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GREGORY F. PETERS, A.A.S., is Director; and MARGHI R. MCKEON, B.S., is Quality Assurance Manager, Lab Safety Corporation, Cumberland, WI. WILLIAM T. WEISS, B.S.PHARM., is Pharmacy Production Laboratory Manager, Mayo Clinic, Rochester, MN.

Address correspondence to Mr. Peters at Lab Safety Corporation, 1580 North Northwest Highway, Park Ridge, IL 60068 (valiteq{at}aol.com).

Purpose. The ability of turbulent- and unidirectional-airflow compounding aseptic isolators (CAIs) to control airborne contamination during aseptic compounding of compounded sterile preparations (CSPs) was studied. Methods. A three-phase challenge of the comparative airborne-contamination management capabilities of five CAIs was conducted using augmented, industry-standard visual tracer and discrete particle counting methods. In phase 1, a visual smoke tracer was used to conduct a standardized, comparative challenge. In phase 2, CAI operational contamination-control capabilities were measured in accordance with the International Organization for Standardization (ISO) class 5 air cleanliness conditions using a standardized CSP process qualification procedure. Alcohol drying times were also compared. In phase 3, the gross contamination clearance interval required to achieve the ISO class 5 condition after a gross contamination event was measured for each CAI. Results. All four unidirectional-airflow CAIs met ISO class 5 cleanliness requirements throughout all testing phases and areas of the work zone and demonstrated alcohol drying times of 16 seconds or less. The turbulent-airflow CAI tested failed to achieve the ISO class 5 operating condition at any time during the testing and required alcohol drying times of six minutes. The unidirectional-airflow CAIs tested met the laminar-airflow workstation-equivalency requirements of chapter 797 of the United States Pharmacopeia, pharmaceutical aseptic processing standards, the industry-standard definition of a closed isolator, and the rigorous demands of pharmacy and nursing sterile compounding. Conclusion. The performance of four unidirectional-flow CAIs supports their use in pharmacy and nursing CSP operations, whereas the performance of one turbulent-flow CAI does not. Index terms: Air; Aseptic areas; Compounding; Contamination; Control, quality; Equipment; Sterile products