When exposed to deep-cold or ultra-cold temperatures, physical changes to elastomeric components in particular can occur as materials reach or exceed their glass transition state, creating leaks at low temperatures that would otherwise not be observed while at room temperature. This type of leakage is typically observed at primary seal areas, such as that between an elastomeric closure and glass vial being used below-60C. Having a means to test container closure integrity while at these low temperatures enables manufacturers to gain insight into optimal package choice and design, as well as assembly parameters,
to minimize leakage and demonstrate robust understanding of a package system’s performance in accordance with USP 1207.
To meet the market need for evaluating fine leakage at cold temperatures, PTI’s engineering team has created the LT80, or Low Temperature -80°C, Test System for use with the PTI SIMS range of helium leak detectors. Incorporating an SP Corporation Chiller, PTI’s LT80 system allows for concurrent temperature conditioning, temperature monitoring, and helium leak testing of packages down to -80°C. The LT80 is available as an upgrade to existing PTI SIMS units in the field, or as a complete package: the PTI SIMS 1915+ LT80, which incorporates the recently released features of the industry-leading, Agilent Technologies-based SIMS 1915+ with 21 CFR Part 11 compliant SIMS Software. The PTI SIMS 1915+ LT80 package represents the first time a ready to order, off the shelf, Part 11 compliant helium leak testing system specifically configured for low temperature testing down to -80°C has been available in the marketplace.
Cold Storage Testing – Helium testing that utilizes the Cryo Chiller modules 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.
