Evaluation of hydrogen peroxide efficacy against AZD1222 chimpanzee adenovirus strain in the recombinant COVID‐19 vaccine for application in cleaning validation in a pharmaceutical manufacturing industry

This study aimed to evaluate the performance of hydrogen peroxide vapour (HPV) to inactivate the chimpanzee adenovirus AZD1222 vaccine strain used in the production of recombinant COVID‐19 vaccine for application in cleaning validation in pharmaceutical industries production areas. Two matrixes were...

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Bibliographic Details
Published in:Letters in applied microbiology 2022-04, Vol.74 (4), p.536-542
Main Authors: Ajorio, A.C.F.B., Rhodes, V.P., Rodrigues, A.P., Diniz, V.A., Mattoso, J.M.V., Silva, I.B., D`Aiuto, D.M.M., Brandão, M.L.L.
Format: Article
Language:English
Subjects:
Adenoviridae
Adenoviruses
Animals
biopharmaceuticals
ChAdOx1 nCoV-19
Chimpanzees
Cleaning
COVID-19
COVID-19 Vaccines
Deactivation
Decontamination
Disinfectants
Disinfection
Drug Industry
Humans
Hydrogen peroxide
Hydrogen Peroxide - pharmacology
Hydrogen peroxide vapor
Inactivation
Manufacturing
Manufacturing Industry
Monkeys & apes
Pan troglodytes
Performance evaluation
Pharmaceutical industry
Pharmaceutical Preparations
Pharmaceuticals
quality control
Spores
Stainless steel
Stainless steels
Vaccines
Viruses
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Summary:This study aimed to evaluate the performance of hydrogen peroxide vapour (HPV) to inactivate the chimpanzee adenovirus AZD1222 vaccine strain used in the production of recombinant COVID‐19 vaccine for application in cleaning validation in pharmaceutical industries production areas. Two matrixes were tested: formulated recombinant COVID‐19 vaccine (FCV) and active pharmaceutical ingredient (API). The samples were dried on stainless steel and exposed to HPV in an isolator. One biological indicator with population >106 Geobacillus stearothermophilus spores was used to validate the HPV decontamination cycle as standard. HPV exposure resulted in complete virus inactivation in FVC (≥5·03 log10) and API (≥6·40 log10), showing HPV efficacy for reducing chimpanzee adenovirus AZD1222 vaccine strain. However, the optimum concentration and contact time will vary depending on the type of application. Future decontamination studies scaling up the process to the recombinant COVID‐19 vaccine manufacturing areas are necessary to evaluate if the HPV will have the same or better virucidal effectivity in each specific production area. In conclusion, HPV showed efficacy for reducing AZD1222 chimpanzee adenovirus strain and can be a good choice for pharmaceutical industries facilities disinfection during recombinant COVID‐19 vaccine production. Significance and Impact of the Study: Hydrogen peroxide vapour showed efficacy for chimpanzee adenovirus AZD1222 strain elimination in two matrixes: formulated recombinant COVID‐19 vaccine (≥5·03 log10) and API (≥6·40 log10) and can be used in pharmaceutical industries facilities, and can be a good choice for pharmaceutical industries facilities disinfection during recombinant COVID‐19 vaccine production.
ISSN:0266-8254
1472-765X
DOI:10.1111/lam.13635