May 2020

Leak Detection Associates Announces Participation in INTERPHEX 2019

Leak Detection Associates Announces Participation in INTERPHEX 2019


Leak Detection Associates, the leading global supplier of helium based leak detection systems for the Pharmaceutical, Biotechnology and Medical Device Industries, is excited to announce that it will be returning to INTERPHEX in 2019. Leak Detection Associates changed ownership in early February 2019 and the newly installed and highly experienced management team immediately marked Interphex as the show to be at. The event will be held on April 2nd through 4th at New York City’s Javits Convention Center. Leak Detection Associates will be located in booth 3115 and be part of the Container Closure Integrity designated exhibit hall section alongside Package Technologies Inc. (PTI), Nikka Densok USA Inc., Genesis Packaging, Lighthouse Instruments and Lenox Laser. Collectively, this group of instrument manufacturers and service providers represents the world’s leading companies dedicated and committed to Container Closure Integrity.

“INTEPRHEX provides the ideal platform for Leak Detection Associates to engage with current and potential clients,” commented Director of Engineering Jeff Morrow Lucas. “We are excited about a number of key company initiatives that will yield further improvements to our instrument platform, technology, and service offerings. INTERPHEX is an excellent event to share these developments with the industry.”

As stated on the INTERPHEX home page, “For 40 years, INTERPHEX has proven to be the place to find all of the State-of-the-Art Solutions you need to Cost Effectively Develop and Manufacture Quality Product. INTERPHEX is the premier pharmaceutical, biotechnology, and device development and manufacturing event where you can “Experience Science through Commercialization”. INTERPHEX brings over 11,000 global industry professionals and 650 plus leading suppliers together to “Learn It, Experience It, Procure It” through a combination of no cost technical conferences, exhibits, demonstrations, and networking events to leverage quality, efficiency and cost effectiveness in today’s ever-changing global market.”

In addition, the educational programs offered touch on a wide range of relevant and critical topics that are key to success in ever changing drug and device discovery, development, approval and manufacturing processes. Attendees are provided a number of unique knowledge-based tracks to follow and thus have the ability to learn to learn about a wide variety of interrelated topics that are critical to success within in their own organizations. To learn more about INTERPHEX 2019, please visit http://www.interphex.com where you can review the program, view the companies exhibiting and register to attend.

interphex 2019, supplier of helium based leak detection systems
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.

helium leak testing, helium test, advantages of using helium for leak testing
May 2020

Leak Detection Associates to Serve as Technical Presenter at PDA Europe CCIT Training Course

Leak Detection Associates to Serve as Technical Presenter at PDA Europe CCIT Training Course


Download Presetation – 2020 PDA Container Closure Integrity Workshop

Leak Detection Associates, the leading global supplier of helium based leak detection systems for the Pharmaceutical, Biotechnology and Medical Device Industries, is excited to announce that it will be a contributing instrument manufacturer and technical presenter at the Parenteral Drug Association (PDA) Container Closure Integrity Testing Basic Training Course. Held in conjunction with PDA Europe’s 10th Parenteral Packaging Conference, the two-day training program encompasses presentations on theory and real-life applications of all deterministic container closure integrity test (CCIT) technologies referenced in USP 1207. Critically, participating attendees are given the opportunity to witness demonstrations of actual instrumentation, with the unique opportunity for hands-on use in an engaging and learning-based environment.

The PDA 10th Parenteral Packaging Conference will be held in Basel, Switzerland on February 25th & 26th and the CCI specific training course is scheduled to follow on February 26th & 27th. Presenting on behalf of Leak Detection Associates will be Brian Mulhall, CEO and former Founder/President of Whitehouse Analytical Laboratories, while Jeff Morrow Lucas, LDA’s Director of Engineering, will host the hands-on technical training for attendees. In support of these technical presentations and hands-on activities, Leak Detection Associates will be providing its newest model, the SIMS 1915+ Helium Leak Detection System. Attendees will gain an understanding of how the system can be used to establish inherent integrity, optimize manufacturing, and more for a range of package systems and at extreme levels of sensitivity. LDA will also be featuring its new, low temperature add-on system that enables analysis of packages down to -80°C, critical for product-packages stored at these aggressive temperatures.

“We are extremely excited to be part of this highly educational event to specifically represent a key test method for container and package integrity testing specific to USP 1207 requirements,” commented Brian Mulhall, LDA’s CEO. “For more than 20 years, Leak Detection Associates has held a leadership role in the development and use of helium technology for container leak testing and having the opportunity to advance our knowledge and experience as part of a unique training seminar such as this will enable the value of helium leak testing to be shared with many relevant participants who are looking for CCI solutions in this highly regulated area.”

This course focuses on theoretical and practical fundamentals of various CCI testing technologies and provides a systematic approach to apply these testing methods for CCI verification throughout drug product lifecycles. The course, as a whole, will enable the participants to implement CCI testing strategies to ensure adequate drug product protection and be compliant with relevant regulatory and compendial requirements. In this course, participants gain critical problem-solving skills through:

  • Interactive discussions with a panel of cross-functional technical experts consisting of CCI testing laboratory experts, testing instrument suppliers/manufacturers, and pharmaceutical packaging development engineers
  • Hands-on testing training on the newest innovations and state-of-the-art instruments
  • Real-world case studies

Being held in conjunction with the 10th Parenteral Packaging Conference, this training course will utilize lectures, case studies, and interactive hands-on training on testing instruments to provide insight into the latest developments of Container Closure Integrity (CCI) Testing. It is expected that participants will develop an understanding of the most up-to-date regulatory and pharmacopeia requirements on CCIT while learning how to define CCI requirements for various container and drug product types using a risk-based approach. The key focus will be on practical applications using the deterministic methods such as tracer gas detection (e.g. helium leak detection), electrical conductivity and capacitance (HVLD), vacuum decay leak detection, laser-based gas headspace analysis, and mass extraction leak tests. Other key topic areas to be covered include selecting and applying appropriate testing methods for both laboratory and in-process testing to formulate comprehensive package integrity verification profiles, defining CCI testing method development and validation approaches and best practices, and avoiding common issues and pitfalls in CCI testing applications. To learn more about the conference and to register for attendance at this valuable training course, please visit http://www.pda.org.


Parenteral Packaging Conference, Container Closure Integrity Testing, SIMS 1915+ Helium Leak Detection System

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