The document discusses various aspects of water treatment systems for pharmaceutical processes, including different types of water used, common water contaminants, functions of equipment in a treatment system like filtration and reverse osmosis, performance calculations for reverse osmosis, and desired water parameters. It provides schematics of sample water treatment systems and discusses topics like pre-treatment solutions, common problems in reverse osmosis systems, and the difference between single-pass and double-pass or single-stage and double-stage reverse osmosis configurations.

1. TABLE OF CONTENT
1. Functions of Equipments
2. Reverse Osmosis: Working
3. Common problems & Solution of an RO system
4. Reverse Osmosis: Performance Calculations
5. Diff. between Single/Double pass & Single/Double stage RO system
6. Desired Water Parameters
7. Block Diagram
8. Pump Calculation
9. A Example for Water System Electrical Loads
10. Vendors of Water System

2. TYPES OF WATER USED IN
PHARMACEUTICAL PROCESSES
1. PURIFIED WATER
2. WATER FOR INJECTIONS (WFI)
3. SOFTENED WATER
4. WATER FOR FINAL RINSE
5. PURE OR CLEAN STEAM
6. WATER FOR COOLING AUTOCLAVES

3. CONTAMINANTS OF WATER
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

4. Functions of Water System Equipment's
S/N EQUIPMENT FUNCTION
1 Chlorination by Naocl dosing: To Maintain residual free chlorine of 2-4 mg/Lit
To avoid Bacterial Growth in feed water
2 Static mixer To Mix dosing Chemicals
3 Two multimedia Filters /Multi Grade Filter (MGF) for removal of non-dissolved ions)
highly efficient removal of suspended fragmented matter from the water.
foreign particles are removed from the water. (Particles size >50micron &
turbidity < 50NTU)
4 Two water softeners hardness reduction (<5ppm of caco3 by using Ion exchange resin).
To replace Scale causing ions like Ca & Mg with Na
5 One filter of activated carbon bed for removal of chlorine , dissolved organic substances from the water and low
molecular weight organic compound.
6 UF(Ultra Filtration) Skid To Produce Ultra filtered water suitable for RO Feed
TO maintain SDI < 3 & to maintain TSS < 1 mg/Lit(ppm)
UF has 0 .01 micron pore size whereas RO has 0.0001 micron pore size.
UF removes Colloidal Silica, Endotoxins, Bacteria, some viruses and suspended
solids
Bacterial contamination of RO Membrane is very difficult to get rid of, UF
minimizes the possibility of the bacterial contamination.
7 Chemical dosing for RO SMBS Dosing: - To protect RO membrane from Chlorine (Soft water will be de-

5. Functions of Water System Equipments
S/N EQUIPMENT FUNCTION
8 one reverse osmosis membrane system For removal of organic and inorganic substances
removes 90% – 99% of particles, colloids, bacteria, pyrogens, dissolved
organic and inorganic
9 Electro De ionization column To reduce Conductivity (<1 Micro s/Cm @ 25)
To reduce bacterial Count
To maintain PH ( 5 to 7)
To reduce TOC ( <500ppb)
removal of dissolved minerals and salts & some dissolved organic matter,
from the water stream crossing ion exchange resins
10 Ozone treatment to kills bacteria and viruses on contact and kills algae, mold and yeast spores
due to it are act is a strong disinfectant.
11 One storage tank (After ozone treated water)
12 Light UV: 254 nm To reduce TOC
purpose of preventing the growth of microorganisms
to reduce the excess ozone added in previous system.
13 Three 0.05 μm filters in parallel removal of particles and bacteria ranging from 0.05 to 0.5 μm contaminants

6. PRETREATMENT – SCHEMATIC
raw water in
« S” trap to sewer
Water is kept
circulating
To water
softener &
DI plant
cartridge
filter
5 micrometers
activated
carbon
filter
spray ball
break tank
air break to drain
centrifugal pump
air filter
float
operated
valve
sand filter
excess water recycled
from deioniser

7. WATER SOFTENER – SCHEMATIC
DRAWING
brine and salt tank
brine
"hard" water
in
zeolite water softener
-exchanges
-Ca and Mg for Na
drain
"soft" water to deioniser
by pass valve

