What BSL designation is required for my modular cleanroom environment?

Biological Safety Level (BSL) is a biocontainment designation system with requirements intended to protect personnel from potentially harmful pathogenic exposure in a research or manufacturing environment. When designing my cleanroom, I am interested to understand how the Biological Safety Level (BSL) designation is determined through concrete evidence and requirements.

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The Centers for Disease Control (CDC) specifies four broad Biological Safety Levels. Each of these four biological safety levels aligns to a level of danger associated to biological agent exposure which assigns a set of design specifications and cleanroom operation protocol. Each increasing level builds on the previous biological safety level(s):

  • BSL-1: Required in the presence of microbes that do not consistently cause disease, such as E. coli. Work can be done on an open bench, and minimal Personnel Protective Equipment (PPE) is required. Doors separate the BSL-1 lab from the rest of the facility.
  • BSL-2: Required in the presence of moderately hazardous microbes, such as Staphylococcus aureus. The lab is restricted behind self-closing doors. Personnel wear minimal PPE plus face shields; many operations are performed within biological safety cabinets (BSCs – see explanation below). Negative-pressure containment is generally advised, and exhausted air may require filtration.
  • BSL-3: Required in the presence of potentially lethal, often “exotic” airborne microbes, such as tuberculosis. The lab is restricted behind two sets of doors. Workers may require immunizations, and PPE plus respirators are advised. All work is performed within a BSC. Filtered room air must be exhausted.
  • BSL-4: Required in the presence of high risk of airborne transmission; infections are frequently fatal, as from Ebola. Decontaminate all material before exiting lab; shower after exiting. Full body, positive-pressure cleanroom suit. All work performed in Class III BSC. Lab is in a separate building

All BSL facilities require that personnel follow “standard microbial practices”: no food or drink; no cosmetics; hands and gloves are frequently washed and surfaces routinely decontaminated. Sterilization and entry/exit protocol vary by BSL level.
Get complete BSL information from the Centers for Disease Control.

Answered on April 10, 2019.
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