PRESENTATION ON

HVAC
& WATER SYSTEM

Presented by:Md. Ali Akbar Hossain & Anil Chandra Dey

The University of Asia Pacific

2

HVAC SYSTEM

HVAC System

FUNDAMENTAL OF HVAC
HVAC is an acronym that stands for heating, ventilating and airconditioning system .

This system generally includes a variety of active mechanical or electrical systems employed to provide thermal control in buildings.

Fig: HVAC System

FUNDAMENTAL OF HVAC
An air-conditioning system by ASHRAE (American Society of Heating, Refrigerating and Air-Conditioning Engineers) definition is a system that must accomplish four objectives simultaneously. These objectives are to:

Control Control Control Control

air air air air

temperature humidity circulation and quality.

FUNDAMENTAL OF HVAC
H in HVAC

A heating system (H in HVAC) is designed to add thermal energy to a space or building in order to maintain some selected air temperature that would otherwise not be achieved due to heat flows (heat loss) to the exterior environment.

FUNDAMENTAL OF HVAC
Heating a system contains :

Boiler Furnace or Heat pump to heat water, steam and air

FUNDAMENTAL OF HVAC
V in HVAC

A ventilating system (V) is intended to introduce air to or remove air from a space to move air without changing its temperature. Ventilating systems may be used to improve indoor air quality or to improve thermal comfort. Methods for ventilating a building may be divided into : 1.Mechanical forced and 2.Natural types ventilation

FUNDAMENTAL OF HVAC
Mechanical or forced ventilation

Mechanical ventilation is provided by an air handler and used to control indoor air quality. Excess humidity ,odors and contaminants can often be controlled via dilution or replacement with outside air. In pharmaceutical Company normally use this type of ventilation system.

FUNDAMENTAL OF HVAC
Natural ventilation

Natural ventilation is the ventilation of a building with outside air without the mechanical system. It can be achieved with open able windows or trickle vents.

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FUNDAMENTAL OF HVAC
AC in HVAC

Cooling systems are normally considered as part of the AC in HVAC.AC stands for air-conditioning.

A cooling system is designed to remove thermal energy from a space or building to maintain some selected air temperature.

FUNDAMENTAL OF HVAC
AC in HVAC

Air conditioning and refrigeration are provided through the removal of heat. The definition of cold is the absence of heat and all air conditioning systems work on this basic principle. Heat can be removed through radiation, convection and by heat pump systems through a process called the refrigeration cycle.

FUNDAMENTAL OF HVAC
The Refrigeration Cycle

The Compressor The Condensing Coil The Metering Device The Evaporator

FUNDAMENTAL OF HVAC

Psychrometric Chart

Fig : Psychrometric ChartSaturation Line

FUNDAMENTAL OF HVAC
To understand the relationship between water vapor, air, and temperature, we will consider two conditions.

First Condition:
The temperature is constant, but the quantity of water vapor is increasing. If the temperature remains constant, then, as the quantity of water vapor in the air increases, the humidity increases.

FUNDAMENTAL OF HVAC
Second Condition:

The temperature is dropping, but the quantity of water vapor is constant. If the air is cooled sufficiently, it reaches the saturation line. If it is cooled even more, moisture will condense out and dew forms.

FUNDAMENTAL OF HVAC
Relative Huminity

The percentage of amount moisture present in a certain area in a certain temperature .

Saturation line

The curved maximum water vapor line is called the saturation line.

Types of HVAC System

HVAC systems come in a broad range of sizes and complexity. The most commonly used types of HVAC systems are listed here.

1.Single Zone 3.Multiple Zone 2.Constant Volume 4.Variable Air Volume(VAV)

Single Zone

A single air handling unit can only serve more than one building area if the areas served have similar heating, cooling, and ventilation requirements. Single-zone efficiently. systems can satisfy all HVAC functions

But contemporary single-zone HVAC equipment performs poorly because of flaws in design and equipment

Multiple Zone

Multiple zone systems can provide each zone with air at a different temperature by heating or cooling the air stream in each zone. Multiple-zone air handling systems inherently cannot perform all HVAC functions and operate efficiently.So, they must be abandoned. Alternative design strategies involve delivering air at a constant temperature while varying the volume of airflow

Constant Volume

Constant volume systems generally deliver a constant airflow to each space. These systems often operate with a fixed minimum percentage of outdoor air. Changes in space temperatures are made by heating or cooling the air or switching the air handling unit on and off, not by modulating the volume of air supplied.

