Stability chambers and stability rooms are temperature-controlled and humidity-controlled environmental units that provide stable conditions for storage and testing purposes. These specialized environmental chambers provide a precise, elevated temperature and/or humidity to determine if there is long-term, intermediate, and accelerated degradation of a product or its packaging over time. Some stability chambers and stability test rooms are designed for shelf life evaluation, shelf life determination, and shelf life testing. Others are suitable for biomedical storage, stability research, drug research, and overall stability testing. Typically, stability chambers and rooms are used to store pharmaceutical and biotechnology products. Product stability, product degradation, packaging stability, and container stability are important variables to measure to ensure compliance with published standards for testing drugs, drug substances, active pharmaceutical ingredients (APIs), foods, life science materials, medical devices, and biomedical supplies.

 

FDA/ICH stability chambers and stability rooms meet requirements from the U.S. Food and Drug Administration (FDA) and the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The FDA’s Q1A standard for the stability testing of new drug substances and products is designed to provide guidance to industry. The drug substance section in Q1A contains subsections about stress testing, batch selection, container closure systems, testing frequency, storage conditions, and stability commitment. The drug product section in Q1A contains many of these same subsections, along with photostability testing and labeling guidelines. In terms of stability commitment, the same stability protocol for long-term studies should be used with primary batches that are tested in stability chambers and rooms.

 

Stability chambers and stability rooms that provide accelerated stability testing are used to determine product stability, product degradation, and packaging stability. Specialized stability chambers and stability rooms are used to measure drug stability, vitamin stability, container stability, pharmaceutical product stability, and food stability. Some stability chambers and rooms feature stainless steel construction and options such as redundant heating capacity and redundant cooling capacity. Others have NIST-traceable sensors and instrumentation that meet guidelines from the National Institute of Standards and Technology (NIST). Stability cabinets, stability enclosures, and stability test chambers that comply with other standards are also available. Often, these stability chambers and rooms may also meet requirements from the National Science Foundation (NSF).