18
Jan 2022

How Helium Mass Spectrometry Ensures Quality and Integrity of Bottles?

How-Helium-Mass-Spectrometry-Ensures-Quality-and-Integrity-of-Bottles

Maintaining the integrity of products from the time it is manufactured to the time it is distributed to the patient is a great challenge. Liquid pharmaceuticals, capsules, and formed tablets are typically packaged in bottles. To assure the quality of these items, leak testing is carried out on each bottle to ensure that it does not leak. Testing pharmaceutical bottles or pharmaceutical package leak detection before filling is a critical step in ensuring the integrity of the container.

Helium leak testing is one of the most sensitive Container Closure Integrity (CCI) testing techniques that can be applied to pharmaceutical bottles for testing quality. Helium is used as a tracer gas, and the quantity of helium leaving through the package is measured and stated as leak rate. Since it is non-toxic, non-flammable, and non-condensable, helium is an ideal tracer gas for finding leaks. Its atmospheric presence is restricted to 5ppm. Due to its tiny atomic size, helium can easily pass-through leaks. Helium is also safe to use since it does not react with the materials of the components under test.

Significance of Helium Mass Spectrometry in Leak Testing Pharmaceutical Bottles

Helium mass spectrometry is a leak detection standard for pharmaceutical containers including bottles. Helium mass spectrometer, a commonly used instrument detects and locates tiny leaks. It usually works with a vacuum chamber and a sealed container filled with helium. A mass spectrometer detects the rate at which helium is leaking out of the container. This method uses tracer gas - helium to fill the product attached to the detector. The tested product leaks helium into the detector, where its partial pressure is measured and displayed.

The leak detector's principle is based on a sector field mass spectrometer. In vacuum, entering helium gases are ionized. The helium ions are then accelerated by adding voltage and then separated in a magnetic field. The ion current is converted to an electric current by using a particular detector. This current is accelerated using leak detection units and displayed on the screen. The current measured will be directly proportional to the concentration of helium and therefore equal to the leak measured.

Applications of Helium Leak Detection

  • Ensure container closure integrity.
  • Seal integrity monitoring during stability studies.
  • Verify and predict shelf-life seal integrity.
  • Useful in the early stages of the development of a pharmaceutical product packaging system.
  • Closure formulation and configuration selection.

Bottles are useful in the healthcare industry, hence evaluating them is a challenging task nowadays. These containers are extremely difficult to test, however, helium leak detection can be used to qualify them prior to use or as a proof of concept. LDA provides professional engineering solutions for the Active Pharmaceutical Ingredient (API) sterile container testing.

Readmore...
helium mass spectrometry, pharmaceutical package leak detection, pharmaceutical leak detection, mass spectrometer, mass spectrometry
43
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.

Readmore...
helium leak detection, helium test, leak detection, helium detector, helium leak testing, pharmaceutical package leak detection
155

Popular Blogs

Tags

The Advantages of Using Helium for Leak Testing

May 13, 2020   |   3544

The use of helium gas as a medium for leak testing dates back to the 1940’s.Using helium as the “tracer” gas enables the user to discover and measure extremely small leaks.

Applications of HeLD to Cartridge Package Development and Validation

Nov 04, 2020   |   3209

A study on the applications of helium leak detection for cartridges, which are frequently used as part of a device delivery system in pharmaceutical industry

An Overview of 21 CFR Part 11 Compliance Requirements

Nov 02, 2020   |   2815

A review of some simple and direct questions regarding Part 11 compliance to help you to understand its requirements and implementation.

Leak Detection Associates Celebrates Major 2019 Milestones

Dec 27, 2019   |   2587

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 celebrate the completion of its first calendar year under new management.

Leak Detection Associates Announces New and Updated Helium Leak Detection System

Nov 01, 2020   |   1646

Leak Detection Associates (LDA), the world’s premier manufacturer of custom built, helium-based leak testing instruments is excited to announce the launch of its newest and most advanced helium leak detection system, the SIMS Model 1915 that is engineered incorporating industry-leading Agilent Technologies components and is custom designed to meet the stringent requirements of clients in FDA-regulated industries.
COPYRIGHT 2020, LDA, ALL RIGHTS RESERVED PRIVACY AND COOKIES
Popup