20
Jan 2022

Quality Control Testing for Foil Pouches Using Helium Leak Detection

Quality-Control-Testing-for-Foil-Pouches-Using-Helium-Leak-Detection

Foil pouches are commonly used when a product requires multi-layered packaging. They are utilized as the innermost layers of packaging. Since the foil pouches come into direct contact with the packaged product, they must be of the highest quality and extremely hygienic. They are typically composed of aluminum and are used to protect products from high temperatures. Furthermore, foil pouches have a low moisture vapor transfer rate. Foil pouches usually contain three to four layers. The higher the number of layers, the higher the pouch quality. Each extra layer increases the strength of the pouch.

Foil pouch integrity testing offers a unique set of challenges. The occurrence of foil punctures is an issue in most packaging techniques that use foil as the product barrier. These imperfections can occur when the foil is rolled into thin sheets and microscopic particles are rolled into the foil by mistake. Handling of the packages during the assembly of the foil and insertion of the drug product is the most typical source of the defect. Although the human eye can only reliably spot punctures bigger than 100 µm, these faults are difficult to identify. Punctures smaller than this can cause substantial ingress and, as a result, affect the effectiveness of the product.

How to Inspect Foil Pouches for Quality Control Using Helium Leak Test?

A highly sensitive method of detecting leaks in enclosed systems by using helium as a "tracer gas" is known as helium leak testing. Pre-filled syringes, foil pouches, and cold form blister cards are the most common applications of helium leak testing. Each of these package types is meant to keep out harmful environmental pollutants including debris, germs, and even gases while maintaining the sterility of the drug product inside. The leak rate is calculated from the amount of helium that escapes from the package.

The sensitivity of the helium leak detection methods makes it an ideal platform for quality control testing foil-based packaging systems. The test technique is designed to identify helium that has been trapped in the packaging system and has leaked via micro-voids in the pouch. Placing the foil pouch in the custom-designed test fixture and drawing a vacuum is the first step in a test sequence. Helium thus escapes through possible defects in the package as a result of the resultant pressure difference. The flow is directed to the analyzer cell at vacuum pressure, where the escaping helium gas is measured in the cell.

The average test cycle time is between 20 and 60 seconds. The test chamber is evacuated to the environment when the test cycle is completed and the measurement is recorded, and a new sample can be tested. The LDA HSAM helium concentration device is used to detect the helium concentration value of each pouch once all samples in the designated set have been tested. This approach normalizes the helium leak rate to 100%, allowing direct comparison of all test samples as well as the manufacturing line configuration.

Helium leak testing, one of the most commonly used CCI testing methods, is used to accurately determine the tiniest of the leaky opening in the foil pouches. Using this method, leaks can be quantified and detected with a high level of sensitivity and quality control testing. The Food and Drug Administration- FDA has long recognized helium leak detection as a consensus standard for package integrity evaluation.

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helium leak detection methods, helium leak testing, helium leak detection, leak test, foil pouches
42
21
Dec 2021

Testing Container Closure Integrity at Low Temperature

Testing-Container-Closure-Integrity-at-Low-Temperature

The integrity of the seal between the container and the closure is a major concern when choosing packaging components for a parenteral drug product. The packaging must protect the pharmaceutical product from a number of possible sources of contamination, such as microbial ingress. Container closure integrity (CCI) is defined as the capacity of a container closure system to preserve a drug product and hence retain its efficiency and sterility throughout its shelf life. The purpose of container closure integrity testing is to determine the effectiveness of packaging closure.

To ensure CCI of pharmaceutical drugs, a number of methods are used. Helium Leak Detection is one of them. In this method, helium is used as a tracer gas, to detect leaks. This testing produces quantitative data that are more repeatable and reliable than qualitative pass/fail results. Despite the fact that it is a destructive test, helium leak testing is widely used because of its sensitivity and ability to run samples at temperatures below ambient. After the sample is prepared, it may be kept and analyzed at the proper temperature.

CCI Testing of Pharmaceuticals at Low Temperature

The CCI of pharmaceuticals may be determined using a variety of approaches. Under sub-ambient temperature circumstances, several methods of container closure integrity testing, such as blue dye ingress, microbial ingress, and vacuum decay, are insufficiently sensitive or simply unsuitable. Helium leak testing is a reliable method for testing closures and ensuring product effectiveness and sterility. This method is more sensitive than other CCI testing methods.

LDA has created the LT80, Low Temperature -80°C, Add-On test system for use with the LDA SIMS helium leak detectors to meet the market demand for analyzing leaks at cold temperatures. Concurrent temperature conditioning, temperature monitoring, and helium leak testing of packages approaching -80°C are all possible with the LT80 system. Even at temperatures as low as –80°C, helium leak detection is an effective method to ensure container closure integrity. While there are alternative methods for measuring CCI, many of them are ineffective at temperatures below –80°C. The LT150 low-temperature add-on unit allows for sample testing at temperatures as low as -150° C. The highly sensitive nature of the instrument allows for leaks as low as a 2µm hole can be recognized as a failure. The quantitative results provide the analyst with a numerical value, which allows for better data trends and greater confidence in the packaging system's performance than qualitative techniques can provide.

Container closure integrity or CCI, on packaging for parenteral drug products, is crucial for drug product preservation. The packaging closing components must be carefully chosen in order to eliminate sources of contamination that could harm the pharmaceutical product. The need to extend container closure integrity testing into the cryogenic temperature range is already becoming apparent. Container closure integrity must be achieved at cryogenic temperatures if pharmaceuticals are to be kept at cryogenic temperatures. For these types of drug items, newer packaging solutions like prefilled syringes and complex self-dosing devices are increasingly being used, and CCI will need to be proved for them as well.

