Basic Documentation

Ventilation Systems
Siemens Industry, Inc. 127
Topic Requirement(s) Commentary
Periodic
Inspection
and Testing -
Canada
(Continued)
6. Integrity of HEPA filter housings with inlet and outlet bubble tight dampers
installed into supply ductwork, where HEPA filters are used as backdraft
protection, and exhaust ductwork to be tested in situ by pressure decay testing in
accordance with ASME N510(2).Acceptance criteria: rate of air leakage not to
exceed 0.1% of housing vol/min at 1000 Pa (4 in. w.g.) minimum test pressure.
This test is not a mandatory requirement for recertification if no physical
modification or changes have been made. If modifications have been performed
then the laboratory supervisor, in consultation with the Biological Safety Officer/
Institutional Biosafety Committee, shall determine the degree of change and
whether this test is subsequently required.
7. Supply ductwork, where backdraft protection is required on supply, and exhaust
air ductwork located between containment perimeter and HEPA filter or bubble
tight backdraft damper to be tested in situ by pressure decay method in
accordance with ASME N510(2).Acceptance criteria: rate of air leakage not to
exceed 0.1% duct vol/min at 1000 Pa (4 in. w.g.) minimum test pressure.
8. Item 8 is not required for CL3 labs.
9. Recommendation: Supply and exhaust air ductwork between containment
perimeter and HEPA filter or bubble tight backdraft damper to be tested in situ by
pressure decay method in accordance with ASME N510(2). Acceptance criteria:
rate of air leakage not to exceed 0.1% duct vol/min at 1000 Pa (4 in. w.g.)
minimum test pressure.
10. Pressurization relationships across adjacent areas to be verified (that is, clean
change to dirty change, dirty change to laboratory). Acceptance criteria: inward
directional airflow (under normal operations) to be visually demonstrated (e.g., by
holding a smoke pencil at each door leading to adjacent areas).
11. Control systems to be tested for fail-safe operation by failure of system
components, (that is, exhaust fan failure, supply fan failure, power failure [where
possible], Class II B2 BSC exhaust failure). This is to include audible/visual alarm
testing. Acceptance criteria: inward directional airflow. The sustained reversal of
airflow across containment barrier is to be prevented. This test is not a mandatory
requirement for recertification if no control system hardware or logic changes or
upgrades have been done; if modifications have been performed, or if frequent
control system problems or failures have been encountered, then the requirement
for retesting should be determined in consultation with the Biological Safety
Officer/ Institutional Biosafety Committee. Note, this may necessitate the need for
decontamination. While not required annually, control systems should be retested
periodically. Consult Manufacturer's specifications.
(Continued on Next Page)