Hvac - Ali Raza

8/14/2019 Hvac - Ali Raza

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HHVAC SYSTEMVAC SYSTEMA Tool ToA Tool To MaintainMaintainEnvironmentEnvironment

In Pharmaceutical Plant.In Pharmaceutical Plant.

by:

Ali RazaMicrobiologist

Fassgen Pharma, Pakistan


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Heating

Ventilation

Air - Conditioning


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EnvironmentalEnvironmental

RequirementsRequirements

In PharmaceuticalsIn PharmaceuticalsTTemperatureemperature

RRelative Humidityelative Humidity

AAir Cleanliness Classesir Cleanliness Classes

AAir Distributionir Distribution

AAir Motionir MotionAAir Filtrationir Filtration

AAir Changesir Changes


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ContdContd

DDifferential Air Pressuresifferential Air Pressures

MMonitoring & Data Loggingonitoring & Data Logging

MMaintenanceaintenance


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Heating, Ventilation,Heating, Ventilation,

Air-ConditioningAir-Conditioning

CFR-211.46 (a,b)CFR-211.46 (a,b)

AAdequate ventilation shall be provided.dequate ventilation shall be provided.

EEquipment for adequate control over airquipment for adequate control over airpressure , microorganisms, dust,pressure , microorganisms, dust,

humidity, and temperature shall behumidity, and temperature shall be

provided when appropriate for theprovided when appropriate for the

manufacture, processing, packaging, ormanufacture, processing, packaging, or

holding of a drug product.holding of a drug product.


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ContdContd

AAir filtration systems, includingir filtration systems, includingprefilters and particulate matter airprefilters and particulate matter airfilters, shall be used when appropriatefilters, shall be used when appropriateon air supplies to production areas.on air supplies to production areas.

IIf air is circulated to production areas,f air is circulated to production areas,measures shall be taken to controlmeasures shall be taken to controlrecirculation of dust from production.recirculation of dust from production.

IIn areas where air contaminationn areas where air contamination

occurs during production, there shalloccurs during production, there shallbe adequate exhaust systems or otherbe adequate exhaust systems or othersystems adequate to controlsystems adequate to controlcontaminantscontaminants


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Factors Affecting The HVAC systemFactors Affecting The HVAC systemDesignDesign

CCritical parametersritical parameters

RRequired Level of Protectionequired Level of Protection

RReliabilityeliability

EEconomic Analysis Criteriaconomic Analysis Criteria FFuture Growth/Flexibility Needsuture Growth/Flexibility Needs

BBudgetudget

GGovernment Regulationsovernment Regulations


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Critical ParametersCritical Parameters

TTemperatureemperature

HHumidityumidity

AAir borne particulatesir borne particulates AAir flow patternir flow pattern

AAir changesir changes

RRoom pressureoom pressure MMicrobial contaminationicrobial contamination


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ContdContd

EExposure time is important for temperature sensitivexposure time is important for temperature sensitive

products.products.

TThe storage temperature should be maintained for rahe storage temperature should be maintained for ra

& Packaging materials according to QA documents.& Packaging materials according to QA documents.

TThe storage temperature should be maintained forhe storage temperature should be maintained for

semi finished & finished products according to QAsemi finished & finished products according to QA

documents & label claim.documents & label claim.


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Relative HumidityRelative Humidity

ControlControl

HHumidification & Dehumidificationumidification & Dehumidification TTypes of equipment for dehumidificationypes of equipment for dehumidification Refrigerant typeRefrigerant type

Desiccant typeDesiccant type SolidSolidDesiccantDesiccant Liquid DesiccantLiquid Desiccant

HHumidity (moisture content) affects theumidity (moisture content) affects the

products or materials sensitive to air moistureproducts or materials sensitive to air moisture


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Air Cleanliness ClassesAir Cleanliness Classes

ir Cleanliness classesir Cleanliness classes

FFor FS209 cleanliness classes 100,or FS209 cleanliness classes 100,1000 & 10000 terminally installed1000 & 10000 terminally installed

HEPA filters are required.HEPA filters are required.

FFor cleanliness class 100,000or cleanliness class 100,000centrally installed filter bank ofcentrally installed filter bank of

99.97% may be installed although99.97% may be installed although

terminal filteration is preferred.terminal filteration is preferred.


