The production of pharmaceuticals is strictly regulated throughout manufacturing, storage, and distribution — especially in the cleanroom. Whether in the laboratory or during production, pharmaceutical products are particularly susceptible to contamination or detrimental effects of harmful environmental conditions because they are not yet packaged. Therefore, monitoring a wide range of parameters in the cleanroom plays a significant role for the integrity and safety of the product.

This guide provides basic information on the regulatory and general requirements for the hardware and software of environmental monitoring solutions used in cleanrooms.