HVAC Validation

7/26/2019 HVAC Validation

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HVAC Validation

MP Platform

--supporting better manufacturing of pharmaceuticals


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Introduction

Heating, Ventilation and Air Conditioning

System (HVAC)

HVAC systems can have an impact on product quality

It can provide comfortable conditions for operators The impact on premises and prevention of contamination and

cross-contamination to be considered at the design stage

Temperature, relative humidity control where appropriate

upplement to basic !"#


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Air conditioner

AH$s %ehumidifier & Heater

'ilters (#re ) H*#A+

%ust *tractors

%ucting ('or delivery of controlled air+ upply 'ans

moe %etector

%ampers

Humidity & Temperature & #ressure sensors .ag 'ilters

Heating & Cooling Coils

HVAC system consists of/


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HVAC

Impure air

Area 0

Area 1

Area 2

Area 3

I

"#

$

4

*

AI

4

#ure air

*haust air

4eturn Air

'resh Air


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FilterSilencer

Terminal flter

Weather louvre Control damper

FanFlo rate controller

!umidifer

!eatin"coil

Coolin"coil

ithdroplet

#eparator

$roduction %oom

!&AC Component#

+

$reflter

E'hau#t Air (rille

!eater

Secondar) Filter

%ecirculated air


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It includes:-

Commissioning

5ualification

"aintenance

Validation of HVAC systems


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#recursor to qualification

Includes setting up, balancing, ad6ustment and testing

of entire HVAC system to ensure it meets requirements

in $47

Acceptable tolerances for parameters

Training of personnel

Commissioning


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Records and data maintained include:- Installation records 8 documented evidence of measure

capacities of the system

%ata/ design and measurement for, e7g7 air flow, systempressures

9)" manuals, schematic drawings, protocols, reports

Conti:


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To ensure that equipment is designed as per requirement,

installed properly7

Action of proving that any equipment wors correctly andleads to the epected results7

5ualification


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Validation "aster #lan

5$A;I'ICATI97 Temperature and 4elative Humidity/

$se a sling psycrometer to measure the dry bulb and wet

bulb temperature of the air7

Chec the wic of the sling psycrometer, it should be

always in wet conditions in order to record correct wetbulb temperature7

ling the psycrometer in air for about a minuteDs time and

record the dry bulb and wet bulb temperature7

Chec the wet bulb depression i7e7 difference between drybulb and wet bulb temperature7

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Acceptance criteria/

Temperature/ 1@oC

Humidity/ 3> N >>K

'requency / %aily

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A*Air chan"e rate7

"easurement of the air supply volume and determination of

the air change rate (AC4+ is a measure of the frequency of

air turnover in the clean room7

This gives some idea as to how quicly contamination maybe removed from the clean room provided there is

acceptable miing of air in the room7

The AC4 can be determined by measuring the mean air

velocity at the supply H*#As or grilles and calculating the

air change rate based on the mean air supply volume7

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*quipment/ Anemometer

ample locations

At least four positions are tested across the filter or grille

face to obtain the mean supply air velocity7'requency of sampling

ch " - ? "onthly

!"# compliance 8 5uarterly

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A@7 "IC49.I9;9!ICA; T*T

olid growth media (e7g7 settle and contact plates+ oybean

Casein %igest Agar medium can be used for both .acteria )

'ungi tested7

The recommended si=e of solid media is ME mm in diameter (for

settle plates+

>> mm for contact plates7

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ampling condition/ ampling in the at rest condition may be continued at anagreed frequency to monitor baseline contamination levels

The operational conditions and the activities being

performed at the time of testing should be recorded

Incubation condition/ Incubation of samples, inverted, at 1E 8 1>o C for at least >

days is suitable for the growth of mould and fungi7

Incubation of samples, inverted, at 2E - 2>EC for at least 1days is suitable for the growth of bacteria7

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Acceptance criteria for Airborne .ioburden test/

Critical *nvironment/ no more than 0 C'$&m2, or

E7E2 C'$&ft2($# monograph+

Acceptance criteria for urface .ioburden test/

Critical *nvironment/ no more than 0 C'$&017Mcm1,

or 1 in1 ('%A Aseptic #rocessing !uidelines+

Conti:

4eferences


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upplementary guidelines on good manufacturing practicesfor HVAC systems for non-sterile pharmaceutical dosage

forms7 (H9 Technical 4eport- eries,

Documents

HVAC Validation