December 15, 2022 | Author: Anonymous | Category: N/A
HEATING VENTILATION & AIRCONDITIONING
HELLO! I am Avishek Sensarma I am here to give a presentations on HVAC. You can find me at
[email protected] 2
CONTENT ▰
Introduction of HVAC
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History of HVAC
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Application Applicatio n of HVAC
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Component of HVAC
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Clean Area /Room Classification of Clean Area Airlocks Qualification of HVAC system
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1 INTRODUCTION
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H= Heating V= Ventilation AC= AC = Ai Airr Co Cond ndit itio ion nin ing g 5
INTRODUCTION OF HVAC
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HVAC refers to Systems which are mechanical arrangements that treats outside air to produce cleaned (from dust and microbes) conditioned air ( temperature and humidity) which is circulated or re-circulated for use in controlled and critical areas with wi thin in th the e ph phar arma mace ceut utic ical al ma manu nufa fact ctur urin ing g sp spac ace e OR
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Can be simply said to be a utility system used to provide air ventilation, heating, cooling and air conditioning services to a buil bu ild din ing g or a ph phar arma mace ceut utic ical al sp spac ace e fo forr dr drug ug man anuf ufac acttur urin ing g
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2 HISTORY 7
The first comfort HVAC system Newwas Yorkinstalled Stock in Exchange in the Year of 1902
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FATHER OF HVAC SYETEM
Will llis is Hav avil ilan and d Ca Carr rrie ierr (N (Nov ovem emb ber 26 26,, 187 876 6 – Wi O can ee nrgninee becsto t bekrn7o,w1n950f)orwasinavnenAtim ngerica mnod arir, conditioning . Carrier invented the first .electrical air conditioning unit in 1902 and, in 1915, he founded Carrier Corporation , a com co mpa pany ny spe peci cial aliz iziing in the man anu ufac actu ture re an and d distribution of heating, ventilation, and air cond co ndit itio ioni ning ng (H (HVA VAC) C) sy syst stem ems. s. 9
3 APPLICATION
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HOTELS
SHOPPING MALL
HOSPITALS 185,244 users PHARMA INDUSTRIES
TELECOM INDUSTRIES
100%
IT INDUSTRIES
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4 COMPONENTS
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COMPONENTS OF HVAC
The HVAC system is mainly consists of Air Handling Units (AHU). HVAC is the central unit to which AHU is connected. Components of AHUs are as follows :
Weat We athe herr lo louv uvre re
Silencer Flow Fl ow ra rate te co cont ntro roll ller er
Cont Co ntro roll da damp mper er
Fan/Blower
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COMPONENTS OF HVAC
Components of AHUs are as follows :
Heatin Heat ing g Un Unit it Cool Co olin ing g Un Unit it// De Dehu humi midi difi fier er
Humidifier
Filters Ducts
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OVERVIEW COMPONENTS Silencer
Weather louvre
Flow rate controller
Fan
Filter
Control damper +
Humidifier
Prefilter
Cooling coil with droplet separator Heating coil
Terminal filter
Production Room
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INSIDE THE AIR HANDLING UNIT
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SCHEMATIC DIAGRAM OF AHU
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AHU CIRCULATION TYPE
100% FRESH AIR TYPE
RECIRCULATION TYPE
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WEATHER LOUVRE
To prevent insects, leaves, dirt and rain from entering
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SILENCER
To reduce noise caused by Air Circulation.
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FAN /BLOWER
To suck the fresh air from the atmosphere or from the th e pr prod oduc ucti tion on ro room om.. F an erful blul owmot er or. is run by a powerf pow motor.
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FLOW RATE CONTROLLER
Automated adjustment adjustment of volume of air (night and day, pressure control)
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CONTROL DUMPER
Fixed adjustment of volume of air
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HEATING UNIT
To heat the air to the proper temperature
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COOLING UNIT /DEHUMIDIFIER
To cool the air to the required temperature or to remove moisture from the air ▰
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HUMIDIFIER
To bring the air to the proper humidity, if too low ▰
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DUCTS
To transport the air
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FILTERS
To eliminate particles of pre-determined dimensions and/or microorganisms ▰
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FILTERS TYPES
DUST FILTER
STANDARD
AEROSOL
COARSE
FINE
HEPA
G1-G4
F5-F9
H11-H13
ULPA
U14-U17
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GRADE WISE FILTER EFFICENCY
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GRADE WISE FILTER EFFICENCY
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5 CLEAN AREA/ROOM
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NASA's Goddard Space Flight Center is Worlds Largest Clean Room
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WHAT IS CLEAN ROOM l
A room/area in which the concentration of airborne particles is controlled.
