1. GUIDED BY:
Dr. M. R. PATEL
Principale & HOD in
pharmaceutics
PRESENTEDE BY:
SAHILHUSEN I . JETHARA
M. PHARM – I (2013-14)
ROLL NO. - 02
DEPARTMENT OF PHARMACEUTICS
SHRI B. M. SHAH COLLEGE OF PHARMACEUTICAL EDUCATION
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AND REASERCH, MODASA-2013 SHRI B.M.C.P.E.R, MODASA

2. CONTENTS
 UTILITY SERVICES
 SERVICE FACILITIES
 HVAC
INRODUCTION
ROLE IN PHARMACEUTICAL INDUSTRY
LEVEL OF PROTECTION
COMPONENTS
FILTER CLASSES
AIR FLOW PATTERNS
VALIDATION AND QUALIFICATION
 PERSONNEL FACILITIES
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3. UTILITY SERVICES
1.
2.
3.
4.
5.
6.
7.
8.
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HVAC
PLUMBING
DRAINAGE SYSTEM
GAS SYSTEM
SANITATION
WATER FOR PHARMACEUTICAL USE
FIRE PROTECTION SYSTEM
Services used by a factory include compressed gases, water,
vacuum, electricity and room air conditioning
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4. 1.HVAC: (The Heating, Ventilating, and Air conditioning)
2.PLUMBING:
Portable water shall be supplied under continuous positive pressure in a
plumbing system free of defects that could contribute contamination to
any drug product.
The pipes and fittings must be of quality good enough to withstand the
pressure and heat conditions
Plumbing
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in
Industry
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5.  Compatibility of
the materials of construction with the
characteristics of the waste water must be considered during the
design of the facility. For example: Copper plumbing should not
be used in drain line for acidic waste water .
COLOUR CODE
MATERIALS
GREY
RAW WATER
ORANGE
DISTILED WATER
GREEN
COOLING WATER
WHITE
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AIR
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6. 




3.DRAINAGE SYSTEMS
They remove effluent from spaces , systems, or process.
Adequate size
easy to clean
For biological waste, it should be treated in a proper manner before
disposal to not to harm the environment.
Dissolved oxygen content in the waste to be disposed in lake or river
must be within limits.
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7. Biological Waste System
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8. Sanitary waste system
 A separate sanitary waste drainage and vent system is provided to
convey waste from toilets, lavatories, non-process service sinks
and floor drains.
Laboratory waste system
 A separate laboratory waste drainage and vent system is often
provided in cases
 where acids or caustics used in laboratory processes must be
sampled and potentially neutralized before disposal into the
sanitary waste system.
Hazardous Material Waste and Retention
 Provided in cases where hazardous materials such as solvents,
toxins, radio actives, high concentrations etc.
 To maintain isolation of the hazardous material for other drainage
systems.
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9. Process Waste System
 A separate process waste drainage and vent system is often provided in
cases where products used in the manufacturing process must either be
contained separately or treated before disposal into the sanitary waste
system
Storm Drainage System
 A separate storm drainage system is provided to drain rainwater from all
roof and area drains
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10. 4.GAS SYSTEMS
 All gases used in manufacturing and processing operations, including the
sterilization process
Compressed Air
 In general compressed air should be supplied by an “oil- free” type
compressor and
 must be free of oil and oil vapour unless vented directly to a noncontrolled environment area.
 It should also be dehumidified to prevent condensation of water vapour.
Breathing Air
 Breathing air is generally provided for use to personnel working in
hazardous environment.
 Provided centrally through a breathing air distribution system or at the
local level with “backpack” type breathing air units worn by each person.
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11. Nitrogen
 Used for the purging of electrical equipment in volatile or explosive
environments
vacuum
 Vacuum is utilized in the encapsulation and tablet compression
areas.
Vacuum Cleaning
 For dry particulate and powder pickup
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12. 5. SANITATION IN THE MANUFACTURING PREMISES





