臭氧的使用用于PHARMODUCT®自动系统的抗新生素化合物的消毒
Vito Lovino1, Antonio Riglietti1, Anna Tolomeo1
1Itel Telecomunicazioni srl-Radiopharmaceutical Division, Via Antonio Labriola SNC, 70037 Ruvo di Puglia, Italy.
臭氧气有效地消毒PHARMODUCT®系统用于抗新生菌制备,从而减少了微生物污染的6个日志. 这种生物污染方法为自动化复合系统提供了卓越的清洁性.
科学领域:
- 制药技术 制药技术 制药技术
- 微生物学 微生物学
- 环境科学环境科学
背景情况:
- 臭氧消毒已在食品和水中确立,但在药品方面缺乏数据.
- PHARMODUCT®系统用于抗瘤制备.
- 确保自动化复合的清洁性至关重要.
研究的目的:
- 为了证明臭氧气体对PHARMODUCT®系统消毒的有效性.
- 为了在抗瘤制备之前确保高度的清洁性.
- 为自动化复合系统开发可翻译的生物污染处理程序.
主要方法:
- 使用四种微生物菌株 (ATCC) 测试了臭氧有效性.
- 采用了两个消毒周期:40分钟40ppm,40分钟60ppm.
- 通过CFU计数 (暴露前和暴露后) 测量微生物减少.
主要成果:
- 40 ppm的臭氧在所有测试的微生物菌株中实现了4-log的减少.
- 60 ppm的臭氧导致所有测试的微生物菌株减少了6个日志.
- 臭氧消毒显著降低了微生物负载.
结论:
- 与手工方法相比,PHARMODUCT®系统的臭氧消毒可以获得更高的清洁性.
- 这项研究提供了关于臭氧在制药自动化合成中的应用数据.
- 臭氧治疗显示出超越抗炎用途的潜力.
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