PT  - JOURNAL ARTICLE
AU  - Hirotaka Sudo
AU  - Michael O'driscoll
AU  - Kenji Nishiwaki
AU  - Yuji Kawamoto
AU  - Philip Gammell
AU  - Gerhard Schramm
AU  - Toni Wertli
AU  - Heino Prinz
AU  - Atsuhide Mori
AU  - Kazuhiro Sako
TI  - Development of a Nondestructive Leak Testing Method Utilizing the Head Space Analyzer for Ampoule Products Containing Ethanol-Based Solutions
AID  - 10.5731/pdajpst.2012.00882
DP  - 2012 Sep 01
TA  - PDA Journal of Pharmaceutical Science and Technology
PG  - 434--444
VI  - 66
IP  - 5
4099  - http://journal.pda.org/content/66/5/434.short
4100  - http://journal.pda.org/content/66/5/434.full
SO  - PDA J Pharm Sci Technol2012 Sep 01; 66
AB  - 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. LAY ABSTRACT: 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.