Fill finish processing is perilous in biotech product manufacturing where the product value, and hence the risk, is high. Because of its criticality, fill finish has historically been an area with a focus on “proven solutions” and less innovation, but due to current shift in the pharmaceutical industry, this is changing.
An increasing trend towards small batch sizes is pushing manufacturers to increase the level of flexibility of aseptic production. Processes need to accommodate multiple products – products which are high in value, very sensitive, highly potent and produced in smaller batch sizes. This brings about a need for facilities that can provide more flexibility, decrease investment costs and increase productivity for smaller batch sizes (format change, cleaning, sterilization, maintenance, qualification etc.).
We at Pharma Access help customers design and implement future-proof solutions for fill-finish facilities. We apply our process technology knowledge from conceptual design over commissioning and qualification to operational support with complete engineering within the entire fill-finish area to supply a full range of services to our clients.