Every pharmaceutical product must be put on stability trial. Even when it has been approved, it is typical to continue stability trials, which monitor quality throughout the product lifetime. Storage conditions in stability chambers and warehouses have been standardized to a degree.
Usual conditions are 25 °C at 60% RH and 40 °C at 75% RH. However, with biotechnology and more biological products being developed, storage at -20, -40 and even -80 °C is not unusual. A few products are kept in comparatively small cabinets, but bulk materials are frequently stored in extremely big warehouses or rooms. The usual storage conditions must not be different from the conditions of the stability trials.
Stability Chamber and Warehouse Storage Challenges
It can be time-consuming testing products for stability performance. While the material costs are marginal, the overall expense is comparatively high. Therefore, test quality and data validity are highly important. When storing the final product, whether in freezers or warehouses, it may result in stocks of several million EUR being held in one location. The expense of a monitoring system with alarm conditions is trivial in comparison to the value of the product that it protects.
Suitable Solutions from Ellab
Ellab endorses using both TrackSense® LAB Wireless Temperature Data Loggers and TrackSense® LAB Wireless Relative Humidity and Temperature Data Loggers. They are perfect for continuously monitoring and recording the temperature and humidity in environmental chambers, stability chambers and warehouses. The data loggers are fitted with an LED and have a variety of alarm functions, making it instantly clear when a cabinet has strayed from its usual conditions.
Image Credit: Ellab
Validation of Stability Chamber and Warehouse Processes
Qualification of stability chambers, warehouses and rooms does necessitate similar standards as those applied to the qualification of autoclaves, ovens, etc. Particularly for warehouses, one of the most vital measures is the calculation of MKT, Mean Kinetik Temperature, which is part of the ValSuite™ Software.
Several organizations depend on initial Operational Qualifications (OQ) to map cabinets and then continuous monitoring afterward. However, more companies have realized the need to intensify their process validation effort regarding stability chambers and, therefore, validate yearly.
Advantages of selecting Ellab data loggers for warehouse storage and stability chambers include:
- Minimizing the loss of product quality and value
- Built-in alarm functions
- Stable and dependable monitoring of stability chambers, rooms and warehouse storage
- Real-time data available thourgh SKY option
Image Credit: Ellab
This information has been sourced, reviewed and adapted from materials provided by Ellab.
For more information on this source, please visit Ellab.