Before and after approval, all pharmaceutical products receive a mandatory stability trial. Post-approval stability trials continue to monitor quality throughout the product lifetime and storage conditions in stability chambers and warehouses have been partially standardized.
With biotechnology and biological product development, storage at -20, -40 and even -80 °C is common rather than the usual 25 °C at 60% RH and 40 °C at 75% RH. Bulk materials are often stored in large warehouses or rooms, and some products are kept in comparatively small cabinets. However, the storage conditions must not be different from the conditions of the stability trials.
Stability Chamber and Warehouse Storage Challenges
The cost of a monitoring system with an alarm is small in comparison to the value of the product it protects. Storing the final product in freezers or warehouses may result in several million Euro’s worth of stock being held in one location. Testing products for stability performance can be laborious, costly and take some time despite the material costs being marginal, which is why testing quality and data validity are vital.
Suitable Solutions from Ellab
Perfect for continuously monitoring and recording the temperature and humidity in environmental chambers, stability chambers and warehouses, TrackSense® LAB Wireless Temperature Data Loggers and TrackSense® LAB Wireless Relative Humidity and Temperature Data Loggers are endorsed by Ellab. The data loggers are fitted with an LED, along with several alarm functions, instantly aware of when a cabinet’s conditions have changed.
Image Credit: Ellab
Validation of Stability Chamber and Warehouse Processes
The qualification of stability chambers, warehouses and rooms requires similar standards to those in the qualification of autoclave, ovens, and so on. Part of the ValSuite™ Software, one of the most vital measures, particularly for warehouses, is the calculation of mean kinetic temperature (MKT).
Initial operational qualifications (OQ) are used by organizations to map cabinets and subsequently continuous monitoring. Many of the corporations have found it necessary to intensify their process validation effort in regard to stability chambers, therefore, validating annually.
The advantages of selecting Ellab data loggers for warehouse storage and stability chambers are built-in alarm functions, the minimization of losing quality and value, real-time data being available through the SKY option and stable monitoring of stability chambers, rooms and warehouse storage.
Image Credit: Ellab
Ellab Validation & Monitoring Solutions - Industry Leading Accuracy
Ellab has been your validation and monitoring partner since 1949, offering wireless data loggers and thermocouple systems for thermal validation processes as well as environmental wireless monitoring solutions.
We serve both small and large companies within the Life Science and Food industries and have solutions for almost all applications such as sterilization, freeze drying, environmental chamber testing, depyrogenation, warehouse mapping, pasteurization and many more.
In 2019 we joined forces with Hanwell Solutions Ltd. in UK in order to expand our product offering to cover industry leading wireless environmental monitoring systems.
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