INTRODUCTION

In pharmaceutical manufacturing, how space conditions impact the product being

made is of primary importance. The pharmaceutical facilities are closely supervised by Good

Manufacturing Practices. These regulations, which have the force of law, require that

manufacturers, processors, and packagers of drugs to take proactive steps to ensure that their

products are safe, pure, and effective. GMP regulations require a quality approach to

manufacturing, enabling companies to minimize or eliminate instances of contamination, mix

ups, and errors.

The GMP for HVAC services embraces number of issues starting with the selection

of building materials and finishes, the flow of equipment, personnel and products,

determination of key parameters like temperature, humidity, pressures, filtration, airflow

parameters and classification of cleanrooms. It also governs the level of control of various

parameters for quality assurance, regulating the acceptance criteria, validation of the facility,

and documentation for operation and maintenance.

HVAC system performs four basic functions:

1. Control airborne particles, dust and micro-organisms - Thru air filtration using high

efficiency particulate air (HEPA) filters.

2. Maintain room pressure (delta P) - Areas that must remain “cleaner” than

surrounding areas must be kept under a “positive” pressurization, meaning that air

flow must be from the “cleaner” area towards the adjoining space (through doors or

other openings) to reduce the chance of airborne contamination. This is achieved by

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the HVAC system providing more air into the “cleaner” space than is mechanically

removed from that same space.

3. Maintain space moisture (Relative Humidity) - Humidity is controlled by cooling air

to dew point temperatures or by using desiccant dehumidifiers. Humidity can affect

the efficacy and stability of drugs and is sometimes important to effectively mould

the tablets.

4. Maintain space temperature - Temperature can affect production directly or

indirectly by fostering the growth of microbial contaminants on workers.

Each of above parameter is controlled and evaluated in light of its potential to impact

product quality.

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CLEAN ROOM OVERVIEW

A cleanroom is defined as a room in which the concentration of airborne particles is

controlled. The cleanrooms have a defined environmental control of particulate and microbial

contamination and are constructed, maintained, and used in such a way as to minimize the

introduction, generation, and retention of contaminants.

Cleanroom classifications are established by measurement of the number of particles

0.5 micron and larger that are contained in 1 ft3 of sampled air. Generally class 100 to 100,000

rooms are used in the pharmaceutical industry. [Note - rooms may be classified as clean at

class 1 or 10 for other applications, particularly in the microchip /semiconductor industry].

Cleanroom Air Flow Principles

Cleanrooms maintain particulate-free air through the use of either HEPA or ULPA

filters employing laminar or turbulent air flow principles. Laminar, or unidirectional, air

flow systems direct filtered air downward in a constant stream. Laminar air flow systems

are typically employed across 100% of the ceiling to maintain constant, unidirectional

flow. Laminar flow criteria is generally stated in portable work stations (LF hoods), and is

mandated in ISO-1 through ISO-4 classified cleanrooms.

Proper cleanroom design encompasses the entire air distribution system, including

provisions for adequate, downstream air returns. In vertical flow rooms, this means the use

of low wall air returns around the perimeter of the zone. In horizontal flow applications, it

requires the use of air returns at the downstream boundary of the process. The use of

ceiling mounted air returns is contradictory to proper cleanroom system design.

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Cleanroom Classifications

Cleanrooms are classified by how clean the air is. In Federal Standard 209 (A to D)

of the USA, the number of particles equal to and greater than 0.5mm is measured in one

cubic foot of air, and this count is used to classify the cleanroom. This metric nomenclature

is also accepted in the most recent 209E version of the Standard. Federal Standard 209E is

used domestically. The newer standard is TC 209 from the International Standards

Organization. Both standards classify a cleanroom by the number of particles found in the

laboratory's air. The cleanroom classification standards FS 209E and ISO 14644-1 require

specific particle count measurements and calculations to classify the cleanliness level of a

cleanroom or clean area. In the UK, British Standard 5295 is used to classify cleanrooms.

This standard is about to be superseded by BS EN ISO 14644-1.

Cleanrooms are classified according to the number and size of particles permitted

per volume of air. Large numbers like "class 100" or "class 1000" refer to FED_STD-209E,

and denote the number of particles of size 0.5 mm or larger permitted per cubic foot of air.

The standard also allows interpolation, so it is possible to describe e.g. "class 2000."

Small numbers refer to ISO 14644-1 standards, which specify the decimal

logarithm of the number of particles 0.1 µm or larger permitted per cubic metre of air. So,

for example, an ISO class 5 cleanroom has at most 105 = 100,000 particles per m³.

Both FS 209E and ISO 14644-1 assume log-log relationships between particle size

and particle concentration. For that reason, there is no such thing as zero particle

concentration. Ordinary room air is approximately class 1,000,000 or ISO 9.

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TYPES OF CLEANROOMS

Cleanrooms are also categorized by the way supply air is distributed. There are generally

two air supply configurations used in cleanroom design:

1) Non-unidirectional

2) Unidirectional.

Non-unidirectional air flow

In this airflow pattern, there will be considerable amount of turbulence and it can be

used in rooms where major contamination is expected from external source i.e. the make up

air. This turbulent flow enhances the mixing of low and high particle concentrations,

producing a homogenous particle concentration acceptable to the process.

Air is typically supplied into the space by one of two methods. The first uses supply

diffusers and HEPA filters. The HEPA filter may be integral to the supply diffuser or it may

be located upstream in the ductwork or air handler. The second method has the supply air

pre-filtered upstream of the cleanroom and introduced into the space through HEPA filtered

work stations. Non-unidirectional airflow may provide satisfactory control for cleanliness

levels of Class 1000 to Class 100,000.

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Unidirectional air flow

The unidirectional air flow pattern is a single pass, single direction air flow of

parallel streams. It is also called 'laminar' airflow since the parallel streams are maintained

within 18 deg - 20 deg deviation. The velocity of air flow is maintained at 90 feet per minute

±20 as specified in Federal Standard 209 version B although later version E does not specify

any velocity standards.

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Unidirectional cleanrooms are used where low air borne contaminant levels are

required, and where internal contaminants are the main concern.

They are generally of two types:

1. Vertical down-flow cleanrooms where the air flow is vertical ‘laminar’ in direction.

2. Horizontal flow where the air flow is horizontal ‘laminar’ in direction.

In vertical down-flow arrangement, clean make-up air is typically introduced at the ceiling

and returned through a raised floor or at the base of the side walls. Horizontal flow

cleanrooms use a similar approach, but with a supply wall on one side and a return wall on

the other.

Typically a down-flow cleanroom consists of HEPA filtered units mounted in the

ceiling. As the class of the cleanroom gets lower, more of the ceiling consists of HEPA

units, until, at Class 100, the entire ceiling will require HEPA filtration. The flow of air in a

down-flow cleanroom bathes the room in a downward flow of clean air. Contamination

generated in the room is generally swept down and out through the return.

The horizontal flow cleanroom uses the same filtration airflow technique as the

down-flow, except the air flows across the room from the supply wall to the return wall.

Between the two, the vertical down-flow pattern yield better results and is more adaptable to

pharmaceutical production.

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Cleanrooms HVAC different from a normal comfort air conditioned space

A cleanroom requires a very stringent control of temperature, relative humidity,

particle counts in various rooms, air flow pattern and pressure differential between various

rooms of the clean air system. All this requires:

1. Increased Air Supply: Whereas comfort air conditioning would require about 2-10 air

changes/hr, a typical cleanroom, say Class 10,000, would require 50 - 100 air changes. This

additional air supply helps, to dilute the contaminants to an acceptable concentration.

2. High Efficiency Filters: The use of HEPA filters having filtration efficiency of 99.97%

down to 0.3 microns is another distinguishing feature of cleanrooms.

3. Terminal Filtration and Air Flow pattern: Not only are high efficiency filters used,

but a laminar flow is sought.

4. Room Pressurization: With the increased fresh air intake, cleanrooms are pressurized

in gradients. This is important to keep external particulates out of clean spaces.

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SYSTEM DESIGN

The HVAC design process begins with meetings with process engineers, architects,

and representatives from the owner or facility user. The process and instrument diagrams

(P&IDs) are reviewed, and a general understanding of the process is conveyed to all

interested parties. Operation of the facility is reviewed, and any plans for future additions or

modifications are discussed.

