety. Container Closure Integrity Testing (CCIT) methods play a crucial role in detecting leaks that could compromise the product. Traditionally, dye ingress testing has been widely used to identify package leaks. However, advancements in testing methods have led to the adoption of more sensitive and reliable methods, such as helium leak detection.

Limitations of Dye Ingress Methods

Dye ingress testing has been a conventional method for assessing container closure integrity, but it presents several limitations that can impact the reliability of test results.

  • Lack of Sensitivity – Dye ingress testing relies on the visual detection of dye penetration through leaks. This method typically detects leaks in the range of 20–25 microns, which may not be sufficient for ensuring sterility, especially for aseptic packaging that requires leak detection at the sub-micron level.
  • Subjectivity in Results – The accuracy of dye ingress testing depends on the observer's ability to detect the presence of dye within the container. Human errors, variations in lighting conditions, and inconsistencies in interpretation can lead to false positives or false negatives.
  • Destructive Testing – Dye ingress testing is a destructive method, meaning the tested samples cannot be used for further evaluation or product release. This can lead to increased product wastage and higher testing costs.
  • Long Testing Time – The test requires samples to be immersed in dye for a specified duration, typically ranging from a few minutes to several hours, to allow dye penetration through leaks. This prolonged testing time reduces efficiency in quality control processes.
  • Inability to Detect Microscopic Leaks – Dye ingress testing may fail to detect micro-leaks that are smaller than the detectable range, especially under vacuum conditions. Such leaks can still allow microbial ingress, posing a significant risk to product sterility.

Given these challenges, there is a growing need for more advanced, reliable, and non-destructive methods for container closure integrity testing. Helium leak detection technology effectively addresses these limitations and provides superior leak detection capabilities.

Overcoming Limitations with Helium Leak Detection Technology

Helium leak detection is a highly reliable method for assessing the integrity of complex pharmaceutical and parenteral products. This technique works by introducing helium gas into a sealed system and detecting any leaks based on the gas’s escape. By measuring helium concentrations, even the smallest leaks can be identified with precision.

This advanced testing method is widely used for evaluating the integrity of pre-filled syringes, cold form blister packs, foil pouches, and various other pharmaceutical packaging formats. It is particularly effective in ensuring a secure seal between primary container closure system components, making it a trusted solution for maintaining product safety and quality in the pharmaceutical industry.

Why is Helium Used as a Tracer Gas?

Helium is widely preferred as a tracer gas for leak detection due to its unique properties, which make it ideal for highly sensitive and precise testing. Here’s why:

  • Non-toxic, non-condensable, and non-flammable – Helium is completely safe for use in pharmaceutical applications.
  • Chemically inert – Helium does not react with the packaging materials, ensuring that test results are accurate and uncontaminated.
  • Extremely small atomic size – Helium molecules can easily pass through even the tiniest leak pathways, making it highly effective in detecting micro-leaks.
  • Cost-effective and readily available – Compared to other tracer gases, helium is more economical and widely accessible.
  • Low natural concentration in the atmosphere – With a presence of just a few parts per million (ppm) in the air, helium provides highly reliable and precise leak detection results.

Benefits of Helium Leak Detection Technology

  • Regulatory Compliance – Helium leak detection meets FDA and USP <1207> standards, ensuring product sterility with reliable, quantitative methods.
  • Improved Product Safety – Detects even small leaks, ensuring sterility and minimizing contamination risks.
  • Cost-Effectiveness – Non-destructive and efficient, leading to long-term savings by reducing product loss and rework.
  • Versatile Application – Suitable for various packaging types, including vials, ampoules, and blister packs.
  • Enhanced Manufacturing Efficiency – Quick, reliable results streamline production, reducing downtime and bottlenecks.

While dye ingress testing has been a traditional method for container closure integrity testing, its limitations in sensitivity, subjectivity, and efficiency make it less suitable for modern pharmaceutical and medical packaging requirements. Helium leak detection technology provides a superior alternative by offering highly sensitive, non-destructive, and quantitative leak detection. As industry standards continue to evolve, helium leak detection is set to become the preferred method for ensuring package integrity and patient safety.

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helium leak testing, helium leak detection, pharmaceutical packaging, helium leak detection solutions, ccit
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27
Jan 2021

How can Helium Leak Detection Technology Ensure Pharmaceutical Package Integrity?

How-can-Helium-Leak-Detection-Technology-Ensure-Pharmaceutical-Package-Integrity

Over the last two decades, pharmaceutical industry has seen tremendous growth in the form of technological advancements and drug delivery system innovations. However, such innovations have increased quality assurance challenges for drug manufacturers. For this reason, drug product manufacturers give at most importance to their quality control procedure as well as package integrity tests.

