Inspection (Biocontainment)

Facility containment levels are selected to provide the end-user with a description of the minimum containment required for handling human pathogens safely in a laboratory setting. The containment system includes the engineering, operational, technical and physical requirements for manipulating specific pathogen(s). These containment levels are applicable to facilities such as diagnostic, research, clinical, teaching and production. Four containment levels are described as follows:

Containment Level 1 (CL1): Requires no special design features beyond those suitable for a well-designed and functional laboratory. Containment is achieved through the use of practices normally employed in a basic microbiology laboratory.

Containment Level 2 (CL2): Primary containment devices such as Biological Safety Cabinets (BSC) and centrifuges with sealed rotors or safety cups are to be used as well as appropriate personal protective equipment (i.e. gloves, laboratory coats, protective eyewear).

CL2 Checklist

Containment Level 3 (CL3): Emphasizes additional primary and secondary barriers to minimize the release of infectious organisms into the immediate laboratory and the environment. Additional features to prevent transmission of CL3 organisms include appropriate respiratory protection, HEPA filtration of exhausted laboratory air and strictly controlled laboratory access.

• Process for the Certification of CL3 Facilities
• Form A - Contact Information
• Standard Operating Procedures (SOP) Biosafety Manual Requirement Checklist
• Example Table of Contents SOP Manual
• Drawings Review Checklist
• Form B - Document Submission Requirements for the Certification Performance and Verification Testing of CL3 Laboratories
• Process for the Re-certification of CL3 Facilities
• Form C - Document Submission Requirements for the Re-certification Performance and Verification Testing of CL3 Laboratories

CL3 Checklist ( instruction how to download)

Containment Level 4 (CL4): Emphasizes maximum containment of infectious agents by complete sealing of the facility perimeter, isolation of researcher from the pathogen by his/her containment in a positive pressure suit or containment of the pathogen in a Class III BSC, and decontamination of air and other effluents produced in the facility.

• Process for the Certification of CL4 Facilities (coming soon)
• Form A - Contact Information
• Form E - Document Submission Requirements for the Certification Performance and Verification Testing of CL4 Laboratories
• Process for the Re-certification of CL4 Facilities (coming soon)
• Form F - Document Submission Requirements for the Re-certification Performance and Verification Testing of CL4 Laboratories

Large Scale Containment: “Large scale” work generally refers to manipulations of a single volume in excess of 10L and is not necessarily more hazardous than research/laboratory scale work. A thorough risk assessment should be carried out on a case-by-case basis. The scale of operations poses a hazard for the potential release of large volumes of pathogenic organisms into the facility and/or the environment, and as such it is essential to ensure that an appropriate containment facility, equipment and practices are in place. Also, a detailed contingency and response plan must be in place so that potential exposures will be minimised if a malfunction in the process occurs.

Large Scale Containment Checklist (instruction how to download)