2 ENVIRONMENT CONTROL SYSTEM HVAC system-Air filtration-Pressurization-Temperature-Humidity-AirbornecleanlinessArchitectural or isolation system-Walls-Flooring materials-Door & window-Glove box/isolator-Door interlockingdevicePersonnel contamination control- Uniform- Mask- GlovesCleaning and disinfection system-Material-Method-EquipmentMonitoring and control system
3 HVAC SYSTEM1)Provide a specific set of environment condition required for PURPOSE the manufacturing process.1) Heating and cooling2) Humidifying and dehumidifyingFUNCTIONS ) Cleaning the air4) Regulate air flow5) Pressurization1) To prevent contaminationUSES ) To provide comfortable working conditions
4 HEATING VENTILATION AIR CONDITIONING Heating is significant in maintainingadequate room temperature especiallyduring cold weather conditions.VENTILATIONProcess of "changing" or replacing air in any space to control temperatureor remove any combinationAIR CONDITIONINGAir conditioning and refrigeration areprovided through the removal of heat
5 ObjectiveGoal: To develop an automotive air-conditioning system that is smaller and lighter than with conventional technology.The Challenge: The system must be capable of keeping a temperature of 22˚C inside a room, with an outside temperature of 40˚C. Also, the system must be an efficient heating system, keeping an internal temperature of 15˚C with an outside temperature of 0˚C.
6 H.V.A.C H.V.A.C – Heating, Ventilation and Air Conditioning system The HVAC regulatesRoom TemperatureHumidityAir QualityAir Flow
8 DESIGN PARAMETERS Energy efficiency Cleanliness Cost Temperature uniformityHumidity controlChemical exhuast efficiencyNoise control
9 Schematic Representation of HVAC system Outside airDistribution networkExhaustoutletHeating coil Cooling coilfanhumidifier80% %Intermediate filterMixingchamberPre-filterValve / DampersReturn airRoomHEPA filter
10 COMPONENTS OF HVAC SYSTEM Air handling unitBlower/FanHeating and cooling coilsHumidifiersDehumidifiersAir distribution NetworkDuct networkInsulatorsDampers or valvesAir filtersPre-filterIntermediates or low efficiency filterTerminal filter (HEPA filter)
11 Air system failure alarm (ASFA) HVAC SPECIFICATIONSTemperature18-23 o CRelative humidity45% ± 5%Dry powder = 30% ± 5%Moisture sensitive drug = 5% ± 5%Air velocityft/minAir flowLaminar airflowPressure gradient15 PascalParticulate count (Critical area)NMT 100 particles of 0.5 µm/ft3Air system failure alarm (ASFA)
12 ENVIRONMENTAL MONITORING (Schedule-m) Particulate monitoring in airMonthlyDailyBHEPA filter integrity testingYearlyCAir change rateDTemperature and HumidityEAir pressure differentialsFMicrobiological monitoringDaily ( In aseptic areas)Decreased frequency in other areas
13 Sources of contamination A. External SourcesThe external contamination is controlled primarily by1. High efficiency filtration,2. Space pressurization and3. Sealing of space penetrations
14 B. Internal Sources- Control is primarily through airflow design. Construction finishes; personnel and garments; materials and equipments.Important control precautions include:1. Walls, floors, ceiling tiles, doors, and windows.2. People must wear garments.3. Materials and equipment must be cleaned before entering the clean room.4. Room entrances such as air locks .5. Air showers are used to remove contaminants from personnel before entering .
15 Classification Of Clean Room Class Limits "not to exceed" particles per cu ft for particle size shown0.1μm0.2μm0.3μm0.5μm5 μm135.07.503.01.0--1035075.030.010.010075030010007.01000070.0100000700
16 AIR FLOW PATTERNSWorkbench (vertical) Cabin/ booth Ceiling
17 Air conditionersAn air conditioner designed to change the air temperature and humidity within an area (used for cooling and sometimes heating depending on the air properties at a given time). The cooling is typically done using a simple refrigeration cycle, but sometimes evaporation is used,
18 AHUsThe air handling unit is an equipment consisting of fans, heating and cooling coils, air-control dampers, filters .It collect and mix outdoor air with that returning from the building space.The air mixture is then cooled or heated, after which it is discharged into the building space through a duct
19 Dehumidifiers/ Heater In dehumidifier evaporator and condenser coils are placed in the same air path, and the entire unit is placed in the environment .Having the condenser coil in the same air path as the evaporator coil produces warm, dehumidified airThe air next passes over the condenser coil, re-warming the now dehumidified air.
20 FiltersA particulate air filter is a device composed of fibrous materials which removes solid particulates such as dust, pollen grains, mold, and bacteria from the airA chemical air filter consists of an absorbent or catalyst for the removal of airborne molecular contaminants such as volatile organic compounds or ozoneAir filters are used in applications where air quality is important.
21 Dust extractoreA dust collection system is an air quality improvement systemDust collection systems work on the basic formula of capture, convey and collect.
22 Ducting (for delivery of controlled air) Ducts are used to deliver and remove air.A duct system is often called as ductwork.Materials1. Polyurethane and Phenolic insulation panels (pre-insulated air ducts)1. Fiberglass duct board (preinsulated nonmetallic ductwork1. Flexible Ducting
23 Supply fansFlow rate controlled by inlet vanes or outlet dampers on the fan.The supply fan speed is controlled to maintain pressure in the supply duct.
