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For further mformat1on . see relevant ISPE Baselinee> Gu1des (Reference 13, AppendiX 12).
Construction methodologies for both architecture and HVAC designs should be coordmated
Room tightness where pressure differential IS s1gn1ficant, floor to ceiling walls should be used Hard (gypsum or
gasketed, mterlockmg, steel or FRP panels) ce11ing construction may be used for pressure-controlled spaces. In
add1t1on . a1r m1grat1on above a ceiling should be mln1m1zed between controlled and uncontrolled spaces If RH
1s s1gmficant, reducmg mo1sture m1grat1on through unsealed penetrations, drams, door seals, and porous wall
matenals should be addressed Door specifications should address seals, Windows, mterlocks, construction of
the door, actuatiOn, d1rect1on of sw1ng, and hardware
To minimiZe a1r leakage, the gap between finished floor and the bottom of door should be un1form (typically
approximately 125 to 5 1nch (3 to 14 mm)) when closed Door sweeps are typ1cally not recommended for
swmg1ng doors 1n manufacturing spaces, because of their accumulation of dirt, scratching of the floor, and
mcreased maintenance
A commJssJonmg test to venfy room tightness (I e , room leakage test or room 1ntegnty test per ISO 14644-3)
should be considered
The use of prefabncated modular fac111ty construction techmques may Impose add1t1onal restnct1ons on a HVAC
des1gn (e g , des1gn may be l1m1ted to equipment suppliers w1th wh1ch the module contractor has an established
relationship, the s1ze of AHUs may be limited to the size of a standard module). Owners should understand the
lim1tat1ons and preferences associated With each module supplier, for example
duct and p1p1ng JOints at each module Interface, misalignment, and leakage potential
limited height
constramts on duct rout1ng
t1ght access to mechanical spaces for serv1ce and removal/replacement
Where possible, serv1ce distribution and p1pe work should be located outs1de a cleanroom 1n an adJacent ut11ity
space to promote better a1rflow patterns and to produce fewer pockets for dirt to accumulate In addition, th1s
location IS helpful for the mamtamab1lrty of equ1pment
The effect of HVAC systems on programm1ng and layout Will vary depend1ng on the type of facility. See Chapter
2.4.3
For individual use only. Copynght ISPE 2009. All rights reserved.
Page 43
For individual use only Copyright ISPE 2009 All rights reserved.
Page 44
access pomts
safety and regulatory requirements, mcluding se1sm1c category
As there IS no standardrzed 1n 1ts approach, organrzat1ons may have "standard practices that fall between AFDs and
AF&IDs .
An AFO/AF&ID may be used as a master record" that IS mamtamed on an ongo1ng basis for regulatory purposes
The master record AFD/AF&ID should mclude
the volumetnc a1rflows to the rooms and acceptable tolerances
the des1gn and operat1ng hmrts for room temperature and hum1d1ty
area class1ficat1ons
a1rflow d1rect1ons/pressure d1fferent1als and mfiltrat1on/exfittrat1on
the process flow
cr1t1cal instruments
Note : References p1pe and ductwork routmg (d1mens1onal) draw1ngs may be Included in the list of requirements for
an 'as built' record draw1ng, but these are not cons1dered to be cr1t1cal for an HVAC application
Other drawmgs, such as 1nstallat1on drawmgs wh1ch are kept for engmeenng record purposes, may be updated on an
'as needed' bas1s
A nomenclature for "tag numbers" shown on AF&IDs should be established to help 1mprove understanding between
des1gners contractors, and operators Industry systems, such as the taggmg nomenclature established by ISA,
commonly are used For example, 1n ISA TE-209 IS a Temperature Sensing Element (TE) on control loop 209 or room
209
As the AF&ID develops, a descnpt1on of how a HVAC system satisfies User Requirements can be developed (i e ,
the 'functional design ). Programmers of the HVAC control and mon1tormg systems, commlss1onmg personnel, and
regulators who need to understand the role of the HVAC system 1n protecting product should find this helpful
For individual use only Copynght ISPE 2009 All rights reserved.
Page 50
may not be applicable 1f return hum1d1ty 1s too h1gh (high Internal latent load)
add1t1onal maintenance (for pretreatment equ1pment)
add1t1onal space requ1red for pretreatment eqUipment and associated ductwork
1f a des1ccant dehum1d1f1er 1s added to the pretreatment system, 1n place of over-cool1ng and preheat m
rewculat1on , 1t mcreases complex1ty and may add a new type of eqUipment
3.3
3.4
IS
ENERGY RECO\otRY
COl. (OPTlONAI.)
EXHAUST
AIR
~-~
~II
LOUVER
INTAlC
PLOAAI
wI ACCE.SS
IE~TlNG
PRE -41..1ER/
1NlERMEDIA1E
fl.!U!
R~
COW"'C
COIL
COIL
SECTION
MOUN!Ell
OOiAUST
~
~
fAN
(OPTI!l'IAI.)
SECTION
r---
_____ T __ _ _____ T __ _
I
I
I
I
I
I
I
I
BALANCI"'C
r"ll
DAMPER OR~
C\0 (rn>.) :
I
I
I
------1-------------~-------------~
~I
TuNCLASSRD
I
I
I
AIRLOCK
I
I
_,
I
I
I
I
LEt DrnCTOR
UNClASSifiED
RtACTOR
R~
j_j 1~
I
\_REACTOR
OlARQNC HOOO
Note: Instrumentation - RH stat tn reactor room controls coohng co1l and hum1d1f1er Thermostat tn reactor room controls reheat co1l.
Thermostat set at 50' F (1 oc) controls preheat c011 DP gauges on each filter bank Emergency ventilation controlled by Spill Help
alarm. Not shown - DP gauges on atr filter banks
3.4. 1
For IndiVIdual use only. Copyright ISPE 2009. All rights reserved.