ABSTRACT
The majority of sterile dosage forms are solution
products; however, there are a number of sterile products
in which the API is not in solution, including both
suspensions and sterile powders. In many of these
products, the API is aseptically filtered while in solution
in an appropriate solvent system, and then crystallized
under aseptic conditions. The sterile solid is then separ-
ated from the liquid phase, dried, size modified as
needed, blended (if necessary) and then bulk packaged
for shipment to a dosage form site for final formulation
and/or filling. A similar process may be appropriate for
sterile additives that are used in these formulations
such as arginine hydrochloride and sodium carbonate.
In this chapter, sterile BPCs can be either APIs or sterile
excipients. Support for the aseptic processing activities
utilized in the production of all sterile BPCs is a regulat-
ory requirement (1).
