validation of hvac systems
TRANSCRIPT
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8/10/2019 Validation of HVAC Systems
1/6
Special Edition: Utilities Qualification32
Brian Scott Jeff Hargroves
nd
Jerry Bauers
V LID TION OF HV C
SYSTEMS IN
PH RM CEUTIC L
& BIOTECHNOLOGY
F CILITIES
P RT
Editor s Note:
The following article
is
the first in a
two-part series. Part One addresses the fund men-
tal requirements
nd
installation qualification of
HVAC systems. Part Two which will appear in the
May issue
of
the Journal will discuss the opera
tional qualification
nd
performance qualification
of hese systems.
An HVAC system, which encompasses heating,
ventilation,
and air conditioning, is an integral
component
of
a facility's functionality. t impacts the
safety
of
scientists and technicians working in a lab
or production facility, the integrity of processes, and
the environment outside.
There are three core phases of HVAC system
validation: installation qualification (IQ), opera-
tional qualification (OQ),
and
performance qualifi
cation (PQ). An important element of successful
HVAC validation is prevalidation design work. This
article
explores the
correlation
between
prelimi
nary design and each
phase
of validation.
HVAC SYSTEM FUNDAMENTALS
Construction and validation of an HVAC system usu
ally involves compiling the following documents,
which typically are developed in the order presented
in
Figure
:
Functional Specification (the conceptual design)
Design Drawings, Plans,
and
Specifications
Validation Master Plan
Contractor Documents e.g., shop drawings
and submittals)
Testing, Adjusting, and Balancing TAB) and
Start-up Reports
Commissioning Report (The actual execu
tion
of
validation protocols may commence;
commissioning may be performed as part
of
the development
phase of
validation.)
Validation (IQ, OQ,
&
PQ)
When PQ is complete, process validation com-
mences
and product
manufacture or
laboratory
processes)
can
begin.
Whatever the components
of an
HVAC system,
the functional requirements must be determined up
front. In fact, functional specifications are the cor
nerstone
of
any project.
t
is
important that design criteria
is
not the sole
basis for establishing validation acceptance criteria .
Design criteria may be written with extreme precision,
but acceptance criteria for validation may not need to
be
so stringent. This determination comes from
understanding the process in question. The design
team must understand and assist in determining what
a system needs to do in the context
of
processes
and other operations carried out within a facility.
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Special Edition: Utilities Qualification 33
Brion Scatt JeH
Hargraves
and Jerry Bo uers
Figure
DOCUMENT T ON
SU
P
POR
TI NG CONSTRUCfION
ND V LI D TION OF N HV C SYSTEM
CODI.ltdOr
Operational Qualification
OQ)
Performance
Qualification
PQ)
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Special Edition: Utilities Qualification34
Brian Scott, Jeff Hargroves,
and
Jerry Bauers
A description
of
functional requirements
should include:
HVAC system functionality as it relates to
processes.
Points in a process that
expose
a
product to
the environment.
Source of design guidelines (e.g., an existing
similar facility, a domestic
or
foreign
regulatory body).
The
following
is an excerpt
from
a functional
requirements description for a typical manufactur
ing facility:
Air
handling unit
AHU-Ol seroes
an aseptic fill
ing suite
in
the New Product Facility. The suite
includes
an
aseptic area, clothes changing
room, two
equipment pass-throughs,
and
an
incubator room.
The
air handling
unit draws a
mixture of
makeup air
and
return air into a mixing section,
through a series of ilters,
and
a cooling
coil;
then
blows the air
through
a heating coil and dis
charges it into distribution ductwork. Filtration
is
prOVided
by 30 ASH
RAE
efficiency
pre-filters,
95% ASHRAE efficiency bag filters,
and
99.97%
HEPA
filters. Terminal
99.995
HEPA
filter dif
fusers provide
final
filtration
and
air distribution
in
each room.
Air
is
returned
through low wall
louvered return grilles. Temperature is maintained
at
66
F.
Humidity
is maintained
between 20%
and
50%
RH.
Space pressurizations are shown on
Drawing XX-lOJ-AA.
Once deSigners understand the functionality of a
faCility the next questions are who
or
what holds
regulatory responsibility and what are the particular
performance requirements.
The
answers to these
questions lead to perhaps the most significant issues
in validating
an HVAC
system: The processes that
the system is supporting
and who
monitors the per
formance of the facility. Validation criteria must
be
established within this context
and
not in a vacuum
or against arbitrary right or wrong conditions.
