Which risk level would apply to vials with the stopper removed to compound for patient who are allergic to latex?
The stopper must be removed by contacting only sterile surfaces, e.g., sterile forceps. If stopper and content removal occur within an ISO Class 5 environment, and if the vial is one of three or fewer sterile ingredients, then this qualifies as either a Low-risk Level CSP or a Low-Risk Level CSPs with 12-Hour or Less BUD, depending on whether or not the primary engineering control, PEC or ISO Class 5 source is located in an ISO Class 7 buffer area. If the vial is one of more than three sterile ingredients, then this requires compliance with Medium-Risk Level CSPs standards. If the stopper is removed by contacting only sterile surfaces in worse (dirtier) than an ISO Class 5 environment, then this qualifies as an Immediate-Use CSP.
