IPP Final - Alcorn - Intro to sterile compounding part 2

What does compounding sterile preparations involve (SATA)

• manipulating commercially available components that are already sterile (low and medium risk)

• use of equipment and/or ingredients that are not sterile (high risk)

• Mixing things in a tube based on what the TV Show does (Natural selection risk)

What is the most likely source of contamination of a sterile compound

• operator involved in compounding
• environment the compound is made in
• ingredients from the manufacturers
• cleaning supplies from previous compound

What type of contamination can cause infections

• microbial
• chemical
• physical

What type of contamination can have immunogenic and toxic effects

• microbial
• chemical
• physical

What type of contamination leads to occlusion of blood vessels, thrombus formation, phlebitis, death

• microbial
• chemical
• physical

What is a pyrogen

• any substance foreign to the body that elicits a febrile response
• toxic, heat-stable lipopolysaccharide contained within cell wall of gram-neg bacteria

What is an endotoxin

• any substance foreign to the body that elicits a febrile response
• toxic, heat-stable lipopolysaccharide contained within cell wall of gram-neg bacteria

What are some characteristics of pyrogen (SATA)

• preparations can be considered sterile and still contain pyrogens

• may come from equipment, containers, closures, chemical solutes, uman touch, aqueous vehicles

• can exist for years in aq solutions or dried forms

• difficult to detect and destroy

• Something naturally found in the body

What are some characteristics of endotoxins

• type of pyrogen
• causes immunogenic and toxic effects
• USP <797> requires specific parenteral products be tested to ensure endotoxins are not present
• USP <797> requires specific parenteral products be tested to ensure endotoxins are present

What are factors related to contamination and sterility of CSPs (This is all of them and more for reference)

• environmental quality

• primary and secondary engineering controls

• personal protective equipment, proper hand washing

• maintenance of equipment and environment

• aseptic technique