24 Smoke detectarsA smoke detector is a device that detects smoke, typically as an indicator of fire. Commercial, industrial, and mass residential devices issue a signal to a fire alarm system
25 DamperA plate or gate placed in a duct to control air flow by increasing friction in the duct.Smoke damperA damper or adjustable louver designed to augment the ventilation of a space during a fire.
26 Humidity/Temp./ Pressure sensors This function board is used to measure humidity.Temperature sensors are devices used to measure the temperature.A pressure sensor measures pressure, typically of gases or liquids.
27 Heating & Cooling coils A heating coil is a piece of equipment built for efficient heat transfer from one medium to anotherA cooling coil cools air blown across it and into the building occupied space.
28 What can HVAC do? Control airborne particles, dust and micro-organisms Maintain room pressure (delta P)Maintain space moisture (Relative Humidity)Maintain space temperature
29 What HVAC can’t do?1. HVAC can not clean up the surfaces of a contaminated places, room or equipment2. HVAC can not compensate for workers who do not follow procedures
31 AIRFLOW DISTRIBUTION AND CONTROL UnidirectionalNon-unidirectional airflowMixed patternsClean roomClassAirflow TypeAv.Airflow Velocity,fpmAir changes/hr1Unidirectional70-1001060-11010050-901000Mixed40-901000025-4060-12010000010-3010-40
32 ROOM PRESSURIZATIONThe clean room is positively pressurized with respect to theadjacent areas.This is done by supplying more air and extracting less air from the room than is supplied to itThe pressure differential should be of sufficient magnitude to ensure containment and prevention of flow reversal, but should not be so high as to create turbulence problems.Example :-Cascade airlock: high pressure on one side of the airlock and low pressure on the other.
33 TYPES OF CLEAN ROOMS Horizontal Clean Room – Horizontal Laminar flow (HEPA filters in a wall force clean air from one side of the room to other.)Vertical Clean Room – Vertical Laminar flow(HEPA filters on the ceiling push clean air down to the floor.)
34 FOUR BASIC PRINCIPLES OF CLEAN ROOM Not To Bring Any DustNot To Accumulate Any DustNot To Generate Any DustTo Remove Any Dust Quickly
35 Validation of AHU/HVAC System Temperature control testHumidity control testFilter integrity testAir velocity testAir flow pattern(Smoke test)Microbial test
36 1.Temperature control test:- Objective:- To demonstrate the ability of the HVAC systemto control temperature.Equipment- ThermometerTest procedure:-Environment is divided by a gridSize of square- 60cm×60cm or moreSampling location- work heightResult compare with specification60×60cmAcceptance criteria:- Temp. 20±2ºC
37 2.Humidity control test:- Objective:- To demonstrate the ability of the HVACsystem to control humidity.Equipment- Automatic humidity recorderTest procedure:-Environment is divided by a gridSize of square- 60cm×60cm or moreSampling location- work heightResult compare with specification60×60cmAcceptance criteria:- Humidity: 45±5%Fig.. Digital moisturemeter
38 Filter Integrity Test:- Objective:- To provide evidence of the integrity of theHEPA filterAcceptance criteria:-99.97 efficiency % particles of 0.3 µm99.99 efficiency % particles of 0.3 µm100%0.03%HEPA filter
40 Air flow velocity and uniformity test:- Test procedure:-Environment is divided by gridMeasure by Airflow meterFig.- Airflow meterAcceptance criteria:-Vertical flows0.30 m/sec ± 20%Horizontal flows0.45 m/sec ± 20%Fig.- laminar air flow unitAction: Deviation indicates blockage of filterSolution : Alteration of fan speed HEPA filter replacement
41 Air flow system (Smoke test ) :- Test procedure:- (smoke test)Generate visible smoke upstream from the work zoneEstablish the reference pointVideotape the direction of the flow in both caseDetermine the direction
42 MICROBIOLOGICAL TESTS :- Solid growth mediaSampling conditionsSampling in the at rest condition may be continued at an agreed frequency to monitor baseline contamination levels.The operational conditions and the activities being performed at the time of testing should be recorded.Incubation conditionsIncubation of samples, inverted, at 20 – 25C for at least 5 days is suitable for the growth of mould and fungi.Incubation of samples, inverted, at C for at least 2 days is suitable for the growth of bacteria.
43 APPLICATIONS OF HVAC Health-Care Facilities Residences Educational FacilitiesLaboratoriesPharmaceutical IndustriesNon Pharmaceutical IndustriesTall BuildingsHotelsPlaces of AssemblyNuclear FacilitiesCommercial and Public Buildings
45 CONCLUSIONHVAU is of Pharmaceutical Industries that purify the outside air and circulate all over the areas.HVAC system provide specific set of environment condition which required to make quality product so therefore it must be validated.Heart
46 References :- www.cedengineering.com. www05.abb.com A. Bhatia, B.E. PDH Online | PDH Center,5272 Meadow Estates Drive,Fairfax, VAen.wikipedia.org