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helium leak testing, helium leak detection, container closure integrity testing, container closure integrity, helium detector
88
15
Dec 2021

An Overview of Helium Leak Detection Services

An-Overview-of-Helium-Leak-Detection-Services

Helium Leak Testing is used to locate and identify extremely tiny leaks in any component that can produce a differential pressure. Helium Leak Rate can be expressed quantitatively (the quantity of leak rate). The helium leak testing method is also used to examine the performance of a component or system, as well as to study or evaluate the lifetime of a product. Helium gas is primarily utilized as a leak testing medium due to its ability to detect and quantify leak rates at very low levels.

LDA offers various helium leak testing services for pharmaceuticals and medical devices. The services are as follows:

Leak Testing Services

  • Installation & Quality Assurance of Helium Leak Detector
  • Leak Detection Associates guarantees that each custom instrument comes with comprehensive service delivery, installation, and validation program that is appropriate for the regulated environments in which the instruments will be used. Prior to delivery, the LDA Engineering Technician will collaborate with delivery site personnel to confirm that the location has the appropriate gas and electrical supplies for instrument functioning. Once the instrument is on-site and in the position specified by the customer, the Engineering Technician will perform a formal Installation Qualification (IQ), Operation Qualification (OQ), and Performance Qualification (PQ). Prior to execution, these can be pre-approved by local Quality Assurance.

  • Helium Leak Detector Service Agreement
  • Leak Detection Associates recognizes that maintaining instrument performance is an important part of the business’s success. While the instruments offered by LDA are simple to use and maintain, it helps to improve productivity by proactively guaranteeing performance with an LDA Annual Service Agreement. Leak Detection Associates provides service contract plans that are customized to the unique needs and specifications. The following are examples of key components of any service program:

    1. Repair and replacement parts are available on-site at no additional charge

    2. Annual On-Site Preventative Maintenance

    3. Detailed Annual Requalification & Calibration

  •  Helium Leak Detector Calibration Services
  • Annual calibration services for all components of the test system, including internal and exterior leak standards and HSAM probes, are also available as an alternative to a full-service contract. Failure to calibrate the leakage criteria may result in a decrease in the accuracy and validity of the results over time, as well as concerns of individuals working in a CGMP or other controlled environment. A complete calibration program at regular intervals is designed to ensure proper instrument readings for the life of the device with minimal instrument downtime. LDA can set reminders when service is required once in our calibration database, ensuring that SIMS 1915+ does not skip a beat.

  • Training for Helium Leak Testing
  • Leak Detection Associates offers on-site training relevant to how the SIMS 1915+ Helium Leak Testing device will be utilized, with the objective of being a comprehensive solutions provider to the clients. More sophisticated parts of leak testing, as well as system care and maintenance, can be covered in training programs. The Leak Detection team has over 20 years of hands-on expertise and can help the organization with anything from basic knowledge and understanding of leak testing basics to specialized leak test method development and validation.

  • Helium Leak Detection Feasibility Studies
  • LDA offers dependable feasibility and method development services. Prior to procuring an instrument or moving on with outsourcing solutions, feasibility services can provide proof of concept for its intended usage, or they can assist to expand existing capabilities by designing solutions for new package systems. LDA also provides full method development utilizing industry-standard positive control techniques in the cases where clients do not have internal resources experience in the development of helium leak detection tests, or where current resources need to be expanded. Methods created at LDA can be transferred and verified at the client site, or they can be utilized frequently at LDA for lab-scale, non-cGMP research.

  • Onsite or In-House CCI for Package Systems
  • LDA offers testing capabilities at both the client's site and our location. A SIMS 1915+ purchased and installed in a controlled context can be used for client onsite testing. With hands-on expertise in cGMP and regulated laboratory and production environments, documentation procedures are quite often in line with internal and external quality standards. LDA also provides the option of bringing one of our test units to a client's site for particular investigations. In-house testing is an alternative for clients looking to analyze package systems or designs on a contract basis.

LDA provides its customers with the highest quality of services. We are the world's leading manufacturer of high sensitivity helium-based leak detection systems for the pharmaceutical and biologic industries. Our engineers and support staff are highly trained and certified, allowing us to provide professional services across a wide range of testing domains.

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helium leak detector, helium leak testing, helium leak detection, mass spectrometry, helium mass spectrometry
137
09
Dec 2021

Blister Pack Leak Testing: The Limitations of the Blue Dye Test

Blister-Pack-Leak-Testing-the-Limitations-of-the-Blue-Dye-Test

Blister packages are a convenient format for users and a practical way to keep tablet and capsule quality preserved. The majority of blister package applications are considered low-risk, and they do an excellent job of protecting pharmaceutical products from moisture intrusion, which can cause product degradation. Tablets with a hydrophilic nature, or a natural tendency for absorbing moisture, require extra protection.

Due to an increase in the number of hormone-based and steroidal therapies in recent years, worries concerning the integrity of blister packing have emerged. Given their propensity to degrade and impair treatment outcomes, packaging these and other groups of pharmaceutical products is considered a high-risk application. To combat this, most manufacturers choose a totally aluminum, cold-formed package, which offers the best protection against oxygen penetration, while some industries have packaged very sensitive steroidal therapies in thermoformed blister packaging. As these products are more susceptible to environmental conditions than most other tablets and capsules, it is critical to inspect for tiny leaks, regardless of the packaging utilized in this high-risk application.

Limitations of Blue Dye Test

One or more blister packs are submerged in a chamber holding blue liquid and a vacuum is drawn to conduct the blue dye test. The chamber is then restored to atmospheric pressure, and the packages are retrieved and examined to determine if any dye has entered them. No defect is detected if there is no dye in the blister packaging. The blue dye only enters the package after the vacuum phase, which is the major defect of this method. As a result, when the chamber is returned to atmospheric pressure, nothing prevents the operators from removing the packages from the dye during this final stage.

Package headspace and dye surfactant concentration are the other difficult factors to control in the blue dye test. In reality, the test just determines how easily or quickly the dye may enter the blister cavity. It does not tell you about oxygen or vapor intrusion. This is a significant disadvantage since gaseous pollutants may penetrate foil and film more readily through a tiny leak, which is subject to surface tension. This requires a relatively large single passage to enter the package. Another major disadvantage and difficulty to control is the subjective nature of the operator's inspection.

