title: Development of a nondestructive leak testing method utilizing the head space analyzer for ampoule products containing ethanol-based solutions.
abstract: The application of a head space analyzer for oxygen concentration was examined to develop a novel ampoule leak test method. Studies using ampoules filled with ethanol-based solution and with nitrogen in the headspace demonstrated that the head space analysis (HSA) method showed sufficient sensitivity in detecting an ampoule crack. The proposed method is the use of HSA in conjunction with the pretreatment of an overpressurising process known as bombing to facilitate the oxygen flow through the crack in the ampoule. The method was examined in comparative studies with a conventional dye ingress method, and the results showed that the HSA method exhibits sensitivity superior to the dye method. The results indicate that the HSA method in combination with the bombing treatment provides potential application as a leak test for the detection of container defects not only for ampoule products with ethanol-based solutions, but also for testing lyophilized products in vials with nitrogen in the head space.
  The application of a head space analyzer for oxygen concentration was examined to develop a novel ampoule leak test method. The proposed method is the use of head space analysis (HSA) in conjunction with the pretreatment of an overpressurising process known as bombing to facilitate oxygen flow through the crack in the ampoule for use in routine production. The result of the comparative study with a conventional dye leak test method indicates that the HSA method in combination with the bombing treatment can be used as a leak test method, enabling detection of container defects.
authors.affiliation: Astellas Pharma Inc.
authors.forename: Hirotaka
authors.initials: H
authors.lastname: Sudo
authors.forename: Michael
authors.initials: M
authors.lastname: O'driscoll
authors.forename: Kenji
authors.initials: K
authors.lastname: Nishiwaki
authors.forename: Yuji
authors.initials: Y
authors.lastname: Kawamoto
authors.forename: Philip
authors.initials: P
authors.lastname: Gammell
authors.forename: Gerhard
authors.initials: G
authors.lastname: Schramm
authors.forename: Toni
authors.initials: T
authors.lastname: Wertli
authors.forename: Heino
authors.initials: H
authors.lastname: Prinz
authors.forename: Atsuhide
authors.initials: A
authors.lastname: Mori
authors.forename: Kazuhiro
authors.initials: K
authors.lastname: Sako
mesh_terms: D004349:Drug Packaging; D000431:Ethanol; D005612:Freeze Drying; D008461:Meat Products; D009584:Nitrogen; D019999:Pharmaceutical Solutions; D012996:Solutions
chemical_list: D019999:Pharmaceutical Solutions; D012996:Solutions; D000431:Ethanol; D009584:Nitrogen