Quality Guarantee in Parenteral Nutrition: Implementation of Chemical and Microbiological Quality Controls

Abstract

In the preparation of a parenteral nutrition (NP) is always present the risk of errors in the addition or omission of nutrients (chemical composition) or rupture of strict aseptic technique (microbiological quality). Both the Pharmacopoeia and national legislation suggest basic qualitative controls of areas, so the objective of this study is to implement additional analytical and microbiological quality controls, to verify the preparation process, as well as to ensure chemical stability and absence of contamination. For chemical control it included glucose, sodium, calcium, magnesium, phosphorus, potassium and chlorine in 40 samples in the Cobas®B221 and Vitros®4600 equipment, pH, and microbiological control, through NP culture in blood agar after preparation and after 5 days of storage. At day 0, the concentrations of glucose, sodium and calcium correlate with the theoretical concentration. On day 5 of storage glucose, sodium, calcium, magnesium, phosphorus, potassium and chlorine correlated with the theoretical concentration on day 0. No growth of microorganisms was observed in any sample. It is established as a chemical control of elaboration glucose, sodium and calcium; and as chemical stability controls glucose, sodium, calcium, magnesium, phosphorus, potassium and chlorine, maintaining its sterility.