Leak Testing Blister Packages Using Deterministic Test Method

Helium leak testing is a deterministic method for identifying package leaks in blister packs using helium as a tracer gas. The change in its concentration is measured as it escapes due to leakage. The quantity of helium that escapes from the package is expressed as a leak rate. Helium leak detection is a very sensitive technique for testing pharmaceutical package integrity.

Seal Integrity Monitoring System (SIMS) 1915+ is the optimum leak detection system using helium. When compared to traditional methods such as vacuum bubble and dye penetration test, packages may be quantitatively examined with high accuracy. This method enables a comparison of different packaging materials and forms, as well as production line settings and storage conditions, thus supporting the entire life cycle. Package design, tooling qualification, production line setup and ongoing product quality monitoring are the applications that come under SIMS 1915+. It is specially designed for the pharmaceutical and medical device industries.

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blister packs, helium leak testing, helium leak detection, helium mass spectrometry, mass spectrometry
116
06
Dec 2021

Significance of Helium Mass Spectrometer in Blister Pack Leak Detection

Significance-of-Helium-Mass-Spectrometer-in-Blister-Pack-Leak-Detection

Blister packaging is a type of pre-formed plastic packaging that includes a base card with artwork and a clear plastic pocket called the blister. The cavity, which is composed of either plastic or aluminum foil, and the lid, which is made of paperboard, paper, plastic, or aluminum, are the two main components of blister packaging. The product is enclosed in the cavity, and the lid seals the package. Blister packing is used in the pharmaceutical industry to pack tablets, pills, capsules, granules, and lozenges. Blister packaging gets its name from the fact that each item is kept within its own small plastic bubble or blister. Blister packs can provide tamper resistance as well as barrier protection for shelf-life requirements.

Due to its extreme sensitivity, a helium-based test method is used for verifying the integrity of the blister pack. The test method operates by detecting helium that has been enclosed in the package system and is escaping through micro-channels in the package. This test sequence begins with the package being placed in the test fixture and immediately drawing a vacuum. The helium thus escapes through potential holes or cracks in the packaging as a result of the pressure differential.

Blister Pack Leak Testing Using Helium Mass Spectrometry

The Mass Spectrometer Leak Detector is a comprehensive system for locating and detecting leaks within or outside of product. This approach employs the use of helium as a tracer gas, which is utilized to fill the product attached to the detector. Helium leaks into and out of the tested product, causing its partial pressure to be measured and shown on a screen.

The leak detector works on the principle of a sector field mass spectrometer. Helium gas is ionized in a vacuum. Helium ions are accelerated and separated in a magnetic field using additional voltage. The ion current is converted to an electric current using a specific detector. The current is accelerated by leak detection units and displayed on the screen. The measured current is proportional to the helium concentration and equal to the observed leak. Helium leak detection using helium mass spectrometry is widely known for its suitability for packaging such as blister packs.

Helium Leak Detection Benefits

  • With a high degree of sensitivity, leaks can be identified and measured
  • No effect on the materials under test, due to the inert properties of the helium
  • The testing procedure is mostly dry and temperature-independent
  • Helium leak testing has a faster cycle time, which reduces the cost and overall processing time

Helium leak detection offered by Leak Detection Associates (LDA) can greatly improve the safety and health of blister package users. Blister packaging ensures that tablets and capsules are properly sealed. It is simple to do a leak test after packaging. Blister packaging is popular because of its convenience of packing, easy dosing for the patient, with its popularity increasing for many new drug solid dose/oral dose products.

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mass spectrometer, helium leak detection, helium mass spectrometry, mass spectrometry, helium leak testing
139
02
Dec 2021

A Guide to SIMS 21CFR Part 11 Compliant System Software

A-Guide-to-SIMS-21CFR-Part-11-Compliant-System-Software

LDA, the global leader in helium-based leak detection systems for the pharmaceutical and medical devices industries. Helium leak testing is a technique for locating and identifying leaks in a closed vessel using a tracer gas, helium. The method of helium leak testing is often used to evaluate system performance. Helium gas is commonly employed as a leak testing medium because of its ability to detect and quantify leak rates at extremely low levels.

SIMS Version 1.11.19 21 CFR Part 11 compliant software program

SIMS Version 1.11.19 21 CFR Part 11 is a compliance software application particularly created and manufactured for custom-built helium leak testing equipment. The application was created to support SIMS 1915+ units and makes LDA the only helium-based leak testing system provider on the market that meets all the FDA's (Food & Drug Administration’s) 21 CFR Part 11 data integrity software criteria.

With the growing usage of computer systems and electronic records over the last two decades, the FDA has published a number of guidance documents and directives outlining particular requirements for electronic data management. Users must be able to log in at different levels, utilize electronic signatures and approvals, have secure data management that prohibits changes to current results, and have an electronic audit trail that captures all relevant activities in a time and date stamped pattern.

LDA was able to build a robust and thorough helium leak testing procedure on our custom-designed and built systems. This improves functionality and usability compared to existing software options, by contracting with a development team that specializes in the development of instrument operation software programs and has extensive experience in the Part 11 area. LDA is offering a system software update program for current SIMS devices in the market for quick onsite installation for a client's existing installation base. The 21 CFR Part 11 program consists of all the instruments, including SIMS 1915+ and SIMS 1915+ LT low temperature add-on units.

Leak Detection Associates has been the major provider of custom helium leak detection equipment to the pharmaceutical, and medical device industry for over 20 years. Based on intended usage and target package system configuration, each test system is developed to meet regulated quality system requirements as well as the particular client's specifications. The LDA team creates custom add-on components for clients that need a flexible leak detection system that can be used with a variety of package types and configurations. This ensures flexibility in reaching particular research goals.