Variable Air Volume

Variable air volume systems maintain thermal comfort by varying the amount of heated or cooled air delivered to each space, rather than by changing the air temperature. Overcooling or overheating can occur within a given zone if the system is not adjusted to respond to the load.

Fig: Variable Air Volume (VAV) System

HVAC Components
HVAC system components may be grouped into three functional categories: 1.Source components :

Source components provide or remove heat or moisture.

2.Distribution components :

Distribution components convey a heating or cooling medium from a source location to portions of a building that require conditioning.

3.Delivery components :

Delivery components serve as an interface between the distribution system and occupied spaces.

Source components

Source components

Space heat may be added or removed by an electromechanical system which is termed an active systems.

Space heat may be added or removed by a system designed to make use of naturally occurring environmental forces. Such a system is termed a passive system.

Source components
Basic sources for building heat:

A. On-site combustion : Heat may be generated by the combustion of some flammable material (a fuel) such as coal or natural gas. B .Electric resistance: Electricity may be converted to heat through the process of electric resistance. C. Solar collector on roof to furnace: Solar radiation or other renewable energy resources may be collected on site and converted to heat. D.Heat pump in furnace: Heat may be removed from some material on site and transferred into a building.

Source components

The choice of a heat source is usually based upon.

Required HVAC System Source availability Required system capacity Equipment and Fuel costs.

Fig : Typical Boiler

BOILER

A boiler is a closed vessel in which water or other fluid is heated and produced steam. Boiler is a heating system component designed to heat water for distribution to various building space. The heated or vaporized fluid exits the boiler for use in various processes or heating applications. Boilers are only used in central systems where hot water is circulated to delivery devices ( air-handling units). Worked at low to medium pressure (1300 psi/0.069 20.684 bar; 6.8952,068.427 kP).

BOILER
Materials of Boiler:

Stainless steel is virtually prohibited for use in wetted parts of modern boilers In live steam models, copper or brass is often used because it is more easily fabricated in smaller size boilers. Highest grade of iron is used.

BOILER
Fuel of Boiler:

Wood Coal Oil or Natural gas. Nuclear fission is also used as a heat source for generating steam.

BOILER
Boilers can be classified into the following configurations:

Pot boiler Fire-tube boiler Water-tube boiler. Flash boiler Fire-tube boiler with Water-tube firebox. Sectional boiler.

BOILER

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Fig : Fire tube boiler

BOILER
Fire-tube boiler

A boiler in which hot gases from a fire pass through one or more tubes running through a sealed container of water. The heat of the gases is transferred through the walls of the tubes by thermal conduction heating the water and ultimately creating steam.

BOILER
Types of Fire tube boiler

Cornish boiler Lancashire boiler Scotch marine boiler Locomotive boiler Vertical Fire Tube boiler Horizontal Return Tubular boiler

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Fig: Water tube boiler

BOILER
water tube boiler

A water tube boiler is a type of boiler in which water circulates in tubes heated externally by the fire. In a pharmaceutical company mostly used this type of boiler.

Fig: Typical Chiller

Chiller

A chiller is a machine that removes heat from a liquid or water via a vapor-compression or absorption refrigeration cycle. This liquid can then be circulated through a heat exchanger to cool air or equipment as required. Chiller produce chilled water(cool water) that is used in commercial building or in pharmaceuticals. Chilled water temperatures can range from 35 to 45 degrees Fahrenheit (1.5 to 7 degrees Celsius) depending upon application requirements.

Chiller
Chillers may operate on either the vapor compression principle or the absorption principle.

Vapor-Compression Chiller Technology Absorption Chiller Technology

Chiller
vapor compression chillers
There are basically four different types of compressors used in vapor compression chillers: Reciprocating compression Scroll compression Screw-driven compression and Centrifugal compression. All mechanical machines that can be powered by electric motors, steam, or gas turbines. They produce their cooling effect via the "reverse-Rankine cycle, also known as vapor-compression.