After the initial meeting, a written basis of design is produced that describes the

regulations and codes that will govern the design. Spaces are defined by function, and

temperature and humidity requirements are determined. Room classifications are listed and

adjacency of spaces and pressure relationships are documented. Any unusual or unique

facility requirements must also be designed into the HVAC system at this time, such as

emergency backup or redundancy for HVAC systems. This is also the stage of the design

process during which alternate studies are conducted to compare options for the HVAC

system. The cost of a backup or redundant HVAC supply system may be compared with the

cost of product loss or experiment interruption should temperatures or airflow go out of

control or specification. Heat recovery from exhaust systems and thermal storage are

examples of other potential areas for study. Airflow diagrams are produced that show areas

served by a particular air handling system including supply, return, exhaust, and transfer air

between spaces. The basis of design also describes major equipment to be used and the level

of quality of components and construction material.

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The efficiency of the system design is based on proper consideration of the following

factors:

1. Building construction and layout design

2. Defining the HVAC requirements system-wise and then room-wise.

– Cleanliness level

– Room temperature, relative humidity

– Room pressure

– Air flow pattern

3. Cooling load and Airflow compilation

4. Selection of air flow pattern

5. Pressurization of rooms

6. Air handling system

7. Duct system design and construction

8. Selection, location and mounting of filtration system

9. Defumigation requirement

10. Commissioning, performance qualification and validation

11. Testing and validation

12. Documentation

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DESIGN WORKS

Temperature and Humidity

The design for each room are according to the its application. Each application have the

recommended temperature and humidity that suitable for the human activity and appliances

in that room. Required psychometric chart was selected

Table: Design temperature and humidity for normal room at Level 1 (first floor)

Room

Room RH (%) Temp room (°C) Temp room (°F) Enthalpy, H (btu/lb)Training room 50.0 25.0 77.0 21.70Prefunction 50.0 25.0 77.0 21.70Finance & Administration Dept. 50.0 25.0 77.0 21.70H&R Department 50.0 25.0 77.0 21.70Reception 50.0 25.0 77.0 21.70FABX & Server room 45.0 23.0 73.4 19.70Visitors lounge 50.0 25.0 77.0 21.70Purchasing Department 50.0 25.0 77.0 21.70Q&A Office 50.0 25.0 77.0 21.70Meeting room 50.0 25.0 77.0 21.70Rest room 1 50.0 25.0 77.0 21.70Rest room 2 50.0 25.0 77.0 21.70Corridor 1 50.0 25.0 77.0 21.70Corridor 2 50.0 25.0 77.0 21.70Corridor 3 50.0 25.0 77.0 21.70Engineering workshop 45.0 23.0 73.4 19.70Canteen 45.0 23.0 73.4 19.70Engineering office 50.0 25.0 77.0 21.70Corridor lift 50.0 25.0 77.0 21.70Equipment room 45.0 23.0 73.4 19.70Goods lift 50.0 25.0 77.0 21.70

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Table: Design temperature and humidity for clean room at Level 1 (first floor)

Cleanroom

cleanroom RH (%) Temp room (°C) Temp room (°F) Enthalpy, H (btu/lb)Bosch Filling room 50 23 73.4 19.8Packing room 1 45 24 75.2 19.7Packing room 2 45 24 75.2 19.7Packing room 3 45 24 75.2 19.7Bottle Blower room 45 24 75.2 19.7Bottle washing room 45 24 75.2 19.7Filling room 45 24 75.2 19.7Mixing room 45 24 75.2 19.7Transfer air lock 1 40 23 73.4 17.5Air Lock 1 40 23 73.4 17.5Air Lock 2 40 23 73.4 17.5Air Lock 3 40 23 73.4 17.5Clean equipment room 45 24 75.2 19.7Wash room 45 24 75.2 19.7Wash booth 45 24 75.2 19.7WIP Dispeen 45 24 75.2 19.7Weihing booth 45 24 75.2 19.7Liquid air lock 40 23 73.4 17.5Liquid dispensary 40 23 73.4 17.5Liquid store 40 23 73.4 17.5Pharmacy store 50 25 77 22.3Blending room 50 25 77 22.3Air Lock 4 40 23 73.4 17.5Wet Granulation & Drying room 50 25 77 22.3WIP Storage 50 25 77 22.3Encapsulation 50 25 77 22.3Preparation rooom 50 25 77 22.3Coating room 50 25 77 22.3Service area 50 25 77 22.3Tablet coating WIP 45 24 75.2 19.7Air Lock 5 40 23 73.4 17.5Transfer air lock 2 40 23 73.4 17.5Tronic labelling 45 24 75.2 19.7

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Table: Design temperature and humidity for normal room at Level 2 (second floor)

Room

Room RH (%) Temp room (°C) Temp room (°F) Enthalpy, H (btu/lb)QC Product Development Dept 50 24 75.2 20.2Board room 50 24 75.2 20.2General Manager 50 22 71.6 19.7Managing Director 50 22 71.6 19.7Senior Manager 50 22 71.6 19.7Secretary 50 22 71.6 19.7Corridor 50 25 77 21.2Write station 50 25 77 21.2Existing Platform 50 25 77 21.2M & E Room 50 25 77 21.2

Table: Design temperature and humidity for clean room at Level 2 (second floor)

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Clean room

Clean room RH (%) Temp room (°C) Temp room (°F) Enthalpy, H (btu/lb)Analytical laboratory 45 22 71.6 18.9Instrument room 45 22 71.6 18.9Coating room 45 22 71.6 18.9Blister pack room 45 22 71.6 18.9Oven room 45 22 71.6 18.9Liquid storage 40 21 69.8 17.9Liquid Mfg 1 40 21 69.8 17.9Liquid Mfg 2 40 21 69.8 17.9Corridor 40 21 69.8 17.9Wash room 1 40 21 69.8 17.9Wash room 2 40 21 69.8 17.9Clean hose room 40 21 69.8 17.9Operation room 40 21 69.8 17.9Cream packing room 40 21 69.8 17.9Cream filling room 40 21 69.8 17.9Wet Granulation 45 23 73.4 19.3WIP storage 45 23 73.4 19.3Encapsulation 45 23 73.4 19.3Air lock 1 40 23 73.4 19.5Air lock 2 40 23 73.4 19.5Air lock 3 40 23 73.4 19.5Filling 1 45 24 75.2 22.1Filling 2 45 24 75.2 22.1Tablet press 1 50 24 75.2 23.4Tablet press 2 50 24 75.2 23.4Blending room 50 25 77 22.4Technical mezzanine 50 25 77 22.4

HVAC SYSTEM

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Pharmaceutical buildings have many room areas that required the HVAC system

installation which are air conditioning and ventilation. The system selection is plan

according to the application of the room, area, air volume flow rate and capacity required

for each room.

Table: Design HVAC system for each room at Level 1(first floor)

Room HVAC systemTraining room VRFPrefunction VRFFinance & Administration Dept. VRFH&R Department VRFReception VRFFABX & Server room VRFVisitors lounge VRFPurchasing Department VRFQ&A Office VRFMeeting room VRFRest room 1 VRFRest room 2 VRFCorridor 1 VRFCorridor 2 VRFCorridor 3 VRFEngineering workshop VRFCanteen VRFEngineering office VRFCorridor lift VRFEquipment room VRFGoods lift VRFFemale toilet VentilationMale toilet VentilationFemale surau VentilationMale surau Ventilation

Table: Design HVAC system for clean room at Level 1(first floor)

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Clean room HVAC systemBosch Filling room AHUPacking room 1 AHUPacking room 2 AHUPacking room 3 AHUBottle Blower room AHUBottle washing room AHUFilling room AHUMixing room AHUTransfer air lock 1 AHUAir Lock 1 AHUAir Lock 2 AHUAir Lock 3 AHUClean equipment room AHUWash room AHUWash booth AHUWIP Dispeen AHUWeihing booth AHULiquid air lock AHULiquid dispensary AHULiquid store AHUPharmacy store AHUBlending room AHUAir Lock 4 AHUWet Granulation & Drying room AHUWIP Storage AHUEncapsulation AHUPreparation rooom AHUCoating room AHUService area AHUTablet coating WIP AHUAir Lock 5 AHUTransfer air lock 2 AHUTronic labelling AHU

Table: Design HVAC system for room at Level 2(second floor)

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Room HVAC SystemQC Product Development Dept VRFBoard room VRFGeneral Manager VRFManaging Director VRFSenior Manager VRFSecretary VRFCorridor VRFWrite station VRFExisting Platform VRFM & E Room VRF

Table: Design HVAC system for clean room at Level 2(second floor)

Clean room HVAC systemAnalytical laboratory AHUInstrument room AHUCoating room AHUBlister pack room AHUOven room AHULiquid storage AHULiquid Mfg 1 AHULiquid Mfg 2 AHUCorridor AHUWash room 1 AHUWash room 2 AHUClean hose room AHUOperation room AHUCream packing room AHUCream filling room AHUWet Granulation AHUWIP storage AHUEncapsulation AHUAir lock 1 AHUAir lock 2 AHUAir lock 3 AHUFilling AHUTablet press AHUBlending room AHUTechnical mezzanine AHU

AIR LEAKAGE

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The leakage air is driven by air pressure differences that exist between the room and other

room and also between the inside of the building and the outside of the building. The

leakage air has the velocity according the pressure differences. The area of the opening area

will give the volume flow rate of air leakage that flow through the opening area.

