ABSTRACT
INTRODUCTION The preparation of many parenteral products must be accomplished by aseptic processing due to limitations of the formulation and/or container to withstand the conditions necessary for sterilization of the final dosage form. Considered in the simplest manner, the preparation of an aseptically processed product requires that the placement of a sterile material inside a sterile container, and securing that container with a sterile closure (Fig. 1).1 In practice, the task is substantially more complex, and successful aseptic processing entails a substantially larger number of considerations all of which can influence the outcome of the process (Fig. 2). Aseptic processing can be defined as
Rearranging the elements of the Parenteral Drug Association definition into similar activities is perhaps more useful as they provide a means for understanding the major concerns that must be addressed to assure sterility of the materials being produced. Successful aseptic processing requires at a minimum the following: Suitably developed and validated sterilization processes for the components, formulation,
and equipment product contact parts. Establishment/maintenance of a suitable environment in which microbial contamination is
controlled appropriately to mitigate contamination risk. Defined methods for the set-up and operation of the sterilized equipment. Appropriately gowned and trained individuals to conduct the process in the prescribed
manner. A monitoring program for the assessment of contamination control on an ongoing basis.
