期刊
LETTERS IN APPLIED MICROBIOLOGY
卷 75, 期 6, 页码 1639-1644出版社
OXFORD UNIV PRESS
DOI: 10.1111/lam.13831
关键词
biopharmaceuticals; pharmaceuticals; quality control; vaccines; viruses
This study evaluated the effectiveness of accelerated hydrogen peroxide wipes (HPW) in decontaminating chimpanzee adenovirus AZD1222 strain used in the production of recombinant COVID-19 vaccine in the pharmaceutical industry. The results showed that HPW completely removed the virus strain from the vaccine and active pharmaceutical ingredient on stainless-steel and low-density-polyethylene surfaces, making it a suitable option for disinfection during vaccine production.
This study aimed to evaluate the performance of accelerated hydrogen peroxide (R) wipes (HPW) for decontamination of the chimpanzee adenovirus AZD1222 vaccine strain used in the production of recombinant COVID-19 vaccine in a pharmaceutical industry. Two matrices were tested on stainless-steel (SS) and low-density-polyethylene (LDP) surfaces: formulated recombinant COVID-19 vaccine (FCV) and active pharmaceutical ingredient (API). The samples were spiked, dried and the initial inoculum, possible residue effect (RE) and titre reduction after disinfection with HPW were determined. No RE was observed. The disinfection procedure with HPW resulted in complete decontamination the of AZD1222 adenovirus strain in FCV (>= 7 center dot 46 and >= 7 center dot 49 log(10) infectious unit [IFU] ml(-1) for SS and LDP carriers respectively) and API (>= 8 center dot 79 and >= 8 center dot 78 log(10) IFU ml(-1) for SS and LDP carriers respectively). In conclusion, virucidal activity of HPW was satisfactory against the AZD1222 adenovirus strain and can be a good option for disinfection processes of SS and LPD surfaces in pharmaceutical industry facilities during recombinant COVID-19 vaccine production. This procedure is simple and can be also applied on safety unit cabins and sampling bags made of LDP as well.
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