Gravimetric quality control in the assessment of compounding techniques in oncology: a non-randomized experimental process evaluation study
Controle de qualidade gravimétrico na avaliação da acurácia de técnicas de manipulação em um Hospital Oncológico
DOI:
https://doi.org/10.30968/jhphs.2026.172.1508Abstract
Objective: To evaluate and compare four intravenous compounding techniques used in a Pharmacy Intravenous Admixture Service of an oncology hospital, assessing their accuracy through gravimetric quality control. Method: This is a non-randomized experimental process evaluation study conducted at Hospital Erasto Gaertner, Curitiba, Paraná, Brazil, from September 1 to 30, 2024, to evaluate compounding techniques in an oncology pharmacy service using gravimetric quality control. The mean density of five antineoplastic drugs was determined, as well as that of the diluents and materials involved in preparing the unit dose. Based on these data, a database was developed to calculate the estimated weight of the preparations. Four unit-dose techniques were defined based on different combinations of diluent volume removal and air handling in the infusion bag. A total of 60 doses were prepared and weighed using an electronic balance. The actual weight of each unit dose was compared to estimated weight, with a maximum acceptable variation of 5% as the gravimetric approval criterion. Results: All 60 doses met the 5% accuracy criterion. Mean weight variations were 0.95% (technique 1), 1.11% (technique 2), 0.93% (technique 3) and 1.31% (technique 4). All techniques remained within the predefined 5% acceptance threshold, indicating comparable gravimetric performance across methods. Neither the use of a beaker versus syringe for diluent removal nor the handling of air in the infusion bag significantly affected gravimetric conformity. Conclusion: All four compounding techniques demonstrated satisfactory gravimetric accuracy in a real production environment, and the gravimetric method proved to be a feasible and effective quality control tool for intravenous compounding in oncology pharmacy practice.
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