05 Performance Verification and validation of Biological Safety Cabinets or Small Clean Areas | ||
| Journal of Measurement Science and Applications (JMSA) | ||
| Volume 5, Issue 1, February 2025, Pages 55-68 PDF (283.31 K) | ||
| Document Type: Technical notes | ||
| DOI: 10.21608/jmsa.2025.422983 | ||
| Author | ||
| Khaled E Elnagar* | ||
| Chemical Metrology Division, NIS-Egypt | ||
| Abstract | ||
| The information that is provided in this report is of the utmost significance for end-users, manufacturers, and certifiers of Biological Safety Cabinets (BSCs), and it is fundamentally vital for them to have a complete comprehension of the subject matter. The purpose of this study is to provide a comprehensive analysis of a substantial number of significant topics that are linked with BSCs. This section covers a variety of subjects, including their significance, the standard validation methods that are applied, the many types of BSCs, the calibration procedures that are utilized, and their special relevance in medical laboratories, particularly those that are participating in COVID-19 research and testing. There is a full discussion on the evaluation of the performance of BSCs that is presented in the manuscript. Procedures for cleaning and disinfection, roles and responsibilities, testing for leaks in HEPA filters, inflow and downflow velocities, airflow patterns, considerations regarding lighting and noise, safety guidelines, and operational and performance qualification checklists are some of the important aspects that are addressed in this document. | ||
| Keywords | ||
| Biological safety cabinets; Performance; Verification; Validation; Calibration; COVID 19; NSF 49; HEPA filter | ||
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