Page 42

ISPE Good Practice Guide

Healing, Ventilation , and A1r Cond1tion1ng

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

AFD and AF&ID

On ce functional relat1onsh1ps between areas are established along w1th the1r HVAC reqUirements, and product
contam1nat1on and operator nsks are Identified a s1mple AFD can be created Cnt1cal components of filtrat1on or
parameter momtonng systems also may have been Identified, and provide the JnJtlal elements of an AF&ID. (On
completion, an AF&ID should show all1n strumentat1on )
An AF&ID may be considered the HVAC vers1on of a P&ID. For a defin1t1on of P&ID, see AppendiX 12
An AF&ID usually will include
mstrumentat1on w1th tag numbers
equ1pment w1th tag numbers

For individual use only. Copynght ISPE 2009. All rights reserved.

ISPE Good Practice GUide

Healing Vent1lat1on and Air Conditioning

Page 43

control and manual valves/dampers w1th tag numbers

duct and p1p1ng, sizes, and Identification references
vents, drams, fittmgs ( e g., reducers , mcreasers ), sample po1nts
flow d1rect1ons
control mputs and outputs mterlocks
safety and regulatory requirements, mclud1ng se1sm1c category
annunciation inputs
supplier and contractor Interfaces
identification of components and subsystems delivered by others, 1e system boundaries
This should be supplemented by documentation of intended physical sequence of the equipment, startup, and
operational information
An AF&ID typically does not Include:
Instrument root valves
control relays
manual sw1tches
equ1pment capacity
pressure temperature and flow data
An AFD w111 usually include
ductwork
maJor HVAC equ1pment wrth tag numbers
valves and dampers that affect operation of the system. including balancing dampers
1nterconnect1ons w1th other systems
system ratings and operat1onal values as a mm1mum, normal and maximum flow, temperature, and pressure
An AFD typically does not mclude
duct class1ficat1on and matenal
line numbers
minor bypass duct
1Solat1on and shutoff dampers

For individual use only Copyright ISPE 2009 All rights reserved.

ISPE Good Pract1ce Gu1de

Healing, Ventilalion. and A1r Condilion~ng

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.

ISPE Good Practice Guide

Healing Venlllaton. and A1r Cond11ion1ng

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

Air Flow Diagrams by Facility Type

The typ1cal bas1c (AFDs included 1n th1s sect1on were developed as examples and may not be approprrate for all
products or factl!ltes Some 1nstrumentat1on (as found on an AF&ID) IS shown. The detail of des1gn and the extent of
control are meant for example only and do not constitute recommended praclice.
Note that RHC stands for Reheat Co1l, and Constant Volume Damper (CVD)
atr flow constant

3.4

IS

an airflow flow control dev1ce to hold

Active Pharmaceutical Ingredients (APis) - (Wet End)

A Sample HVAC P&ID

Figure 3.1: Chemical APis
OPl"IONAl
REIAT

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

System Design Considerations

Product-spec1fic requirements are covered 1n the ISPE Baseline~ GUide on APis (Reference 13, Appendix 12)

For IndiVIdual use only. Copyright ISPE 2009. All rights reserved.