Modern ambient warehouse, designed in accordance with the guidelines of Good Distribution and Good Storage Practices, equipped with modern systems of air conditioning and monitoring as well as a specially designed shelving system, allows storage of medications and medical equipment that follows the highest standards.
The prescribed limit values of temperature in ambient part of the warehouse are 15-25 °C .
Monitoring of temperature and relative humidity is achieved through a validated software VTP μSCADA which is in accordance with standard 21CFR part 11.
In addition to controlled ambient conditions, medications are stored in cold chambers at 2-8°C, which are validated and operate fully automated and independent.
Furthermore, we offer our clients the option of storage below 0°C, specifically ranging from (-25°C) to (-15°C). A validated freezing chamber has become part of our facility, providing a secure storage space for clinical trial materials requiring such storage conditions.
A pre-chamber at 2-8°C is located in front of all cold rooms and the freezing chamber as an anteroom, protecting them from uncontrolled influx of warmer air and ensuring stable temperature conditions in all chambers.
The prescribed temperature limits in the pre-chamber, cold rooms, and freezing chamber are as follows:
– Pre-chamber: 2-8°C
– Cold chamber: 2-8°C
– Freezing chamber: (-25°C) – (-15°C)
Transportation of goods is performed via our own validated delivery vehicles adapted for the transport of pharmaceutical products.
The loading space of the vehicle is insulated and has a device to maintain the prescribed temperature regimes during transport, in all weather conditions (winter and summer).
By installing a thermograph with a printer in the vehicle, it is possible to print the temperature range of the space in which the goods were held during transport.
Goods can be accompanied by a validated digital temperature gauges, which are placed next to the medications, in order to adittionaly monitor and appropriately document changes in temperature.