Emerging Fourth Generation Pharmaceutical Containment Technologies

By Sterling Kline, RA IPS

Barrier technology has become overwhelmingly accepted as the basis for new aseptic processing facilities in 2013. The traditional clean room facilities of the 20th century are being rapidly replaced with advanced barrier based technology filling facilities. This technological evolution is dramatically reducing the risk of product contamination and risk of infection to patients.

In the 20th century, aseptic filling was performed in class 100 (ISO 5) clean rooms. Risk of product contamination existed from 1) personnel through constant interventions in the filling process and 2) questionable techniques and procedures in transferring product, components and change parts into the class 100 aseptic facility core. The environmental risk to product was increased with the evolution of European guidance allowing a class 10,000 (ISO7) background room classification. How do you transfer components and change parts through a class 10,000 (ISO7) room directly into the class 100 (ISO 5) filler without transition space? How do personnel operating in a class 10,000 environment reach into a filling machine for interventions, manual cleaning and sanitization? Neither can be done without significant risk to the product.