Poisson Patrick, Sinclair Colin S, Tallentire Alan
Cardinal Health, Inc., Biotechnology and Sterile Life Sciences, Woodstock, IL 60098, USA.
PDA J Pharm Sci Technol. 2006 Sep-Oct;60(5):323-30.
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.
在624型吹灌封一体机处理生长培养基时，对具有广泛不同干热抗性的空气传播微生物进行的对照挑战试验表明，耐热性越高，小瓶污染程度越大。当通过对三个工艺变量（鼓泡空气供应、模具真空延迟和型坯挤出速率）中的每一个进行改变来故意操纵型坯和小瓶成型时，耐热性差异也会影响小瓶污染程度。研究结果表明，在该研究系统中，挑战微生物暴露于工艺中固有的热量对小瓶污染具有控制作用，这种作用也可以控制生产环境中的微生物风险。
