Sterile Injectable Division manufacturing of injectable has been at the forefront of both industry news and drug developers’ minds recently for a variety of reasons unfair by capacity. An increase in demand for parenteral drugs, driven by growth in biologics R&D, has created greater demands for capacity. However, the financial investment needed to establish an sterile fill-finish operation in addition to the challenges in realizing and maintaining compliance presents a significant barrier to any obvious short-term solution for increased capacity.
A higher number of sterile industrialists and increased Sterile Inspection by the has also improved capacity issues, as unsuccessful inspections have led to temporary shutdowns in order to address compliance concerns.
