Listings in Cleaning Systems

Insufficient or inadequate cleaning can have various consequences. From a health point of view, an absence of good cleaning can lead to contaminated drugs with a risk for patients, but also for the workers within the pharmaceutical company due to a lack of correct protection. The ecological problems can be summarized in pollution risks. The regulatory issues are linked with warnings from agencies up to possible authorization withdrawn. Economic problems start with a diminution of production and stock shortage which imply increased internal costs and financial loss. In addition, image problems for a company exist when patients must return medications to the pharmacy as in the case of batch recall.

Contamination is a process with three main factors: the source of contamination (i.e. previous API or excipients, cleaning agents), the vector (for example, unclean apparatus or co-workers), and the receptor (for example, the next batch). Numerous solutions exist to break the links between the factors, and cleaning is one of the most critical. Cleaning should be efficient in all parts of the equipment, but also in rooms and for all the parts or places in which contamination could exist. Some zones which are not easy to clean (O rings, U-bend, etc.) are often called critical points that are defined as “zones or spots in systems on which an absence of control will bring an unacceptable risk for security.