Chiller
vapor compression chillers

Their coefficients-of-performance (COPs) are very high. In recent years, Variable Speed Drive (VSD) technology has increased efficiencies of vapor compression chillers. VSDs are being applied to rotary screw and scroll technology compressors.

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Fig: VSD

Chiller
Absorption Chiller Technology

Absorption chillers use heat instead of mechanical energy to provide cooling. A thermal compressor consists of an absorber, a generator, a pump, and a throttling device, and replaces the mechanical vapor compressor. The two most common refrigerant/ absorbent mixtures used in absorption chillers are water/lithium bromide and ammonia/water. Compared with mechanical chillers, absorption chillers have a low coefficient of performance (COP = chiller load/heat input).

Chiller
Absorption chillers come in two commercially available designs: single-effect and double-effect. Single-effect A single-effect absorption machine means all condensing heat cools and condenses in the condenser is released to the cooling water. Single-effect machines provide a thermal COP of 0.7 & require about 18 pounds of 15-pound-per-square-inch-gauge (psig) steam per ton-hour of cooling. Double-effect A double-effect machine adopts a higher heat efficiency of condensation and divides the generator into a high-temperature and a low-temperature generator. Double-effect machines are about 40% more efficient.

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Fig: Cooling Tower

Cooling Tower

A cooling tower is a heat rejection device installed outside of the building envelope, through which condenser water is circulated. A cooling tower is a latent heat exchanger. Heat rejected from the refrigerant increases the temperature of the condenser water. The condenser water is circulated to the cooling tower where evaporative cooling causes heat to be removed from the water and added to the outside air. The cooled condenser water is then piped back to the condenser of the chiller.

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Cooling Tower

The towers vary in size from small rooftop units to very large up to 200 metres tall and 100 metres in diameter Rectangular structures that can be over 40 metres tall and 80 metres long.

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Cooling Tower
Classification Cooling Tower by use:

HVAC:Chillers Industrial cooling towers: Machinery or heated process material.

Classification Cooling Tower by build:

Package Type: Hospitals, hotels, malls, chemical processing plants. Field Erected Type: Power plants, steel processing plants, petroleum refineries.

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Cooling Tower : Categorization byair-to-water flow

Crossflow

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Cooling Tower : Categorization byair-to-water flow

Counterflow

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source components
Others source components are :

Portable Heaters Electric Baseboard Radiation Solar Thermal Collector Heat Pump Vapor Compression Refrigeration Unit Absorption Refrigeration Unit

Distribution

components

Distribution components
A central system will always require distribution components to convey the heating or cooling effect from the source to the conditioned locations.

Hot water and steam can be used as heating media. Cold water can used cooling medium.

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Distribution components
PIPE SYSTEM

In a water-based central system pipes are used to convey water from the source to the final delivery components. A minimum of two pipes is necessary one for supply water and one for return water to establish a distribution loop. When both heating and cooling are required in a building, 3pipe and 4-pipe distribution systems may be used to increase system flexibility.

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Distribution components

A 2-pipe system can only heat or cool, simultaneous heating and cooling not an uncommon requirement in large buildings is not possible with a 2-pipe system. A 3-pipe system has two supply pipes (hot and cold water) and a single return. The mixing of heating and cooling water in a single return is not energy efficient and is not recommended. A 4-pipe distribution system has two supply pipes and two separate return pipes (hot and cold). The 4-pipe arrangement provides the greatest control flexibility in the most energyefficient manner.

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Distribution components
Several piping materials are used in HVAC distribution systems.

Steel pipes are most commonly used, although copper may be used when economic or environmental conditions dictate. Hot and cold (chilled) water pipes in HVAC distribution systems are normally insulated. Yellow color pipe chilled water supply and green color pipe for return chilled water.

Distribution components

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Fig: Insulated pipe

Distribution components
Valve

Valves are used to control water flow as a means of adjusting system heating or cooling capacity to the demands of the building thermal zones. Valves are also used to shut off water flow so that equipment may be maintained.

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Distribution components

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Fig: Common valves for HVAC applications.

Distribution components
Gauge

A range gauges is used to balance system flows and verify temperature and pressure conditions.

Fig: Gauges for HVAC 62 applications.

Distribution components

The typical central HVAC system may require the use of several pumps: for hot water, for chilled water, and often for condenser water.

