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.
“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