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Revista de la OFIL
On-line version ISSN 1699-714XPrint version ISSN 1131-9429
Abstract
MIRANDA, D; FAUNDEZ, G; NAVEA, D and SALAS, C. Quality guarantee in parenteral nutrition: implementation of chemical and microbiological quality controls. Rev. OFIL·ILAPHAR [online]. 2021, vol.31, n.2, pp.191-195. Epub Aug 16, 2021. ISSN 1699-714X. https://dx.doi.org/10.4321/s1699-714x2021000200014.
The elaboration of a parenteral nutrition (NP) is not exempt of risks due to its complex composition and manufacture, susceptible to errors in addition or omission of nutrients (chemical composition) or rupture of the strict aseptic technique (microbiological contamination).
The current pharmacopoeia and national legislation only suggests basic controls, some not quantitative, in addition to the supervision of personnel and work areas. Considering the importance of the composition and sterility of a NP, analytical and microbiological quality controls that account for the preparation process, as well as chemical stability and sterility, were analyzed prior to administration considering a 5-day storage.
As chemical quality control, glucose, sodium, calcium, magnesium, phosphorous, potassium and chlorine were quantified in 40 samples in the Cobas®B221 and Vitros®4600 kits. Microbiological controls (blood agar) were performed after preparation and at 5 days of storage, prior to administration.
The results from day 0 show that for glucose, sodium and calcium the concentrations correlate with the theoretical concentration, while for day 5 post storage; glucose, sodium, calcium, magnesium, phosphorus, potassium and chlorine are correlated with the theoretical concentration on day 0. In no sample was growth of microorganisms observed.
According to the results, it is established as control of NP preparation: glucose, sodium and calcium, as chemical stability controls: glucose, sodium, calcium, magnesium, phosphorus, potassium and chlorine, and sterility is ensured 5 days after storage.
Keywords : Parenteral nutrition; quality control; stability; sterility.
