Evaluation of two sterility testing methods for intravenous admixtures.
The Addi-Chek Quality Control System (Millipore Corporation) and Ivex-2 Filterset (Abbott Laboratories) were evaluated to determine their effectiveness, applicability, and cost as part of a pharmacy quality-control program. Each method was tested using 50 solutions, 25 of which had been contaminated by inoculation with one of five micro-organisms; the other 25 solutions were used as controls. Aseptic technique was used, and procedures were carried out in a laminar air flow hood. Contaminated solutions were blinded from the person performing the tests. Addi-Chek detected contamination in all the inoculated solutions and in three of the uninoculated solutions. The latter may have been a result of adventitious contamination during the testing procedure. Ivex-2 detected contamination in 24 of the 25 inoculated solutions; no other contamination was found. The effectiveness of the methods in detecting low-level microbial contamination appears comparable. Both methods have been shown to be useful in the pharmacy setting, but Ivex-2 could be used to test for contamination when used as an in-line filter at the patient level. Ivex-2 is less expensive and warrants further evaluation in monitoring for microbial contamination during preparation and administration of intravenous solutions.
D001900:Boston; D003428:Cross Infection / Q000517:prevention & control*; D004339:Drug Compounding / Q000592:standards; D004340:Drug Contamination / Q000517:prevention & control*; D005069:Evaluation Studies as Topic; D006745:Hospital Bed Capacity, 300 to 499; D006801:Humans; D007263:Infusions, Parenteral / Q000592:standards*; D008722:Methods; D010607:Pharmacy Service, Hospital / Q000592:standards; D011786:Quality Control