PT  - JOURNAL ARTICLE
AU  - Frank Leo
AU  - Patrick Poisson
AU  - Colin S. Sinclair
AU  - Alan Tallentire
TI  - Impact of Blow/Fill/Seal Process Variables in Determining Rate of Vial Contamination by Air Dispersed Microorganisms
DP  - 2005 Sep 01
TA  - PDA Journal of Pharmaceutical Science and Technology
PG  - 320--331
VI  - 59
IP  - 5
4099  - http://journal.pda.org/content/59/5/320.short
4100  - http://journal.pda.org/content/59/5/320.full
SO  - PDA J Pharm Sci Technol2005 Sep 01; 59
AB  - Controlled challenges of air dispersed spores of Bacillus subtilis NCIMB 8649 have been generated in a custom-built challenge room housing a Blow/Fill/Seal machine filling filter-sterilized trypticase soy broth into 5.5 cm3 low density polyethylene vials. The effects on the rate of vial contamination of systematic changes in the process variables, rate of provision of ballooning air, delay in the application of mould vacuum and duration of transfer of the open vial, have been examined. Overall, the findings show that the conditions of vial formation can affect appreciably the rate of vial contamination from airborne spores. The indications are that heat lethality, associated with the elevated temperature required for polymer extrusion and vial formation, has a role in determining such contamination.