ABSTRACT
The formulation system typically consists of a bulk vessel containing concentrated active ingredient, a bulk vessel containing diluent, a sterilizable dilution vessel with mixing capability, a scale or load cell, disposable tubing or stainless steel piping, and a pump or pressure delivery system for transfer. The dilution vessel is chosen to accommodate the range of possible diluted batch sizes. Once a homogeneous state is established in the bulk vessel, the filling system must accurately and aseptically deliver a set volume to the product’s primary container. Delivery of homogeneous suspension product is often aided by recirculation loops on the bulk vessel, with the filling system drawing product from the recirculation loop. Sterility of drug product is assured through good aseptic processing design along with terminal product sterilization or a sterile filtration unit operation. The goal of sterile filtration is to render the filtrate free of viable microorganisms.