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A room/area, which is constructed and used in a manner to min mi nim imiz ize e th the e in intr tro odu duct ctio ion, n, ge gene nera rati tio on and re rettent ntio ion n of pa part rtic icle les s insi in sid de th the e ro roo om.
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A room/area in which other relevant parameters e.g. Temperature, Humidity and Pressure are controlled as necessary.
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WHY CLEAN ROOM
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To av avoi oid d cr cros oss s co cont ntam amin inat atio ion. n.
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To av avoi oid d ph phy ysic ica al con onta tami mina nati tion on li like ke Ai Airr bo born rne e Fo Fore reig ign n pa part rtic icle les s and an d fi fibe bers rs..
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To av avoi oid d mi micr crob obia iall co cont ntam amin inat atio ion. n.
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CLEAN ROOM CLASSIFICATION AS PER ISO
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CLEAN ROOM CLASSIFICATION AS PER EU
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CLEAN ROOM CLASSIFICATION AS PER USFDA
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6 AIRLOCKS
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WHAT IS AIRLOCK
Airlock is a small room with controlled air flow acting as barrier between spaces, minimises volume of contaminated air that is introduced into the cleaner area when door is opened. ▰
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Air lock should open and close fast( minimise time of contamination No simultaneous opening of booth doors
High air change rate and smaller airlock ensure faster recovery time
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TYPES OF AIRLOCK
Airlock are mainly four types •
Bubb Bu bble le ty type pe
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Casc Ca scad ade e ty type pe
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Sink Si nk ty type pe
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Dual Du al Co Comp mpar artm tmen entt Ai Airl rlock ock
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7 HVAC QUALIFICATION
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HVAC QUALIFICATION
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QUALICATION FLOW CHART
QUALIFICATION ACTIVITY FLOW
Design Qualification
Installation Qualification
Operation Qualification
Performance Qualification
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DESIGN QUALIFICATION
Design Des ign Qua Qualif lifica icatio tion n inc includ ludes es •Sys System tem des descri cripti ption. on.
•Ba Basi sic c De Desi sign gn Co Conc ncep eptt •Methodology • Acceptance Acceptance Criteria •Su Summ mmar ary y & Co Conc nclu lusi sion on
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INSTALLATION QUALIFICATION
Instal Ins tallat lation ion Qua Qualif lifica icatio tion n inc includ ludes es •
Equipment specification & Identification
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Major component Verification
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Levelling and Alignment
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Verification of Installation & Verification of Utilities
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Check List for Duct Network
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Drawings & Documents
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SOP Verification
OPERATION QUALIFICATION
Operat Ope ration ion Qualif Qualifica icatio tion n includ includes es • •
Instrument Calibration Key Functionality
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Operational Checks
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Safety Features
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SOP verification
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PM planner verification. 49
PERFORMANCE QUALIFICATION
Perfor Per forman mance ce Qualif Qualifica icatio tion n includ includes es (Cont. (Cont..) .) • Pressure Drop across the HEPA and Fine filters of Air Handling Unit • Air Velocity Measurement Measurement and Calculation Calculation of Air Changes •
Integrity test of HEPA filters
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Differential Pressure Test
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Temperature and Relative Humidity Test
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PERFORMANCE QUALIFICATION
Perfor Per forman mance ce Qua Qualif lifica icatio tion n inc includ ludes es (co (cont. nt..) .) • Air Flow Direction Test Test • Cleanliness Class Verification (Non viable Particle Count) •
Sound level Test
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Light Level Test
• Air Borne Viable Particle Particle Monitoring
Recovery test 51
REQUALIFICATION Scheduled Sched uled Quali Qualificat fication ion Sche Sc hedu dule led d qu qua ali lifi fica cati tion ons s as pe perr va vali lida dattio ion n pl plan an sha hall ll be car arri rie ed ou outt. Unsc Un sche hed dul uled ed Qu Qual alif ific icat atiion sh sha all be car arri ried ed out in inca case se of ; •
Substitution of existing HVAC system with a new system.
