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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 !