Personnel responsible for
HVAC
validation
should
be
involved in the design process from
early conceptual meetings
through
periodic design
reviews to final design approval. In doing so, they
have a voice in identifying the criteria against
which a system
should
be validated and
can
offer
observations
and
recommendations about design
which
might ultimately impact validation.
VENDOR
REQUIREMENTS
There
are many reasons that a
validation
team
should
participate in the design
phase
of a project.
One
is to identify the documentation that equip
ment vendors must
provide.
Documentation
should
specify the following requirements and tol
erances:
Material certification (e.g., serial numbers
for
HEPA
filters)
Performance characteristics (e.g.,
CFM
for
air flow
on
air handling units; air flow vs.
static pressure for fans)
TAB
Pressure ratings (for ductwork and the
distribution system)
Factory performance testing of critical
equipment
Factory leak testing for cooling or heating
coils
I f contractors
and equipment
vendors are
not
told
up front what they are required to provide, it's
very difficult
to
get necessary information as a pro
ject progresses. In many scenarios, specifications
typically are written just for acquisition
and
instal
lation of equipment. A better procedure one that
will make
the
validation process more
efficient is
to require vendors to supply supporting documen-
tation. Requirements also
should
be
applied to
any
software that may
be
part of controls or building
management
systems.
In addition to outlining documentation that ven
dors must furnish, this is the time in the validation
process to define responsibilities for delivery, instal
lation, and start-up or commissioning. This proce
dure encompasses activities such as starting air han
dling unit motors, verifying correct fan rotation, and
point-to-point verification
of
control loops.
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INST LL TION QUALIFICATION
The goal of IQ is to verify and document the quality,
installation, and integrity of
HV C
system compo
nents. Use design documents and literature provided
by vendors to develop IQ protocols, which often
take the form
of
inventories or checklists. Execution
of
IQ protocols provides assurance that an HV C sys
tem
is
installed according to the manufacturer's rec
ommendations
and requirements for the specific
facility being validated. (Note: Some readers may find
that the requirements listed in the following discus
sion are more typical of aseptic areas and may not
be
universal for all HV C systems.)
A Description
of
Operation (System Description)
identifies an HV C system, as well as the process
es
it
supports and areas
it
serves.
It
should give a
clear
and
concise description
of
the system
in
question, focusing
on
operational attributes of the
system rather than
technical specifications
of
equipment.
In most
cases,
a one-paragraph
description
is
sufficient, unless a system
is unusu
ally
complex.) When appropriate and useful,
include diagrams showing
temperature and
humidity control zones, room
pressure
relation
ships, and other key information.
It is important to avoid over specifying sys
tem attributes. For example, a diagram with arrows
to
indicate room-to-room directional air flows may
be more useful than a drawing showing numeric
pressure relationships.
Information
provided in
a Description of
Operation should cover the following:
Brief description
of
the system
Identification of all the spaces served
by
the
system
Room temperature setpoints, including
acceptable deviations )
Room humidity setpoints, including accept
able deviations )
Minimum
space
air
change
requirements
Space particulate classifications
IQ documentation generally is
broken
down into
the following major sections:
Brian Scott, Jeff Hargroves,
and
Jerry Bauers
Installation rawings
Specifications List) -
Documents as-built drawings
and
design specifica
tions for an HV C system about to be qualified
(validated). As-built
drawings
normally
are sup
plied by mechanical contractors. These drawings
offer a record of system installation in its validated
state,
provided
they reflect
changes
made
to the
system during validations.
Document
the
sheet
number, description, and
latest revision date of each drawing. Compare the
finished installation
to
as-built drawings to make
sure
that installation conforms to the drawings.
Major discrepancies between as-built drawings and
conditions found during validation should be
marked
on the drawings and reported to the
appropriate personnel.
Execution
of
IQ may
be
easier if an installation
checklist is
generated based
on
information
in
design drawings
and
specifications. This checklist
should include all fans, fan motors, coils, and filters
in the air handling unit. Zone reheat coils and ter
minal HEP filters also may be incorporated.
I f construction is
complete
before validation
starts,
some
HV C devices may
become
concealed
by insulation or architectural elements.
