Sterile product means a drug or nutritional substance that is free from living microorganisms and is compounded, manipulated, or repackaged by pharmacy personnel, using aseptic technique and other quality assurance procedures. Parenteral drug delivery systems and many medicinal products, such as dressings and sutures, must be sterile in order to avoid the possibilities of microbial degradation or infection occurring as a result of their use. Sterility is also important for any material or instrument likely to contact broken skin or internal organs. Although pathogenic bacteria, fungi or viruses pose the most obvious danger to a patient, it should be also realized that micro-organisms usually regarded as non-pathogenic and which inadvertently gain access to body cavities in sufficient numbers may cause a severe, possibly fatal infection. Consequently, injections, ophthalmic preparations, irrigation fluids, dialysis solutions, sutures and ligatures, implants, and certain surgical dressings, as well as instruments necessary for their use or administration, must be presented in a sterile condition.

The most obviously recognized sterile pharmaceutical preparations are injections. These vary from very small-volume antigenic products to large-volume, total parenteral nutrition products. Other sterile products include ophthalmic preparations, creams and dusting powders. This section describes their formulation and packaging and the...