Objectives
Removal of dirt and other waste material;
Minimize the risk of cross contamination between different products in the
same area;
Reduce the number of micro-organisms in work area;
Control pests so that these do not affect the quality of materials to be used
in the manufacture of drugs.
Cleaning procedure to be followed, including equipment and materials to
be used for cleaning.
CLEANING AGENTS AND DISINFECTANTS:
 Cleaning agents help to remove extraneous materials from surfaces.
 Disinfectants destroy pathogenic and other micro organisms and are used
to reduce microbial count in manufacturing area.
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13. 6.WATER FOR PHARMACEUTICAL USE
 Water is most widely used material in pharmaceutical manufacturing.
A greater volume of water is used in cleaning and rinsing processes than
in formulation in most facilities. Regardless of the water volume used in
actual drug formulation all pharmaceutical water is subject to cGMPs
even when the water does not remain in the finished product.
WATER QUALITY REQUIREMENTS
 The types of water defined in the pharmacopoeial monographs such as
Purified Water and Water for Injection (WFI) are known as compendial
waters.
 Other quality waters used in manufacturing, not defined by USP or other
recognized compendia are known as non-compendial waters.
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14. Rain water
river
Water purchased
in bulk
Sources
of water
Dams, ponds
Municipal or
civil water
Lakes
Well water
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15. MONOGRAPH REQUIREMENTS
 The monographs require that the water purity is proven by
conductivity and total organic carbon (TOC).
 conductivity test requires measurement of conductivity and
water temperature.
 The conductivity limit varies from 0.6 µS/cm at 0 C
3.1 µS/cm at 100 C.
 1.3 µS/cm at 25 C and 2.7 µS/cm at 80 C.
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16. 7.FIRE PROTECTION SYSTEMS
 Pharmaceutical manufacturing facilities are with
typically
provided with automatic fire suppression and protection system
throghout.
 The provision of specific suppresion and protection throughout
the facility might be the
requirement.
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consequence of a strict code
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17. Sprinkler Systems
 Wet Sprinkler System
 Dry Pipe Sprinkler System
 Preaction Sprinkler System
 Antifreeze Sprinkler System
 Foam-Water Sprinkler System
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18. Wet Sprinkler System
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Dry Pipe Sprinkler System
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19. Preaction Sprinkler System
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Foam-Water Sprinkler System
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20. SERVICE FACILITIES

Medical Services

Canteen Facilities

Washing and Toilet Facilities

Protective Clothing facilities

Change Rooms Facilities

Educational Programmes and Training facilities

Safety Programmes will be covered in the personal facilities.
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21. HVAC
 The Heating, Ventilating, and Air conditioning -HVAC the technology
of indoor environmental comfort.
 HVAC system based on the principles of thermodynamic, fluid
mechanics and heat transfer.
HVAC system performs four basic functions:
1.Control airborne particles, dust and micro-organisms
2. Maintain room pressure.
3. Maintain space moisture.
4. Maintain space temperature.
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22. 1. Heating
 There are different types of standard heating systems.
Central heating
 It is used in cold climates to heat private houses and public
buildings.
 contains a boiler, furnace, or heat pump to heat water, steam, or
air, all in a central location such a furnace room in a home or a
mechanical room in a large building.
Boiler
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23.  also contains either ductwork, for forced air systems, or piping to
distribute a heated fluid .
2. Ventilation
 It is the process of "changing" or replacing air in any space to control
temperature or remove moisture, odors, smoke, heat, dust and airborne
particle.
 Ventilation includes both the exchange of air to the outside as well as
circulation of air within the building.
 Methods for ventilating a building may be divided into
mechanical/forced and natural types.
Mechanical Ventilation
Mechanical ventilation is the use of mechanical air handling systems—
commonly referred to as heating, ventilation, and air conditioning
(HVAC) systems—toB.M.C.P.E.R, MODASA
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25. Natural Ventilation
 Natural ventilation is the use of differences in air pressure that exist
between the inside of a building relative to the outside of it.
 These air pressure differences are created by natural forces such as wind
and temperature.
 Air moves into and out of naturally ventilated buildings through
windows, doors, vents and other openings incorporated into the
building design.
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26. 3. Air conditioning
 Air conditioning and refrigeration are provided through the
removal of heat.
 Heat can be removed through the process of radiation,
convection and cooling through a process called the
refrigeration cycle.
 The system uses mediums such as water, air, ice, and
chemicals referred to as refrigerants.
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27. WORKING OF HVAC
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28. Diagram Of HVAC System
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29. System Design Criteria









Temperature and Moisture
Air Cleanliness
Pressurization
Building Intake and Exhaust
Heating Systems
Humidification Systems
Dehumidification Systems
Supply Air Handling Systems
Prime movers
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30. Temperature and Moisture
 Space and process temperature and moisture conditions are
generally determined by the product or process performed.
Air Cleanliness
 The level of acceptable airborne contamination within the
space must be identified ,for product quality or employee
safety.





