title: Investigation on residual-related error and the effect of solution properties using protective devices for the reconstitution of cytotoxic agents in actual situations.
abstract: OBJECTIVE
  Three products can be used in Japan for the reconstitution of cytotoxic agents: PhaSeal, Chemo CLAVE and Chemo Mini Spike (CMS). The low preparation volume may be affected by residual-related volume in their devices. In this study, the residual-related error in their devices was examined and compared.
  
  
  METHODS
  The blank of each component of these devices was weighed using a precision electric balance. After ejecting distilled water (DW) for injection, each was weighed again with the balance. In addition, for etoposide in the cases of PhaSeal and Chemo CLAVE, the components of the devices were similarly weighed.
  
  
  RESULTS
  The weight gains of each device after ejecting DW were as follows: CMS-V (440 mg) greater than the combined components of Chemo CLAVE (128-171 mg)/CMS-MT (123 mg) greater than the combined components of PhaSeal (13-56 mg). For etoposide, the weight gains of PhaSeal (208 mg) and Chemo CLAVE (223 mg) showed no significant difference. The priming volume of each device was calculated from the specific gravity of water. The residual-related volume was 'CMS-V > Chemo CLAVE, CMS-MT > PhaSeal', although this was very slight in actual situations.
  
  
  CONCLUSIONS
  The residual-related volume was marked in its low preparation volume. In water-soluble drugs, the residual volume of PhaSeal was lowest of the devices in this study, but in viscous drugs, such as etoposide, the residual volume of PhaSeal was almost identical to Chemo CLAVE; that is, the residual volume of these devices was affected by the solution property. The residual-related volume in the devices will lead to errors; therefore, residual-related errors need to be considered in the use of these devices.
authors.affiliation: Department of Pharmacy, Kobe City Medical Center General Hospital, Kobe, Hyogo, Japan. hama_k@kcgh.gr.jp
authors.forename: Koji
authors.initials: K
authors.lastname: Hama
authors.forename: Noriaki
authors.initials: N
authors.lastname: Kitada
authors.forename: Koichi
authors.initials: K
authors.lastname: Fukushima
authors.forename: Tohru
authors.initials: T
authors.lastname: Hashida
authors.forename: Kazusaburo
authors.initials: K
authors.lastname: Kataoka
mesh_terms: D000970:Antineoplastic Agents / Q000737:chemistry / Q000592:standards*; D004339:Drug Compounding / Q000295:instrumentation / Q000379:methods; D004867:Equipment Design; D004868:Equipment Failure; D006801:Humans; D007564:Japan; D016273:Occupational Exposure / Q000517:prevention & control*; D011482:Protective Devices; D012995:Solubility; D014783:Viscosity
chemical_list: D000970:Antineoplastic Agents