title: Impact of Blow/Fill/Seal process variables in determining rate of vial contamination by air dispersed microorganisms.
abstract: 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.
authors.affiliation: Cardinal Health Inc, Biotechnology and Sterile Life Sciences, Woodstock, IL 60098, USA.
authors.forename: Frank
authors.initials: F
authors.lastname: Leo
authors.forename: Patrick
authors.initials: P
authors.lastname: Poisson
authors.forename: Colin S
authors.initials: CS
authors.lastname: Sinclair
authors.forename: Alan
authors.initials: A
authors.lastname: Tallentire
mesh_terms: D000391:Air Microbiology; D000392:Air Movements; D001412:Bacillus subtilis / Q000502:physiology*; D004340:Drug Contamination / Q000517:prevention & control; D004349:Drug Packaging; D006358:Hot Temperature; D013171:Spores, Bacterial / Q000254:growth & development; D013678:Technology, Pharmaceutical / Q000295:instrumentation / Q000379:methods*; D013997:Time Factors