Environmental cleanliness is determined by several factors:The quality of air introduced into the space
The quantity of air introduced into the space
The effectiveness of air distribution through the space
The effectiveness of the removal of the air contaminant
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31. Air flow sheets
 The airflow sheets should be developed on full size drawings and should
show air quantities supplied, returned, and exhausted from each space.
 They also must show air transferred into and out of spaces.
 The airflow sheet is a useful tool for transfer of information to the owner
or user, for agency reviews, for transmission of information to HVAC
designers, and for other engineering disciplines.
Air Flow Pattern
 The air distribution has to be appropriate with the class of clean
room. Air turbulance in the space can cause particulates which have
settle onto the floor and work surfaces to become re-entrained in
the air.
 Air turbulance is greatly influenced by the configuration of air supply
and return grilles, people traffic and process equipment layout.
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32. Pressurization
 Space relative pressurization will be determined primarily by requirements
of the product.
 Where product contamination control is required, the space relative
pressurization must be designed to assure that the movement of exfiltred
air is from the clean to the less clean areas.
Building Intake and Exhaust
 Careful attention must be paid to the incoming system air quality.
 An industrial area may have a more corrosive or there are chemical in air
quality.
 These issues must be carefully considered when selecting filtration
systems so as to minimize the possibility of product contamination.
 Careful consideration must be made as to the impacts of building exhaust
and relief systems, loading docks and other incidences of vehicle exhaust
and electrical generator exhaust
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33. Heating Systems
 Using steam or hot water as the heat source.
 Heating can also be provided by electric means that is easily controlled.
Cooling System
 chilled water, condenser water, /anti-freeze solution or other heat exchange
fluid may be utilized.
Humidification Systems
 In most cases, air supplied to the space or process will require the addition of
moisture to maintain relative humidity conditions.
 Moisture is generally provided utilizing steam injection and in some cases
atomized water utilizing compressed air.
Dehumidification Systems
 For moisture removal
These mehtods includes;
 solid and liquid drying systems
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

34. Supply Air Handling Systems
 It assists in determining the temperature, moisture level, and
cleanliness of that environment.
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35. Different Components of HVAC and their Function
1. FLOW RATE CONTROLLER
 Automated adjustment of volume of air.
2. HUMIDIFIER
 For humidification purposes, especially in clean areas, high purity water
should be used, to avoid contamination.
HUMIDIFIER
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36. 3. CONTROL DAMPER
 Dampers to control pressure differentials are important. They can be
automated or fixed.
4. DEHUMIDIFIRE
 In some cases, it is necessary to have very dry air.
 To generate dry air, the air supplied to the production is passed over an
adsorbent, where the humidity is removed from the air.
5. DUCT
 To transport air.
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37. 6. AIR DIFFUSOR (REGISTER)
 The air flows into the rooms via so-called registers (diffusor), which are
built and installed in such a way that the air is distributed evenly.
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38. 7. FILTERS
 To eliminate particles of predetermined dimensions and/or micro-
organisms.
Types of Filters Used in HVAC
 Primary Panel filters
 Secondary filters
 HEPA or tertiary filters
FILTER CLASSES
ULPA- Ultra-Low Penetration Air filter
HEPA- High Efficiency Particulate Air filter
 Leak tests (integrity tests), showing leakage of air through the filter itself
or through its frame, therefore, have to be performed. Integrity tests
are usually only carried out on the Aerosol filters.
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39. HEPA Filter
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40. FILTER POSITION
The filtered air entering a production room can be coming from:
 An air-handling unit, equipped with pre-filtration and the main
(HEPA) filter, but at some distance from that room (AHU mounted
final filter)
 for injectables and sterile forms, it is recommended that they be
placed in terminal position.
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41. DIFFERENT AIR TYPES TO BE CONSIDERED WITHIN THE
AIR HANDLING SYSTEM
FRESH AIR
 If the plant is of the re-circulation type, it is necessary to replace
some of the re-circulating air with fresh air, which is then called
make-up air.
SUPPLY AIR
There are two ways to supply air to a room or a piece of equipment
 Turbulent air flow
 Uni-directional flow, often called laminar flow
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42. Role of HVAC in Pharmaceutical Industry
 PRODUCT PROTECTION
 PERSONNEL PROTECTION
 PROTECTION OF THE ENVIRONMENT
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43. 1. PRODUCT PROTECTION
 Contamination control
 Cross-contamination protection
This can be achieved with the aid of the following methods.
 Adequate premises
 Good ventilation and dedusting system.
 Closed production systems:
 Validated cleaning procedures.
2. PERSONNEL PROTECTION





