Formulation and filling
include process steps that are necessary to get a purified active component into the final dosage form. The active ingredient is often stored in a frozen state and is first brought in the correct concentration using buffers. After the active component is ready, it is mixed with the inactive components of the drug. Thereby, it is especially important to follow and document the temperature and mixing time (see mixing) as an optimal environment (e.g. pH or ion concentration) for the active ingredient should be reached in which it is stable and functional 1. If the parameters are not met, inhomogeneity can occur which can impair the quality and quantity of the final product 1. Afterwards, the mixture must be transported from the formulation tank to the filling. After transportation the final sterilization, normally a sterile filtration, and the subsequent final filling take place 1.