Get Low And Medium Risk Sterile Compounding Quiz

(V) For a medium-risk preparation, in the absence of passing a sterility test the storage periods cannot exceed the following time periods: before administration, the compounded sterile preparations are properly stored and are exposed for not more than 30 hours at controlled room temperature, for not more than 9 days ...

Medium Risk Level Compounded Sterile Products CSP's are compounded entirely within ISO Class 5 or better air quality using only sterile ingredients. ISO Class 5 PEC is located within an ISO Class 7 or better buffer room.

Medium Risk Level Compounded Sterile Products CSP's are compounded entirely within ISO Class 5 or better air quality using only sterile ingredients. ISO Class 5 PEC is located within an ISO Class 7 or better buffer room. ISO 8 ante room in located adjacent to ISO 7 buffer room.

Low-risk level compounded sterile preparations are those compounded under all of the following conditions. (I) The compounded sterile preparations are compounded with aseptic manipulations entirely within ISO Class 5 or better air quality using only sterile ingredients, products, components, and devices.

Medium Risk Level Compounding: Products are compounded with aseptic manipulations entirely within an ISO Class 5 or better air quality device, usually within an ISO Class 7 environment, using sterile products, components, and devices.

For a medium risk preparation in the absence of passing a sterility test, the storage period cannot exceed the following time periods: 30 hours at room temperature, 7 days at cold temperature, and 25 days in a solid frozen state at -20 C or colder.

Medium Risk Level Compounding: Products are compounded with aseptic manipulations entirely within an ISO Class 5 or better air quality device, usually within an ISO Class 7 environment, using sterile products, components, and devices.