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7/26/2019 HVAC Validation
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HVAC Validation
MP Platform
--supporting better manufacturing of pharmaceuticals
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Copyright CM Plus Corporation. All Rights Reserved. EA-05-02-00 2
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
Conti:
C ti
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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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Conti
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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,
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THANK YOU
FORYOUR ATTENTION
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