Using a medium-fill simulation to evaluate the microbial contamination rate for USP medium-risk-level compounding.
OBJECTIVE
The estimated microbial contamination rate for complex, multiple-step, medium-risk-level compounding was studied.


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 degrees 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.


CONCLUSIONS
. 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%.
Trissel
Lawrence A
LA
Division of Pharmacy, The University of Texas M. D. Anderson Cancer Center, Houston 77030, USA.
Gentempo
Joseph A
JA
Anderson
Roger W
RW
Lajeunesse
Joel D
JD
D004339:Drug Compounding / Q000379:methods*; D004340:Drug Contamination / Q000517:prevention & control* / Q000706:statistics & numerical data; D005069:Evaluation Studies as Topic; D006801:Humans; D010604:Pharmacy