(e) Unless immediately and completely administered by the person who prepared it or immediate and complete administration is witnessed by the preparer, the CSP must bear a label listing the patient identification information, the names and amounts of all ingredients, the name or initials of the person who prepared the CSP, and the exact one hour BUD and time. (f) If administration has not begun within one hour following the start of preparing the CSP, the CSP must be discarded. (C) The compounding area of the facility must meet the facility requirements relative to the risk level of products they prepare. (1) Facility design and environmental control must be designed to minimize airborne contamination from contacting critical sites. (a) A PEC must maintain ISO Class 5 or better conditions while compounding. (b) The PEC HEPAfiltered air must be supplied in critical areas at a velocity sufficient to sweep particles away from the compounding area. (2) The buffer area must maintain at least ISO Class 7 conditions under dynamic operating conditions. (a) The room must be segregated from surrounding, unclassified spaces to reduce the risk of contaminants being blown, dragged, or otherwise introduced into the HEPAfiltered airflow environment. (b) For buffer areas not physically separated from the ante areas, the principle of displacement airflow must be employed. The displacement concept shall not be used for high–risk compounding. (c) The PEC must be placed out of the traffic flow in a manner to avoid conditions that could adversely affect their operation. (d) Cleaning materials must be nonshedding and dedicated for use only in the sterile compounding area. (e) Only the furniture, equipment, supplies, and other material required for the compounding activities to be performed may be brought into the buffer area, and they must be nonpermeable, nonshedding, cleanable, and resistant to disinfectants. They must be cleaned, then disinfected before brought into the area. (f) The surfaces of ceilings, walls, floors, fixtures, shelving, counters, and cabinets in the buffer area must be smooth, impervious, and nonshedding in order to promote cleanliness.
(e) Unless immediately and completely administered by the person who prepared it or immediate and complete administration is witnessed by the preparer, the CSP must bear a label listing the patient identification information, the names and amounts of all ingredients, the name or initials of the person who prepared the CSP, and the exact one hour BUD and time. (f) If administration has not begun within one hour following the start of preparing the CSP, the CSP must be discarded. (C) The compounding area of the facility must meet the facility requirements relative to the risk level of products they prepare. (1) Facility design and environmental control must be designed to minimize airborne contamination from contacting critical sites. (a) A PEC must maintain ISO Class 5 or better conditions while compounding. (b) The PEC HEPAfiltered air must be supplied in critical areas at a velocity sufficient to sweep particles away from the compounding area. (2) The buffer area must maintain at least ISO Class 7 conditions under dynamic operating conditions. (a) The room must be segregated from surrounding, unclassified spaces to reduce the risk of contaminants being blown, dragged, or otherwise introduced into the HEPAfiltered airflow environment. (b) For buffer areas not physically separated from the ante areas, the principle of displacement airflow must be employed. The displacement concept shall not be used for high–risk compounding. (c) The PEC must be placed out of the traffic flow in a manner to avoid conditions that could adversely affect their operation. (d) Cleaning materials must be nonshedding and dedicated for use only in the sterile compounding area. (e) Only the furniture, equipment, supplies, and other material required for the compounding activities to be performed may be brought into the buffer area, and they must be nonpermeable, nonshedding, cleanable, and resistant to disinfectants. They must be cleaned, then disinfected before brought into the area. (f) The surfaces of ceilings, walls, floors, fixtures, shelving, counters, and cabinets in the buffer area must be smooth, impervious, and nonshedding in order to promote cleanliness.
3161_20130220.docx