HVAC SYSTEM

ENVIRONMENT CONTROL SYSTEM HVAC system -Air filtration -Pressurization -Temperature -Humidity -Airborne cleanliness Architectural or isolation system -Walls -Flooring materials -Door & window -Glove box/isolator -Door interlocking device Personnel contamination control - Uniform - Mask - Gloves Cleaning and disinfection system -Material -Method -Equipment Monitoring and control system

HVAC SYSTEM 1)Provide a specific set of environment condition required for PURPOSE the manufacturing process. 1) Heating and cooling 2) Humidifying and dehumidifying FUNCTIONS 3) Cleaning the air 4) Regulate air flow 5) Pressurization 1) To prevent contamination USES 2) To provide comfortable working conditions

HEATING VENTILATION AIR CONDITIONING Heating is significant in maintaining adequate room temperature especially during cold weather conditions. VENTILATION Process of "changing" or replacing air in any space to control temperature or remove any combination AIR CONDITIONING Air conditioning and refrigeration are provided through the removal of heat

Objective Goal: 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.

H.V.A.C H.V.A.C – Heating, Ventilation and Air Conditioning system The HVAC regulates Room Temperature Humidity Air Quality Air Flow

H.V.A.C COMPONENTS:- Air conditioners AHUs Dehumidifiers/ Heater Filters (Pre & HEPA) Dust extractore Ducting (for delivery of controlled air) Supply fans Smoke detectores Damper Humidity/Temp./ Pressure sensor Heating & Cooling coils

DESIGN PARAMETERS Energy efficiency Cleanliness Cost Temperature uniformity Humidity control Chemical exhuast efficiency Noise control

Schematic Representation of HVAC system Outside air Distribution network Exhaust outlet Heating coil Cooling coil fan humidifier 80% 20% Intermediate filter Mixing chamber Pre-filter Valve / Dampers Return air Room HEPA filter

COMPONENTS OF HVAC SYSTEM Air handling unit Blower/Fan Heating and cooling coils Humidifiers Dehumidifiers Air distribution Network Duct network Insulators Dampers or valves Air filters Pre-filter Intermediates or low efficiency filter Terminal filter (HEPA filter)

Air system failure alarm (ASFA) HVAC SPECIFICATIONS Temperature 18-23 o C Relative humidity 45% ± 5% Dry powder = 30% ± 5% Moisture sensitive drug = 5% ± 5% Air velocity 80- 120 ft/min Air flow Laminar airflow Pressure gradient 15 Pascal Particulate count (Critical area) NMT 100 particles of 0.5 µm/ft3 Air system failure alarm (ASFA)

ENVIRONMENTAL MONITORING (Schedule-m) Particulate monitoring in air Monthly Daily B HEPA filter integrity testing Yearly C Air change rate D Temperature and Humidity E Air pressure differentials F Microbiological monitoring Daily ( In aseptic areas) Decreased frequency in other areas

Sources of contamination A. External Sources The external contamination is controlled primarily by 1. High efficiency filtration, 2. Space pressurization and 3. Sealing of space penetrations

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 .

Classification Of Clean Room Class Limits "not to exceed" particles per cu ft for particle size shown 0.1μm 0.2μm 0.3μm 0.5μm 5 μm 1 35.0 7.50 3.0 1.0 -- 10 350 75.0 30.0 10.0 100 750 300 1000 7.0 10000 70.0 100000 700

AIR FLOW PATTERNS Workbench (vertical) Cabin/ booth Ceiling

Air conditioners An 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,

AHUs The 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

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 air The air next passes over the condenser coil, re-warming the now dehumidified air.

Filters A particulate air filter is a device composed of fibrous materials which removes solid particulates such as dust, pollen grains, mold, and bacteria from the air A chemical air filter consists of an absorbent or catalyst for the removal of airborne molecular contaminants such as volatile organic compounds or ozone Air filters are used in applications where air quality is important.

Dust extractore A dust collection system is an air quality improvement system Dust collection systems work on the basic formula of capture, convey and collect.

Ducting (for delivery of controlled air) Ducts are used to deliver and remove air. A duct system is often called as ductwork. Materials 1. Polyurethane and Phenolic insulation panels (pre-insulated air ducts) 1. Fiberglass duct board (preinsulated nonmetallic ductwork 1. Flexible Ducting

Supply fans Flow rate controlled by inlet vanes or outlet dampers on the fan. The supply fan speed is controlled to maintain pressure in the supply duct.