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Airborne ParticulateAirborne Particulate

ControlControl

TThrough Air Filtrationhrough Air Filtration Types of Filters & Filter ClassesTypes of Filters & Filter Classes

TThrough Air Washinghrough Air Washing

TThrough Other meanshrough Other means

TThe filtration system should behe filtration system should beevaluated for capturing possibleevaluated for capturing possible

contamination particulatescontamination particulates


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..Contd..Contd IIn multi-product facility wheren multi-product facility where

product has no tolerance for crossproduct has no tolerance for crosscontamination, air should not becontamination, air should not bereturned (even if HEPA filtered) forreturned (even if HEPA filtered) forre-circulationre-circulation

WWhen air re-circulation is feasible andhen air re-circulation is feasible andeconomically justifiable, the returneconomically justifiable, the returnair should be filtered to preventair should be filtered to preventpotential for cross-contaminationpotential for cross-contamination

FFor multiple product facility dedicatedor multiple product facility dedicatedAHUs and ductwork are moreAHUs and ductwork are morepractical and cheaper than filtrationpractical and cheaper than filtrationof return air or use of once throughof return air or use of once through

airair


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>9

9.99

5%

H14

>99.999

9%

EU14

>9

9.99

9995%

U17

>9

9.99

995%

U16

>9

9.9995%

U15

>9

9.95%

H13

>99.9999%

EU14

>9

9.5%

H12

>99.97%

EU12

>9

5%

H11

>99.9%

EU11

>8

5%

H10

>95%

EU11

F5

>40%

EU5

F6

>60%

EU6

F7

>80%

EU7

F8

>90%

EU8

F9

>95%

EU9

G2

>65%

EU2

G3

>80%

EU3

G4

>90%

EU4

EUROVENT 4/5

EN 779

COARSE FILTERS

EUROVENT 4/5

EN 779

FINE FILTERS

W

eightA

rrestanc e

DustSpo

t

ABSOLUTE FILTERS

EUROVENT 4/4

MIL STD 282

EN 1822

MPPS

MostPe

netratingParticleS

ize

DOP

0.3m

(--) Efficiency (++)


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Air Flow PatternsAir Flow Patterns

TTurbulent Flowurbulent Flow

LLaminar Flowaminar Flow

DDilution Versus Displacementilution Versus Displacement


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Air ChangesAir Changes

IImportance of Air Changes to Areamportance of Air Changes to Area

ClassificationClassification

CCalculation of Air Changes Ratesalculation of Air Changes Rates

Recovery PeriodsRecovery Periods


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..Contd..Contd

AAir cleanliness classes 1000 andir cleanliness classes 1000 and

10,00010,000

3 30 air changes/h0 air changes/h Air cleanliness classes 100,000Air cleanliness classes 100,000

20 air changes/h20 air changes/h

PPharmaceutically clean roomharmaceutically clean room

(Secondary rooms - ISO class 9)(Secondary rooms - ISO class 9)

10 10 air chan es hair chan es h


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Room Pressure ControlRoom Pressure Control

IIt is important to cleanliness cascade.t is important to cleanliness cascade.

TThe velocity and direction of airflow shouldhe velocity and direction of airflow should

be adequate to reduce contaminationbe adequate to reduce contamination AAir locks must be used to separate areasir locks must be used to separate areas

from different cleanliness class.from different cleanliness class.

TThe door interlocks must be provided tohe door interlocks must be provided to

separate area of two different class.separate area of two different class.

AAir locks may be positive or negativeir locks may be positive or negative


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..Contd..Contd

CCritical areas against less cleanritical areas against less cleanareasareas 12.5 Pascal12.5 Pascal

CControlled areas againstontrolled areas against

uncontrolled areas - with closeduncontrolled areas - with closeddoorsdoors 12.5 Pascal12.5 Pascal

AAdjacent rooms of differentdjacent rooms of different

grades should have a pressuregrades should have a pressuredifferential of 10 - 15 Pascaldifferential of 10 - 15 Pascal


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Mi bi lMi bi l C t i tiC t i ti


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MicrobialMicrobial ContaminationContaminationControlControl

TThrough filtration.hrough filtration.

TThrough fumigation.hrough fumigation. TThrough irradiation.hrough irradiation.

M it i & D tM it i & D t


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Monitoring & DataMonitoring & Data

LoggingLogging

MManualanual SSemi Automaticemi Automatic AAutomaticutomatic AAll critical parameters should be monitoredll critical parameters should be monitored

regularly and non-compliances should beregularly and non-compliances should beindicatedindicated

AA

lert limit alarms may be utilized tolert limit alarms may be utilized to

indicate when a critical parameter goes outindicate when a critical parameter goes outof the set limitof the set limit


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..Contd..Contd

TThehe sensors, alarms, andsensors, alarms, and

recording systems forrecording systems for

critical parameters shouldcritical parameters should

carefully be selected andcarefully be selected and

installedinstalled


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MaintenanceMaintenance

BBreak downreak down

PPreventivereventive

PPredictiveredictive


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Thank You !Thank You !

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Hvac - Ali Raza

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