Modbus TCP-IP interface of particle and microbiological counts for the sterile manipulation of highly potent active ingredients

Highly active ingredients require special rules for their production, because accidental contamination with other materials could have serious consequences, for the health of patients and because they, could also represent an occupational risk for personnel, who come into direct contact with these substances, during all production phases . As with regulations regarding the production and handling of some food products, even more attention must be paid to medicines. Among the greatest dangers associated with the production of any drug, and particularly during the production of those classified as highly active or sensitizing, we find cross-contamination (a term used to describe the process by which microorganisms or unwanted substances are transferred from a surface , food or object to another) characterized by the spread of germs. Above all, GMPs underline the problem of contamination by substances that could be harmful to health, therefore the production of some products (in particular, sensitizing and/or highly active) must take place in dedicated areas in order to guarantee a clear separation of these substances from other materials [8]. The environmental and production process monitoring program is part of the overall CCS (Contamination Control Strategy) and is used to monitor controls aimed at minimizing the risk of microbial and particulate contamination. In this thesis work we will focus on Modbus interfacing with particle and microbiological counts as a control strategy to detect the presence of contaminants during the production phase of ingredients considered highly active.