Cleanroom Humidity Out of Specification

Purpose/ Applicability: The maximum allowable cleanroom humidity according to USP <797> is 60%. This limit is set to minimize bacterial and fungal growth potential in a sterile space. Historically, the cleanroom has had issues with high humidity and subsequent fungal growth on culture. Therefore, a backup plan is necessary to ensure that patient care is not compromised when cleanroom humidity is above the allowable limit.

Scope: This SOP addresses the preparation of injectable chemotherapy when the hazardous drug preparation room humidity is greater than 60%. 

• Biological Safety Cabinet (BSC) in SAC 20C (internal medicine lab space)
• Equashield syringes and adaptors
• Chemotherapy transport bags
• Alcohol bottle and disposable cleaning towels
• Chemo gown
• Chemo mat
• Sterile and non-sterile chemo gloves
• N95 mask
• Hazardous transport bag for waste


  1. When cleanroom humidity is noted to be above 60%, a pharmacist will send an email to internal medicine faculty that utilize the lab space (Drs. Gal, Barko, Williams, and Reinhart) to let them know we will likely need to use their BSC for chemo preparation that day. 
  2. A pharmacist will notify oncology ( and/or neurology ( that the cleanroom humidity is above 60% so we will be utilizing an alternative preparation location.
  3. A pharmacy technician will immediately go to the lab and turn the hood on and clean all interior surfaces of the hood with 70% isopropyl alcohol. The hood will be left running until all chemo has been prepared for the day or the cleanroom is usable again.
  4. When the chemo batch is ready to be prepared, a pharmacy technician will obtain all necessary drug from the hazardous drug storage area and use a chemo transport bag to transport the necessary vials to the BSC. The technician will also take all necessary Equashield syringes, adaptors and diluents in a separate bag or basket along with a chemo mat, all chemo prescription labels, an appropriately sized chemo transport bag for each prescription, and all necessary PPE and cleaning supplies.
  5. The technician will complete another clean of the BSC in SAC 20C with 70% isopropyl alcohol immediately prior to preparing the chemo.
  6. After cleaning, the technician will don an N95 mask, chemo gown, non-sterile chemo gloves and sterile chemo gloves. After all PPE is donned, the technician will spray all items with alcohol prior to placing them into the BSC.
  7. The technician will prepare the chemo in the BSC. When the chemo is prepared, the technician will call the pharmacist to let them know that chemo is ready.
  8. The pharmacist will go to SAC 20C and verify the accuracy of all chemotherapy prepared. 
  9. After verification, the technician will label and bag all syringes. All leftover drug will be brought back utilizing the chemo transport bag and returned to the hazardous drug storage areas or be disposed of as appropriate. All other supplies and waste will be transported back to the dispensary for disposal/restocking.
  10. Prior to leaving the room, the technician will clean the BSC with 70% isopropyl alcohol.
  11. After the last chemo batch of the day is completed, the technician will turn off the BSC

Keywords:Pharmacy, dispensary, cleanroom, humidity, specification, USP fungal, growth, compromise, limit, BSC, Equashield, Chemo   Doc ID:124738
Owner:Jenny C.Group:University of Illinois College of Veterinary Medicine Teaching Hospital
Created:2023-03-10 14:39 CDTUpdated:2023-03-10 15:04 CDT
Sites:University of Illinois College of Veterinary Medicine Teaching Hospital
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