d. Provide evenly distributed ceiling supply vents, 5 percent ceiling coverage
(20-30 fpm) for class 8 rooms and 10-20 percent ceiling coverage (15-20 fpm)
for class 7 clean rooms.
e. Maintain a minimum of 0.05 inches of water gauge (WG) positive pressure in
the clean room and in the air lock where it is used. This is intended to avoid
reversing or loss of air pressure in the clean room. Maintain a lesser positive
pressure of 0.01 inches WG in the ante room.
f. Maintain indoor temperature of 64 -72 degrees F with 40-60% relative
humidity (RH), but provide system capacity to maintain 62-72 degree F with
40-60% RH.
g. Supply a minimum of constant volume of 45 air changes per hour of HEPA
filtered air into the Clean room. This air change rate must be increased to
maintain the defined particle count during peak operations. However, a
minimum of 30 air changes per hour may be maintained in an existing
building where it may not be possible to provide 45 air changes per hour due
to physical and other constraints.
h. The particulate matter is produced by the supply air; internal particle
generation (room size and number of people); and infiltration from adjacent
spaces. Therefore all three sources need to be controlled. HEPA filters should
be provided with a minimum filter efficiency of 99.97 % for 0.30 micron
particles. Provide pre-filters upstream of HEPA filters to extend useful life of
HEPA filters. HEPA with pre-filters should be accessible for service from
outside the clean room.
i. Locate exhaust fans near the end of exhaust streams. Provide a minimum of
two exhaust outlets near the floor level in the Clean room. The exhaust
system should be dedicated for the biological safety cabinet by having
separate exhaust fan with its own duct work.
j. Location of outside air intake is critical. The intake should not be located near
automobile entrances, driveways, passenger drop offs, cooling towers,
incinerator and boiler stacks and any other item that may degrade the quality
of air. The intakes should be at least 30 feet above the ground level. There
should be separation of at least 30 feet between the air intakes and exhaust
air outlets.
k. Maintain NC (Noise Criteria) 35 level in the Clean room.
l. Do not re-circulate air in the Clean room by even use of local HEPA filters.
m. Monitor room temperature, relative humidity and pressure via monitoring
devices in the Clean room on a continuing basis.
n. Provide monolithic and cleanable walls, floors and ceilings.
o. Do not provide floor drains and sinks in the Clean room.
p. Operate biological safety cabinets on continuing 24/7 basis.
q. The external lens of any lighting fixture must be smooth and cleanable.
r. The doorway into the buffer zone or clean room must be of sufficient size to
move LAFWs in and out of the buffer zone when required.
s. Duct liners in the supply air duct work are not permitted.
t. Seal all wall openings, slots, piping and electrical conduits and other
penetrations to minimize air leakage from the clean room.
9. Provide a separate space for hazardous drugs. Following items should be considered for
this area for maintaining proper environment:
a. The area is served by a common system described in paragraph 8.a.
b. Maintain a minimum of 12 air changes per hour of constant supply air in the room
Previous Page
