Challenges and Innovation in Aseptic Filling: Case Study with the Closed Vial Technology

Abstract

Aseptic filling of injectable drugs is one of the most critical manufacturing processes in the pharmaceutical manufacturing industry as it presents a significant risk for the patient in case of bacterial contamination. Therefore, a series of constraints are imposed to the manufacturers, leading to a very complex process requiring intensive validation, training and care during operation. To optimize this process, several improvements have been made, focusing on (1) the design of pharmaceutical facilities to ensure an optimal environment for the filling area, (2) optimal gowning of operator, and (3) separation of the operators from the filling area. Regarding containers, the pharmaceutical industry disposes of a wide range of solutions to aseptically fill injectable products. The most classical ones such as ampoules and vials are now challenged by new technologies which offer several advantages to the pharmaceutical manufacturer, to the healthcare practitioner and/or to the patient. Four recent technologies came to the market in the last decades, all of them with their own profile of advantages: on one side, the prefilled syringe and the cartridge which provide a ready-to-inject solution to the practitioner and the patient; on the other side, the blow-fill-seal container and the Closed Vial technology which offer a safer solution and an easier solution for the manufacturer. In this article, these new solutions are compared to the well-established ones and their profiles of advantages and disadvantages are detailed.