Pumps come in a variety of designs and capacities and can be driven by electric motors, combustion engines, or steam. Electric motor driven centrifugal pumps.

63Centrifugal pumps

Fi

Air Handling Unit(AHU)

Air Handling System

Supply Air

ProductionRoom With Defined Requirements

Outlet Air

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Distribution components
Air Handling Unit(AHU):

AHU is a device used to condition and circulate air as part of a HVAC system. AHU is to suck air from the rooms and fresh air let it pass through chilled water cooling coils and then discharging the cooled air back to the rooms. Air handlers usually connect to ductwork that distributes the conditioned air through the building and returns it to the AHU. A certain amount of fresh air(20%) and (80%) recirculated air introduced at the suction duct of the AHU that balance the oxygen & carbon dioxide in the room for comforting.

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Distribution components
Some Air handler components

Mixed (recirculated 80%+ outside20%) air duct Filter compartment Cooling coil Heating Coil Vibration isolator ('flex joint') Fan compartment Final filtr Supply duct

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Distribution components
Mixed (recirculated 80%+ outside20%) air duct.

The 80% recirculated air is enter the mixing box section and mixed with 20% fresh air. Recirculated air is come from the HVAC controlling room by return pipe. By filtering fresh air is come from Fan Coil Unit (FCU)

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Distribution components
Pre filter: Panel filter used in HVAC applications as a coarse dust filter or pre-filter. Filtering the mixed air by pre-filter-G4 (averrage arrestance <35%. Medium Filter Then again filtering the pre-filtrated air by medium filter F-7 (Efficiency 85%)

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Filter classes

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Distribution components
Cooling Coil Section

Large commercial air handling units contain coils that circulate chilled water for cooling the air. Coils are typically manufactured from copper for the tubes with copper or aluminum fins to aid heat transfer. Cooling coils will also employ eliminator plates to remove and drain condensate. The chilled water is provided by a central chiller.

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Distribution components

Heating Coil Section

Air handling units contain coils that circulate hot water or steam for heating The hot water or steam is provided by a central boiler.

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Distribution components
Vibration isolator ('flex joint')

The blowers in AHU can create substantial vibration and duct system would transmit this noise and vibration to the occupants of the building. To avoid this, vibration isolators (flexible sections) are normally inserted into the duct immediately before and after the air handler and often also between the fan compartment and the rest of the AHU.

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Distribution components
Fan compartment

Multiple blowers present in large commercial AHU. They are typically placed at the end of the AHU and the beginning of the supply ductwork (therefore also called "supply fans"). They are often augmented by fans in the return air duct ("return fans") pushing the air into the AHU.

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Distribution components

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Fig:Centrifugal fan.

Fig: Axial fan

Distribution components
Supply duct:

At the ending of AHU the controlled air is supply to the various room.

Final filter:

Before supplying the conditioned air to room filtering the air by final filter. Normally High Efficiency Particulate Air (HEPA) filter (Efficiency is 99.997%) is used

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Distribution components
High Efficiency Particulate Air (HEPA) filter

A high efficiency particulate air (HEPA) filter is a type of air filter that satisfies certain standards of efficiency such as those set by the United States Department of Energy (DOE). HEPA filters are composed of a mat of randomly arranged fibres. The fibres are typically composed of fiberglass and possess diameters between 0.5 and 2.0 micrometer. Larger particles(>.2micron) can not pass the filter.

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Specifications of HEPA filter

HEPA class
E10 E11 E12 H13 H14 U15 U16 U17

Retention (total%)
>85 >95 >99.5 >99.95 >99.995 >99.9995 >99.99995 >99.999995

Retention (local %)
>99.75 >99.975 >99.9975 99.99975 >99.9999

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AHU to Production Room

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AHU to Production Room

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Production Room to AHU

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HVAC Thermostat wire color code

Wire Red Green Yellow White Orange Color code R G Y W O Description 24VACControlPower Fan Cooling Heating CoolingAux(reversing valvefailtoheat)

Blue

HeatingAux(reversing valvefailtocool)

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Distribution components
HVAC Duct Design
In an air-based central system, ducts (ductwork) are used to convey air from a primary or secondary source to the final delivery components.

Typically two duct paths are necessary one for supply air and one for return air.

