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[Study of physicochemical and bacteriological impact of a weekly assembly of automated compounding BAXA(®) Exacta-Mix 2400 on parenteral nutrition admixture manufacturing].

作者信息

Chappuy L, Charroin C, Vételé F, Durand T, Quessada T, Klotz M-C, Bréant V, Aulagner G

机构信息

Service pharmaceutique, groupement hospitalier Est, hospices civils de Lyon, 28, avenue Doyen-Lépine, 69677 Bron cedex, France.

Service pharmaceutique, groupement hospitalier Est, hospices civils de Lyon, 28, avenue Doyen-Lépine, 69677 Bron cedex, France.

出版信息

Ann Pharm Fr. 2014 Jan;72(1):22-7. doi: 10.1016/j.pharma.2013.07.003. Epub 2013 Aug 22.

DOI:10.1016/j.pharma.2013.07.003
PMID:24438665
Abstract

INTRODUCTION

The parenteral nutrition admixtures are manufactured with an automated compounding BAXA(®) Exacta-Mix 2400. A 48-hour assembly has been validated. To optimize time and cost, a weekly assembly was tested.

MATERIALS AND METHODS

Assembly was made on the first day. Ten identical parenteral nutrition admixtures (different volumes and compositions) were produced each day. A macroscopic examination was done at D0, D7 and D14. Physicochemical controls (electrolytes determinations by atomic absorption spectrophotometry, osmolalities measurements) were performed. Microbiological tests included a filtration membrane sterility test (Steritest(®)) and a plate count agar environmental monitoring.

RESULTS

All mixtures were considered stable. The 12 Steritest(®) (H24, H48, D7 and D14) did not show any bacterial or fungal contamination. No microorganism has been detected on the plate count agar at D4 and D7. Concerning the physicochemical parameters of each parental nutrition admixture, no significant difference (Wilcoxon test) with the first day was found.

DISCUSSION AND CONCLUSIONS

The automated filling system BAXA(®) Exacta-Mix 2400 improves the quality and safety of production. According to these results, the weekly assembly is validated and permit to save time (80hours/year) and cost (40 000 euros on consumable/year).

摘要

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