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Sterile products administered by injection or infusion inorder to bypass the gastrointestinal tract. Administration involves the use of a needle topenetrate the skin. Parenteral administration technically means non-oral administration, but ittypically refers to the injection of drugs into the body intravenously, intramuscularly, or subcutaneously. Parenteral drug delivery bypasses the body’s natural defenses against bacteria and viruses, which increases the risk of infection to patients. Consequently, parenteral drugproducts and biologics must undergo sterilization to destroy any potential contaminants andensure patient safety.
There are two ways a sterile drug product can be manufactured: They are manufactured byeither terminal sterilization or aseptic technique process.
Personal Hygiene Procedures and Requirements
In Locker Room: Change from personal clothes, shoes and other personal wares to thefollowing:
Protective Uniforms: Non-sterile clean, single or two-piece, white (other light color) uniformswithout pockets made from lint-free weave, e.g. polyester/cotton (67/33).
Footwear: Non-sterile special/separate white snickers/clogs and worn at all times within thearea.
Head Gear: Non-sterile disposable headgear totally enclosing hair and facial hair
Face Mask: Non-sterile, non-linting face mask be worn before entering Personnel Air Lock.
