Be sure wipers are not dripping with solution - an overly wet wiper can redisperse contaminants and can increase the chances of the solution itself becoming a contamination source. Wipers can be purchased either pre-wetted with 70% IPA or they can be wetted at the time of use with the solution of choice. However, in areas where a more stringent environment is necessary (such as the interiors of BSCs, CAIs, CACIs, and LAFWs), a knit polyester wiper is suggested. In an ISO Class 5 area, a non-woven polyester/cellulose wiper can be used. Wipers should be “low-linting” - that is, wipers should not leave particles and fibers behind when they are used to clean surfaces. Surfaces within arm’s reach can be cleaned using wipers and solutions (such as 70% isopropyl alcohol (IPA) or a disinfectant) appropriate to the environment. 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. It is required that independent certification be performed before use.Using the right techniques and procedures can make cleaning sterile compounding areas a matter of routine. Each LFGI undergoes rigorous physical testing before shipping to assure the unit meets all performance requirements. The LFGI Series of barrier isolators meet or exceed ISO 14644-1 for Class 5 air quality. In accordance with the NIOSH alert on the handling of hazardous drugs, the LFGI can be configured for no recirculation and total exhaust of all air exiting the work area. Operator and product protection from gas and fumes are NOT provided by HEPA filtration, but limited protection from gas and fumes can be provided by venting or ducting. Microbiological particulates and aerosols, with the possible exception of Prions, are also removed. The Laminar Flow Glovebox/Isolator provides personnel and product protection from particulates, dust, powders and aerosols. These filters are even more effective at removing particulates both larger and smaller than 0.3 microns. All filters are rated to remove particulates and aerosols 0.3 micron in size with a minimum efficiency of 99.99%. Additionally, there are two HEPA filters located inside the HEPA Purge airlock that filter the purged air. The exhaust HEPA filter handles all air exiting the Laminar Flow Glovebox/Isolator. The supply HEPA filter provides laminar flow air which bathes the entire work area. The Laminar Flow Glovebox/Isolator (LFGI) uses HEPA (High Efficiency Particulate Air) filters to provide the highest level of operator and product protection. MODEL # LFGI (Laminar Flow Glovebox / Isolator)
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