validation of hvac systems

8/10/2019 Validation of HVAC Systems

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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.


2/6

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)


3/6


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


6/6


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