Isolation Technology News

In summary, the Compounding Aseptic Isolators (CAIs) are used to physically isolate compounded sterile preparations (CSPs) from contamination from the background environment and to protect compounding personnel from contamination from hazardous drugs. The CAIs are rated as ISO Class 5 devices in terms of air particle cleanliness and are maintained as sterile environments to a sterility assurance level (SAL) of 10^-3. Per USP<797> cleaning and surface sanitization of these engineered controls and their background environments are required to prevent cross-contamination from one CSP to the next, and is required at the beginning of each shift. The following is a summary information on how to achieve the cleaning and disinfection requirements of USP<797>. The cleaning and disinfecting activities for CAIs can be separated into three areas: cleaning and disinfecting the CAI at the beginning of each shift, cleaning and sanitizing of the CAI between the CSPs, and cleaning the background environment. For wipers and mops, much of the literature on isolators cleaning refers to the need for low-linting fabrics that do not shed. Since the isolator is most often cleaned and disinfected while closed; to maintain the aseptic condition of the isolator, the consumables such as:wipers, prewetted wipers, mops,cleaning/disnfecting agents, water, 70% IPA, etc.-must be disinfected and introduced through an appropriate transfer device such as an antechamber of the CAIs. Intermittently,the use of a cold sterilant as a substitute for IPA as a disinfectant is required when sporicidal activities are needed. To avoid cross contamination between CSPs, the accepted procedure is to wipe the CAIs with IPA 70 % before each use. The USP<797> requires that floors in the CAIs background to be mopped daily, white walls, ceiling, and shelvings are to be mopped monthly. This article was written by Howard Siegerman,PhD and published in Pharmacy Purchasing & Products,September 2006, Vol.3 No.6.