Challenges to a blow/fill/seal process with airborne microorganisms having different resistances to dry heat.
Controlled challenges with air dispersed microorganisms having widely different resistances to dry heat, carried out on 624 BFS machine processing growth medium, have shown that higher the heat resistance, the greater the extent of vial contamination. Differences in heat resistance affected also the extent of vial contamination when parison and vial formation were knowingly manipulated through changes made to each of three process variables, provision of ballooning air, mould vacuum delay, and parison extrusion rate. The findings demonstrate that, in this investigational system, exposure of challenge micoorganisms to heat inherent in the process has a controlling influence on vial contamination, an influence that could also control microbiological risk in production environments.
Poisson
Patrick
P
Cardinal Health, Inc., Biotechnology and Sterile Life Sciences, Woodstock, IL 60098, USA.
Sinclair
Colin S
CS
Tallentire
Alan
A
D000391:Air Microbiology; D001419:Bacteria / Q000254:growth & development; D004340:Drug Contamination / Q000517:prevention & control; D006358:Hot Temperature; D010316:Particle Size; D004364:Pharmaceutical Preparations / Q000592:standards*; D012306:Risk; D013171:Spores, Bacterial / Q000502:physiology; D013242:Sterilization / Q000379:methods*
D004364:Pharmaceutical Preparations