Mission for success

LEAK DETECTION ASSOCIATES

Developing, manufacturing and installing integrated helium leak detection systems for more than 25+ Years

SIMS 1284+ Helium Leak Detector

Seal Integrity Monitoring System

Leak Detection Associates manufactures high sensitivity leak detection systems for the pharmaceutical, medical device and food industries.  Our present helium leak test system, called the SIMS 1284+, combines the latest in helium leak detection technology along with our SIMS software for data collection and analysis. Using helium as a tracer gas, packages can be quantitatively tested to levels far exceeding bubble/dye penetration tests, pressure decay, mass extraction, and high voltage leak detection. Our systems follow the guidelines set forth by USP 1207 and more specifically by ASTM F2391-05. This test method description was authored by Leak Detection Associates.

Quantitative leak rate data not only provides pass/fail package seal quality and container closure integrity, but allows for direct comparison across various packaging materials/forms, production line settings, and stability storage conditions. The technology and equipment can be used for package design, tooling qualification, production line setup and package quality monitoring.

Our systems are ideally suited for packages (cold form aluminum blisters, foil pouches, vials, syringes, and cartridges) requiring a higher level of seal and closure integrity to provide gas permeation or microbial ingress protection/security. With proper test fixtures to eliminate helium permeation, plastic packaging components (vials, syringes, and cartridges for example) can utilize the helium leak methodology.

Leak Detection Associates is considered the world leader in pharmaceutical helium leak detection, as well as other industries, with our strong technical background and years of experience.

The technology and equipment can be used for package design, failure analysis, tooling qualification, line setup and validation, and product quality monitoring. LDA also provides package testing and consulting services. Pharmaceutical, contract packaging, and medical device companies in thirteen countries around the world are presently employing our testing machines and utilizing our technical support and testing services.

Helium leak detection technology is used to confirm the presence or absence of channels and/or holes in packages; in effect, provides verification of package integrity.

The detection of these defects involves the use of a light tracer gas which is capable of locating even the smallest leak quickly. The turnkey SIMS 1284+ unit, offered by LDA, Inc., measures the helium flow rate escaping from the test package through any and all leaks that are present thanks to a calibrated helium-specific mass spectrometer. The rate at which helium escapes from a package can be closely correlated to the rate at which water vapor, oxygen or other gasses may enter or escape from a package.

Packages are filled with helium on-line, or off-line, and then placed in a Vacuum Test Fixture Module to measure the rate at which helium escapes from the package. A Head-Space Analysis Module is then used to measure the concentration of helium in the package, and provide an Actual Helium Leak Rate. Obtaining the helium concentration level normalizes the leak rate to 100% helium, thereby allowing a direct comparison between various package forms and packaging conditions.

The SIMS 1284+ Helium Leak Detector is ideally suited for a wide variety of packages (cold form blisters, foil pouches, parenteral vials, etc.) requiring a higher level of seal integrity to provide gas permeation or microbial ingress protection and security. It is also a reliable means of ensuring properly sealed packages at the onset of stability packaging runs.

Quality verification of stability test packages have saved some of our customers thousands of dollars by not having to re-start stability studies due to poorly sealed packages.

We offer different versions of the basic pharmaceutical SIMS unit which are available for purchase/lease as well as rental options with technical support and R & D programs. While there are common elements to each SIMS Unit, there are also product-specific custom elements that are designed to meet the needs of a given client.

 Pharmaceutical Helium Leak Testing services on a project or contract basis – On-site or Off-site.

 On-site Installation, Validation, and Training services for our helium leak testing units.

 Industrial Helium Leak Testing services such as weld seams, vessels, pump casings, valves, etc.

 Test Methodology development and Design of Experiment (DOE) capabilities.

 On-Site Technical Support and Consulting for Helium Leak applications.

 Package Design and Development.

Frequently Asked Questions 
Q.
Why Helium?
A.
Helium is a non-flammable, colorless, odorless gas. Its concentration in the atmosphere is 5-50 ppm. Its small molecular size and ease of quantitative detectability make it an ideal medium for leak detection.
Q.
Why use a helium leak detector?
A.
Helium leak detection offers unparalleled sensitivity for finding leaks. It is quantitative, giving an accurate measurement of the rate of a leak, as opposed to the pass/fail results obtained with bubble/dye penetration tests, pressure decay, mass extraction, and high voltage leak detection.
Q.
How sensitive is it?
A.

Helium leak testers offer a sensitivity of 1 x 10-10cc/s.

Vacuum Bubble/Dye Penetration 1 to .0001 cc/s Pressure Decay 1 to 1×10-5 cc/s Helium Leak Detection 1 to 1×10-10cc/s
Q.
How versatile is it?
A.
Helium leak testers cover the sensitivity ranges of other methods and up to a million times beyond.
Sensitivity
Std.
cc/sec
Time
for 1 cc
to leak
Bubble
Time
In Water
 
1×10-1
10
seconds
1.3
seconds
 
1×10-2
100
seconds
13.3
seconds
 
1×10-3
16.7
minutes
14.5
minutes
Dye
Penetration
Test
1×10-4
2.8
hours
24
minutes
Pressure
Decay Test
1×10-5
27.8
hours
4
hours
Microbial
Ingress Limit
1×10-6
11.6
days
>
1 day
 
1×10-7
3.9
months
——–
 
1×10-8
3.2
years
——–
Gas/Vapor
Protection
1×10-9
32
years
——–
Helium
Leak Test
1×10-10
320
years
——–
Q.
Who uses helium leak detectors?
A.
Our clients include pharmaceutical clients such as Merck/MSD, Pfizer, Amgen, Novartis, Bristol-Myers Squibb, West Pharmaceutical Services, Noven Pharmaceutical, and Lohmann Therapy Systems.
“In improving our container/closure integrity testing capabilities, we found a valuable business partner in LDA. The LDA equipment has an excellent reputation. Pre-purchase discussions and negotiations were factual and courteous. Lead times were respected and training was provided as described in the contract. LDA was very helpful in after-sales service.”

– Renaud Janssen, Head of Regulatory Affairs and Chemical Compliance, R&D and Innovation – Datwyler Pharma Packaging International NV


“For over ten years Leak Detection Associates has been our go-to source for timely and quality leak detection services. Using a third-party testing service provides our customers with independent verification that products meet or exceed specified leak rate requirements.”

– Teikoku USA/Chempump


The LDA helium leak detection system is suitable for development and routine operations. The system is easy to operate and delivers fast results with great sensitivity.”

– Rasmus Damgaard, Senior Project Manager – Novo Nordisk A/S

ON SITE

Validation Available

These systems are completely self-contained and we offer on-site validation packages for both the hardware and software. It offers the most sensitive means of determining seal quality and seal integrity. No other test device can match the sensitivity of the helium method. 

Contact Us.