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helium-based leak detection systems, helium leak testing, helium leak detection, helium mass spectrometry, sims 1915+
143
30
Nov 2021

Integrity Testing of Seals Using Tracer Gas - Helium

Integrity-Testing-of-Seals-Using-Tracer-Gas-Helium

Using helium as a tracer gas is the most sensitive and commonly used tracer gas leak detection technique for CCI. When moisture-sensitive pharmaceutical products are lyophilized, their shelf life is extended, and they are better prepared for storage and transportation. A lyophilized medicinal product's quality is ensured by maintaining consistent moisture content. Proper container closure system (vial, stopper, seal) selection and sealing conditions are equally important factors. Demonstrating Container Closure Integrity (CCI) is one way of achieving this goal.

Why use helium?

Helium gas is one of the smallest molecules. In addition to being non-flammable, non-destructive, non-toxic, and inert, helium only has a trace presence in the atmosphere. Helium is generally safe to employ (compared to hydrogen) since it will not react with any of the components in the test part. Mass spectrometers detect helium in the vast majority of leak testing applications. A residual gas analyzer, on the other hand, is also an option. In general, helium leak testing ensures higher levels of sensitivity than conventional pressure decay methods.

Tracer gas method to test seal integrity

Tracer gas leak testing is a simple and very effective way of detecting leaks that offer great sensitivity, accuracy, and repeatable results. Being one of the most effective method of leak detection, tracer gas leak testing offers great sensitivity and accuracy. Micro-leaks between 1x10-4 to 10-9 scc/s can be detected using the tracer gas leak test, which utilizes the tracer gas - helium. Tracer gas leak testing can be done with either pure helium or by mixing it with another gas such as nitrogen or dry air to reduce the overall cost. A mass spectrometer is used in the standard test method for measuring package and seal integrity. Due to its low concentration in the atmosphere, and its detection using a mass spectrometer, helium is employed. It is done by injecting helium into sealed packages or adding it to sealed package’s headspace after sealing. In the following step, a mass spectrometer is used to identify and measure the presence of helium in the surrounding enclosed space.

Vacuum test method is the commonly employed tracer gas method for testing the seal integrity of pharmaceuticals products. In this method, seals are put under stress by a vacuum, which measures tiny leaks. Helium transfer rate captures the real transmission rate through the material as well as via the seals. Transmission of helium through the material as well as seals is captured by helium transmission rate. As a result, the vacuum technique is more effective in detecting leaks since it monitors helium gain in the external environment within the enclosed sample.

When packaging seals are tested for integrity, it helps guarantee that the packaging offers necessary product protection for patient safety. To ensure product quality, package seals must be reliable. Seal integrity tests are commonly used to evaluate sustainable packaging options, lower-cost packaging, and changes in manufacturing line sealing parameters, among others. Evaluating the seal strength of packing materials with reduced costs and alternative sealing procedures confirms that the seals do not leak over time.

Leak Detection Associates (LDA) designs and manufactures high-performance tracer gas (helium) leak detection systems to ensure the integrity of seals for the pharmaceutical and biological industries. Helium leak detection is the one of the most effective leak detection method to identify and locate leaks in a closed system.

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helium leak testing, mass spectrometer, helium mass spectrometry, mass spectrometry, helium detector
111
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
155
15
Jul 2021

Why is SIMS 1915+ an Ideal Choice for Helium Based Leak Detection?

Why-is-SIMS-1915-an-Ideal-Choice-for-Helium-Based-Leak-Detection

Leak testing may be understood as a form of non-destructive quality control procedure used to determine if an object, product, or system functions within a specified leak limit. When a gas or liquid escapes through a manufacturing defect such as a hole, crack or weak seal, it is considered a leak. Since such a leak can compromise quality of the product, appropriate leak testing is an important quality control criteria for manufacturers.

Overview of helium leak testing?

Helium leak testing is considered as one of the most sensitive Container Closure Integrity test methods. In simple terms, it can be understood as the process of using helium mass spectrometry for finding leaks in some type of enclosed or sealed system using helium as a “tracer” gas and measuring its concentration as it escapes due to leakage. This technique is widely used for evaluating integrity of critical parenteral or injectable products. Helium is used as a tracer gas because it is non-toxic, non- flammable, non-condensable and its presence in the atmosphere is not more than 5ppm. The small atomic size of helium makes it easier to pass through leaks. Since helium does not react with other materials, it is safe to use. Additionally, compared to other tracer gases helium is less expensive and is available in multiple cylinder sizes.

Helium leak detection using SIMS 1915+

LDA's Seal Integrity Monitoring System (SIMS) 1915+ is a helium-based leak detection technique proven to be effective for a variety of pharmaceutical and medical device product package systems. Using helium as the tracer gas, packages can be quantitatively tested to levels far exceeding the vacuum bubble and dye penetration test methods. This technique is applicable across a wide range of pharmaceutical and parenteral products including vials, syringes, cartridges and blister cards.

SIMS 1915+ enable quantitative analysis of packages at a sensitivity level as low as 1 x 10-10 mbar/L/sec. and provides relevant data sets in place of a simple pass/fail criteria while enabling testing to be performed at ambient temperature as well as cryo storage conditions. Each SIMS 1915+ Helium Leak Testing instrument is custom built to client specific standards and package configurations. We specialize in the engineering and development of custom test fixtures tailored to the component to be tested, which ensures precision and accuracy to meet your study goals, package configurations and quality monitoring needs.

SIMS 1915+ Options:

  • LT 80 and LT 150 Low Temperature Add-on Systems for ultra-cold CCI testing using helium leak methodology.
  • Various sizes of Vacuum Test Fixtures to accommodate all package types and sizes.
  • Custom Test Fixtures to allow Helium leak testing for non-vacuum chamber applications.
  • Additional External Helium Leak standards in various leak rate ranges.
  • Helium Sniffer probe – for site specific determination of leak sites.
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helium leak testing, sims 1915+, helium mass spectrometry
447
16
Jun 2021

Testing Integrity of Bottles with Helium Leak Detection

Testing-Integrity-of-Bottles-with-Helium-Leak-Detection

Like vials package systems, bottles whether composed of plastic materials or glass, continue to be one of the most widely used package systems and Helium remains the gold standard for quality testing purposes.

