过氧乙酸-紫外线联合处理对制药用水系统微生物和内毒素水平的影响

IF 1.6 4区 环境科学与生态学 Q3 WATER RESOURCES Journal of Water Sanitation and Hygiene for Development Pub Date : 2022-10-05 DOI:10.2166/washdev.2022.071
Afsaneh Farjami, Shiva Eradati, H. Hamishehkar, M. Siahi-Shadbad, F. Lotfipour
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引用次数: 0

摘要

在制药行业,水的微生物质量至关重要。本研究调查了过乙酸(0.1%V/V)和紫外线(>150mJ/cm2)作为广谱消毒剂如何影响制药用水系统中的微生物和内毒素水平。从整个系统的12个点无菌采集水样。采用平板法和膜过滤法进行微生物计数。用鲎试剂(LAL)凝胶凝块法研究了蒸馏水中内毒素的存在。过乙酸-紫外线联合处理后,样品的微生物计数与单独紫外线处理相比显著下降(P<0.05),并且低于欧洲药典规定的作用限值(纯化水为100 CFU/ml,注射用水为10 CFU/100ml)。此外,水样主要为LAL阴性(12份报告中有10份为阴性周报)。结果表明,过乙酸-紫外线组合对水系统各阶段的消毒显著改善了水系统的微生物质量。因此,建议在多个消毒政策和过乙酸-紫外线组合定期消毒水系统之间轮换,以最大限度地减少对水系统和药品的污染以及产品消费者的细菌感染。
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Effect of peracetic acid–ultraviolet combination treatment on microbial and endotoxin levels in a pharmaceutical water system
In the pharmaceutical industry, the microbiological quality of water is vital. This research investigated how combining peracetic acid (0.1% V/V) and UV light (>150 mJ/cm2) as wide-spectrum disinfectants affect microbial and endotoxin levels in a pharmaceutical water system. Water samples were taken aseptically from 12 points across the system. The pour plate technique and membrane filtration were used for microbial counts. The presence of endotoxin in distilled water samples was investigated by the Limulus amebocyte lysate (LAL) test gel-clot method. After peracetic acid–UV combination treatment, microbial counts of samples significantly decreased (P < 0.05) compared with UV treatment alone, and they were lower than the action limits specified by the European Pharmacopeia (100 CFU/ml for purified water and 10 CFU/100 ml for water for injection). In addition, water samples were mainly LAL-negative (10 negative weekly reports out of 12 total reports). It is concluded that disinfection of all stages of the water system with peracetic acid–UV combination remarkably improved the microbial quality of the water system. Therefore, rotation between more than one disinfectant policy and periodic disinfection of the water system by peracetic acid–UV combination is recommended to minimize contamination of the water system and pharmaceutical products as well as bacterial infections in product consumers.
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来源期刊
CiteScore
3.10
自引率
11.80%
发文量
58
审稿时长
16 weeks
期刊介绍: The Journal of Water, Sanitation and Hygiene for Development is a peer-reviewed journal devoted to the dissemination of high-quality information on the science, policy and practice of drinking-water supply, sanitation and hygiene at local, national and international levels.
期刊最新文献
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