Table: Air leakage table and it’s extend continuation below

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Leakage velocity (fpm) = 4005 x (∆P) 1/2

in w.g

Leakage rate (cfm) = leakage veloccity x opening area (ft²)

Q (btu/hr) = 4.5 x air flow cfm x ∆h enthalpy difference (btu/lb)

Room Pressureenthalpy ∆h Opening type pressure enthalpy ∆h

Pa in (w.g) (btu/lb) or door Pain

(w.g) (btu/lb)Bosch Filling room 10 0.04 19.8 two side door 0 0 20.4Packing room 1 12 0.048 19.7 two side door 0 0 20.2Packing room 2 12 0.048 19.7 two side door 0 0 20.2Packing room 3 12 0.048 19.7 two side door 0 0 20.2Bottle Blower room 10 0.04 19.7 two side door 0 0 20.2Bottle washing room 10 0.04 19.7 two side door 0 0 20.2Filling room 8 0.032 19.7 two side door 0 0 20.1Mixing room 8 0.032 19.7 one side door 0 0 21.2Transfer air lock 1 1 0.04 17.5 two side door 0 0 20.2Air Lock 1 1 0.04 17.5 one side door 0 0 21.3Air Lock 2 1 0.04 17.5 one side door 0 0 21.3Air Lock 3 1 0.04 17.5 one side door 0 0 21.3Clean equipment room 15 0.06 19.7 two side door 0 0 20.2Wash room 15 0.06 19.7 two side door 0 0 21.2Equipment room 15 0.06 19.7 one side door 0 0 21.2WIP Dispeen 15 0.06 19.7 two side door 0 0 21.2Weihing booth 13 0.052 19.7 two side door 0 0 21.2Liquid air lock 13 0.052 17.5 one side door 10 0.04 20.4Liquid dispensary 13 0.052 17.5 one side door 0 0 20.4Liquid store 13 0.052 17.5 one side door 0 0 20.4Pharmacy store 15 0.06 22.3 two side door 0 0 23.1Blending room 15 0.06 22.3 two side door 0 0 23.1Air Lock 4 1 0.04 17.5 one side door 0 0 21.3Wet Granulation & Drying room 15 0.06 22.3 two side door 0 0 23.1WIP Storage 10 0.04 22.3 one side door 0 0 22.9Encapsulation 13 0.052 22.3 two side door 0 0 23.1Preparation rooom 15 0.06 22.3 one side door 0 0 23.1Coating room 12 0.048 22.3 one side door 0 0 23.2Service area 10 0.04 22.3 one side door 0 0 23.2Tablet coating WIP 15 0.06 19.7 one side door 0 0 20.4Air Lock 5 1 0.04 17.5 one side door 0 0 21.3Transfer air lock 2 1 0.04 17.5 two side door 0 0 20.2Tronic labelling 10 0.04 19.7 two side door 0 0 23.3corridor lift 8 0.032 19.7 two side door 0 0 22.3

dimension opening area leakage velocity leakage rate enthalpy Capacity, Q

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∆hwidth

(m)height

(m) (m²) (ft²) FPM (m/s) CFM CMH (btu/lb) (btu/hr)1.7 2 3.4 36.6 801.00 4.07 29317.29 49803.11 0.6 79156.71.7 2 3.4 36.6 877.45 4.46 32115.49 54556.57 0.5 72259.81.7 2 3.4 36.6 877.45 4.46 32115.49 54556.57 0.5 72259.81.7 2 3.4 36.6 877.45 4.46 32115.49 54556.57 0.5 72259.81.7 2 3.4 36.6 801.00 4.07 29317.29 49803.11 0.5 65963.91.7 2 3.4 36.6 801.00 4.07 29317.29 49803.11 0.5 65963.91.7 2 3.4 36.6 716.44 3.64 26222.19 44545.25 0.4 47199.91.2 2 2.4 25.8 716.44 3.64 18509.78 31443.71 1.5 124941.01.7 2 3.4 36.6 801.00 4.07 29317.29 49803.11 2.7 356205.11.2 2 2.4 25.8 801.00 4.07 20694.56 35155.14 3.8 353877.01.2 2 2.4 25.8 801.00 4.07 20694.56 35155.14 3.8 353877.01.2 2 2.4 25.8 801.00 4.07 20694.56 35155.14 3.8 353877.01.7 2 3.4 36.6 981.02 4.98 35906.21 60996.1 0.5 80789.01.7 2 3.4 36.6 981.02 4.98 35906.21 60996.1 1.5 242366.91.2 2 2.4 25.8 981.02 4.98 25345.56 43056.07 1.5 171082.51.7 2 3.4 36.6 981.02 4.98 35906.21 60996.1 1.5 242366.91.7 2 3.4 36.6 913.28 4.64 33426.86 56784.28 1.5 225631.31.2 2 2.4 25.8 438.73 2.23 11334.88 19255.26 2.9 147920.21.2 2 2.4 25.8 913.28 4.64 23595.43 40083.02 2.9 307920.41.2 2 2.4 25.8 913.28 4.64 23595.43 40083.02 2.9 307920.41.7 2 3.4 36.6 981.02 4.98 35906.21 60996.1 0.8 129262.31.7 2 3.4 36.6 981.02 4.98 35906.21 60996.1 0.8 129262.31.2 2 2.4 25.8 801.00 4.07 20694.56 35155.14 3.8 353877.01.7 2 3.4 36.6 981.02 4.98 35906.21 60996.1 0.8 129262.31.2 2 2.4 25.8 801.00 4.07 20694.56 35155.14 0.6 55875.31.7 2 3.4 36.6 913.28 4.64 33426.86 56784.28 0.8 120336.71.2 2 2.4 25.8 981.02 4.98 25345.56 43056.07 0.8 91244.01.2 2 2.4 25.8 877.45 4.46 22669.76 38510.52 0.9 91812.51.2 2 2.4 25.8 801.00 4.07 20694.56 35155.14 0.9 83813.01.2 2 2.4 25.8 981.02 4.98 25345.56 43056.07 0.7 79838.51.2 2 2.4 25.8 801.00 4.07 20694.56 35155.14 3.8 353877.01.7 2 3.4 36.6 801.00 4.07 29317.29 49803.11 2.7 356205.11.7 2 3.4 36.6 801.00 4.07 29317.29 49803.11 3.6 474940.21.7 2 3.4 36.6 716.44 3.64 26222.19 44545.25 2.6 306799.6

AIR VOLUME FLOWRATE

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There are 2floor of pharmaceutical factory and each floor has the different space and

different applications. Different applications of the place have different air change per hour

and different air volume flow rate that required to supplies to the place.

There are the formulas required in order to calculate the volume flow rate:-

The Air flow rate calculation is only for the room that using the ductings which are its

using the AHU with centralized chiller or ventilation system with exhaust fan. In order to

design the ductwork, air flow rate of each room is important.

Table 10: The ACH (air change per hour) are selected according the standard.