Evaluating seal integrity of bottles or containers used for liquid contents is what ensures the quality of the bottles surpass the quality parameters. Seal integrity testing of bottles is done to ensure that the contents of the container do not leak out in any condition. As weak seals, partial seals or no seals can occur in the final sealing stage, manufacturers often conduct high-quality seal integrity tests that guarantee reliability and quality of bottle seals.

Thread shape, mating surface shape, and composition of the material used for making the container and the closure are common factors that can affect the seal integrity of bottles. An ideal seal can be generated if the container and closure materials are made up of distinct composition. Seal quality can also be affected by time-dependent factors. This is especially possible if containers, closures, or both are constructed using plastic resins. Similarly, exposing the bottle and its contents to freezing temperatures can affect the seal via expansion and contraction of the materials in threads and mating surface area.

Before dispatching, leak detection of sealed containers is a crucial vital step to ensure container’s seal integrity, food and nutrition, medical device and pharmaceutical industries require highly sensitive leak testing techniques to measure seal strength of the containers. One such method is helium leak detection.

Overview of helium leak testing?

Helium leak testing refers to the process of finding leaks in some type of enclosed or sealed system using helium as a “tracer” gas and measuring its concentration as it escapes due to leakage. It is an effective container closure integrity test method, aimed at evaluating the integrity of pharmaceutical and parenteral products. Helium leak detection works in the following way: Initially, the package is helium filled and subjected to vacuum. Then using a helium leak detector, the amount of helium escaping the package is quantitatively measured and stated as a leak rate. Apart from analyzing container closure integrity, helium leak testing is also applicable in product design, product quality analyses, failure analyses and validation. Helium leak testing is a flexible method that can be used with or without a test chamber in order to test "in-leakage" or "out-leakage", as well as leak location.

Why use helium as a tracer gas?

Helium is considered as an ideal choice of tracer gas because of the following reasons:?

  • Helium is non-toxic, non-condensable, non-flammable.
  • It is inert, making it safe for use as it will not interact with the components being tested.
  • The atom size of helium is really small, allowing it to breach pathways reliably and easily.
  • Compared to other tracer gases, helium is less expensive and readily available.
  • Its presence in the atmosphere is not more than?ppm.
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bottle leak testing, helium leak testing, helium leak detection, helium leak detection for bottles, seal integrity of bottles
422
10
Jun 2021

Purpose of Using Helium Mass Spectrometry for Combination Products

Purpose-of-Using-Helium-Mass-Spectrometry-for-Combination-Products

Over the past decades, there has been steady stream of advances over combination products and a deepening trend towards self-care. This is because combination products offer a safe and convenient method of operating drug or biologic therapies. Medical devices that can be self-administered are increasingly being used to shorten procedure time and reduce the chance for practitioner errors.A combination product is a mixture of a drug and device that includes pre-filled syringes, insulin injector pens, transdermal patches, and catheters with antimicrobial coatings. These are often termed as high-risk devices in the life science industry. As such, devices they require in-depth testing and evaluation.

The risk associated with combination products depend on the likelihood of interaction between the package and the drug, as well as the level of risk associated with the administration route. For many drug-device combination products, inhalations and injections are specified as high-risk routes of administration. Hence, evaluating seal integrity of combination products is extremely critical. Due to inadequate sealing, there is a chance for water vapor or oxygen to enter the package through a permeable surface. In such cases, surfaces and seals may need to be tested depending on the nature of the products. Also, there is a need to evaluate the packaging components and dosage, ignoring which, could cause serious health risk to the patient.

Importance of Helium Mass Spectrometer Leak Detector in Combination Products

The Mass Spectrometer Leak Detector is a system used for localization and measuring leaks inside or outside a product. This method uses tracer gas – helium, which is used to fill up the product connected to a detector. It is well documented that helium mass spectrometry is most suited for non-porous packaging such as vials and syringes. The same methodology can also be applied to cartridge-based delivery systems. In most cases, the key to success is developing a text fixture device, designed and manufactured to cater to the needs of specific cartridge system being tested.

Applications of helium leak testing.

Following are the applications of helium leak testing:

  • Ensuring Container Closure Integrity
  • Closure formulation and configuration
  • Seal integrity monitoring during stability studies
  • Extremely valuable in early-stage pharmaceutical product package system development
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helium mass spectrometry, mass spectrometer leak detector, prefilled syringes, combination product leak testing, helium leak testing
355
09
Apr 2021

Why Helium Leak Detection is an Ideal Solution for Evaluating Integrity of High Risk Pharmaceuticals?

Why Helium Leak Detection is an Ideal Solution for Evaluating Integrity of High Risk Pharmaceuticals.

The global pharmaceutical industry has seen tremendous growth over the past few decades. However, complex nature of the industry coupled with frequent breakthroughs has made it a favorite subject of scrutiny. Adding to that, the COVID-19 pandemic has accelerated pharmaceutical industry challenges. Along with COVID-19 vaccine, the industry has seen a spike in the production of cell and gene therapy treatments, biologics, and other large-molecule products that demand unique storage conditions to maintain sterility of the drug throughout its shelf life or until it is administered.

Since most high-risk pharmaceutical products are filled and sealed in combination devices, it’s critical for manufacturers to ensure that the components function well together. Hence, design and distribution considerations are critical to the early design of both the drug and the container. Manufacturing inconsistencies and tolerance differences in packages containing multiple components are primary contributors to distribution issues. Often, such inconsistencies result in container closure failure, causing serious implications down the supply chain. For instance, glass vials and pre-filled syringes may not seal properly at critical fill-finish closure points. Such a failure can cause oxygen or other environmental contaminants to enter the product and compromise the efficacy of the drug in the barrel. At this point, it is critical to use the most precise leak testing method possible.

