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Copyright © 2005 by American Society of Health-System Pharmacists
Reports |
Using a medium-fill simulation to evaluate the microbial contamination rate for USP medium-risk-level compounding
LAWRENCE A. TRISSEL, B.S.PHARM., FASHP, is Director, Clinical Pharmaceutics Research; JOSEPH A. GENTEMPO, M.S., is Pharmacist Trainer; ROGER W. ANDERSON, Dr.P.H., is Vice President; and JOEL D. LAJEUNESSE, M.S., is Deputy Division Head, Division of Pharmacy, The University of Texas M. D. Anderson Cancer Center, Houston.
Address correspondence to Mr. Trissel at the Division of Pharmacy, Box 90, The University of Texas M. D. Anderson Cancer Center, 1515 Holcombe Boulevard, Houston, TX 77030.
Methods. The results of evaluations of the aseptic technique of pharmacists and technicians in compounding complex USP medium-risk-level sterile preparations were compiled to estimate the microbial contamination rate. The testing took place in 2002 and 2003 at a single institution and involved reconstitution of sterile dry growth medium and a series of complicated transfers of the medium from vials and ampuls to intravenous bags. The bags were incubated at 25–35 °C for 14 days and observed for microbial growth.
Results. Of 539 evaluations, 28 (5.2%) resulted in preparations that yielded microbial growth. Pharmacists’ compounding resulted in a slightly lower contamination rate (4.4%) than that of technicians (6.2%). Inadvertent touch contamination may have been the principal source of the contamination.
Conclusion. A two-year series of 539 evaluations of the aseptic technique of pharmacists and technicians conducted with sterile growth medium and designed to simulate the compounding of USP medium-risk-level sterile preparations yielded an overall contamination rate of 5.2%.
Index terms: Compounding; Contamination; Drugs; Injections; Methodology; Personnel, pharmacy; Pharmacists; Stability; Sterile products; Storage
Purpose. The estimated microbial contamination rate for complex, multiple-step, medium-risk-level compounding was studied.
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