Table: Area, volume and air volume flow rate for each room at 1st floor

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Area = length x width

Volume = Area x height

Volume flow rate = ACH x Volume

AHU 11st floorfor clean room

No. RoomHeigh

t Area Volume ACH Volume Flow rate

m m² m³ CMH L/s CFM

1 Bosch Filling room 3.5 126.63 443.2 55 24376.3 6771.1875 14349.43

2 Packing room 1 3.5 40.16 140.6 45 6325.6 1757.1094 3723.65

3 Packing room 2 3.5 27.30 95.6 45 4299.8 1194.375 2531.11

4 Packing room 3 3.5 65.30 228.6 45 10285.1 2856.9625 6054.45

5 Bottle Blower room 3.5 65.30 228.6 55 12570.6 3491.8431 7399.88

6Bottle washing room 3.5 65.30 228.6 55 12570.6 3491.8431 7399.88

7 Filling room 3.5 37.41 130.9 60 7855.3 2182.0167 4624.11

8 Mixing room 3.5 14.16 49.6 60 2973.6 826 1750.45

9 Transfer air lock 1 3.5 9.92 34.7 70 2431.0 675.28125 1431.05

10 Air Lock 1 3.5 18.24 63.8 70 4468.8 1241.3333 2630.62

11 Air Lock 2 3.5 5.52 19.3 70 1353.0 375.83681 796.47

12 Air Lock 3 3.5 6.70 23.4 70 1640.9 455.80208 965.93

13 Corridor lift 3.5 130.38 456.3 35 15971.6 4436.5417 9401.88

Supply AirVolume flow rate / diffuser Actual Volume Flow rate

cfm/diffuser Diffuser/supplyCMH/diffuser CMH L/s CFM

1354.2 24376.3 6771.2 14349.4 1,794 1,800 81265.1 6325.6 1757.1 3723.6 1,241 1,240 31074.9 4299.8 1194.4 2531.1 1,266 1,260 21714.2 10285.1 2857.0 6054.4 1,211 1,200 51571.3 12570.6 3491.8 7399.9 1,480 1,480 51571.3 12570.6 3491.8 7399.9 1,480 1,480 51309.2 7855.3 2182.0 4624.1 1,156 1,200 41486.8 2973.6 826.0 1750.5 1,750 1,750 11215.5 2431.0 675.3 1431.0 1,431 1,430 1

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1117.2 4468.8 1241.3 2630.6 1,315 1,300 21353.0 1353.0 375.8 796.5 796 800 11640.9 1640.9 455.8 965.9 966 1,000 11597.2 15971.6 4436.5 9401.9 1,567 1,550 6

Return Air

Return airVolume flow

rate / diffuser Actual Volume Flow ratecfm/grille Grille/return

Percentage CMH/diffuser CMH L/s CFM

0.7 1138 17063.393 4739.8 10044.6 1,674 1,680 60.7 1107 4427.9156 1230.0 2606.6 1,303 1,300 20.7 1003 3009.825 836.1 1771.8 886 880 20.7 1200 7199.5455 1999.9 4238.1 1,413 1,400 30.7 1257 8799.4445 2444.3 5179.9 1,727 1,700 30.7 1257 8799.4445 2444.3 5179.9 1,727 1,700 30.7 1100 5498.682 1527.4 3236.9 1,618 1,600 20.7 1041 2081.52 578.2 1225.3 1,225 1,200 10.7 851 1701.7088 472.7 1001.7 1,002 1,000 10.7 1043 3128.16 868.9 1841.4 1,841 1,840 10.7 947 947.10875 263.1 557.5 558 560 10.7 1149 1148.6213 319.1 676.2 676 680 10.7 1398 11180.085 3105.6 6581.3 1,645 1,650 4

Table: Area, volume and air volume flow rate for each room at 1st floor

AHU 2

No. Room Height Area Volume ACH Volume Flow rate m m² m³ CMH L/s CFM

1 Equipment room 3.5 12.3 43.05 35 1506.75 418.5 887.02 Weihing booth 3.5 69.68 243.88 45 10974.6 3048.5 6460.43 Liquid air lock 3.5 7.68 26.88 50 1344 373.3 791.24 Liquid dispensary 3.5 12.8 44.8 50 2240 622.2 1318.65 Liquid store 3.5 14.08 49.28 50 2464 684.4 1450.56 Pharmacy store 3.5 145 507.5 35 17762.5 4934.0 10456.1

23

7 Blending room 3.5 59.69 208.915 50 10445.75 2901.6 6149.08 Air Lock 4 3.5 25.8 90.3 70 6321 1755.8 3720.99 Transfer air lock 2 3.5 48.45 169.575 70 11870.25 3297.3 6987.6

10 Tronic labelling 3.5 256.5 897.75 50 44887.5 12468.8 26423.7

Supply AirVolume flow rate / diffuser Actual Volume Flow rate

cfm/diffuser Diffuser/supplyCMH/diffuser CMH L/s CFM

1506.75 1506.75 418.5 887.0 887 890 11371.83 10974.6 3048.5 6460.4 1,615 1,600 41344.00 1344 373.3 791.2 791 800 11120.00 2240 622.2 1318.6 1,319 1,300 11232.00 2464 684.4 1450.5 1,450 1,450 11480.21 17762.5 4934.0 10456.1 1,307 1,300 81305.72 10445.75 2901.6 6149.0 1,230 1,230 52107.00 6321 1755.8 3720.9 1,240 1,240 31187.03 11870.25 3297.3 6987.6 1,747 1,750 4

1726.44 44887.512468.

8 26423.7 1,651 1,650 16

Return Air

Return airVolume flow rate /

diffuser Actual Volume Flow ratecfm/grille Grille/

returnPercentage CMH/diffuser CMH L/s CFM

0.7 1054.73 1054.7 293.0 620.9 621 620 10.7 1280.37 7682.2 2134.0 4522.2 1,507 1,500 30.7 940.80 940.8 261.3 553.8 554 550 10.7 1568.00 1568.0 435.6 923.0 923 930 10.7 862.40 1724.8 479.1 1015.3 1,015 1,100 10.7 1243.38 12433.8 3453.8 7319.3 1,464 1,470 50.7 1218.67 7312.0 2031.1 4304.3 1,435 1,440 30.7 1106.18 4424.7 1229.1 2604.7 1,302 1,300 20.7 1038.65 8309.2 2308.1 4891.3 1,630 1,630 30.7 1745.63 31421.3 8728.1 18496.6 1,541 1,500 12

24

Table: Area, volume and air volume flow rate for each room at 1st floor

AHU 3

No. Room Height Area Volume ACH Volume Flow rate

m m² m³ CMH L/s CFM

1 Clean equipment room 3.5 71.34 249.69 50 12484.5 3467.91 7349.2

2 Wash room 3.5 64.8 226.8 50 11340 3150 6675.4

3 WIP Dispeen 3.5 45.76 160.16 50 8008 2224.44 4714.0

4Wet Granulation & Drying room 3.5 66.24 231.84 50 11592 3220 6823.8

5 WIP Storage 3.5 61.44 215.04 50 10752 2986.66 6329.3

6 Encapsulation 3.5 66.24 231.84 45 10432.8 2898 6141.4

7 Preparation rooom 3.5 43.5 152.25 40 6090 1691.66 3585.0

8 Coating room 3.5 39.55 138.425 55 7613.375 2114.82 4481.7

9 Service area 3.5 39.55 138.425 40 5537 1538.05 3259.4

10 Tablet coating WIP 3.5 29.29 102.515 45 4613.175 1281.43 2715.6

11 Air Lock 5 3.5 9.3025 32.55875 70 2279.1125 633.086 1341.6

Supply AirVolume flow rate /

diffuserActual Volume Flow rate cfm/diffuser Diffuser/

supply

25

CMH/diffuser CMH L/s CFM1248.45 12484.5 3467.91 7349.2 1,470 1,470 51417.50 11340 3150 6675.4 1,669 1,700 41334.67 8008 2224.44 4714.0 1,571 1,580 31449.00 11592 3220 6823.8 1,706 1,700 41344.00 10752 2986.67 6329.3 1,266 1,300 51304.10 10432.8 2898 6141.4 1,228 1,290 51522.50 6090 1691.67 3585.0 1,195 1,200 31268.90 7613.375 2114.89 4481.7 1,494 1,500 31384.25 5537 1538.06 3259.4 1,086 1,100 31153.29 4613.175 1281.45 2715.6 1,358 1,400 21139.56 2279.1125 633.086 1341.6 1,342 1,340 1

