
Automated Low and Ultra-Low Temperature Storage in Regulated Environments
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Maintaining sample integrity and operational efficiency is critical in regulated environments. This is especially true in clinical research, including drug stability studies and clinical trial sample storage, as well as in pharmaceutical manufacturing, where precise handling and storage of finished products are essential. Manual storage methods often present challenges, such as temperature fluctuations, limited audit trail options, inefficient workflows, lack of scalability, and labor-intensive processes. Additionally, ensuring compliance with regulatory GxP standards, including GAMP5 and 21 CFR Part 11, requires precise environmental control and comprehensive sample traceability—both of which can be difficult to achieve with manual processes.
This review explores the implementation of automated systems for ultra-low temperature (ULT) (-for -80°C) and low temperature (-20°C) storage across three key application areas: syringe storage and handling for drug quality control; large-bottle Active Pharmaceutical Ingredient (API) storage and handling; and tube storage for clinical trial serum samples. The purpose for developing these systems included protecting sample integrity, streamlining workflows, and enhancing compliance through real-time temperature monitoring, automation, and validated processes.

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