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Distribution components
Typical duct materials are:

Sheet metal Fiberglass ductboard Flex duct.

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Fig: Sheet metal

Distribution components

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Fig:Fiberglass ductboard

Fig: Flex duct.

Distribution components
Duct shapes include

Square Rectangular Circular and Flat oval cross sections

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Fig :Ductwork shapes A - rectangular

Distribution components

Figure:Typical ductwork shapes B - square; C -circular; D - flat ov

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Distribution components

Fig: Air flow control damper

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Distribution components

Fig: Fire damper

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Distribution components

Fig: Turning vanes

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DELIVERY COMPONENT S

DELIVERY COMPONENTS

The heating or cooling effect produced at a source and distributed by a central system to spaces throughout a building needs to be properly delivered to each space to promote comfort. In air-based systems, heated or cooled air could theoretically just be dumped into each space. In water-based systems, the heated or cooled media (water or steam) can not just be dumped into a space. Distribution components are collectively termed delivery devices.

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DELIVERY COMPONENTS
Diffuser

A diffuser is a device designed specifically to introduce supply air into a space, to provide good mixing of the supply air with the room air, to minimize drafts that would discomfort occupants. Diffusers are intended for ceiling installation and are available in many shapes, sizes, styles, finishes, and capacities.

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Figure . Common diffuser designs.

DELIVERY COMPONENTS
Register:

Used for floor air supply and Side wall air supply applications or as return air inlets.

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Fig : Common register designs

DELIVERY COMPONENTS
Grille
Grilles are simply decorative covers for return air inlets. They are used to block sightlines.

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Figure . A grille.

typical

DELIVERY COMPONENTS

Figure : Hydronic baseboard

Figure: Hydronic convecto

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DELIVERY COMPONENTS

Production floor in the Granulation ,Blending ,Encapsulation,dry syrup filling maintain 23 to 25 Celsius and RH is 40 to 45%. In Dispensing,weighing materials store,Blister packaging,Corridor bottle drying area maintain 23 to 25 Celsius and RH 45 to 50%. In cold room maintain 2 to 8 Celsius. All process room maintain negetive pressure. In sterile manufacturing room maintain positive pressure.

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Cleanroom Class defined by Critical Parameters

Air Handling System

Additional Measures

Test Parameter

Objective

Maximum time interval

Test procedure* and key aspects

Filtermediaand filterseal integrity Timetaken maximum15 minutes Airflowdirection, documented evidence

Filterleakage

Verifyfilter integrity

12months

Recovery(time) Verifyclean-up 12months time Airflow visualization Verifyrequired airflowpatterns 12months

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Test ParameterObjective

Maximum time Test interval procedure* and key aspects

Measurepressure difference Measuresupply andreturnair, calculateair changerate Velocity measurement

Airpressure difference Airflowvolume

Absenceofcross- 12months contamination Verifyairchange 12months rates

Airflowvelocity

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Verify unidirectional airflowandor containment condition

12months

Factors contributing to quality products

Personnel Validated processes Procedures Starting materials Equipment Packing materials Premises Environment

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Water System

Typesofwaterusedin pharmaceuticalprocesses
Water for Injections PFW & WFI Softened Water Water for Final Rinse Pure, or Clean Steam Purified Water Water for Cooling Autoclaves

1. 2. 3. 4. 5. 6.

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purified water

1.The most common type of water in use in a pharmaceutical factory is purified water. This is used as an ingredient for manufacture of nonsterile pharmaceuticals.

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Water For Injections.

2.The highest quality is Water For Injections.Water for Injections is used in parenteral products. In bulk, this type of water is also called Pyrogen Free Water, or PFW, and if sterilized, it is called Sterilized Water for Injections. For other purposes, other types of water may also be used.

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.Water for Final Rinse

3.Water for Final Rinse is used for rinsing equipment after washing. It must be of the same quality as the water used for manufacturing the product. In some countries this can be prepared using different equipment to the ingredient water. For example, ultrafiltered water may be used for rinsing equipment for parenteral use, but WFI must be used as the parenteral ingredient.

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potable water

4. Besides potable water, there is softened water, which has had its Calcium and Magnesium removed. Such a water can be used e.g. for first washing steps. Certain processes require special well-defined qualities of water.