Packaging plays a vital role in preserving product quality and maintaining a sterile barrier against external damaging force. Even a minute breach in the package can cause moisture, reactive gases, or other harmful substances to enter the product- thus compromising its healing properties. Moreover, a contaminated drug product can cause serious health issues to the user, making it more of a threat than treatment. Given the sensitive nature of pharmaceutical products, ensuring Container Closure Integrity holds high relevance.

Container Closure Integrity testing (CCIT) is a leak detection technique for evaluating the ability of container closure systems in maintaining sterile barrier against external contaminations. Such tests can be broadly classified into Probabilistic and Deterministic test methods. Although Probabilistic test methods like Bubble Tests and Dye Ingress were initially popular, with more technical advances, better, non-destructive methods are now the go-to solutions to insure container integrity. Manufacturers are encouraged to switch to more reliable Deterministic test methods that provide guaranteed quantitative results with precision. In this blog we will be discussing in detail Helium Leak Detection Technology.

What is Helium Leak Detection Technology?

Helium Leak Detection Technology is a Container Closure Integrity test method that is used to find leaks in different types of enclosed or sealed systems. The technique uses helium as a tracer gas and its concentration is measured as it escapes through the leaks. Under this method, the package is helium filled and subjected to vacuum. The amount of helium escaping the package is quantitatively measured and stated as a leak rate. Helium is an ideal choice for package leak testing and container closure integrity testing in particular during container closure development for pharmaceutical products, due its key qualities:

  • It is inert, non-toxic, non-condensable and non-flammable.
  • Being inert, it is safe to use as it will not react with other materials being tested.
  • The atom size of helium is really small therefore it can easily pass through leaks.
  • The instrument noise due to environmental helium is inherently low because of its limited presence in the atmosphere at less than 5ppm and thus gives incredibly accurate reports.
  • Helium is relatively inexpensive and is available in multiple cylinder sizes.

Seal Integrity Monitoring System

The Seal Integrity Monitoring System (SIMS) 1915+, is the ideal choice for your helium-based leak detection system for testing rigid containers including vials, syringes, and cartridges and blister cards. Using helium as the tracer gas, packages can be quantitatively tested to levels far exceeding the vacuum bubble and dye penetration test methods. This quantitative approach allows direct comparison across various packaging materials and forms, production line settings and stability storage conditions, supporting the entire lifecycle.

THE SIMS 1915+. features an oil-free detector and power system that is designed for the needs of the pharmaceutical and medical device industries. In addition, this system will enable you to quantitatively analyze package system at a sensitivity level as low as 1 x 10 -11 mbar-L/s and provides relevant data sets in place of a simple pass/fail criteria while enabling testing to be performed at room temperature.

Each SIMS 1915+ Helium Leak Testing instrument manufactured by Leak Detection Associates is custom built to client specific standards and package configurations.

Custom Built to Client Specification SIMS 1915+ Leak Detection System with Add -On Components

  • Helium Leak Detector Module (HLDM): Oil Free, Production version in Console Frame Assembly, with Stainless Steel working surface and Dual Test Port Manifold (allows concurrent use of VTFM & HSAM on HLDM unit).
  • Vacuum Test Fixture Model (VTFM) – custom designed for use in testing of vial container samples
  • Head Space Analyzer Module (HSAM) – Model VM-2 that includes three (3) Puncture Probes (two spares) for determination of Helium Concentration in the headspace of vial containers.
  • Integral Calibration Chamber (w/ Calibrant Gas Flow Meter/Controller) provided for HSAM Calibration and a Universal Holder to be used for various vial diameters.
  • Helium Filling Device specific for vial testing sample prep to enable vials to be filled with helium
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helium leak detection technology, helium leak testing, helium leak detector, helium leak detection, pharmaceutical package integrity, helium leak detection solutions
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Packaging Technologies & Inspection

PTI offers inspection systems for package leak testing, seal integrity and container closure integrity testing (CCIT). Our technologies exclude subjectivity from package testing, and use test methods that conform to ASTM standards. PTI's inspection technologies are deterministic test methods that produce quantitative test result data. We specialize in offering the entire solution including test method development and equipment validation.

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Packaging Technologies & Inspection

PTI offers inspection systems for package leak testing, seal integrity and container closure integrity testing (CCIT). Our technologies exclude subjectivity from package testing, and use test methods that conform to ASTM standards. PTI's inspection technologies are deterministic test methods that produce quantitative test result data. We specialize in offering the entire solution including test method development and equipment validation.

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Our technologies conform to ASTM and other regulatory standards.

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