25
Nov 2021

Applications of Helium Leak Testing Across Different Industries

Applications-of-Helium-Leak-Testing-Across-Different-Industries

Helium leak detection is referred to as the process of detecting leaks in various packaged or sealed systems by utilizing helium as tracer gas and measuring its concentration as it escapes due to leakage. A package system such as a vial that consists of a container and an elastomeric closure, is a good example. The vial is filled with helium and vacuum is applied. The quantity of helium that escapes from the package is quantified and expressed as a leak rate. A pre-filled syringe, a foil pouch, or a cold form blister card are some more examples of package systems. Each of these package types is designed to keep the pharmaceutical product enclosed while keeping out potentially harmful environmental pollutants like dust, bacteria, or even gases. The helium leak testing method can evaluate each of them.

Helium leak testing is widely utilized in the pharmaceutical and medical device industries because of its relevance in guaranteeing package integrity and quality. Now, let us see how these sectors benefit by using this technique.

1. Pharmaceutical Industry: The pharmaceutical industry has experienced enormous progress in terms of technological developments and drug delivery system innovations over the last two decades. However, such developments have created new quality assurance challenges for drug manufacturers. As a result, pharmaceutical manufacturers give major priority to both quality control procedures and pharmaceutical package leak detection.

CCI Testing is a leak detection technique that evaluates the capacity of container closure systems to maintain a sterile barrier against external contamination. These tests may be divided into two types: probabilistic test and deterministic test. Although probabilistic test methods like Bubble Tests and Dye Ingress were initially common, due to technological advancements, non-destructive approaches are now the preferred way for ensuring container integrity. Hence, pharmaceutical manufacturers are encouraged to switch to more dependable deterministic test methods, such as helium leak detection, which offer quantitative findings that are assured and precise. By using helium leak detection early in the development process, companies can improve the quality of their drug delivery system. This not only saves money and time, but also improves safety.

2. Medical Devices Industry: In the medical device industry, package integrity testing is important since product failure presents considerable risks to patients and healthcare professionals, as well as liability for manufacturers. Barriers between fluids or gases are frequently used in medical equipment. These barriers must be functional in order to safeguard the patient and, in many cases, the medical equipment. Some devices operate as channels for delivering or extracting fluids to or from specific parts of the body. If a leak develops along the channel, fluids might be supplied to the incorrect place by mistake or wrong fluids could be extracted, resulting in hazardous effects. As a result, medical device industries use various CCI test methods including helium leak testing to ensure package integrity.

Helium leak testing is the most common tracer gas method in the medical device industry. Helium or a helium-air combination is used to pressurize the test component within a vacuum chamber. The chamber enclosing the part is next evacuated, generating a vacuum that allows the helium to enter the chamber through any leaks. A mass spectrometer designed to detect helium takes a sample of the vacuum chamber and ionizes any helium detected. Even a small amount of helium is easily detected in this method.

The major reason for choosing the tracer gas technique by manufacturers is the necessity for high leak-detection sensitivity in particular medical device equipment applications. Product testing is a crucial part of the device production process in the medical industry. As quality requirements have gotten increasingly strict, leak testing has become increasingly important for medical equipment as well as pharmaceutical manufacturers.

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helium leak detection, helium test, leak detection, helium detector, helium leak testing, pharmaceutical package leak detection
490
13
May 2019

Leak Detection Associates Announces Release of New Heliumleak.com Website

Leak Detection Associates Announces Release of New Heliumleak.com Website

EGG HARBOR TOWNSHIP, N.J. (PRWEB) MAY 13, 2019

Leak Detection Associates (LDA), the world’s premier manufacturer of custom built, helium-based leak testing instruments for the Pharmaceutical, Biotechnology, Medical Device and Food Packaging Industries’ is excited to announce the go-live of a completely new Heliumleak.com company website. The redesigned website aims to improve LDA’s ability to communicate directly with the marketplace; serving as a destination to learn LDA’s product and service offerings, news and events, but also as a knowledge center for those interested in helium leak detection applications and CCIT in general.

“For those first exploring any topic, whether it be CCI or unrelated, the first step will be to seek information online.” commented Brian Mulhall, CEO of Leak Detection Associates. “In redesigning LDA’s Heliumleak.com, this was kept in mind. In addition to more detailed descriptions of products, services, and applications of helium to specific package systems, the Resource Center will serve as an industry-leading destination for up-to-date information on all aspects of CCI. Blogs and Whitepapers will routinely be released discussing unique applications of helium leak detection and CCI in general, and an entire section is dedicated to topics such as FDA, EMA, USP, and ASTM guidance.”

The Products section now includes more detail about LDA’s flagship detector, the SIMS 1284+, but also will serve to highlight current and future complimentary offerings, such as LDA’s proprietary vial filling kit and Headspace Analyzing Module (HSAM), which allow for testing of pre-sealed vials. The redesigned services section now clearly highlights LDA’s 20+ years of experience in qualification, calibration, but also consultation, feasibility, and method development services. Uniquely, an entirely new section was added for Applications, which discusses helium-leak approaches for specific package systems, such as vials, pre-filled syringes, combination products, blisters, and more.

READ THE FULL PRWEB PRESS RELEASE

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helium-based leak testing instruments, helium leak detection, leak detection
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