Basic Documentation

Table Of Contents
Laboratory Ventilation Codes and Standards
Siemens Industry, Inc. 154
Topic Requirement(s) Commentary
Commissioning
- Canada
Public Health Agency of Canada, Office of Laboratory Security, Biosafety
Division, Laboratory Biosafety Guidelines, 3
rd
Edition 2011:
5.1 Introduction
For the purposes of this document, "commissioning" is defined as the verification of
the physical construction and performance of critical containment components and
is one part of the overall certification process. "Certification" is defined as the
successful completion of commissioning and verification that the facility and
operational protocols meet the requirements outlined in the current edition of the
Laboratory Biosafety Guidelines. "Recertification" is verification that the facility
continues to comply with the current edition of the Laboratory Biosafety Guidelines
and has undergone a recommissioning process as outlined below.
5.1.1 Commissioning
To ensure that the physical requirements for the intended containment level and
use of the facility have been met, each laboratory must undergo a detailed
commissioning regimen. This requires verification and documentation of critical
containment components, equipment start-up, control system calibration, balancing
and performance testing. A complete set of drawings and specifications, an
understanding of the intended use and work to be performed, a list of equipment
requirements, all test results, and an understanding of the intent of the systems'
operation are all part of the commissioning process. Commissioning is a
requirement for the certification of containment levels 3 and 4 laboratories.
5.1.2 Certification
A matrix of critical containment components to be verified during initial certification
is provided below. Operational protocols must also be established before work with
pathogens at the specified containment level can be carried out. Training of
personnel is a critical aspect of this process and may involve initial work with
pathogens normally requiring a lower containment level. Users must understand
the containment systems and their operation in addition to scientific procedures.
Detailed records of the certification process and test results must be maintained.