According to GMP/GDP, modern production and storage of pharmaceuticals are high-tech facilities that use HVAC systems to ensure their efficient operation. The main purpose of these systems is to maintain optimal microclimate parameters for ensuring proper conditions.
It is impossible to determine visually whether medicinal products were exposed to adverse conditions (temperature, humidity, etc.). If a medicinal product loses some or all of its quality, its outward appearance may be unchanged in most cases. Monitoring of storage conditions is the main instrument to ensure the integrity and quality of medicinal products during their storage.
The monitoring system of storage conditions for pharmaceuticals is the system for recording, storage, and analysis of temperature and humidity data that provides the safe storage of pharmaceuticals and allows to identify deviations in the utility system operation.
Electronic devices (wireless recorders) are used for data recording. They record data in the internal memory and send the data to the monitoring system server. Wireless recorders are high-precision instruments designed for measuring temperature, humidity, atmospheric pressure, current, and pulse. For convenience, the devices are equipped with a display to help visually evaluate the measured parameters and an alarm to indicate deviations from the established acceptable conditions.
Wireless recorders provide flexibility in adding and/or relocating measurement points, ease of use, and ease of disassembly for performing their calibration and maintenance. An independent power source ensures data safety in the event of a power outage.
Special software compliant with FDA 21 CFR Part 11 manages data storage and analysis. The software allows users to choose their preferred language, has a friendly interface and many functions, having the ability to fully automate the data monitoring process.
The software enables to set alarm levels and action levels in the event of deviations from the established storage conditions and provides visual and audio alarms and text notifications via SMS or е-mail.
The pluggable cloud helps combine the farthest measurement points into a single network and perform monitoring from anywhere in the world.
Please contact specialists of Validation Center, if you need further information.