RT Journal Article
SR Electronic
T1 Airborne Microbial Challenges of Blow/Fill/Seal Equipment: A Case Study
JF PDA Journal of Pharmaceutical Science and Technology
JO PDA J Pharm Sci Technol
FD Parenteral Drug Association (PDA)
SP 187
OP 192
VO 45
IS 4
A1 Bradley, A.
A1 Probert, S. P.
A1 Sinclair, C. S.
A1 Tallentire, A.
YR 1991
UL http://journal.pda.org/content/45/4/187.abstract
AB 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.