Leak Detection Associates (LDA), the world’s premier manufacturer of custom built, helium-based leak testing instruments for the Pharmaceutical, Biotechnology, Medical Device and Food Packaging Industries is excited to announce its second major product launch of 2019. The new LDA LT80 (LOW TEMPERATURE -80C) helium leak testing system is designed for testing containers at temperatures as low as -80°C. Incorporating an SP Corporation Chiller, LDA’s LT80 system allows for concurrent temperature conditioning, temperature monitoring, and helium leak testing of packages. 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, incorporating 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.
“Many innovative biopharmaceutical products coming to market today feature proteins that typically degrade at room temperature. Companies continue to drive toward deeper cold storage to support these products, and are in need of developing container and package systems that can maintain container closure integrity at these challenging conditions and throughout the product lifecycle, as set forth by USP 1207,” commented Jeff Morrow Lucas Director of Engineering for Leak Detection Associates. “Based on expressed needs of the marketplace, the SIMS 1915+ LT80 unit is designed for this specific application – testing packages while at cold conditions down to -80C – and provides an easy to implement solution to this evolving need for analysis.”
The key objective of any CCI program is to ensure that the container closure system maintains integrity throughout its lifecycle by preventing ingress of elements detrimental to a product’s efficacy and sterility, such as microbes or reactive gases, or egress of product or package headspace. The freeze/thaw cycle that is common with biologically-based products frequently require extremely low storage and shipment 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. This is of particular relevance for those shipping on dry ice, which reaches temperatures down to approximately -78C. 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.
The new SIMS Model 1915+ LT80 model is available for immediate order and will be customized to client’s specific testing needs. Each SIMS 1915+ LT80 can be complimented with Leak Detection Associates’ robust service and contract offerings, custom test fixtures, and change parts to provide end-to-end leak testing solutions.