In these
cases, packing lists, purchase orders, or other doc
umentation should provide evidence that installed
equipment
meets design requirements. The source
of
information
used
to verify acceptance should
be
noted in a protocol. In addition, duct leak tes
reports may
be referenced and attached as evi
dence
that ductwork has
been
installed in accor
dance
with industry
standards e .g ., ASHRAE
SM CN standards).
Materials in Product Contact -
Normally does no
apply to
most HV C systems. However, in a clean
process environment where product or ingredient
are exposed to air provided by an HV C system
this
evaluation must
consider materials used in
construction of the system that may become air
borne and directly contact product. Because of the
risk of contamination to the system, such materials
should
be appropriate
and
safe for
product
contac
and non-particle shedding.
In other
words, con
struction materials
should not
be reactive, addi
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Brian Scott Jeff Hargroves and Jerry Bauers
tive, or absorptive
so
as to alter the safety, identity,
strength, quality, or purity of the drug beyond the
official or established
requirements.
(21
FR
211.94 - Drug
product
containers nd closures.
IQ
documentation may include
materials in
final filters, along with any devices downstream of
them
that serve
an
area in question. These materi
als should meet industry-accepted
standards
for
suitability in drug processing, packaging, labeling,
or other
activities taking place.
Lubricants -
Identifies lubricants used to maintain
an
HVAC system. This list may
be
as simple as fan
bearing grease. A more detailed list would include
lubricants provided with system components prior
to installation, such as damper lubricants.
Food
or
pharmaceutical grade lubricants should
be
used
if there is potential for
product
contact
(where equipment design permits possible product
contamination by the lubricant). Consult a mainte
nance supervisor or other maintenance personnel to
ensure that all applicable lubricants are listed here.
Utilities -
Lists utilities critical
to
the operation
of
an HVAC
system.
All
systems require
supporting
utilities to function properly. Include applicable
design
and
actual data for utilities as follows:
Electrical requirements and provisions for
each
HVAC utility (e.g., fan, pump, condens
ing unit, etc.) -
Document
voltage, phase,
full
load
amperage, and conductor size.
Steam requirements (e.g., plant steam or clean
steam, as applicable) for each steam coil or
humidifier, including line size and steam
pressure for each device - Steam flow (usually
expressed in pounds per hour) is not easily
measured and usually not included here.
Hot and chilled water coil requirements,
including supply temperature, pressure,
and
flow rate -
f
a TAB contractor has
made adjustments to a system, reference
the TAB report (submitted by a contractor
certified by the National Environmental
Balancing Bureau) for information provided
in this section.
Instrumentation Calibration -
Ensures accurate con
trol of critical operational parameters. List all calibrat
ed instruments critical to system operation. Instrument
calibration should be current at the time that IQ is
performed. Document the dates that calibrations were
executed and that recalibrations are due.
In some cases, the only devices included in a
routine calibration program
are those
used for
closed-loop control or critical system alarms. For
example,
pressure
gauges
in chilled
water
lines
entering and leaving a cooling coil may be consid
ered non-Critical, but temperature sensors in spaces
served by the cooling coil may
be
considered criti
cal.
f
the
temperature
sensors
are
critical,
they
require routine calibration. If calibration data sheets
are available, they may be attached to the protocol.
Preventive Maintenance - Identifies procedures used
to maintain an HVAC system in good operating condi
tion. Preventive maintenance
PM)
also provides assur
ance that a system will be kept in a validated state.
List preventive
maintenance numbers
and
effective dates.
PM
procedures for an HVAC sys
tem
may include
inspection of filters, bearings,
belts, gaskets, and
any other
moving parts, as well
as parts with limited lifespans. Maintenance per
sonnel normally write PM procedures.
Spare Parts -
Identifies filters, belts,
or other
items
that will be replaced
according
to a regularly
scheduled
preventive maintenance
program.
During the life
of
a typical HVAC system, certain
parts
will need
to be replaced
as a
result of
expected wear
and tear. Record the manufacturer
and model
number of
each item. Spare parts
should be identical or equivalent to original parts.
A facility's maintenance department should keep
these parts in stock.
Special Procedures -
Identifies special procedures,
such as a controls system software walk-through
and initial HEPA filter integrity testing. Certain pro
cedures involved in HVAC system start-up should
be
documented
as evidence
of
proper configura
tion or performance of system elements. Some of
this information
may
be useful for troubleshooting
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