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.

Readmore...
helium leak testing, helium leak detection for prefilled syringes
189
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

Readmore...
helium leak testing, SIMS 1915+, helium leak detection system, benefits of SIMS 1915+
280
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 small”. 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.

Readmore...
helium leak testing, helium test, advantages of using helium for leak testing
219

Popular Blogs

Tags

2019 PDA Container Closure Integrity Testing Workshop Presentation

Nov 03, 2020   |   284

The 2019 PDA Container Closure Integrity Testing Workshop in Gothenburg, Sweden, had the following presentation that was given as a 20 minute introduction to the use of helium leak detection for container closure integrity testing (CCIT).

Leak Detection Associates Announces New and Updated Helium Leak Detection System

Nov 01, 2020   |   280

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.

Leak Detection Associates Celebrates Major 2019 Milestones

Dec 27, 2019   |   262

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.

The Advantages of Using Helium for Leak Testing

May 13, 2020   |   219

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.

History of Helium Leak Detection

Nov 05, 2020   |   211

The genesis for the use of helium as a method for leak detection can be traced back to the 1940’s and the Manhattan Project. It was determined that helium flow as sensitive as 10-6 std?cm3 could easily be detected.
COPYRIGHT 2020, LDA, ALL RIGHTS RESERVED PRIVACY AND COOKIES
Popup