This review article will provide general guidance to product development scientists for the
justification for the use of aseptic filling for sterile injectable products in the place of terminal …

The sterility test has been utilized for many years to formally support the sterile release of
products terminally sterilized by moist heat and other sterilization modalities. It is well-known …

The design, validation, and monitored delivery of the sterilization process, and validated
post-process integrity of the product package are the primary means to assure the end-use …

Aseptic processing offers many advantages over terminal sterilization, including increased
product shelf life and a lower incidence of sterilization-induced impurities such as …

With the increase in emphasis by the FDA on sterility assurance, representatives of the FDA
have made statements regarding upcoming guidelines for parenteral processing mandating …

Sterile products have several unique dosage form properties, such as freedom from micro-
organisms, freedom from pyrogens, freedom from particulates, and extremely high standards …

The FDA has issued proposed regulations to require that manufacturer's evaluate the “steam
sterilizability” of parenteral products. There are many different ways to assess sterilizability …

Aseptic filling is an aseptic process that requires the close coordination and complex
interaction between personnel, sterilized product, the fill/finish equipment system, clean …

Terminal sterilization is considered the preferred means for the production of sterile drug
products because it affords enhanced safety for the patient as the formulation is filled into its …

Terminal sterilization is considered the preferred means for the production of sterile drug
products because it affords enhanced safety for the patient as the formulation is filled into its …