Using the right techniques and procedures can make cleaning sterile compounding areas a matter of routine.

Since the June 1, 2008 revision of USP general chapter 797, pharmaceutical compounding personnel have been held responsible for the cleanliness of their sterile compounding areas, including biosafety cabinets (BSCs), compounding aseptic isolators (CAIs), compounding aseptic containment isolators (CACIs), and laminar airflow workbenches (LAFWs), as well as their buffer areas, ante-areas, and segregated compounding areas. Cleaning and disinfecting these controlled environments is required to minimize the risk of environmental contact as a source of microbial contamination of compounded sterile preparations (CSPs).¹

WHAT HAS TO BE CLEANED AND WITH WHAT FREQUENCY?
All of the surfaces of the sterile compounding areas must be cleaned regularly and frequently. It is required that the surfaces of BSCs, CAIs, CACIs, and LAFWs be cleaned and disinfected at the beginning of each shift, before each batch of product is compounded, not longer than 30 minutes following the previous surface disinfection when ongoing compounding activities are occurring, after spills, and when surface contamination is known or suspected.

In addition to the sterile compounding areas, counters and easily cleanable work surfaces shall be cleaned and disinfected daily. Floors in all areas, including the buffer area, anteroom, and compounding area, are to be cleaned and disinfected daily. All mopping should take place when no compounding is in progress.

All other surfaces, walls, ceilings, carts, and storage area shelving, should be cleaned and disinfected at least monthly, again when no compounding is in progress.

HOW SHOULD THE CLEANING OCCUR AND WHAT SHOULD BE USED?
USP Chapter 797 requires written standard operating procedures (SOPs) and cleaning logs to ensure the quality of the environment for the preparation of CSPs. SOPs for cleaning should include a procedure (how to clean), as well as the frequency (when to clean), and the supplies (what to clean with). Charts, checklists, and training posters for cleaning are useful tools for ensuring compliance with cleaning SOPs.