Pharmaceuticals Sterile Injectable Manufacturing and Filling Line produces a variety of products including liquid and lyophilized types, therefore a risk based rationale should be adopted with permutations and combination of Batch size, fill volume, filling speed, filling duration, container closure type, process or steam sterilization, product form (liquid or lyophilized), mode of product sterilization (filtration, terminal sterilization, aseptic process etc.), Inert gassing after filling of containers, equipment trail etc.