Return AirReturn air Volume flow rate / diffuser Actual Volume Flow rate

cfm/grille Grille/returnPercentage CMH/diffuser CMH L/s CFM

0.7 1456.53 8739.2 2427.5 5144.4 1286 1290 40.7 1323.00 7938.0 2205.0 4672.8 1558 1560 30.7 1401.40 5605.6 1557.1 3299.8 1650 1650 20.7 1352.40 8114.4 2254.0 4776.7 1592 1600 30.7 1254.40 7526.4 2090.7 4430.5 1108 1100 40.7 1217.16 7303.0 2028.6 4299.0 1075 1100 40.7 1421.00 4263.0 1184.2 2509.5 1255 1300 20.7 1332.34 5329.4 1480.4 3137.2 1569 1600 20.7 1291.97 3875.9 1076.6 2281.6 1141 1150 20.7 1076.41 3229.2 897.0 1900.9 950 950 20.7 1595.38 1595.4 443.2 939.1 939 950 1

26

AHU 1 (2nd floor)

No. Room Height Area Volume ACH Volume Flow rate

m m² m³ CMH L/s CFM

1 Analytical laboratory 3 167.4 502.2 70 35155.6 9765.4 20694.8

2 Instrument room 3 57.5 172.4 55 9480.9 2633.6 5581.1

3 Coating room 3 39.0 117.0 55 6435.0 1787.5 3788.1

4 Blister pack room 3 39.0 117.0 55 6435.0 1787.5 3788.1

5 Oven room 3 39.0 117.0 55 6435.0 1787.5 3788.1

6 Liquid storage 3 21.8 65.5 60 3931.2 1092.0 2314.2

7 Liquid Mfg 1 3 21.8 65.5 60 3931.2 1092.0 2314.2

8 Liquid Mfg 2 3 21.8 65.5 60 3931.2 1092.0 2314.2

9 Corridor 3 170.5 511.4 35 17898.8 4971.9 10536.4

10 Wash room 1 3 27.6 82.7 55 4547.4 1263.2 2676.9

27

11 Wash room 2 3 27.6 82.7 55 4547.4 1263.2 2676.9

12 Clean hose room 3 27.6 82.7 55 4547.4 1263.2 2676.9

13 Operation room 3 46.9 140.6 55 7734.4 2148.4 4552.9

14 Cream packing room 3 46.9 140.6 55 7734.4 2148.4 4552.9

15 Cream filling room 3 46.9 140.6 60 8437.5 2343.8 4966.9

16 RHL Preparation & Cleaning 3 81.3 243.8 60 14630.4 4064.0 8612.4

17 Air lock 1 3 21.84 65.5 70 4586.4 1274.0 2699.8

Supply AirVolume flow rate / diffuser Actual Volume Flow rate

cfm/diffuser Diffuser/supplyCMH/diffuser CMH L/s CFM

1597.98 35155.6 9765.4 20694.8 1,478 1,480 141580.15 9480.9 2633.6 5581.1 1,395 1,400 41608.75 6435.0 1787.5 3788.1 1,263 1270 31608.75 6435.0 1787.5 3788.1 1,263 1270 31608.75 6435.0 1787.5 3788.1 1,263 1270 31310.40 3931.2 1092.0 2314.2 1,157 1200 21310.40 3931.2 1092.0 2314.2 1,157 1200 21310.40 3931.2 1092.0 2314.2 1,157 1200 21491.57 17898.8 4971.9 10536.4 1,317 1320 81136.85 4547.4 1263.2 2676.9 1,338 1340 21136.85 4547.4 1263.2 2676.9 1,338 1340 21136.85 4547.4 1263.2 2676.9 1,338 1340 21546.88 7734.4 2148.4 4552.9 1,518 1500 31546.88 7734.4 2148.4 4552.9 1,138 1140 41205.36 8437.5 2343.8 4966.9 1,242 1250 41219.20 14630.4 4064.0 8612.4 1,435 1440 61146.60 4586.4 1274.0 2699.8 1,350 1350 2

Return AirReturn air Volume flow rate / diffuser Actual Volume Flow rate

cfm/grille Grille/returnPercentage CMH/diffuser CMH L/s CFM

0.7 1538.1 24608.9 6835.8 14486.4 1449 1450 100.7 1659.2 6636.6 1843.5 3906.7 1302 1300 30.7 1501.5 4504.5 1251.3 2651.6 1326 1330 20.7 1501.5 4504.5 1251.3 2651.6 1326 1330 2

28

0.7 1501.5 4504.5 1251.3 2651.6 1326 1330 20.7 1375.9 2751.8 764.4 1619.9 1620 1620 10.7 1375.9 2751.8 764.4 1619.9 1620 1620 10.7 1375.9 2751.8 764.4 1619.9 1620 1620 10.7 1566.1 12529.2 3480.3 7375.5 1229 1230 60.7 1061.1 3183.2 884.2 1873.8 937 950 20.7 1061.1 3183.2 884.2 1873.8 937 950 20.7 1061.1 3183.2 884.2 1873.8 937 950 20.7 1353.5 5414.1 1503.9 3187.1 1594 1590 20.7 1353.5 5414.1 1503.9 3187.1 1062 1100 30.7 1476.6 5906.3 1640.6 3476.8 1159 1200 30.7 1280.2 10241.3 2844.8 6028.7 1507 1500 4

AHU 2No. Room Height Area Volume ACH Volume Flow rate m m² m³ CMH L/s CFM

1 Wet Granulation 3 87.5 262.5 40 10500.0 2916.7 6181.02 WIP storage 3 45.4 136.2 40 5448.3 1513.4 3207.23 Encapsulation 3 45.4 136.2 40 5448.3 1513.4 3207.25 Air lock 2 3 14.2 42.5 70 2974.1 826.1 1750.86 Air lock 3 3 18.5 55.4 70 3874.5 1076.3 2280.87 Air lock 4 3 17.3 52.0 70 3638.3 1010.6 2141.7

29

8 Filling 1 3 24.7 74.2 60 4451.0 1236.4 2620.19 Filling 2 3 24.7 74.2 60 4451.0 1236.4 2620.1

10 Tablet press 1 3 34.0 101.9 55 5603.8 1556.6 3298.811 Tablet press 2 3 34.0 101.9 55 5603.8 1556.6 3298.812 Blending room 3 89.1 267.3 60 16038.0 4455.0 9441.013 Technical mezzanine 3 382.1 1146.3 50 57313.1 15920.3 33738.2

Supply AirVolume flow rate / diffuser Actual Volume Flow rate

cfm/diffuser Diffuser/supplyCMH/diffuser CMH L/s CFM

1312.50 10500.0 2916.7 6181.0 1,545 1,550 41362.08 5448.3 1513.4 3207.2 1,069 1,100 31362.08 5448.3 1513.4 3207.2 1,069 1,100 31487.06 2974.1 826.1 1750.8 1,751 1750 11291.50 3874.5 1076.3 2280.8 1,140 1200 21212.75 3638.3 1010.6 2141.7 1,071 1100 21112.74 4451.0 1236.4 2620.1 1,310 1300 21112.74 4451.0 1236.4 2620.1 1,310 1300 21400.95 5603.8 1556.6 3298.8 1,649 1650 21400.95 5603.8 1556.6 3298.8 1,649 1650 21336.50 16038.0 4455.0 9441.0 1,573 1570 61791.04 57313.1 15920.3 33738.2 1,687 1690 20

30

31

Return Air

Return airVolume flow rate /

diffuser Actual Volume Flow rate cfm/grille Grille/returnPercentage CMH/diffuser CMH L/s CFM

0.7 1225.0 7350.0 2041.7 4326.7 1442 1440 30.7 1271.3 3813.8 1059.4 2245.1 1123 1120 20.7 1271.3 3813.8 1059.4 2245.1 1123 1120 20.7 1040.9 2081.9 578.3 1225.5 1226 1230 10.7 1356.1 2712.2 753.4 1596.5 1597 1600 10.7 1273.4 2546.8 707.4 1499.2 1499 1500 10.7 1038.6 3115.7 865.5 1834.1 917 930 20.7 1038.6 3115.7 865.5 1834.1 917 930 20.7 1307.6 3922.7 1089.6 2309.1 1155 1200 20.7 1307.6 3922.7 1089.6 2309.1 1155 1200 20.7 1403.3 11226.6 3118.5 6608.7 1652 1660 40.7 1671.6 40119.2 11144.2 23616.7 1687 1690 14

