Trusted GxP compliance for simple or complex storage facilities
Whether GMP, GDP, or HACCP, cold rooms and warehouses must be monitored by an independent monitoring system — regardless of whether raw materials, pharmaceutical products or foodstuffs are involved. During the qualification of the room, monitoring points for temperature and relative humidity are identified. To select the right monitoring solution in warehouses, the following questions arise:
Determining the location and number of temperature measurement points in the warehouse
The number of temperature measuring points in a GxP-qualified cold store or warehouse is determined by means of a winter and a summer mapping. This results in the warmest and coldest points where the temperature must be continuously monitored. In very large warehouses, temperature sensors are sometimes installed at additional locations for safety and risk considerations.
Does humidity need to be monitored in the warehouse? Where?
GDP does not make any firm regulations regarding humidity. In the GMP environment where open products are stored or processed, humidity must be monitored. Relative humidity plays an important role in the quality of many other products. Humidity is distributed very quickly and homogeneously within a room. It is therefore usually sufficient to monitor the relative humidity per room at a single central point.
In a small non-qualified indoor space where goods are stored at room temperature, it is often sufficient to monitor the temperature
at a single, central measuring point. In the following video, we discuss the requirements and present three possible solutions.
See the table below for a direct product comparison of three monitoring solutions for a single storage room.
If you just need compliant monitoring.
If you need compliant monitoring and want local alarming.
If you need compliant monitoring and want remote alarming also on weekends & holidays.
Cold rooms, warehouses and handling areas in the GxP environment need to be qualified and monitored. In this video, we discuss the requirements and solutions for larger warehouses.
In the table below you will get a direct product comparison of three monitoring solutions suitable to monitor temperature and humidity in large warehouses.
Easy installation, without local network.
Local antenna and battery powered wireless sensors.
Everything under own control: network, software and data.
Are your storage facilities spread across different buildings - or even different locations or countries? Do you also need to monitor intra-logistics as goods move between warehouses and locations? In this video, we discuss the requirements and solutions for distributed infrastructure and moving objects.
In the following table you will get a direct product comparison of two monitoring solutions that are suitable for distributed structures.
Suitable for single measurement points in a distributed infrastructure, outdoor warehouses and intra-logistics (containers, trucks).
Suitable for a distributed infrastructure in places where there are several measuring points in the same building.
Rooms in which pharmaceutical products are stored - in GMP, GDP or GLP environments - must be qualified. Qualification is proof that a room fulfills its intended purpose: Qualification certifies that the storage or cold room is suitable for intended use and that the defined temperature range is uniformly maintained at each storage position.