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Steam, and Water for Cooling Autoclaves

4.Pure, pyrogen-free steam (called Clean Steam) is needed for sterilization, if the steam comes into contact with parenteral product or equipment that is going to be used for preparing parenteral products. 5. Steam, and Water for Cooling Autoclaves, are also used and must be properly prepared if they have the potential to come into contact with sterile or non-sterile product.

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Water hardness
Water hardness Classification mg/L or ppm as CaCO3

Sf ot

06 -0

Md ra e oe t

6-2 110

Hrd a

1110 2-8

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Raw water storage

May

be required prior to pre-treatment according to local circumstances Check material of construction - Concrete, steel are acceptable but check corrosion - Plastics or plastic linings may leach
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Why purify raw water?

1. 2. 3. 4. 5.

Although reasonably pure, it is always variable Seasonal variations may occur in water Some regions have very poor quality water Must remove impurities to prevent product contamination. Control microbes to avoid contaminating products

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Contaminants of water (1)

There is no pure water in nature, as it can contain up to 90 possible unacceptable contaminants Contaminant groups: 1. Inorganic compounds 2. Organic compounds 3. Solids 4. Gases 5. Micro-organisms

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Contaminants of water (2)

Treatment depends on waters chemistry and contaminants, influenced by: 1. Rainfall 5. Evaporation 2. Erosion 6. Sedimentation 3. Pollution 7. Decomposition 4. Dissolution

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Contaminants of water (3)

Problem minerals 1. Calcium and magnesium 2. Iron and manganese 3. Silicates 4. Carbon dioxide 5. Hydrogen sulfide 6. Phosphates
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Contaminants of water (4)

Further problem minerals 1. Copper 2. Aluminium 3. Heavy metals Arsenic, lead, cadmium 1. Nitrates

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Contaminantsofwater(5)
Micro-organisms Biofilm 1. Algae 2. Protozoa Cryptosporidium Giardia 1. Bacteria Pseudomonas Gram negative, non-fermenting bacteria Escherichia coli and coliforms

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Pre-treatment steps
Primary

filter Coagulation of flocculation Desalination Softening

filtration and multi-media

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Water pre-treatment complex

External raw water storage

Pretreatment room

Pretreatment schematicdrawing

float operated valve

activated excess water recycled from deioniser carbon air filter sand filterfilter
spray ball

To water softener & DI plant

Water is kept circulating

raw water in break tank

centrifugal pump air break to drain S trap to sewer

cartridge filter 5 micrometers

Plumbing
Source water
S Pre-treatment S S Distillation S S
Holding Take 80oc

chlorination 1.Filtration

S S Pump

-Sand filter -Charcoal filter -Cartridge filter

* S: Sampling

2. Primary water treatment -Water solftener -Deionizer -Reverse Osmosis

Water Softener schematic drawing

"soft" water to deioniser

by pass valve brine and salt tank

brine

zeolite water softener -exchanges -Ca and Mg for Na

"hard" water in

drain

Water purification

RO / Deionizer

Cartridge filtration

Water purification

Reverse Osmosis
Remove particles, bacteria, pyrogen, organic, inorganic ions and silica

Water purification
Deionization Remove organic, inorganic ions, silica and carbon dioxide

Water purification
Distillation
Remove particles, bacteria, pyrogen, organic, non-volatile, inorganic ions and silica for WFI

Water purification
Ultrafiltration Kill bacteria and breakdown TOC

Ultrafiltration
CanbeusedforWFIorforWaterForFinal

Rinsingforparenteralmanufacturing(if permitted)
Removesorganiccontaminants,suchas

endotoxins
Operationat80C,andsterilizationat121C

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Purified water

Auto DI RO/Auto DI 2 stages RO

Typical 2-stage RO schematic

Water from softener Water from softener or de-ioniser or de-ioniser

Second stage reject water goes back to first stage buffer tank
Branch

First stage RO cartridge

Branch

1st stage 1st stage buffer tank buffer tank

1st stage reject concentrate

First stage filtrate feeds second stage RO . with excess back to 1st stage buffer tank Air break to sewer

Second stage RO cartridge

2nd stage buffer tank

High pressure pump

Cartridge filter 1 m

Hygienic pump

Second stage RO water meets Pharmacopoeia standards

Water returns to 1st stage buffer tank Outlets or storage

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Water for Injections

International

pharmacopoeia requirements for WFI are those for purified water plus it must be free from pyrogens. Usually prepared by distillation. Storage time should be less than 24 hours. Microbial limits must be specified.

