air handling system fails, it will not be possible to continue to use the space for sterile
compounding until the system is back up again.
4. Option 2, Class 7 clean rooms would be easier to construct and maintain than option 1 from
an HVAC standpoint requiring on the order of 45-60 air changes per hour and not hundreds.
The room however, must be able to maintain the defined particle count during peak operations.
Architectural features however, will still apply such as monolithic, cleanable surfaces, with ante
room and gowning, masking scrubbing etc. Also, if the air handling system fails it would still be
possible to continue use the space to maintain class 5 environment with in the operating
LAFW.
5. Option 3, the least impacted option could be if PAFBs are used, a surrounding clean room
environment and air lock and ante room are not required. However, it may not be possible to
perform all procedures in these enclosures. The cost of PAFBs equipment would be
approximately ,000 each.
6. Option 4: A portable clean room would cost less than a total physical renovation or new
addition of a space. However, the cost would be anywhere from ,000- ,000 depending
upon the size and specific options selected.
7. The biological safety cabinets should be NSF Class II (Laminar flow), Type B2, with 100
percent exhaust to outside.
8. For options 2 and 4, following items should be considered to maintain proper environment in
the Clean Room:
a. Provide an yearround, all-air, constant volume terminal reheat system with
individual room temperature controls. The air handling unit should be
dedicated 100% outdoor air and served by a dedicated, independent, air-
cooled chiller providing chilled water to the air handling unit. The air handling
unit and the dedicated chiller are common for both clean room and the space
for the hazardous drugs. Use of a DX (Direct Expansion) system for cooling is
not permitted. The dedicated chilled water system should be backed by the
main chilled water system serving remainder of the building. The heating,
ventilating and air-conditioning system including all exhaust fans serving the
clean room and support area should be on emergency power.
b. Air locks and Anterooms: The use of air locks and ante rooms should be
carefully planned. The medical center staff may consider provision of an air
lock in addition to an ante room where they expect a high volume of
compounding in the clean room, otherwise use of an ante room should be
sufficient to maintain pressure in the clean room. The ante room should have
a minimum of 20 air changes per hour of supply air.
c. Pass-through Chamber: Depending on the size and spacing availability in the
clean room and volume of compounding done, the medical center may
consider provision of a pass-through window to facilitate passing out of
compounded drugs without having pharmacy personnel frequently go in and
out of the clean room through an ante room. The pass-through window should
be big enough to facilitate the passage of compounded sterile products or
materials and have a tight seal between the clean room and the pharmacy
area and should have two access doors. To prevent direct exposure from the
clean room to the pharmacy area, both doors should not open at the same
time. Provide door interlocks limiting doors to being open only if the other is
tightly closed.
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