• Repl Replac acem emen entt of ex exis isti ting ng HE HEPA PA-F -Fil ilte terr or cr crit itic ical al co comp mpon onen ent. t. • Any major modification to the existing HVAC system since purchase or af afte terr th the e la last st pe perf rfor orma manc nce e qu qual alif ific icat atio ion. n.
Frequent surpassing of the alert or action limits of routine enviro env ironme nmenta ntall mon monito itorin ring g par parame ameter ters s
PERFORMANCE QUALIFICATION TESTS
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PRESSURE DROP ACROSS THE HEPA AND FINE FILTERS OF AIR HANDLING UNIT Objective: The purpose of this test is to check the Clogged or clean condition of the across filters of the Air Handling Unit. Test Equipment: Differential pressure Transmitter or Manometer Procedure for HEPA, Fine and Pre Filters: Ensure that the differential pressure transmitter is connected to before the filter and after the filter. Check the status of the filter whether the filter is in clean condition or Clogged condition.
Acceptance Criteria: HEPA Pre and Fine Fine filters filters should be be in clean conditio condition n AIR VELOCITY MEASUREMENT AND CALCULATION OF AIR CHANGES Objective: To demonstrate that the air system is balanced and capable of delivering air velocities and providing number of air changes per hour in the respective rooms as per requirement. Test Equipment: Digital Anemometer / Vane Anemometer Procedure: For compliance of air change rate, velocity to be measured at 5 different
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locations 2 below theofeach Terminal HEPA Filter or Grill (Four Corners and center) with the help calibrated Anemometer.
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AIR VELOCITY MEASUREMENT AND CALCULATION OF AIR CHANGES
Calculate the average velocity of the air coming from Supply Grill / Terminal Filter. Calculate the total airflow from all the Supply Grill / Terminal Filter in the room and add values to get the total airflow in the room (CFM). Acceptance Criteria: Average velocity and subsequent airflow through supply terminals terminals should meet the design criteria of air change rate as per requirement
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INTEGRITY (LEAK) TEST OF HEPA FILTER Objective: To check the installation integrity of the HEPA Filter in Air Handling Units. Test Equipment: Aerosol generator Aerosol Photometer, duly calibrated with national / international traceability. DOP Liquid (Di Octyl Phthalate) / PAO (Poly Alpha Olefin) Liquid
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INTEGRITY (LEAK) TEST OF HEPA FILTER Procedure: Position the Aerosol generator and introduce Aerosol into the upstream air, ahead of the HEPA filters, at the concentration of 80-100 g per liter of air at the filter’s designed airflow rating and set the instrument at 100% concentration. Scan the downstream side of the filter with an appropriate photometer probe at a sampling rate of at least 1 ft3 / min. Acceptance Criteria: During scanning percentage of the PAO/ DOP Liquid penetration shown by photometer should be less than 0.01% through the filter media and should be
zero through mounting joints for 99.97 efficiency HEPA Filters and 0.001% for 99.997 Efficiency.
DIFFERENTIAL PRESSURE TEST Objective: To demonstrate the capability of air system and to provide pressure gradient among different rooms. Equipment Used: Differential Pressure Display Unit or BMS System/Magnehelic Gauges .
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DIFFERENTIAL PRESSURE TEST Procedure: To avoid unexpected changes in air pressure and to establish a baseline, all doors in the facility must be closed and no man movement to be allowed during the observations. Observe the differential pressure through Display Unit or BMS System / Magnehelic Gauges .
Acceptance Criteria: Pressure differentials should meet the requirement as specified in system specification.
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TEMPERATURE & RELATIVE HUMIDITY TEST Objective: To demonstrate the ability of the HVAC system to provide temperature and Relative Humidity within the specified range. Test Equipment: Temperature and Relative Humidity Sensor Display Unit for Temperature and Relative Humidity
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TEMPERATURE & RELATIVE HUMIDITY TEST Procedure: Observe the temperature and relative humidity through respective display unit wh unit whe ere reve verr in inst stal alle led. d. Use Hy Hyg gro rom met ete er to ch chec eck k th the e re rea adi ding ng of Temp mpe era ratture and RH in other rooms. Temperature and RH in the area to be checked and recorded in Static as well as Dy Dyna nami mic c Co Cond ndit itio ion. n. Acceptance Criteria: Temperature and relative humidity should meet the requirement as specified in system specification.
