By Howard Siegerman, PhD

COMPOUNDING ASEPTIC ISOLATORS (CAIs) and Class II biological safety cabinets (BSCs) 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. Both CAIs and BSCs 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>, some form of cleaning and surface sanitization of these engineering controls and their background environments is required to prevent crosscontamination from one CSP to the next, and cleaning is required at the beginning of each shift.

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