![]() ![]() For example, in a monthly cleaning, the order would be: ceilings walls and windows exteriors of process equipment and cabinets countertops and other horizontal surfaces and at last, floors. To minimize crosscontamination, cleaning should also be done from top to bottom. In general, cleaning should be done from the cleanest area to the dirtiest area. Charts, checklists, and training posters for cleaning are useful tools for ensuring compliance with cleaning SOPs. 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). USP Chapter 797 requires written standard operating procedures (SOPs) and cleaning logs to ensure the quality of the environment for the preparation of CSPs. HOW SHOULD THE CLEANING OCCUR AND WHAT SHOULD BE USED? All mopping should take place when no compounding is in progress.Īll other surfaces, walls, ceilings, carts, and storage area shelving, should be cleaned and disinfected at least monthly, again when no compounding is in progress. Floors in all areas, including the buffer area, anteroom, and compounding area, are to be cleaned and disinfected daily. In addition to the sterile compounding areas, counters and easily cleanable work surfaces shall be cleaned and disinfected daily. 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. WHAT HAS TO BE CLEANED AND WITH WHAT FREQUENCY?Īll of the surfaces of the sterile compounding areas must be cleaned regularly and frequently. 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). Since the Jrevision 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. ![]() Using the right techniques and procedures can make cleaning sterile compounding areas a matter of routine. ![]()
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