Blogs

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