RT Journal Article
SR Electronic
T1 Impact of Blow/Fill/Seal Process Variables in Determining Rate of Vial Contamination by Air Dispersed Microorganisms
JF PDA Journal of Pharmaceutical Science and Technology
JO PDA J Pharm Sci Technol
FD Parenteral Drug Association (PDA)
SP 320
OP 331
VO 59
IS 5
A1 Frank Leo
A1 Patrick Poisson
A1 Colin S. Sinclair
A1 Alan Tallentire
YR 2005
UL http://journal.pda.org/content/59/5/320.abstract
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.