Protection from dust
Unidirectional Airflow protection
Air Showers
Protective enclosures
Operator comfort
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44. 3. PROTECTION OF THE ENVIRONMENT
Exhaust air dust
 Exhaust air discharge points on pharmaceutical facilities, such as from
fluid bed driers and tablet coating equipment, and exhaust air from dust
extraction systems, carry heavy dust loads and should be provided with
adequate filtration to prevent contamination.
Effluent discharge
 Effluent control should be designed to ensure that system do not
become source of possible risk or contamination.
Fume removal
 Removal of fumes should be by means of wet scrubbers or dry chemical
scrubbers (deep bed scrubbers).
 Wet scrubbers for fume removal should normally have various
chemicals added to the water to increase the adsorption efficiency.
 Deep bed scrubbers should be designed with activated carbon filters, or
chemical adsorption granular media. The chemical media for deep bed
scrubbers should be specific to the effluent being treated.
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45. GMP MANUFACTURING
ENVIRONMENT
PRODUCT
PROTECTION
PERSONNEL
PROTECTION
Contamination
(Product & Staff)
ENVIRONMENT
PROTECTION
Prevent contact with dust
Dust discharge
Protect from product crosscontamination
Prevent contact with fumes
Fume discharge
Correct temperature & humidity
Acceptable comfort
Conditions
Effluent discharge
SYSTEMS
SYSTEM VALIDATION
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46. VALIDATION AND QUALIFICATION
List of Parameters to be qualified
 room temperature (if there is an impact on product quality)
 room humidity (if there is an impact on product qualit
 return air or exhaust air quantities
 room air change rates
 room pressures
 room air flow patterns
 HEPA filter penetration tests
 room particle counts
 microbiological air and surface counts
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47. PERSONNEL FACILITIES
 EATING AND DRINKING FACILITIES
 LAVATORIES & LOCKERS
 CLOTHING
 FIRST AID FACILITIES
 GOWNING ROOMS
 SAFETY PROGRAMS
 TRAINING FACILITES
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48. 1. EATING AND DRINKING FACILITIES
 Eating & drinking permitted only in separate eating facilities.
 Permanent facilities for breaks & people bringing lunches required.
 Manufacturer should provide facility of canteen; it should be away from
operating areas.
2. LAVATORIES & LOCKERS




Adequate in number for the number of personnel employed.
Conveniently located to all areas.
Complete cleaning with cleansing & disinfectant agents daily.
Lavatory & locker areas separated from all sterile spaces by an air lock.
3. CLOTHING
 Workers in special clean areas wearing only lint- & dust-free garments








to prevent shedding.
Where necessary the following articles are provided by the company:Hats & head covers for clean areas.
Aprons
Safety shoes
Gloves, disposable in clean areas
Safety glasses
Masks
Protective goggles
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49. 4. GOWNING ROOMS
 Gowning areas should be used when exposure to product could put
personnel at risk & when necessary to prevent product contamination.
 Should be provided separate for male and female worker & With locker
facilities Schedule-M prescribes an area of 8 sq. meters for change room.
 Gowning rooms should be adjacent to the washing area and before entry
to the production area.
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50. 5. FIRST AID FACILITIES
 The manufacturer should provide adequate facilities for first aid and
should train some persons from every section in first aid.
 In order to minimize the risk of a serious medical hazard due to crosscontamination, dedicated and self-contained facilities must be available
for the production of particular pharmaceutical products, such as highly
sensitizing materials
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51. 6. RESTROOM FACILITIES
 Restroom facilities should be physically separated from lab & processing
areas by a room, corridor or other intermediate space.
7. SAFETY PROGRAMS
 Plant safety programs play an important role, since hazardous conditions






diminish employee moral and performance.
Posters displayed prominently & changed often.
Safety equipment available free of cost to employee.
Safety showers and eye baths in hazardous areas.
Lectures, movies
Safety bulletin boards listing recent plant accidents & methods of
prevention.
Safety inspection teams from several departments to audit work areas
periodically
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52. 8. TRAINING FACILITES
 Management must provide training in accordance with written program
for all personnel whose duties taken them into manufacturing area or
into control lab & for other Personnel working in areas where
contamination is a hazard those should be given specific training.
 Consultant & contract staff should be qualified for services they provide.
evidence of these should be included in training required.
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53. QUESTIONS





Give role of HVAC in pharmaceutical industry.
Draw a diagram of HVAC.
Give name of different components, their functions.
Give different type of air.
Write a note on different types of filters, position of filters & filter
classes with reference to HVAC?
 Write a note on system design criteria for HVAC?
 PERSONNEL FACILITIES
 What are the personnel facilities required in a pharmaceutical
industry as per GMP?
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54. REFERENCES
 GOOD DESIGN PRACTICES FOR GMP PHARMACEUTICAL FACILITIES








BY:- ANDREW. A.SIGNORE & TERRY JACOBS
VOL-146, PAGE NOS:- 50,90-104,345
GOOD MANUFACTURING PRACTICES FOR PHARMACEUTICALS
BY; - JAMES SWARBRICK VOL-2, PAGE NOS:- 20,21,22,23,36,37
www.wikipedia.com
www.p2pays.org
www.foreigntradeexchange.com
www.industrialleaders.org
Encyclopedia, vol. -7, page - 229
Encyclopaedia of pharmaceutical technology vol-16 water for
pharmaceutical use 293-306
USP 25 Official Monograph pg. No. 1809-1810
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55. Ph. No. :- +918460378336
Address:- 44, Assiyana Society;
Dugarvada Road,
Taluko & City : Modasa
State: Gujarat
Country: India
Email: sahil.pharm4@gmail.com
BEST OF LUCK TO ALL . . . . . . . . . .
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