ABSTRACT

During the filling of containers with a product, the most stringent requirements must be exercised to prevent contamination, particularly if the product has been sterilized by filtration and will not be sterilized in the final container. This process is called an aseptic fill and is validated with media fills (see chap. 21). The assurance of product sterility is supported by the design of the filling complex, the training of the operators, environmental monitoring, filter validation, and by mimicking the manufacturing process through media fills. During the filling operation, the product must be transferred from a bulk container or tank and subdivided into dose containers. This operation exposes the sterile product to the environment, equipment, and manipulative technique of the operators until it can be sealed in the dose container. Therefore, this operation is carried out with a minimum exposure time, even though maximum protection is provided by filling under a blanket of high efficiency particulate air (HEPA)-filtered laminar flow air within the aseptic area.