In such situations, helium leak detection is the most effective sensitive test for ensuring container closure integrity. By utilizing helium leak detection early in development, companies can make considerable improvements in the quality of their drug delivery system. This not only saves cost and time, but will also raise standards of safety.

Understanding helium leak detection technology

Helium is used as a tracer gas because it is non-toxic, non-flammable, non-condensable and its presence in the atmosphere is not more than 5ppm.Being the second smallest molecule on the periodic table, helium can expose virtually any opening. Further, helium does not react with other materials, so it is relatively safe to use. Under this method, a helium leak detector otherwise known as Mass Spectrometer Leak Detector (MSLD) is used to identify and calculate size of the leak. The test part is first connected to a leak detector and then the tracer gas, helium is introduced. In the presence of a leak, helium escapes from the test parts and this partial pressure is measured and results are displayed on the meter.

Applications of Helium Leak testing

  • Ensuring Container Closure Integrity
  • Selecting closure formulation and configuration
  • Seal integrity monitoring during stability studies
  • Extremely valuable in early stage pharmaceutical product package system development
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helium leak detection, high risk pharmaceuticals, parenteral product packaging, helium leak testing
588
30
Mar 2021

Evaluating Integrity of Pre-Filled Syringes with Helium Leak Testing

Evaluating Integrity of Pre-Filled Syringes with Helium Leak Testing

What is helium leak detection?

The pharmaceutical industry has seen a significant rise in the use of pre-filled syringes in recent years. This demand is expected to accelerate over the coming decades. Pre-filled syringes offer benefits to the pharmaceutical industry in the form of reduced drug waste and increased product life span. Health care workers consider pre-filled syringes as an efficient, convenient and reliable drug administration method. However, they pose several challenges in manufacturing and require extensive testing.

Just like any other drug product, pre-filled syringes should be free from pyrogens and should be sterile. Not just that, they are expected to be biologically, chemically and physically stable throughout its shelf life. Considering the complex nature of these products, it isn’t surprising that there are many opportunities for it to fail to meet quality requirements. Defects in pre-filled syringes mainly depend on drug product design and syringe process design. Additionally, patient related issues are also an area of concern. Therefore, it is important for manufacturers to have knowledge and understanding of various tests involved to ensure patient safety.

Container Closure Integrity testing of pre-filled syringes

Sterility is the most important quality attribute associated with any pharmaceutical/ parenteral drug product. Container Closure Integrity (CCI) testing is one of the key tests performed by manufacturers so that the product is guaranteeing sterility and microbiological quality until point of use. Container closure integrity testing evaluates the ability of container closure systems to maintain a sterile barrier against possible contaminants that can deteriorate the quality of final pharmaceutical and biological products. There are multiple methods to conduct container closure integrity tests, each with its own set of benefits and limitations. For instance, techniques like dye ingress and microbiological ingress are destructive to the samples being tested. Such tests rely on statistically representative number of samples from the batch and assume that defects are uniformly present throughout the batch. On the other hand, deterministic methods are non-destructive in nature and can be used to test every unit from the batch.

Helium Leak Testing for Pre-Filled Syringes

Helium leak testing refers to the act of finding leaks in some type of enclosed or sealed system using helium as a “tracer” gas and measuring its concentration as it escapes due to leakage. Under this technique, the package is helium filled and subjected to vacuum. The amount of helium escaping the package is quantitatively measured with the help of a helium leak detector. The result is stated as a leak rate. Apart from being an effective container closure integrity test method, helium leak testing is also applicable in product design, product quality analyses, failure analyses and validation.

Why use helium as a tracer gas?

Helium is considered as an ideal choice of tracer gas because of the following reasons:

  • Helium is non-toxic, non-condensable, non-flammable.
  • It is inert, making it safe for use as it will not interact with the components being tested.
  • The atom size of helium is really small, allowing it to breach pathways reliably and easily.
  • Compared to other tracer gases, helium is less expensive and readily available.
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helium leak testing, pre filled syringes, container closure integrity testing, helium leak detector
622
25
Mar 2021

Understanding Sniffer Probe Helium Leak Detection

Understanding Sniffer Probe Helium Leak Detection

What is helium leak detection?

Helium leak detection refers to the process of identifying leaks in an enclosed or sealed system using helium as a tracer gas. Helium is an ideal choice of tracer gas to find leaks because it is non-toxic, non-flammable, non-condensable, and its presence in the atmosphere is limited to 5ppm. Helium can pass easily through leaks because of its small atomic size. Additionally, helium is safe to use because it does not react with materials of parts being tested.

Overview of sniffer probe leak detection

Sniffer leak testing is a common tracer gas leak detection method that uses a sniffer probe to detect the presence of tracer gas and identify an area that is leaking. Under sniffer probe helium leak detection, helium is used as a tracer gas in combination with instrumentation to detect the presence of helium and more precisely an increase in helium due to the leaking part.

The prime objective behind conducting a sniffer probe leak detection test is to locate leaks in parts or systems so that they can be identified and repaired. The part or system is first pressurized with the tracer gas and then systematically scanned with a sniffer probe so as to detect possible leaks. Sniffer probe leak detection cannot be considered as a quantitative leak detection technique because the test results may vary depending on skill of the operator and the technique used. However, with the use of calibrated instruments, calibrated leak standards, and well-trained operators, quantitative results may be achieved. Sniffer leak testing is considered as an economical leak detection method that involves relatively low tool cost investment depending on the tracer gas used. Although sniffer probe leak testing is very effective in locating micro leaks, it may not be an ideal choice in high volume production environment.

How does sniffer probe leak detection work?

Sniffer probe leak testing begins by first filling the test object with tracer gas. The pressure inside the test object is increased to a pre-determined rate in order to create a differential in pressure. The outside of the test object is scanned using a sniffer probe that is connected to a leak detector. Because of the innate properties of helium, it readily penetrates through leaks and is sucked into the sniffer probe. The leak rate meter shows a display of the signal. On reaching maximum leak rate display, leak is located. Although the sniffer probe leak detection technique is very sensitive, its accuracy can be affected due to the amount of helium present in the atmosphere.

