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 ta...

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Main Authors: Afsaneh Farjami, Shiva Eradati, Hamed Hamishehkar, Mohammadreza Siahi-Shadbad, Farzaneh LotfiPour
Format: Article
Language:English
Published: IWA Publishing 2022-10-01
Series:Journal of Water, Sanitation and Hygiene for Development
Subjects:
Online Access:http://washdev.iwaponline.com/content/12/10/698
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author Afsaneh Farjami
Shiva Eradati
Hamed Hamishehkar
Mohammadreza Siahi-Shadbad
Farzaneh LotfiPour
author_facet Afsaneh Farjami
Shiva Eradati
Hamed Hamishehkar
Mohammadreza Siahi-Shadbad
Farzaneh LotfiPour
author_sort Afsaneh Farjami
collection DOAJ
description 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. HIGHLIGHTS PAA–UV combination treatment for disinfection of water system of a pharmaceutical plant.; Six-month evaluations of the microbial quality (microbial count and endotoxin level of purified water and water for injection).; Individual control charts (I-chart) using microbial count data obtained 3 months with UV treatment alone and 3 months with a combination of PAA–UV treatment.;
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spelling doaj.art-ad8d7df1f13c47dc9eb65b46ae7cc73a2022-12-22T02:39:45ZengIWA PublishingJournal of Water, Sanitation and Hygiene for Development2043-90832408-93622022-10-01121069871010.2166/washdev.2022.071071Effect of peracetic acid–ultraviolet combination treatment on microbial and endotoxin levels in a pharmaceutical water systemAfsaneh Farjami0Shiva Eradati1Hamed Hamishehkar2Mohammadreza Siahi-Shadbad3Farzaneh LotfiPour4 Food and Drug Safety Research Center, Tabriz University of Medical Sciences, Tabriz, Iran Faculty of Pharmacy, Tabriz University of Medical Sciences, Tabriz, Iran Drug Applied Research Center, Tabriz University of Medical Sciences, Tabriz, Iran Food and Drug Safety Research Center, Tabriz University of Medical Sciences, Tabriz, Iran Food and Drug Safety Research Center, Tabriz University of Medical Sciences, Tabriz, Iran 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. HIGHLIGHTS PAA–UV combination treatment for disinfection of water system of a pharmaceutical plant.; Six-month evaluations of the microbial quality (microbial count and endotoxin level of purified water and water for injection).; Individual control charts (I-chart) using microbial count data obtained 3 months with UV treatment alone and 3 months with a combination of PAA–UV treatment.;http://washdev.iwaponline.com/content/12/10/698biocidebiocontolpurified waterwater for injectionwater treatment
spellingShingle Afsaneh Farjami
Shiva Eradati
Hamed Hamishehkar
Mohammadreza Siahi-Shadbad
Farzaneh LotfiPour
Effect of peracetic acid–ultraviolet combination treatment on microbial and endotoxin levels in a pharmaceutical water system
Journal of Water, Sanitation and Hygiene for Development
biocide
biocontol
purified water
water for injection
water treatment
title Effect of peracetic acid–ultraviolet combination treatment on microbial and endotoxin levels in a pharmaceutical water system
title_full Effect of peracetic acid–ultraviolet combination treatment on microbial and endotoxin levels in a pharmaceutical water system
title_fullStr Effect of peracetic acid–ultraviolet combination treatment on microbial and endotoxin levels in a pharmaceutical water system
title_full_unstemmed Effect of peracetic acid–ultraviolet combination treatment on microbial and endotoxin levels in a pharmaceutical water system
title_short Effect of peracetic acid–ultraviolet combination treatment on microbial and endotoxin levels in a pharmaceutical water system
title_sort effect of peracetic acid ultraviolet combination treatment on microbial and endotoxin levels in a pharmaceutical water system
topic biocide
biocontol
purified water
water for injection
water treatment
url http://washdev.iwaponline.com/content/12/10/698
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