Using a medium-fill simulation to evaluate the microbial contamination rate for USP medium-risk-level compounding

• Published in: American journal of health-system pharmacy Vol. 62; no. 3; pp. 285 - 288
• Main Authors: Trissel, Lawrence A, Gentempo, Joseph A, Anderson, Roger W, Lajeunesse, Joel D
• Format: Journal Article
• Language: English
• Published: England 01.02.2005
• Subjects: Drug Compounding - methods; Drug Contamination - prevention & control; Drug Contamination - statistics & numerical data; Evaluation Studies as Topic; Humans; Pharmacy
• ISSN: 1079-2082; 1535-2900
• DOI: 10.1093/ajhp/62.3.285

The estimated microbial contamination rate for complex, multiple-step, medium-risk-level compounding was studied. 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 degrees C for 14 days and observed for microbial growth. 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. . 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%.