VRF Consideration Selection

Level 1 : Room criteria for non cleanroom space

Room name TR kW HPTraining room 4.03 14.17 19Prefunction 1.96 6.91 9Finance & Administration Dept. 4.00 14.06 19H&R Department 3.02 10.64 14Reception 6.19 21.78 29FABX & Server room 0.66 2.32 3Visitors lounge 0.71 2.50 3Purchasing Department 3.44 12.11 16Q&A Office 3.57 12.55 17Meeting room 10.95 38.52 52Female toilet 1.27 4.47 6Male toilet 1.27 4.47 6Janitor 0.30 1.07 1Female surau 2.38 8.36 11Male surau 2.38 8.36 11Rest room 1 1.20 4.22 6Rest room 2 1.20 4.22 6Corridor lift 6.02 21.17 28Equipment room 0.49 1.74 2Corridor 1 2.07 7.29 10Corridor 2 3.41 12.01 16Corridor 3 3.41 12.01 16Engineering workshop 4.66 16.37 22Canteen 6.98 24.55 33Engineering office 2.73 9.59 13

Total HP for this room area is 369 HP

Level 2 : Room criteria for non cleanroom space

32

Room name TR kW HPQC Product Development Dept 14.36 50.51 68Board room 1.13 3.98 5General Manager 0.98 3.46 5Managing Director 0.98 3.46 5Senior Manager 0.61 2.14 3Secretary 0.61 2.14 3Corridor 3.90 13.71 18Write station 2.26 7.93 11RHL Preparation & Cleaning 3.67 12.89 17M & E Room 3.21 11.28 15

Total HP for this room area is 149 HP

SELECTION DIFFUSER

33

AHU 11st floorfor cleanroom

No. Room cfm/grille

grille 1 Bosch Filling room 1,680 62 Packing room 1 1,300 23 Packing room 2 880 24 Packing room 3 1,400 35 Bottle Blower room 1,700 36 Bottle washing room 1,700 37 Filling room 1,600 28 Mixing room 1,200 19 Transfer air lock 1 1,000 1

10 Air Lock 1 1,840 111 Air Lock 2 560 112 Air Lock 3 680 113 Corridor lift 1,650 4

Total cfm for AHU 1 = 17190 cfm

AHU 2

34

No. Room cfm/grille

grille1 Equipment room 620 12 Weihing booth 1,500 33 Liquid air lock 550 14 Liquid dispensary 930 15 Liquid store 1,100 16 Pharmacy store 1,470 57 Blending room 1,440 38 Air Lock 4 1,300 29 Transfer air lock 2 1,630 3

10 Tronic labelling 1,500 12

Total cfm for AHU 2 = 12 040 cfm

AHU 3

No. Room cfm/grille

grille1 Clean equipment room 1290 42 Wash room 1560 33 WIP Dispeen 1650 24 Wet Granulation & Drying room 1600 35 WIP Storage 1100 46 Encapsulation 1100 47 Preparation rooom 1300 28 Coating room 1600 29 Service area 1150 2

10 Tablet coating WIP 950 211 Air Lock 5 950 1

Total cfm for AHU 3 = 14 250 cfm

2nd floor

35

AHU 1No. Room cfm/

grille grille

1 Analytical laboratory 1450 102 Instrument room 1300 33 Coating room 1330 24 Blister pack room 1330 25 Oven room 1330 26 Liquid storage 1620 17 Liquid Mfg 1 1620 18 Liquid Mfg 2 1620 19 Corridor 1230 6

10 Wash room 1 950 211 Wash room 2 950 212 Clean hose room 950 213 Operation room 1590 214 Cream packing room 1100 315 Cream filling room 1200 316 RHL Preparation & Cleaning 1500 417 Air lock 1 960 2

Level 2

Total cfm for AHU 1 = 22 030 cfm

AHU 2

36

No. Room cfm/grille

grille1 Wet Granulation 1440 32 WIP storage 1120 23 Encapsulation 1120 25 Air lock 2 1230 16 Air lock 3 1600 17 Air lock 4 1500 18 Filling 1 930 29 Filling 2 930 2

10 Tablet press 1 1200 211 Tablet press 2 1200 212 Blending room 1660 413 Technical mezzanine 1690 14

Total cfm for AHU 2 = 15 620 cfm

SUGGESTED SPECIFICATIONS

37

Furnish Aluminum Square Diffusers where shown on the plans. The Square

Diffusers shall have margins to cover the ceiling openings and minimize smudging. The

Diffusers shall be of the flush type as shown on the plans. Corners of the outer core shall be

mechanically fastened to provide precise mitered corners. Diffusers shall be in removable

construction to facilitate access to Damper and also for concealed fixing. Where shown, the

Diffusers shall be provided with Opposed Blade Volume Control Dampers manufactured

out of Aluminum. Diffusers shall be powder coated to the approved shade. Dampers shall

be painted to matt black shade.

Table: Selection of size return for AHU

38

Table: Selection of size supply for AHU

39

CAPACITY

First Floor AHU 1

Room Pressure enthalpy ∆h Opening type pressure enthalpy ∆h

Pain (w.g) (btu/lb) or door Pa

in (w.g) (btu/lb)

Bosch Filling room 10 0.04 19.8 hard aluminium 0 0 20.4Packing room 1 12 0.048 19.7 hard aluminium 0 0 20.2Packing room 2 12 0.048 19.7 hard aluminium 0 0 20.2Packing room 3 12 0.048 19.7 hard aluminium 0 0 20.2Bottle Blower room 10 0.04 19.7 hard aluminium 0 0 20.2Bottle washing room 10 0.04 19.7 hard aluminium 0 0 20.2Filling room 8 0.032 19.7 hard aluminium 0 0 20.1Mixing room 8 0.032 19.7 hard aluminium 0 0 21.2Transfer air lock 1 1 0.004 17.5 hard aluminium 0 0 20.2Air Lock 1 1 0.004 17.5 hard aluminium 0 0 21.3Air Lock 2 1 0.004 17.5 hard aluminium 0 0 21.3Air Lock 3 1 0.004 17.5 hard aluminium 0 0 21.3Corridor lift 10 0.04 19.7 hard aluminium 0 0 22.8

dimension opening area leakage velocity leakage rateenthalpy ∆h Capacity, Q

width (m)

height (m) (m²) (ft²) FPM (m/s) CFM CMH (btu/lb) (btu/hr)

1.7 2 3.4 36.6 801.0 4.1 29317.3 49803.1 0.6 79156.71.7 2 3.4 36.6 877.5 4.5 32115.5 54556.6 0.5 72259.81.7 2 3.4 36.6 877.5 4.5 32115.5 54556.6 0.5 72259.81.7 2 3.4 36.6 877.5 4.5 32115.5 54556.6 0.5 72259.81.7 2 3.4 36.6 801.0 4.1 29317.3 49803.1 0.5 65963.91.7 2 3.4 36.6 801.0 4.1 29317.3 49803.1 0.5 65963.91.7 2 3.4 36.6 716.4 3.6 26222.2 44545.3 0.4 47199.91.2 2 2.4 25.8 716.4 3.6 18509.8 31443.7 1.5 124941.01.7 2 3.4 36.6 253.3 1.3 9270.9 15749.1 2.7 112642.01.2 2 2.4 25.8 253.3 1.3 6544.2 11117.0 3.8 111905.71.2 2 2.4 25.8 253.3 1.3 6544.2 11117.0 3.8 111905.71.2 2 2.4 25.8 253.3 1.3 6544.2 11117.0 3.8 111905.71.7 2 3.4 36.6 801.0 4.1 29317.3 49803.1 3.1 408976.3

Total Btu/hr = 1457340.4Tonne = 121.4

40

AHU 2

Room Pressure enthalpy ∆h Opening type pressureenthalpy ∆h

Pain (w.g) (btu/lb) or door Pa

in (w.g) (btu/lb)

Equipment room 15 0.06 19.7 hard aluminium 0 0 21.2Weihing booth 13 0.052 19.7 hard aluminium 0 0 21.2Liquid air lock 13 0.052 17.5 hard aluminium 10 0.04 20.4Liquid dispensary 13 0.052 17.5 hard aluminium 0 0 20.4Liquid store 13 0.052 17.5 hard aluminium 0 0 20.4Pharmacy store 15 0.06 22.3 hard aluminium 0 0 23.1Blending room 15 0.06 22.3 hard aluminium 0 0 23.1Air Lock 4 1 0.04 17.5 hard aluminium 0 0 21.3Transfer air lock 2 1 0.04 17.5 hard aluminium 0 0 20.2Tronic labelling 10 0.04 19.7 hard aluminium 0 0 23.3

dimension opening area leakage velocity leakage rate enthalpy ∆h Capacity, Qwidth

