The location and environmental requirements of the weighing chamber in biopharmaceutical production

In the biopharmaceutical production process, the layout of the weighing room is very critical. Generally speaking, it is often in the front end of raw materials into the production process, is the entry point and transition point of materials from the warehouse into the treatment area, and will be adjacent to the raw material temporary storage area, product area, etc., to facilitate the flow of materials and the next step of processing.
There are strict requirements for the weighing room environment. The first is cleanliness, the 2010 version of GMP stipulates that the weighing room must be consistent with the environmental cleanliness of production and feeding, and there must be protective measures to prevent cross-contamination of the work area. Therefore, the cleanliness of the weighing room must reach grade A for bacteria-free drugs, and grade C or Grade B for non-bacteria-free drugs.
Temperature and humidity also have a corresponding standard range, in the absence of special requirements, the temperature should be controlled at 18-26 degrees Celsius, with relative humidity control at 45%-65%, such a temperature and humidity environment helps to ensure the accuracy of the weighing operation and the stability of all kinds of materials, to avoid moisture, deterioration or affect the accuracy of the weighing instrument due to inappropriate temperature and humidity.
In addition, in terms of pressure difference, the static pressure difference between adjacent rooms with different air cleanliness levels should be greater than 5Pa, the static pressure difference between the weighing room and the outdoor atmosphere should be greater than 10Pa, and there should be a device indicating the pressure difference, to ensure the reasonable flow of air, prevent the outside unclean air into the weighing room to cause pollution, or the air outflow with dust in the weighing room to affect other areas. At the same time, the surrounding area of the weighing room should also minimize interference factors such as dust sources and focal points to ensure that it can play a role in a relatively stable and clean environment.