Smoke detectars A 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

Damper A plate or gate placed in a duct to control air flow by increasing friction in the duct. Smoke damper A damper or adjustable louver designed to augment the ventilation of a space during a fire.

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.

Heating & Cooling coils A heating coil is a piece of equipment built for efficient heat transfer from one medium to another A cooling coil cools air blown across it and into the building occupied space.

What can HVAC do? Control airborne particles, dust and micro-organisms Maintain room pressure (delta P) Maintain space moisture (Relative Humidity) Maintain space temperature

What HVAC can’t do? 1. HVAC can not clean up the surfaces of a contaminated places, room or equipment 2. HVAC can not compensate for workers who do not follow procedures

Animated representation of working of AHU/HVAC

AIRFLOW DISTRIBUTION AND CONTROL Unidirectional Non-unidirectional airflow Mixed patterns Clean room Class Airflow Type Av.Airflow Velocity, fpm Air changes/hr 1 Unidirectional 70-100 350-650 10 60-110 300-600 100 50-90 300-480 1000 Mixed 40-90 150-250 10000 25-40 60-120 100000 10-30 10-40

ROOM PRESSURIZATION The clean room is positively pressurized with respect to the adjacent areas. This is done by supplying more air and extracting less air from the room than is supplied to it The 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.

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.)

FOUR BASIC PRINCIPLES OF CLEAN ROOM Not To Bring Any Dust Not To Accumulate Any Dust Not To Generate Any Dust To Remove Any Dust Quickly

Validation of AHU/HVAC System Temperature control test Humidity control test Filter integrity test Air velocity test Air flow pattern(Smoke test) Microbial test

1.Temperature control test:- Objective:- To demonstrate the ability of the HVAC system to control temperature. Equipment- Thermometer Test procedure:- Environment is divided by a grid Size of square- 60cm×60cm or more Sampling location- work height Result compare with specification 60×60cm Acceptance criteria:- Temp. 20±2ºC

2.Humidity control test:- Objective:- To demonstrate the ability of the HVAC system to control humidity. Equipment- Automatic humidity recorder Test procedure:- Environment is divided by a grid Size of square- 60cm×60cm or more Sampling location- work height Result compare with specification 60×60cm Acceptance criteria:- Humidity: 45±5% Fig.. Digital moisture meter

Filter Integrity Test:- Objective:- To provide evidence of the integrity of the HEPA filter Acceptance criteria:- 99.97 efficiency- 0.03% particles of 0.3 µm 99.99 efficiency- 0.01% particles of 0.3 µm 100% 0.03% HEPA filter

DOP (Dioctyl phthalate) Test HOT DOP Efficiency test Vaporization Mono-disperse aerosol 0.3 µm COLD DOP Integrity test Pressurization Poly-disperse aerosol > 0.3 µm < 0.3 µm 0.3 µm (20-30 %)

Air flow velocity and uniformity test:- Test procedure:- Environment is divided by grid Measure by Airflow meter Fig.- Airflow meter Acceptance criteria:- Vertical flows 0.30 m/sec ± 20% Horizontal flows 0.45 m/sec ± 20% Fig.- laminar air flow unit Action: Deviation indicates blockage of filter Solution : Alteration of fan speed HEPA filter replacement

Air flow system (Smoke test ) :- Test procedure:- (smoke test) Generate visible smoke upstream from the work zone Establish the reference point Videotape the direction of the flow in both case Determine the direction

MICROBIOLOGICAL TESTS :- Solid growth media Sampling conditions Sampling 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 conditions Incubation 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 30 - 35C for at least 2 days is suitable for the growth of bacteria.

APPLICATIONS OF HVAC Health-Care Facilities Residences Educational Facilities Laboratories Pharmaceutical Industries Non Pharmaceutical Industries Tall Buildings Hotels Places of Assembly Nuclear Facilities Commercial and Public Buildings

WORKING OF HVAC SYSTEM

CONCLUSION HVAU 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

References :- www.cedengineering.com. www05.abb.com A. Bhatia, B.E. PDH Online | PDH Center,5272 Meadow Estates Drive,Fairfax, VA 22030-6658. www.who.int www.pharmaguideline.com en.wikipedia.org www.pharmamanufacturing.com www.cleanairtech.com.au

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