General Acute Care Hospital - Pharmacy Clean Room and Sterile Compounding
New or Remodeled Clean Room Administrative Review

Examples of Documentation the Pharmaceutical Consultant Unit May Request to Review

• Certificate of Occupancy issued by the Office of Statewide Health Planning and Development
• California Board of Pharmacy Sterile Compounding License and Inspector’s Report
• Equipment and environmental certification reports (complete and including viable air/surface), completed under dynamic operating conditions
• If issues are indicated in the report, documentation on how they were resolved
• All cleaning logs from the date of certification to present
• Temperature logs (room and refrigerator/freezer), from date of certification to present
• Differential pressure monitoring logs from date of certification to present (not applicable for segregated compounding area)
• All hospital-approved policies and procedures for sterile IV compounding
• A drawing of the compounding space, including all of the following:
• The location of the heating, ventilation, and air-conditioning supply and returns
• Doors
• Pressure monitoring devices
• Primary engineering controls (PEC)
• Pass-through areas
• Water sources (sinks), refrigerators, cabinets, and countertops 
• Employee competency reports, including for new equipment and processes
• High resolution digital images of the completed project, showing all of the following:
• Ante and buffer areas
• All doors, ceiling lights, windows, walls, sinks, and refrigerators
• Pass-through areas
• Pressure monitoring devices
• Air supply and returns
• The PEC room placement