ABSTRACT
This chapter focuses on a few of the advanced technologies available for consideration in the design and installation of an isolated filling machine. The points presented are primarily applications associated with small-volume parenteral installations, but the concepts can be broadly applied to any isolated filling installation. As described in previous chapters, design is a very important element in the lifecycle of an advanced processing technology application. If the desire is to get past installation, and into operation with an isolated filler, design is critical. Not so many years ago it was fairly typical to piece together a washer, a tunnel, and a filling machine with a few turntables and some conveyors and assemble a filling line. With today’s advanced isolated technologies inclusive of integrated programmable controls and feedback loops this is no longer possible. From the conceptual design, through factory acceptance test (FAT), installation, and validation, every aspect of what is required for the users must be defined before the first piece of what will become the integrated filling train is fabricated. It is important to note the word “users” in the previous sentence, this it meant to emphasize that not only operations personnel, but also maintenance, engineering, environmental control, validation, certification, literally anyone who will have a function to perform within the isolator or supporting the isolated environment needs to have a level of involvement in the design. It is important to remember support groups such as materials planning. The planning group needs to fully understand the criticality in defining all product configurations that will be, or are planned to be running on the installation under design. Once a small-vial isolator is in place changing it over to run a 100-mL vial is probably not going to be possible without a significant reinvestment. All it takes is a visit to the mezzanine or that corner of the basement in the facility, to see at least a cage full of equipment where inadequate time in design resulted in a shiny piece ready for the scrap yard shortly after receipt. Isolated filling applications are not simply putting a box over the top of a traditional aseptic filling line and running it as usual. There will be issues that can only be visualized once the design is complete and a fully integrated mock-up is constructed. Only then can it be determined that the mechanics cannot reach the filling pumps or that a nonviable particulate horn is needed where there is a sidewall. So the first technology that is critical in the design of an isolated filler is not a technology at all. It can be foam board or plywood or any structural material set up as a complete and integrated mock-up of the proposed design. This relatively simple process will assure that the investment allocated on technologies supporting the isolated filler will not have to be redesigned, or worse designed out of the application, simply because they will not fit or are not appropriate as determined after installation.
