Cleaning Evaluation and Cross-Contamination in Drug Repackaging Systems

Drug repackaging systems are used to repackage different tablets, capsules and dragges into patient-specific bags or blisters (dose administration aids, DAA), thus improving safety and efficiency during drug delivery at clinics and nursing homes for the elderly. Some of these systems can handle more than 500 different drugs. Because of practical reasons there is a partial overlap of the paths followed by different drugs in the machine, which arises concern over possible cross-contamination during the repackaging process. In this work the cross-contamination under worst-case conditions for a HD Medi system (formerly Dijkstra) model JV 400 SL has been measured. The placebo-batch method has been used for the tests and the limit values were set using the "0.1% dose criterion" accepted in the pharmaceutical industry.. The measured cross-contamination for all tested conditions was well below the limit values. Optimal cleaning methods and frequencies have been defined in accordance with the results.