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


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.


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).
Service pharmaceutique, groupement hospitalier Est, hospices civils de Lyon, 28, avenue Doyen-Lépine, 69677 Bron cedex, France. Electronic address: lchappuy@free.fr.
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Chappuy
Service pharmaceutique, groupement hospitalier Est, hospices civils de Lyon, 28, avenue Doyen-Lépine, 69677 Bron cedex, France.
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Charroin
Service pharmaceutique, groupement hospitalier Est, hospices civils de Lyon, 28, avenue Doyen-Lépine, 69677 Bron cedex, France.
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Vételé
Service pharmaceutique, groupement hospitalier Est, hospices civils de Lyon, 28, avenue Doyen-Lépine, 69677 Bron cedex, France.
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Durand
Service pharmaceutique, groupement hospitalier Est, hospices civils de Lyon, 28, avenue Doyen-Lépine, 69677 Bron cedex, France.
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Quessada
Service pharmaceutique, groupement hospitalier Est, hospices civils de Lyon, 28, avenue Doyen-Lépine, 69677 Bron cedex, France.
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Klotz
Service pharmaceutique, groupement hospitalier Est, hospices civils de Lyon, 28, avenue Doyen-Lépine, 69677 Bron cedex, France.
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Bréant
Service pharmaceutique, groupement hospitalier Est, hospices civils de Lyon, 28, avenue Doyen-Lépine, 69677 Bron cedex, France.
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Aulagner
D001331:Automation; D058491:Bacterial Load; D017046:Cost Savings; D004573:Electrolytes / Q000032:analysis; D005374:Filtration; D005506:Food Contamination; D005516:Food Microbiology; D005524:Food Technology / Q000295:instrumentation / Q000379:methods*; D005526:Food, Formulated / Q000032:analysis / Q000191:economics / Q000382:microbiology; D006801:Humans; D009994:Osmolar Concentration; D010288:Parenteral Nutrition; D057285:Precision Medicine; D013054:Spectrophotometry, Atomic
D004573:Electrolytes
Automated compounding; Automatisation; Control; Contrôle; Cost; Coût; Montage hebdomadaire; Nutrition parentérale; Parenteral nutrition; Weekly assembly