Occasionally, your report may have unwanted results. What can you and your pharmacy do about these results?
There are many potential sources for contamination in a clean room. USP 797 describes common sources of contamination, with an emphasis that human operators working in classified areas are often responsible. Below are some recommendations to assist in eliminating sources of contamination and reducing CFU counts to below the appropriate action levels.
Training: Have pharmacy technicians review internal SOPs in regards to personnel garbing and aseptic technique
Cleaning: Properly disinfect and clean any object entering the classified areas
Supplies: Only essential supplies for a day’s operations should be brought into the controlled areas. Cardboard and packaging should never be brought into any classified areas
Carts: Carts must be cleaned each time before entering a classified area
Sinks: Any sinks should be disinfected frequently and checked for surface contamination regularly
Set a Schedule: Cleaning schedules should at least meet the minimum requirements outlined in USP <797>
What to Use: Cleaning agents should be used per the manufacturer's recommendations and should leave no residue. Cleaning cloths, mops, wipes, etc. should be low-lint and must be re-sterilized before reuse
Air Flow: Take necessary actions to ensure unidirectional flow of air from the PEC through the Buffer Areas into the Ante Room
Air Changes: Ensure that minimum air changes per hour are met or exceeded Example: 30 ACPH in ISO Class 7 areas (of which 15ACPH can be recirculating from the PEC)
Storage: Avoid storing objects in the classified areas; Any objects that slow air flow or provide a surface for particles to accumulate will increase the risk of contamination
LAB 797 is here to help with your compliance. If you have further questions about your results, please contact us.