ABSTRACT
INTRODUCTION Sterile products are frequently administered to patients through the dermal layer to attain rapid therapeutic response and accurate dosing. Delivery in this manner intentionally circumvents the body’s protective mechanisms, and mandates that the product be largely free of infectious microorganisms and endotoxin. These concerns are heightened when the drug is delivered to patients whose health is already compromised as is common in clinical settings. Awareness of the patient has prompted regulatory preference for the use of terminal sterilization (1,2). Although the use of lethal processes on finished formulations in their final container is favored because of their lethality, material considerations have limited their application such that an estimated 85% of all sterile products are manufactured by aseptic processing, which are less abusive of essential material and container properties.1
