title: [Depyrogenation test regarding inox and glass containers in the preparation of parenteral nutrition mixtures].
abstract: BACKGROUND
  The preparation of parenteral nutrition mixture (PNM) in an open chamber requires the use of intermediate containers sterile and non-pyrogenic. A sterilization of containers by moist heat in large autoclaves is the suitable method. However, sterilization by moist heat is not a depyrogenation method. In our study, we report the validation of a sterilization and depyrogenation method for containers by dry heat using a convection oven.
  
  
  METHODS
  Sterilization and depyrogenation of material by dry heat have been audited by the reduction of at least three logarithms of original endotoxin rate. The containers were initially artificially contaminated with a suspension of endotoxin for 16 hours. Contaminated containers were placed in an oven with revolving heat at 250 °C for 1 hour. After treatment with dry heat, the residual endotoxin levels in the containers were determined by a kinetic chromogenic method.
  
  
  RESULTS
  After treatment with dry heat, the average log reductions of endotoxin levels were respectively, for glass and steel containers, 4.78 ± 0.07 and 4.87 ± 0.03.
  
  
  CONCLUSIONS
  The present validation study confirms the effectiveness of treatment with dry heat for sterilization and depyrogenation of glass and steel containers. This method of sterilization and depyrogenation meets the microbiological quality requirements for the preparation of MNP.
authors.affiliation: Service pharmaceutique, fabrication et contrôles des médicaments, plateforme FRIPHARM, pavillon X, groupement hospitalier Édouard-Herriot, place d'Arsonval, 69437 Lyon cedex 03, France.
authors.forename: A
authors.initials: A
authors.lastname: Lajoinie
authors.forename: P
authors.initials: P
authors.lastname: Vasselon
authors.forename: M-L
authors.initials: ML
authors.lastname: Tall
authors.forename: D
authors.initials: D
authors.lastname: Salmon
authors.forename: V
authors.initials: V
authors.lastname: Bréant
authors.forename: E
authors.initials: E
authors.lastname: Diouf
authors.forename: C
authors.initials: C
authors.lastname: Pivot
authors.forename: F
authors.initials: F
authors.lastname: Pirot
mesh_terms: D004339:Drug Compounding; D004349:Drug Packaging; D004731:Endotoxins / Q000737:chemistry; D005526:Food, Formulated / Q000592:standards*; D005898:Glass; D007288:Inosine / Q000031:analogs & derivatives; D010288:Parenteral Nutrition / Q000295:instrumentation*; D011749:Pyrogens / Q000737:chemistry*; D015203:Reproducibility of Results; D013242:Sterilization
chemical_list: D004731:Endotoxins; D011749:Pyrogens; C007390:inosine dialdehyde; D007288:Inosine