Spore elimination of a Wuhan biologics facility

摘要

A biologies CDMO provider in China delayed a $5 million batch because of repeatedly failed EM tests showing fungal contamination until a hydrogen peroxide vapour solution by Bioquell was deployed Following the COVID-19 lockdown, Environmental Monitoring (EM) at a major international provider of biologies CDMO services in Wuhan indicated that there was spore contamination in a production room. As the Chinese facility was just about to begin manufacturing again, this had to be solved quickly. Despite exhausting all disinfection methods in their records, including the manual application of a sporicide, there was repeated failure of EM test standards. Consequently, the production of a valuable batch of product worth $5 million was being delayed. The fungal species identified, (Cheatomium globosum and Chaetomium unguicola) are notoriously challenging to remove using conventional methods, as the key is to locate and eliminate the reservoir from where the contamination starts. There were challenges along the way that needed to be addressed surrounding efficacy, timescale and documentation needs. To demonstrate efficacy against the spores causing the continuous EM failures, Bioquell produced a full evidence-based efficacy report showcasing the decontaminations system's capability in effectively eliminating the targeted pathogen. Bioquell Rapid Bio Decontamination Service (RBDS) was selected to perform enhanced disinfection on an as-needed contract basis. Almost immediately after the lockdown was lifted, Bioquell was able to quickly complete the decontamination of the production space including the HVAC.