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AIR FLOW DIRECTION TEST Objective To ensure that the HFC system in aseptic area, LAF and Pass box provide unidirectional airflow up to the working height during rest and operating condition. To demonstrate that the air pressure is balanced and air is flowing from highpressure zone to low pressure zone. Procedure Place a torch of Dry Ice / TiCl4 under HFC. Observe the flow of Dry Ice / TiCl4 smoke at the filter downstream.
Videotape the smoke flow pattern. 63
AIR FLOW DIRECTION TEST Acceptance Criteria Under HFC, Smoke Flow should be unidirectional up to working height Smoke should flow from the higher-pressure zone to low-pressure zone between the rooms when the door is open.
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CLEANLINESS CLASS VERIFICATION (NON VIABLE PARTICLE COUNT) COUNT) Objective: To verify that the clean rooms are having cleanliness class as specified in specification sheet. Test Equipment: Air borne particulate counter of 1 CFM suction capacity, duly calibrated with traceability to national / international standard. Procedure: Particulate counting shall be carried out at predefined locations. Particulate Count shall be taken in 3 rounds of Static condition
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CLEANLINESS CLASS VERIFICATION (NON VIABLE PARTICLE COUNT) COUNT) Static Condition: In static condition all the machines shall be kept switched ‘OFF’. Only restricted man movement shall take place. Dynamic Condition: In dynamic condition the operator shall mock desired operation and restricted man movement shall take place. Acceptance Criteria: Clean room or clean zone shall meet the acceptance criteria for an air borne particulate as referred in standard ISO 14644-1.
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AIR BORNE VIABLE PARTICLE MONITORING
Objective: To determine the air borne microbial contamination level in critical area. Air borne microbial count by settling plate exposure method: Pre incubated SCDA Media plates shall be exposed in Locations mentioned for 4 hours and incubated for 48 hours at 30°C to 35°C followed by next 72 hours at 20°C to 25°C.Record the results in respective format. PDA plates shall be exposed weekly to monitor
the counts. platesMicroorganisms shall be incubated once in fifteen daysfungal to monitor theSCDA anaerobic 67
AIR BORNE VIABLE PARTICLE MONITORING
Air borne microbial count by Active Air Sampling: T eg ckisthdeonV e in Acirubbaote r ne coausn saomcphlin eiaabnld thepatertsicteled C stettaecstivfoer a 4i8r hours at 30°C to 35°C and further for 72 hours at 20°C to 25°C 25 °C an and d ob obse serv rvat atiion ons s ar are e re reco cord rde ed in th the e re resp spec ecti tiv ve fo form rmat at.. Acceptance Criteria: All the Parameters performed in the the area should meet meet the following requirements
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SOUND LEVEL TEST Objective: To verify that the sound level is in limit in the clean room area. Test Equipment: Sound Level Meter, duly calibrated with traceability to national / international standard. Procedure: Take the reading at 5 locations in the room and take the average of the sound in the unit of decibels.
Acceptance Criteria: The clean room or clean zone shall meet the acceptance criteria for sound level as mentioned below.
LIGHT LEVEL TEST Objective: To verify that the Light level is in limit in clean room area. Test Equipment: Lux Meter, duly calibrated with traceability to national / international standard. Procedure: Take the reading at 5 locations in the room and take the average of the light level in the unit of Lux.
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Acceptance Criteria: The clean room or clean zone shall meet the acceptance criteria for light
RECOVERY TEST Objective: To establish the recovery time frame for the area to attain the required conditions after the simulation of particle counts from class A & class B. Test Equipment: Non-viable particle counter dually calibrated. Procedure: Simulate and ensure to a count equivalent to that of grade C areas at rest by the following methods as below:
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Personnel Movement. Garments dusting.
RECOVERY TEST
Operate the Air borne non – non – viable particulate counter in the Class A & B areas and continuously operate the non viable particulate counter and note down the time taken after restoration as equivalent to class A & B. Acceptance Criteria: During restoration the particle count limits should fall in the class limits (as referred in standard ISO 14644-1).
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Any questions? You can find me at
@8336055587 & avishek.sarma@mankindph
[email protected] arma.com 73
REFERENCES
