Complex drug and biologic formulations have resulted in a continuous drive toward deeper cold storage in an effort to maintain product quality attributes.
In an effort to maintain product quality attributes of increasingly complex and delicate formulations, life science companies continue to drive toward deeper cold storage. These products, often cell or gene therapies, or proteinaceous in nature, often require storage at temperatures below -20°C, and are involved in storage and distribution environments incorporating dry ice (~-78.5°C), or even liquid nitrogen (~-200°C).
While the products demanding such intense cold storage may be complex, oftentimes, the package systems in which the products are placed are rather traditional in nature, such as a screw or crimp top vial. However, at these temperatures, many of the materials used in these package systems and responsible for maintaining package integrity are not typically assessed at these temperatures. 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, LDA’s engineering team has created the LT80, or Low Temperature -80°C, Test System for use with the LDA SIMS range of helium leak detectors. Incorporating an SP Corporation Chiller, LDA’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 LDA SIMS units in the field, or as a complete package: the LDA 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 LDA 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.