Advantages of Sniffer Probe leak detection

  • Sniffer probe is very effective in locating minute leaks.
  • Does not require expensive fixtures or test chambers and can be employed at low cost.
  • Useful in testing small parts as well as complex systems.
  • Higher test sensitivity can be achieved by increasing tracer gas pressure.
  • Capable of detecting leaks in the range of 1.6x10-1 to 1x10-5 scc/s.
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sniffer probe, sniffer probe helium leak detection, helium leak detection, helium leak testing
790
19
Mar 2021

Ensuring Integrity of Glass Vials with Helium Leak Testing

Ensuring Integrity of Glass Vials with Helium Leak Testing

Container closure integrity plays an integral role in maintaining the stability of sterile pharmaceutical products. Most often, defects that cause vials to leak cannot be detected by a visual inspection process. Examples of such defects include microscopic cracks & scratches in the glass or temporary defects such as stopper pop-up that result in temporary container leakage. In such situations, helium leak testing ensures high sensitivity leak detection, which cannot be attained by many other leak test methods.

Overview of helium leak testing

Helium leak testing refers to the process of finding leaks in some type of enclosed or sealed system using helium as a “tracer” gas and measuring its concentration as it escapes due to leakage. It is an effective container closure integrity test method, aimed at evaluating the integrity of pharmaceutical and parenteral products. Helium leak detection works in the following way: Initially, the package is helium filled and subjected to vacuum. Then using a helium leak detector, the amount of helium escaping the package is quantitatively measured and stated as a leak rate. Apart from analyzing container closure integrity, helium leak testing is also applicable in product design, product quality analyses, failure analyses and validation. Helium leak testing is a flexible method that can be used with or without a test chamber in order to test "in-leakage" or "out-leakage", as well as leak location.

Why use helium as a tracer gas?

Helium is considered as an ideal choice of tracer gas because of the following reasons:

  • Helium is non-toxic, non-condensable, non-flammable.
  • It is inert, making it safe for use as it will not interact with the components being tested.
  • The atom size of helium is really small, allowing it to breach pathways reliably and easily.
  • Compared to other tracer gases, helium is less expensive and readily available.
  • Its presence in the atmosphere is not more than ppm.

Glass vial leak testing using SIMS 1915+

Seal Integrity Monitoring System (SIMS) 1915+ is an ideal choice for helium-based leak detection of vials, blister cards, syringes, and cartridge systems. Compared to conventional vacuum bubble and dye penetration test methods, packages can be quantitatively tested using helium as the tracer gas that ensures higher levels of accuracy. Proven to be an affective leak detection method, SIMS1915+ can also be used for package design, tooling qualification, production line setup and on-going product quality monitoring. Designed specifically for the needs of pharmaceutical and medical device industries, SIMS1915+features an oil-free pump, detector and integrated power system that ensures quantitative analysis of package systems at sensitivity levels as low as 1 x 10 -10 cc/s at room temperature. Based on the client’s specific requirement, each SIMS 1915+ Helium Leak Testing instrument manufactured by Leak Detection Associates can be customized. Given below is a list of SIMS 1915+ Leak Detection System specifications along 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
  • LT Low Temperature Add on units specifically designed for testing products under ultra-cold storage testing down to –140 °C.
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Helium leak testing, helium leak detection, glass vials leak testing, sims 1915+, head space analyzer module
679
20
Nov 2020

Helium Leak Detection for Prefilled Syringes -Inherent Integrity

Helium Leak Detection for Prefilled Syringes – Inherent Integrity

In two recent blogs, we’ve discussed the practical applications of helium leak detection to vial and cartridge package systems. A vial, with its single compression-based seal, can be readily tested by helium leak detection in cases to optimize sealing parameters, validate assembly, routinely test production samples, etc. On a cartridge, the compression-based crimp seal can be similarly tested and optimized. On the opposing end, an elastomeric plunger relies on a compression fit against the syringe barrel based on the dimensional overlap of the two components. This seal can be similarly assessed by helium at dimensional extremes to further demonstrate inherent integrity and robust understanding of the package assembly process.

While cartridge-based and specifically vial-based systems represent the majority of pharmaceutical and biotech industry package formats, the rate of one group’s growth far exceeds its peers: prefilled syringes (PFS). From a human factors and dose-delivery perspective, the benefits of a prefilled syringe format over a traditional vial-based injection can be myriad. Not the least is their ability to be incorporated into single-use autoinjection and safety systems. However, the PFS, and autoinjection systems in particular, present unique challenges from a CCI testing standpoint.

In a combination product autoinjection system, most frequently the syringe is fully housed inside of a device. This limits direct access to the product-containing portion of the package, preventing some technologies from being feasible from an analytical standpoint. Further, the product inside is liquid, contributing to increased challenges when testing using a vacuum-based technology. Frequently, this means that testing a fully-assembled injection system for CCI is infeasible or not sensitive enough to provide meaningful assurance. It is in these cases especially that fully characterizing the inherent integrity of the primary package, the syringe, is critical for reducing risk downstream with respect to package integrity.

Much like its application to vial and cartridge systems, helium leak detection is well suited for inherent integrity evaluations of prefilled syringes, regardless of whether their final destination is housed inside of a device body. Similar to cartridge systems, the plunger seal of a PFS system relies on a compression fit between an elastomeric plunger and the syringe barrel. Studies evaluating the inherent integrity of this fit provides insight into the quality of the seal that is likely to be present in final production units. Similarly, helium leak testing at the extreme ranges of the dimensional tolerance stack-up between the barrel inner diameter and plunger outer diameter can ensure integrity at the full range of possible dimensional combinations. This type of study can yield significant insight into seal robustness.

