Investigation on viable spore count of stainless steel carrier biological indicator for hydrogen peroxide vapor sterilization processes

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Author: Wei-Jing PAN ¹ Gao-Min LI ² Ming-Ren WANG ² Mei LIN ¹  Jian LE ¹

Affiliation: 1. NMPA Key Laboratory for Quality Analysis of Chemical Drug Preparations, Shanghai Institute for Food and Drug Control, Shanghai 201203, China 2. NMPA Key Laboratory for Quality Control of Therapeutic Monoclonal Antibodies, Shanghai Institute for Food and Drug Control, Shanghai 201203, China

Keywords: Hydrogen perioxide vapour sterilization processes Biological indicator Viable spore count

DOI: 10.12173/j.issn.1008-049X.202302174

Reference: Wei-Jing PAN, Gao-Min LI, Ming-Ren WANG, Mei LIN, Jian LE.Investigation on viable spore count of stainless steel carrier biological indicator for hydrogen peroxide vapor sterilization processes[J].Zhongguo Yaoshi Zazhi,2023, 26(10):145-149.DOI: 10.12173/j.issn.1008-049X.202302174.[Article in Chinese]  Copied

Abstract
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Abstract

Objective To investigate the influencing factors of viable spore count of stainless steel carrier biological indicator for hydrogen peroxide vapor sterilization processes.

Methods A full factorial test of spore elution was performed respectively on three factors of eluent, elution mode, and elution time at two levels, then the eluted spore suspensions were heat shocked, incubated and counted according to Guidelines for Biological Indicator Tolerance Testing of the Chinese Pharmacopoeia edition 2020, to find out the combination mode with the highest recovery rate.

Results The effects of elution time on the recovery were not statistically significant. The effects of eluent and elution mode on the recovery were statistically significant, and there was an interaction between the two factors, and the main effect of elution mode was the strongest.

Conclusion Using purified water as eluent and ultrasonic elution for 15 minutes could obtain a good recovery. The method is low in cost and easy to operate, and can be used for viable spore count of stainless steel carrier biological indicator for hydrogen peroxide vapor sterilization processes.

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