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Background  A method for process monitoring of the Baxter ACD, Exactamix EM2400, by chemically analyzing the concentrations of the ingredients in parenteral nutrition test preparations was evaluated.    Methods  In the study, three different test preparations were developed consisting of four ingredients varying in volume and concentration, which simulated actual PN products. Each test preparation was produced in triplicate by a trained pharmacy technician using the Exactamix EM2400 from Baxter (Baxter International Inc.). The process was repeated on three consecutive days using the same conditions. The amount of each ingredient in the test preparation was measured in an external contract laboratory using European Pharmacopoeia methods. Based on USP monographies and the Guidelines on the Safe Use of Automated Compounding Devices for the Preparation of Parenteral Nutrition from the ASHP the device was tested to be accurate to deliver within 5 % of the amount programmed.    Results  The study showed that in most cases the ingredient delivery of the automated compounder deviated less than 3 % from the expected concentrations. For certain ingredients out of specification results were detected and analyzed. By resetting the flow factor, it was possible to optimize the performance of the ACD.    Conclusion  The study emphasizes the need for process monitoring of the Exactamix EM2400 during the initial installation and on a regular basis for each ingredient to ensure the accurate delivery of ingredients. Further methods need to be analyzed to determine the most feasible method to regularly conduct process monitoring tests on an ACD in a hospital pharmacy setting.

Evaluation of a Process Monitoring Method for Compounding Parenteral Nutrition with the Baxter EM2400 in a Hospital Pharmacy Department