Abstract
Controlled microbial challenges, comprising air-dispersed spores of Bacillus subtilis var niger. have been generated within a containment room (around 54 m3 in volume) housing a Blow/Fill/Seal machine. ‘Stirred-settling’ conditions were created throughout the room and the airborne spore challenge was monitored to ensure homogeneity within the room for extended periods of time. The Blow/Fill/Seal machine was set to fill 2 cm3ampoules with Tryptone Soya Broth at each of three airborne challenge levels of 104, 10° and 107 spores m-3 (about 102. 104 and 103 spores ft-3 respectively). A relationship has been established between the level of airborne micro-organisms in the machine operating environment and the extent of product contamination. This relationship allows prediction of operating conditions under which a level of sterility assurance. equal to that demanded of terminal sterilization, is attained. It is stressed that the findings apply only to the particular Blow/Fill/Seal machine and to the specific conditions of machine operation.
- Received August 28, 1990.
- Accepted February 1, 1991.
- Copyright © Parenteral Drug Association. All rights reserved.
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