Isolators are increasingly installed in pharmaceutical production laboratories due to the increased handling of hazardous drug ingredients as well as the need for smaller batches and more flexible production environments. Isolators can potentially lower the installation and maintenance costs compared to large scale cleanroom environments. While manufacturing facilities have established SOPs for isolators, this article focuses on the importance of proper cleaning and wiping procedures.

ISOLATORS AND DECONTAMINATION
Decontamination is the reduction or removal of biological or chemical agents, including non-active particles to non-hazardous levels to products, processes, or the environment by means of physical or chemical procedures.

Specifically in pharmaceutical manufacturing environments, research laboratories, and hospital pharmacies, the effective decontamination of biological agents like bacteria, viruses, fungi, protozoa, prions, and spores is essential.

Isolators like fume hoods, biosafety cabinets, and gloveboxes are used to create environments with low levels of environmental pollutants such as biological agents, aerosol particles, and dust. These separative devices have a controlled level of contamination, specified by the number of particles with a defined size per cubic meter, providing controlled environments that are specifically tailored to the needs of its operator. This classification of cleanrooms and isolators, however, is not taking into account specific requirements regarding biological contamination. In order to maintain the low levels of environmental pollutants, isolators have to be decontaminated on a regular basis.

ISOLATOR CLEANLINESS
Isolator cleanliness levels are defined by different classifications, shown in Table 1 and Table 2. These classifications are evaluating the environmental pollution by particles, however, not taking into account specific requirements regarding biological contamination. In order to maintain the low levels of environmental pollutants, isolators have to be decontaminated on a regular basis.

Quality supervisors in facilities using isolators have to determine the acceptable level of biological agents in their respective environment and decide on the method to achieve these levels. Several factors influence the choice of method and materials.