ABSTRACT

INTRODUCTION Parenteral dosage forms are those administered directly into body tissues rather than via the alimentary canal. “Parenteral” is derived from the Greek words para (beside) and enteron (the intestine) and most often refers to subcutaneous (SC), intramuscular (IM), or intravenous (IV) administration of drugs. Parenteral drug delivery can pose significant risk to the patient since the natural barriers of the body (gut, skin, and mucous membranes) are bypassed. The highest standards for quality and purity must be maintained throughout dosage form manufacture to protect the patient from physical, chemical, and microbial contaminants. A single contaminated vial out of a batch of thousands can seriously injure a patient (or worse). Further, if improper or poor aseptic technique is used while administering an injection the patient could be similarly harmed. The minimum quality standards for pharmaceutical manufacturers are expressed in the current good manufacturing practices (cGMPs), which are constantly evolving as technology advances. An equal burden of responsibility is placed on physicians, pharmacists, nurses, and other health professionals to follow strict good aseptic practices (GAPs) as they administer parenteral dosage forms to patients. Nosocomial infections associated with parenteral drug therapy remain a significant issue (1-4).