title: [Stability and sterility of parenteral nutrition admixture for patients home care manufactured by the automated compounding BAXA® EM 2400].
abstract: BACKGROUND
  Initially, parenteral nutrition admixtures are produced by sterile filtration with a stability of 14 days This study was conducted to check the stability (physicochemical and microbiological) when automated compounding BAXA(®) EM 2400 is used.
  
  
  METHODS
  Forty pockets corresponding to 10 patients have been manufactured in according to Good Manufacturing Practice. Macroscopic and physicochemical tests (determination of electrolytes by atomic absorption spectroscopy, osmolality and pH measurements) were performed at different times (D0, D7, D14). To complete these checks, the emulsions were analyzed (size, stability, optical microscopy) at D0 and D14. Finally, microbiological research (Bact-Alert(®), filtration membrane sterility tests Steritest(®) and plate count agar) was performed.
  
  
  RESULTS
  No lipid cluster was observed with an optical microscope. Comparison of data observed for all controls showed no significant difference in the production of D0 by the Wilcoxon test. Microbiology (Bact-Alert filtration membrane sterility tests Steritest(®) and plate count agar) was negative for all samples. Consequently, all mixtures were considered stable.
  
  
  CONCLUSIONS
  The automated compounding BAXA(®) EM 2400 ensures quality and safety of production. The results of this study have shown stability and sterility of parenteral nutrition admixtures for 14 days.
authors.affiliation: Service de pharmacie, groupement hospitalier Est, hospices civils de Lyon, 28, avenue Doyen-Lépine, 69677 Bron cedex, France. Electronic address: lchappuy@free.fr.
authors.forename: L
authors.initials: L
authors.lastname: Chappuy
authors.forename: C
authors.initials: C
authors.lastname: Charroin
authors.forename: F
authors.initials: F
authors.lastname: Vételé
authors.forename: T
authors.initials: T
authors.lastname: Durand
authors.forename: T
authors.initials: T
authors.lastname: Quessada
authors.forename: M-C
authors.initials: MC
authors.lastname: Klotz
authors.forename: F
authors.initials: F
authors.lastname: Pirot
authors.forename: V
authors.initials: V
authors.lastname: Bréant
authors.forename: G
authors.initials: G
authors.lastname: Aulagner
mesh_terms: D001419:Bacteria / Q000737:chemistry; D001431:Bacteriological Techniques; D004355:Drug Stability; D004655:Emulsions; D005374:Filtration; D006699:Home Care Services; D010288:Parenteral Nutrition; D057947:Parenteral Nutrition Solutions / Q000737:chemistry* / Q000592:standards*; D016331:Parenteral Nutrition, Home / Q000379:methods*; D013242:Sterilization
chemical_list: D004655:Emulsions; D057947:Parenteral Nutrition Solutions
keywords: Automate; Automated compounding; Nutrition parentérale; Parenteral nutrition; Preparation; Préparation; Stability; Stabilité; Sterility; Stérilité