Professional Documents
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Regulatory expectation
Same as BL-3 Double container Class III BSC Separate building or isolated
for waste zone
Decontaminate Class I or II Sealed internal shell, can be
everything but BSC using one decontaminated
product leaving the piece suit with Flooded floor drain traps
laboratory connected to waste
ventilation
Access tightly decontamination
controlled, locked HEPA on vents and drains
doors, logbook Minimize dust surfaces
Emergency Seamless bench tops
protocols
Dedicated central vacuum
Access in/out with HEPA at point of use
through shower Backflow prevention for
rooms process fluids
Doors self closing and
locking
Break resistant windows
Corridor Grade D +
Corridor Grade D +
Corridor Grade D +
Clean Area + 30
+
P
aTypically, an
equal amount of
³ 15 Pa air is supplied to
and returned
from the airlock
-
Less Clean Corridor +15
del Valle, Manuel A. PE “Design and Operation of Biotechnology: Design and Operation of
Biopharmaceutical Airlocks” CleanRooms February 2000
³.15 Pa
Clean conditioned
+ +15 air is used to
+ pressurize the
airlock.
³.15 Pa
-
Less Clean Corridor 0
del Valle, Manuel A. PE “Design and Operation of Biotechnology: Design and Operation
of Biopharmaceutical Airlocks” CleanRooms February 2000
Contained
+ Clean Area +15
³15 Pa
All of the air that
- 0 infiltrates into the
- airlock and all of
the supply air is
³ 15 Pa exhausted
+
Less Clean Corridor
+15
del Valle, Manuel A. PE “Design and Operation of Biotechnology: Design and Operation
of Biopharmaceutical Airlocks” CleanRooms February 2000
+ +15
and all of the
- - - ³.15Pa supply air is
- exhausted
-15
.00 -
Less Clean Corridor
Single 24 35 42 49 55 60 65 69 73
Adequate space:
Interlocks:
• Internal furniture & equipment.
Choose types:
Pressurisation & • Electromechanical.
pressure control objectives. • Traffic lights.
Gordon Farquharson
Executive Consultant
gordon.farquharson@pharmout.net
www.pharmout.net