Patients receiving intravenous medications are often hospitalized and immune compromised, and they are more susceptible to infection (Figure 1-2). Since sterile intravenous products can be prepared in many settings, such as hospitals, outpatient pharmacies and clinics, doctor’s offices, and in a patient’s home, the need for extremely clean or sterile preparation is imperative to ensure the wellbeing of these patients. Typically, the normal bacteria that we all have on the surfaces of our body do not affect us because we are healthy, but to a sick person these can cause significant harm, and since patients receiving intravenous therapy are usually the most critical, every precaution must be taken to avoid contamination. The personnel responsible for their preparation must follow certain rules and guidelines as well as use specialized equipment. Technicians perform most of the preparation duties today under the direct supervision of a pharmacist.

FIGURE 1-2 A patient receiving intravenous therapy in a hospital. (Courtesy of CareFusion, San Diego, CA.)

History of aseptic preparations

The practices of medicine advanced very quickly during the early nineteenth century and researchers discovered that germs and unknown organisms caused certain diseases. In the 1600’s people believed that microorganisms spontaneously came from decaying nonliving matter.

Louis Pasteur’s germ theory in the early 1800’s specified that bacteria caused diseases (Figure 1-3). Practices that are common today, such as handwashing, were not practiced routinely. As a result, many deaths were attributed to the unclean conditions of operating rooms and personnel practices. A person was more likely to die of postoperative gangrene than the surgery itself. As a result, many changes in the practices were established. In 1865, Sir Joseph Lister, a well-known surgeon, read a paper by Louis Pasteur and learned about the germ theory of disease. He stated that if infections were caused by microbes, the best way to prevent infections would be to kill the microbes before they reached the open wound. Lister used carbolic acid to kill germs. He wrote about the use of this acid in his work, Antiseptic Principle of the Surgery Practice. (essortment.com)

FIGURE 1-3 Louis Pasteur, 1822-1895. (From US National Library of Medicine, Bethesda, MD)

The use of sanitary dressings and instruments led to the development of disposable supplies, such as syringes, needles, and other intravenous supplies in the 1920’s (Figure 1-4). Sterile solutions and equipment became accepted in health care in the 1930’s. In the 1960’s, following a rash of serious patient complications, the National Coordinating Committee on Large Volume Parenterals (NCCLVP) published the first set of recommendations for pharmacy and other health care professionals. In 1972, the Baxter Corporation produced a training manual which was later revised in 1990. Following these guidelines, American Society of Health-System Pharmacists (ASHP) and United States Pharmacopoeia (USP) published updated guidelines that are considered standard practices for pharmacy personnel when preparing sterile preparations or compounded sterile preparations (CSPs).