(m)height

(m) (m²) (ft²) FPM (m/s) CFM CMH (btu/lb) (btu/hr)1.2 2 2.4 25.8 981.0 5.0 25345.6 43056.1 1.5 171082.51.7 2 3.4 36.6 913.3 4.6 33426.9 56784.3 1.5 225631.31.2 2 2.4 25.8 438.7 2.2 11334.9 19255.3 2.9 147920.21.2 2 2.4 25.8 913.3 4.6 23595.4 40083.0 2.9 307920.41.2 2 2.4 25.8 913.3 4.6 23595.4 40083.0 2.9 307920.41.7 2 3.4 36.6 981.0 5.0 35906.2 60996.1 0.8 129262.31.7 2 3.4 36.6 981.0 5.0 35906.2 60996.1 0.8 129262.31.2 2 2.4 25.8 801.0 4.1 20694.6 35155.1 3.8 353877.01.7 2 3.4 36.6 801.0 4.1 29317.3 49803.1 2.7 356205.11.7 2 3.4 36.6 801.0 4.1 29317.3 49803.1 3.6 474940.2

Total Btu/hr = 2604021.7Tonne = 217.0

41

AHU 3

Room Pressureenthalpy ∆h Opening type pressure

enthalpy ∆h

Pa in (w.g) (btu/lb) or door Pain

(w.g) (btu/lb)Clean equipment room 15 0.06 19.7 hard aluminium 0 0 20.2Wash room 15 0.06 19.7 hard aluminium 0 0 21.2WIP Dispeen 15 0.06 19.7 hard aluminium 0 0 21.2Wet Granulation & Drying room 15 0.06 22.3 hard aluminium 0 0 23.1WIP Storage 10 0.04 22.3 hard aluminium 0 0 22.9Encapsulation 13 0.052 22.3 hard aluminium 0 0 23.1Preparation rooom 15 0.06 22.3 hard aluminium 0 0 23.1Coating room 12 0.048 22.3 hard aluminium 0 0 23.2Service area 10 0.04 22.3 hard aluminium 0 0 23.2Tablet coating WIP 15 0.06 19.7 hard aluminium 0 0 20.4Air Lock 5 1 0.04 17.5 hard aluminium 0 0 21.3

dimension opening area leakage velocity leakage rate enthalpy ∆h Capacity, Qwidth (m)

height (m) (m²) (ft²) FPM (m/s) CFM CMH (btu/lb) (btu/hr)

1.7 2 3.4 36.6 981.0 5.0 35906.2 60996.1 0.5 80789.01.7 2 3.4 36.6 981.0 5.0 35906.2 60996.1 1.5 242366.91.7 2 3.4 36.6 981.0 5.0 35906.2 60996.1 1.5 242366.91.7 2 3.4 36.6 981.0 5.0 35906.2 60996.1 0.8 129262.31.2 2 2.4 25.8 801.0 4.1 20694.6 35155.1 0.6 55875.31.7 2 3.4 36.6 913.3 4.6 33426.9 56784.3 0.8 120336.71.2 2 2.4 25.8 981.0 5.0 25345.6 43056.1 0.8 91244.01.2 2 2.4 25.8 877.5 4.5 22669.8 38510.5 0.9 91812.51.2 2 2.4 25.8 801.0 4.1 20694.6 35155.1 0.9 83813.01.2 2 2.4 25.8 981.0 5.0 25345.6 43056.1 0.7 79838.51.2 2 2.4 25.8 801.0 4.1 20694.6 35155.1 3.8 353877.0

Total Btu/hr = 1571582.1Tonne = 131.0

42

Second Floor AHU 1

Room Pressure enthalpy ∆h Opening type pressure enthalpy ∆h Pa in (w.g) (btu/lb) or door Pa in (w.g) (btu/lb)Analytical laboratory 15 0.06 19.7 hard aluminium 0 0 20.5Instrument room 10 0.04 22.2 hard aluminium 0 0 23Coating room 15 0.06 19.7 hard aluminium 0 0 21Blister pack room 15 0.06 19.7 hard aluminium 0 0 21Oven room 15 0.06 19.7 hard aluminium 0 0 21Liquid storage 12 0.048 20.3 hard aluminium 0 0 21.5Liquid Mfg 1 12 0.048 20.3 hard aluminium 0 0 21.5Liquid Mfg 2 12 0.048 20.3 hard aluminium 0 0 21.5Corridor 15 0.06 19.7 hard aluminium 0 0 20.8Wash room 1 12 0.048 20.3 hard aluminium 0 0 21.3Wash room 2 12 0.048 20.3 hard aluminium 0 0 21Clean hose room 13 0.052 19.9 hard aluminium 0 0 20.8Operation room 13 0.052 19.9 hard aluminium 0 0 20.8Cream packing room 13 0.052 19.9 hard aluminium 0 0 20.8Cream filling room 12 0.048 20.3 hard aluminium 0 0 21.9RHL Preparation & Cleaning 15 0.06 22 hard aluminium 0 0 23

dimension opening area leakage velocity leakage rateenthalpy ∆h Capacity, Q

width (m)

height (m) (m²) (ft²) FPM (m/s) CFM CMH (btu/lb) (btu/hr)

1.7 2 3.4 36.60087 981.0206 4.983342 35906.21 60996.1 0.8 129262.34321.7 2 3.4 36.60087 801 4.068881 29317.29 49803.11 0.8 105542.26121.7 2 3.4 36.60087 981.0206 4.983342 35906.21 60996.1 1.3 210051.30761.7 2 3.4 36.60087 981.0206 4.983342 35906.21 60996.1 1.3 210051.30761.7 2 3.4 36.60087 981.0206 4.983342 35906.21 60996.1 1.3 210051.30761.7 2 3.4 36.60087 877.4515 4.457236 32115.49 54556.57 1.2 173423.63171.7 2 3.4 36.60087 877.4515 4.457236 32115.49 54556.57 1.2 173423.63171.7 2 3.4 36.60087 877.4515 4.457236 32115.49 54556.57 1.2 173423.63171.7 2 3.4 36.60087 981.0206 4.983342 35906.21 60996.1 1.1 177735.72181.7 2 3.4 36.60087 877.4515 4.457236 32115.49 54556.57 1 144519.69311.7 2 3.4 36.60087 877.4515 4.457236 32115.49 54556.57 0.7 101163.78521.7 2 3.4 36.60087 913.2805 4.639239 33426.86 56784.28 0.9 135378.77911.7 2 3.4 36.60087 913.2805 4.639239 33426.86 56784.28 0.9 135378.77911.7 2 3.4 36.60087 913.2805 4.639239 33426.86 56784.28 0.9 135378.77911.7 2 3.4 36.60087 877.4515 4.457236 32115.49 54556.57 1.6 231231.5091.7 2 3.4 36.60087 981.0206 4.983342 35906.21 60996.1 1 161577.929

Total Btu/hr = 2607594.398

43

Tonne = 217.2995332

AHU 2

Room Pressure enthalpy ∆h Opening type pressure enthalpy ∆h

Pa in (w.g) (btu/lb) or door Pain

(w.g) (btu/lb)Wet Granulation 15 0.06 19.7 hard aluminium 0 0 20.5WIP storage 15 0.06 19.7 hard aluminium 0 0 20.2Encapsulation 15 0.06 19.7 hard aluminium 0 0 20.2Air lock 1 1 0.004 23.4 hard aluminium 0 0 24.5Air lock 2 1 0.004 23.4 hard aluminium 0 0 24.5Air lock 3 1 0.004 23.4 hard aluminium 0 0 24.5Air lock 4 1 0.004 23.4 hard aluminium 0 0 24.5Filling 1 12 0.048 20.3 hard aluminium 0 0 21.5Filling 2 12 0.048 20.3 hard aluminium 0 0 20.5Tablet press 1 13 0.052 19.9 hard aluminium 0 0 20.5Tablet press 2 13 0.052 19.9 hard aluminium 0 0 20.5Blending room 15 0.06 19.7 hard aluminium 0 0 20.6Technical mezzanine 10 0.04 22.2 hard aluminium 0 0 23

dimension opening area leakage velocity leakage rateenthalpy ∆h Capacity, Q

width (m)

height (m) (m²) (ft²) FPM (m/s) CFM CMH (btu/lb) (btu/hr)