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Pyrogens and endotoxins

Any compound injected into mammals which gives rise to fever is a Pyrogen.

Endotoxinsarepyrogenic,comefromGramnegativebacterialcellwall fragments

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Pyrogens and endotoxins

Detect endotoxinsusingatestfor lipopolysaccharides (LPS)

rabbittestdetectspyrogens LALtestdetectsendotoxins

Ultrafiltration,distillation,&ROmayremove pyrogens

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Water for Injection (WFI)

USP:...distillationorapurificationprocessthatisequivalentofsuperiorto distillation
Conductivity1.3S/cm@25C TotalOrganicCarbon(TOC)500ppb Microbial10cfu/100ml Endotoxinrequirement<0.25EU/ml

EP:...distillation JP:...distillation...orbytheReverseOsmosisUltrafiltrationofPurified Water

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Water for Injection (WFI) Distillation Techniques

SteaminsubsequentEffectMulti-

EffectStill(MES)

UsesPlantSteamtoconvert

feedwatertopuresteam

Separatorsallowimpuritiesto

dropoutofthepuresteam
Puresteamfromfirsteffectusedto

convertfeedwatertopuresteam

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Water for Injection (WFI) Distillation Techniques

VaporCompression(VC)
Usesplantsteamtoconvert initialfeedwatertovapor(pure steam) Puresteamiscompressed, elevatingtemperature Compressedvaporisusedto evaporatenewfeedwater,giving uplatentheatandcondensingas WFI Higherelectricaldemand,but lowersteamdemand

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WFI testing
Microbial

test, < 1 CFU/10 ml WFI test, < 0.25 Eu/ml

Endotoxin Total

organic count, < 500 g/l

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Typical water storage and distribution schematic

Feed Water from DI or RO Hydrophobic air filter & burst disc Cartridge filter 1 m

Spray ball

Water mustbe kept circulatin g

Optional in-line filter 0,2 m UV light Outlets

Heat Exchanger Ozone Generator Hygienic pump Air break to drain

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Suggested bacterial limits

(CFU /mL)

Sampling location Action Raw water 200 Post multimedia filter 100 Post softener 100 Post activated carbon filter50 Feed to RO 20 RO permeate 10 Points of Use 1

Target 300 300 300 300 200 50 10

Alert 500 500 500 500 500 100 100

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Water system inspection

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Inspection plan
Water quality manual - water system drawing - validation - sampling procedures, location and plan - records of testing - sanitation and maintenance - schedules of maintenance

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Review water quality manual

A

water quality manual is advisable. A brief description of water systems is required. Include drawings of the purification, storage distribution system.

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The manual should contain

Chemical

and microbiological specifications Sampling instructions Test procedures Responsible persons Training requirements
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Review validation
Validation for water systems consists of 3 phases: Phase 1: 2-3 weeks Phase 2: 4 weeks Phase 3: 1 year

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Phase 1

Investigational phase (2-4 weeks) - DQ, IQ and OQ - Develop - operational parameters - cleaning and sanitization procedures and frequencies - Sample daily at each point of use -End of phase 1, develop SOPs for the water system

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Phase 2
Verifying

control (4- 5 weeks)

- Demonstrate the system is in control -Sampling as in phase 1

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Phase 3
Verifying

long- term control ( 1 year)

- Demonstrate the system in control over a long period of time -Weekly sampling
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Conducting the inspection

Take

the drawing and walk around the entire system Check: - dead legs - pumps -filter - UV light -pipe and fittings - sample points -DI - RO -storage tank - non return valves -by pass lines- heat exchangers

Conducting the inspection

Check pipes and pumps

hygienic couplings welded pipes hygienic pumps hygienic sampling points acceptable floor no leaks

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Conducting the inspection

Check condition of equipment Staining on water storage tanks

Corrosion on plates of heat exchangers indicates possible contamination

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 Check:

- air filter - integrity testing, sterilization - replacement frequency - burst discs

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