Re-Certification of Containment Level 3 Facilities

As part of the re-certification process, the Public Health Agency of Canada (PHAC) will verify that the Containment Level 3 (CL3) facility continues to comply with the current edition of the Laboratory Biosafety Guidelines. Facilities handling zoonotic pathogens will also be required to be re-certified by the Canadian Food Inspection Agency (CFIA). Even though only one agency serves as the main point of contact, the PHAC and CFIA collaborate on all re-certification requests for zoonotic facilities.

The re-certification of certain containment components needs to be performed on a yearly basis. Generally, the verification of directional airflow, the detection of any visual leaks in the room perimeter, the recalibration of sensitive controllers and gauges, as well as the monitoring of the efficacy of sterilization systems can all be performed without too much disruption to the operation of the CL3 facility. On another hand, the verification of Biological Safety Cabinets, backflow preventers, HEPA filters and control systems, will require a little more planning as it may entail a full decontamination and requires the assistance of certified professionals.

Re-certification Process

(see CL3 Facilities Re-Certification Process Workflow for an overview)

A re-certification submission, which includes performance and verification test reports must be submitted for approval. For a complete list of items to address in this submission, see Form C: Document Submission Requirements for the Re-Certification Performance and Verification Testing of Containment Level (CL) 3 Laboratories in Accordance with the Laboratory Biosafety Guidelines, 2004, Public Health Agency of Canada (and where applicable, Containment Standards for Veterinary Facilities¸1996, Canadian Food Inspection Agency).

In order to keep your certification active, we ask you to send your re-certification submission to the PHAC at least two months before the certification expiration date.

Furthermore, we strongly recommend that you review your SOP manual on a yearly basis, and submit the updated SOPs for approval. We understand that this might involve a little bit of work on your end, but please bear in mind that SOPs are designed to ensure the safety of your CL3 users. See SOPs Review Checklist (coming soon) and Example Table of Contents SOP Manual for a summary of all elements that must be covered in the SOP manual.

We are here to help, please feel free to contact us at any time with any questions or concerns.

Biocon@phac-aspc.gc.ca
Tel : 613-957-1779
Fax : 613-941-0596