ABSTRACT
The delivery of drugs via the parenteral routes of administration has steadily increased over the past few decades due to the inherent advantages of reaching the systemic circulation quickly. The use of the parenteral routes will continue to increase and will even proliferate due to both the research in targeted (site-specific) delivery and the products derived from biotechnology. That parenterals gain entry to internal body compartments by circumventing the body’s most protective barriers, the skin and mucous membranes, makes it essential that the handling of these products from manufacturing through patient administration be done in accordance with strict procedures for preventing contamination. Freedom from particulate contamination is one specification essential to ensure function and integrity of the product and safety for the patient. The attribute of freedom from undesirable particulates must not only be built into the product and exist when the product is released by the manufacturer, but must be maintained during shipping and storage and upon administration to the patient.
