The pharmaceutical industry depends on deep cold storage for delicate drug and biologic formulations, but traditional packaging may not withstand extreme temperatures, leading to potential leaks and degradation. PTI’s LT add-on units for SIMS helium leak detectors offer an innovative solution by evaluating package integrity at temperatures ranging from 0°C to -160°C. This advanced technology helps manufacturers identify defects and optimize packaging designs, ensuring superior performance under deep cold storage conditions.
LT Low Temperature Systems for SIMS Helium Leak Detectors
PTI’s SIMS 1915+ LT add-on units combine advanced helium leak detection with precise temperature conditioning to provide an effective solution for cold temperature leak detection. These systems are designed to test packages at ultra-low temperatures, ranging from 0°C to -160°C, ensuring package integrity is maintained in deep cold storage environments. Integrating a chiller allows the system to condition and monitor the package temperature while simultaneously conducting helium leak tests. Helium is introduced into the package, and any leaks, particularly in critical areas like elastomeric seals, are detected by the SIMS 1915+ helium leak detector.
This technology enables manufacturers to detect potential leaks in materials like elastomeric closures, which may become brittle or undergo physical changes at low temperatures. By evaluating package performance under cold conditions, manufacturers can optimize packaging designs to prevent leaks and maintain product quality. The LT systems improve product quality by identifying and addressing leaks early in the packaging process. Additionally, the system ensures compliance with regulatory standards such as USP 1207 and USP 382, ensuring product safety and reliability.
By combining precise temperature control with advanced helium leak testing, these systems help manufacturers identify and address potential leaks, particularly in critical areas like elastomeric seals. This technology not only enhances product quality but also improves packaging design and component evaluation to meet regulatory standards. Ultimately, the LT systems ensure the safety, reliability, and performance of delicate drug and biologic formulations in cold storage environments, ultimately protecting life-saving drugs and therapies.
helium leak testing, helium leak detection, pharmaceutical packaging, helium leak detection solutions
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