1.7 2 3.436.6008

7 981.02064.98334

2 35906.21 60996.1 0.8 129262.3432

1.7 2 3.436.6008

7 981.02064.98334

2 35906.21 60996.1 0.5 80788.96448

1.7 2 3.436.6008

7 981.02064.98334

2 35906.21 60996.1 0.5 80788.96448

1.2 2 2.425.8359

1 253.29841.28669

3 6544.195 11117.03 1.1 32393.76427

1.2 2 2.425.8359

1 253.29841.28669

3 6544.195 11117.03 1.1 32393.76427

1.2 2 2.425.8359

1 253.29841.28669

3 6544.195 11117.03 1.1 32393.76427

1.7 2 3.436.6008

7 253.29841.28669

3 9270.943 15749.13 1.1 45891.16605

1.7 2 3.436.6008

7 877.45154.45723

6 32115.49 54556.57 1.2 173423.6317

1.7 2 3.436.6008

7 877.45154.45723

6 32115.49 54556.57 0.2 28903.938621.7 2 3.4 36.6008 913.2805 4.63923 33426.86 56784.28 0.6 90252.51943

44

7 9

1.7 2 3.436.6008

7 913.28054.63923

9 33426.86 56784.28 0.6 90252.51943

1.7 2 3.436.6008

7 981.02064.98334

2 35906.21 60996.1 0.9 145420.1361

1.7 2 3.436.6008

7 8014.06888

1 29317.29 49803.11 0.8 105542.2612Total Btu/hr = 1067707.737

Tonne = 88.97564479

Total Ton

First floor

AHUCapacity, Q

tonne(btu/hr)

AHU 1 1457340.40 121.40AHU 2 2604021.7 217AHU 3 1571582.1 131

Second floor

AHUCapacity, Q

tonne(btu/hr)

AHU 1 2607594.40 217.30AHU 2 1067707.7 88

Total tonne = 774.7 ton

Total capacity required = 774.7 ton

Chiller required capacity = 774.7 ton / 2

= 387.3 ton

AUTOCAD DRAWING

45

- See Appendix

COMPUTATIONAL FLUID DYNAMIC (CFD)

CFD stands for computational fluid dynamics. It is a way of modeling complex

fluid flow by breaking down geometry into cells that comprise a mesh. At each cell an

algorithm is applied to compute the fluid flow for the individual cell. Traditional

restrictions in flow analysis and design limit the accuracy in solving and visualization fluid

flow problems. This applies to both single and multi-phase flows, and is particularly true of

problems that are three dimensional in nature and involve turbulence, chemical reactions,

heat and mass transfer. All these can be considered together in the application of

Computational Fluid Dynamics, a powerful technique that can help to overcome many of

the restrictions influencing traditional analysis.

Computational fluid dynamics (CFD) is prediction fluid flow with the

complications of simultaneous flow of heat, mass transfer, phase change, and chemical

reaction using computers. CFD is a part of fluid mechanics that uses numerical

methods and algorithms to solve and analyze problems that involve fluid flows. Computers

are used to perform the calculations required to simulate the interaction of liquids and gases

46

with surfaces defined by boundary conditions. With high-speed computers, better solutions

can be achieved. With the appearance of powerful and fast computers, new possibilities for

replacing time-consuming model testing and field-testing have arisen.

CFD is used in wide variety of disciplines and industries, including aerospace,

automotive, power generation, chemical manufacturing, polymer processing, petroleum

exploration, pulp and paper operation, medical research, meteorology, and astrophysics.

CFD makes it possible to evaluate velocity, pressure, temperature, and species

concentration of fluid flow throughout a solution domain, allowing the design to be

optimized prior to the prototype phase.

The basic principle of the CFD modeling method is that the simulated flow region

is divided into small cells within each of which the flow either kept under constant

conditions or varies smoothly. Differential equations of momentum, energy, and mass

balance are discretized and represented in terms of the variables at the center of or at any

predetermined position within the cells. These equations are solved iteratively until the

solution reaches the desired accuracy.

CFD modeling provides a good description of flow field variables, velocities,

temperatures, or a mass concentration anywhere in the region with details not usually

available through physical modeling. It is especially useful for determining the parametric

effects of a certain process variable. Once the basic model is established, parametric runs

can usually be accomplished with reduced effort. In addition, CFD can be used to simulate

some of the hard to duplicate experimental conditions or to investigate some of the hard to

measure variables

47

Where Can CFD Utilized?

In validation/optimization of HVAC design parameters:

CFD data can be utilized to validate various design parameters such as the

location and number of diffusers and exhausts, and temperature and flow

rate (CFM) of supplied air to meet design criteria. For example, CFD

simulation helps design verification of the following systems: natural

ventilation systems, displacement ventilation systems, raised floor system,

atrium smoke system, etc.

In modification and improvement of malfunctioning HVAC systems:

The system with suggested modifications can be simulated computationally

without actual physical modifications to the existing systems. The

information from CFD reveals what modification satisfies the design

criteria.

48

In comparisons between alternative systems:

Under some circumstances, there may be several different options for

designing HVAC systems for a space (for example, mixing ventilation or

displacement ventilation). Computer simulation data can provide crucial

information to find the best possible system.

In an engineering investigation:

CFD analysis of temperature, velocity and chemical concentration

distributions can help engineers understand the problem correctly and

provide ideas for the best resolution.

Examples of CFD Applications for HVAC Systems:

- General office/room simulations

- Contaminant/species simulations

- Fume hood design

- Copy machine rooms (VOC)

- Contamination control chemical lab design

- Industrial ventilation design

- Smoking lounges

- External building flows

- Problem solving simulations

- AHU mixing enhancement investigation

49

- Fire and smoke management

- Building atria fire simulations

- Warehouse fire simulation

- Educational facilities

- Libraries

- Classrooms

- Swimming pool ventilation

- Medical facilities (operating rooms)

- Clean room simulations

- Animal and plant environments

- Enclosed vehicular facilities

- Halls, stadiums, arenas, and places of assembly

- Computer cluster rooms

Strengths and weakness of CFD

Property CFD Full scale Model scale Simple method

Continuum no Yes Yes No

Geometric Similarity Approx Yes Some No

Size limitation No Yes Some No

Scale effect Some None Yes Yes

Instantaneous Indirectly Yes Yes NoTurbulence

Hazardous Yes Limited Limited YesEvents

Modeling of moving event Limited Yes Limited Limited

Empirical content Some None Little High

50

Potential accuracy High High Moderate Low

Tuning required Yes No No No

For highest accuracy

Capital cost Moderate High Moderate low

Running cost High High High Low

Experienced user desirable Yes No No yes

Usable at design stage Yes No Yes Yes

CFD Working on Pharmaceutical Choosen Room

The condition space of room in pharmaceutical factory was choosen a packing room. Its

situated at first floor on dimension clean room area. This cleanroom room was choosen by

its function and reliability as a cleanroom space in pharmaceutical factory.

Packing room parameters:

51

Height = 3.5 m

Long = 5.2 m

Width = 5.25 m

Area = 5.2 m x 5.25 m

= 27.3 m²

Volume = 27.3 m² x 3.5 m

= 95.6 m³

Air change = 45

CMH = Volume x ACH

= 95.6 m³ x 45

= 4299.8

L/s = 4299.8 / 1000 x 3600

= 1194.4

CFM = 4299.8 x (3.281^3) / 60

= 2531.1

Diffuser = 2531.1 / 2 diffuser

= 1260 cfm / diffuser

Fluid Dynamic Simulation View

Figure : 3D view on simulation CFD

Figure : Top view on simulation CFD

52

Figure : Side view on simulation CFD

Figure : Front view on simulation CFD

53

CONCLUSION

The pharmaceutical production must effectively control the contamination from

people, raw materials, finished products as well as accommodating-services, process plant

and equipment. The requirements that are available involved in the overall design and a

complex construction process. During process of studying cleanroom technology I firstly

met different requirements and regulations for certain industry. Each of them has their

definite property and purpose. So every clean room in different industry should be designed

according to their own manufacturing characteristics.

In this thesis was shown detailed rules of designing clean rooms by example of

pharmaceutical productionThe present results provide rough estimates of the probable

revenues resulting from improving the air quality in offices in developed parts of the world,

54

and constitute a powerful argument for providing indoor air of a better quality than the

minimum levels required by present Standards. Indoor air quality are very important

especially for pharmaceutical area. In order to determine the perfect design where no

contaminant can enter a workspace is really a challenge for an engineer. Designing a good

design along with good efficiency of system selection, to take into account about utilization

of electricity, water and many more is a good lesson in our study & perhaps it all will be

applied in working field.

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