The opposing end of a PFS is unique in that it includes a staked needle or luer-type connection for a needle to attach. From a helium leak testing perspective, however, there is nothing unique about it. The product-holding volume of the syringe is filled with helium while the needle region of the PFS is exposed to vacuum. If a leak is present, helium will migrate through the leak path and result in an increase in helium leak rate measured by the system. Complete syringe units can even be tested by sealing the opposing end with a plunger and subjecting the entire package to vacuum in a chamber, though proper fixturing is required.

In addition to the unique configuration on a PFS, the staked needle or luer lock seal of a PFS also has another unique property. Since prefilled syringes are supplied as assembled units to drug manufacturers and CMOs, they are one seal not subject to optimization or validation during the manufacturing process. Whereas the plunger seal can be characterized by helium as a function of the compression fit between the two components, the dimensions of which can be monitored, the needle end of a PFS is subject to supplier practices. For this reason, some manufacturers also choose to implement helium leak detection of PFS units on an incoming lot inspection basis, as would be done for component dimensions. This provides some level of ongoing integrity assurance of these unique package systems in the production process. The SIMS 1284+ helium leak detector routinely and successfully supports these types of studies and ongoing analysis to fulfill modern CCI guidance and requirements.

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helium leak testing, helium leak detection for prefilled syringes
1397
01
Nov 2020

Leak Detection Associates Announces New and Updated Helium Leak Detection System

2019 PDA Container Closure Integrity Testing Workshop Presentation

EGG HARBOR TOWNSHIP, N.J. (PRWEB)

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 launch of its newest and most advanced helium leak detection system, the SIMS Model 1915. The SIMS 1915+ unit is engineered incorporating industry-leading Agilent Technologies components and is custom designed to meet the stringent requirements of clients in FDA-regulated industries. The new unit will replace the SIMS 1284+, marketed by LDA for the past 12+ years, and represents the most advanced and sensitive system available worldwide. With a revised interface and corresponding pump configuration specifically intended for pharma/biotech package testing, clients will see an improvement in instrument performance with more intuitive operation. Notably, the launch of the system coincides with the release of the all-new 21 CFR Part 11 compliant software package developed by the Leak Detection Associates software development team.

“While the SIMS 1284+ has proven to be a workhorse with a global client installation base for over 12 years, advancements in vacuum and helium-based technology have enabled our engineering team to improve component configuration and system performance, yielding the most advanced helium leak testing system for pharmaceutical and biotechnology applications. I am confident our clients will appreciate the new features, capabilities, and usability the SIMS 1915+ will offer”, commented Jeff Morrow Lucas Director of Engineering for Leak Detection Associates.

    Key features and benefits of the new SIMS 1915+ model include:
  • Base Helium Leak Detector powered by Agilent Technologies, globally recognized as a leader in the regulated market industries for laboratory equipment
  • An IDP-15 Dry vacuum pump (oil free) rated for 15m3/hour (9 cfm) and a Patented dual pump design for fast clean up and background suppression
  • Improved power-off process keeps spectrometer under vacuum and protects the turbomolecular pump, reducing operator dependency and increasing filament longevity
  • Maximum Test Port Pressure of 13 mbar (10 Torr, 1333 Pa) and 200 mbar (150 Torr, 2000 Pa) in Gross Leak Mode

The new SIMS Model 1915+ model is available for immediate order and based upon an improved supplier relationship with Agilent Technologies, lead times for custom-built orders will decrease from the previous 12-14 weeks to as short as 4 weeks. As clients have come to expect, each new SIMS Model 1915+ will be customized to client’s specific testing needs whether testing vials, blister cards, cartridges, or pre-filled syringes. Each SIMS 1915+ can be complimented with Leak Detection Associates’ robust service and contract offerings to provide end-to-end leak testing solutions.

READ ENTIRE PRESS RELEASE ON PRWEB

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helium leak testing, SIMS 1915+, helium leak detection system, benefits of SIMS 1915+
1646
13
May 2020

The Advantages of Using Helium for Leak Testing

The Advantages of Using Helium for Leak Testing

The use of helium gas as a medium for leak testing during the gas diffusion process dates back to the 1940’s. The mechanism that enables leak testing using helium is the helium mass spectrometer which, at its core, is simply an air sampling tool that takes accurate measurements, using a series of pumps, to quantitatively measure the amount of helium in, around or leaking from a closed vessel or system is completed. Using helium as the “tracer” gas enables the user to discover and measure extremely small leaks. With so many available gases in our ecosystem, what is it about helium that makes it the ideal tracer gas for leak testing?

In the case of leak testing, size really does matter. Helium is one of the smaller molecules known to man and boasts of an atomic mass of 4 making it “light and smalll”. In comparison, only hydrogen is lighter than helium but as the passengers of the Hindenburg can attest, hydrogen displays some other explosive properties that may make the average laboratory technician shy away from its use. Because of its size, helium has the ability to flow through much smaller openings and at a much faster rate than other gas compounds. In technical parlance, you will often see this referenced as helium displays a high sensitivity rate as low as 1 X 10-10 cc/s. In laymen’s terms, this simply means that the small molecule size of helium makes it easy to “quantitatively detect and measure”.

While we note above the major disadvantage of using hydrogen as a tracer gas due to its explosive nature, helium is on the other extreme. Helium has three key characteristics that make its use easy and ideal. It is non-explosive, non-toxic and non-destructive. These characteristics insure that helium will not interfere with, or in any way impact, the type of material or vessel that you are testing. In most instances, the system being leak testing is constructed of plastic, glass or some type of metal. The inert and odorless nature of helium makes it chemically inactive when it comes in contact with any of these material types.

The presence of helium in the atmosphere tends to hold in the 5 ppm (parts per million) range. This feature helps to insure that false readings and general atmospheric interference in a non-factor when using helium gas as a testing agent.

Collectively, the characteristics of helium gas outlined above make it a very user friendly tool for leak testing. Couple these features with the easy availability and relatively inexpensive acquisition cost, helium has become the “first choice” method for leak detection in a wide variety of settings. Advances in the development of better mass spectrometers have led to more superior and more robust techniques and methods.

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helium leak testing, helium test, advantages of using helium for leak testing
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