Helium Testing

PTI offers a full range of Helium Leak Testing Services that will be conducted by our CCIT Centers of Excellence, located in Hawthorne, New York and St-Prex, Switzerland. Testing can be in support of R & D work, component/material selection, packaging equipment qualification, and on-going quality monitoring.

Expertise: Our organization boasts a wealth of knowledge and experience in helium leak testing. We have a proven track record of assisting pharmaceutical companies in assuring packaging integrity. From start-up entities to large pharmaceutical organizations, we have worked with a wide variety of clients.

Prime Test Method: Helium Leak Testing is the prime method for Package Development and R&D data. It provides precise, quantifiable, reliable results crucial for your packaging development process and quality requirements.

Wide Application Experience: We have successfully provided Helium Leak Testing services across the pharmaceutical and industrial sectors. Our extensive experience allows us to tailor our approach to meet your specific needs. Whether you have ten samples or hundreds, we can provide the proper helium leak test method and develop the data you require.

Show more Show Less

Download

PTI-Helium Leak Testing Services-Pharma2024
PTI Comprehensive Services Brochure
PTI Life Science Services brochure

CCIT Helium Leak Testing Services

As you consider Helium Leak Testing for pharmaceutical packaging, you'll appreciate our approach:

Cost-Efficiency – Unlike some testing methods, we can generate leak rate data without the need for a full feasibility study. This not only saves significant time but also eliminates unnecessary expenses.

Reliable Data – With Helium Leak being a Deterministic method, there are no questionable results as would be the case of probabilistic methods. No operator subjectivity.

Time Savings – Compared to headspace analysis, helium leak testing can be performed in less than a day as opposed to many days.

Flexibility – We offer the flexibility to tailor our testing services to your specific needs without the added expense of operating under strict GMP guidelines.

For Pharmaceutical Package applications, we can readily test the following container formats:

Vials: Glass & Plastic versions – crimp seal only or entire vial container.
Cold Temperature Vial Leak Testing – temp range -20° to -160°C.
Syringes & Cartridges - Glass & Plastic versions – Plunger, Crimp, & Needle Shield seal areas.
Foil Blister Cards & Foil Sachets/Pouches – heat seal perimeter and entire package seal.
Tubes – Foil and Foil Laminate versions – Closure/threaded cap & crimp end seals.
IV Bags utilizing the Helium Sniffer Mode test process.
Plastic Containers/Bottles – Closure/threaded cap & Induction seal areas.
Devices – single leak sites or multiple locations can be analyzed.

Cold Storage Testing – Helium testing service that utilizes the Cryo Chiller module to test products which need to be stored at subzero ultra cold temperatures.

Samples can be tested at a wide range of temperatures: from –20° to –160°C.
Both Glass and Polymer (plastic) can be used for low-temperature helium leak rate analysis.

Show more Show Less

914.337.2005