8. Reverse Osmosis: Working
Basic principle
• It is a process where you demineralize or deionize water by pushing it under pressure through a semi-permeable .
• Osmosis : is a process where a weaker saline solution will tend to migrate to a strong saline solution (Examples of osmosis are
when plant roots absorb water from the soil and our kidneys absorb water from our blood)
• A reverse osmosis membrane is a semi-permeable membrane that allows the passage of water molecules but not the majority of
dissolved salts, organics, bacteria and pyrogens. However, we need to 'push' the water through the reverse osmosis membrane
by applying pressure that is greater than the naturally occurring osmotic pressure in order to desalinate (demineralize or
deionize)
• It is important to understand that an RO system employs cross filtration rather than standard filtration where the contaminants
are collected within the filter media.
• Reverse Osmosis is capable of removing up to 99%+ of the dissolved salts (ions), particles, colloids, organics, bacteria and
pyrogens from the feed water
• An RO membrane rejects contaminants based on their size and charge. Any contaminant that has a molecular weight greater
than 200 Likewise, this is why an RO system does not remove gases such as CO2 very well because they are not highly ionized
(charged) while in solution and have a very low molecular weight.
• Because an RO system does not remove gases, the permeate water can have a slightly lower than normal pH level depending on
CO2 levels in the feed water as the CO2 is converted to carbonic acid.

9. 9
Branch
Branch
2nd stage buffer tank
Cartridge
filter 1 µm
Second stage RO cartridge
First stage filtrate feeds second stage RO
with excess back to 1st stage buffer tank.
1ststagerejectconcentrate
Air break
to sewer
Second stage reject water goes back to first stage buffer tank
Second stage RO water
meets Pharmacopoeia
standards Outlets or storage
1st stage buffer tank
Water from softener or de-ioniser
Water returns to 1st stage buffer tank
Hygienic pump
First stage RO cartridge
High pressure
pump
TYPICAL 2 STAGE RO SYSTEM SCHEMATIC
Typical 2-stage RO schematic

10. 10
Water must
be kept
circulating
Spray ball
Cartridge
filter 1 µm
Air break
to drain
Outlets
Hygienic pump
Optional
in-line filter
0,2 µm
UV light
Feed Water
from
DI or RO
Heat Exchanger
Ozone Generator
Hydrophobic air filter
& burst disc
TYPICAL WATER STORAGE AND
DIST. SCHEMATIC

11. Difference between Single/Double pass RO and
Single/Double stage RO system
Single stage RO system Two-stage system
The feed water enters the RO system as one stream and
exits the RO as either concentrate or permeate water
In a the concentrate (or reject) from the first stage then
becomes the feed water to the second stage.
Array:
An array describes the physical arrangement of the
pressure vessels in a 2 stage system. Pressure vessels
contain RO membranes (usually from 1 to 6 RO
membranes are in a pressure vessel). Each stage can
have a certain amount of pressure vessels with RO
membranes. The reject of each stage then becomes the
feed stream for the next successive stage. The 2 stage
RO system displayed on the next slide is a 2:1 array
which means that the concentrate (or reject) of the first
2 RO vessels is fed to the next 1 vessel.
Single pass RO system Two- pass system
The feed water enters the RO system as one stream and
exits the RO as either concentrate or permeate water
The permeate from the first pass becomes the feed water
to the second pass (or second RO) which ends up
producing a much higher quality permeate because it has
essentially gone through two RO systems.
Also it allows the opportunity to remove carbon dioxide
gas from the permeate by injecting caustic between the
first and second pass
This can't be done with a single pass RO because
injecting caustic and forming carbonate (CO3-2) in the
presence of cations such as calcium will cause scaling of
the RO membranes.
C02 is undesirable when you have mixed bed ion
exchange resin beds after the RO. By adding caustic after
the first pass, you increase the pH of the first pass
permeate water and convert C02 to bicarbonate (HCO3-)
and carbonate (CO3-2) for better rejection by the RO
membranes in the second pass.

12. Difference between Single/Double pass RO and
Single/Double stage RO system

13. RO Treatment : Some of common problems an RO system
experiences due to lack of proper pre-treatment.
S/N PROBLEM REASON PREVENTION FUNCTION
1 Fouling • occurs in the front end
of an RO system and
results in a higher
pressure drop across
the RO system and a
lower permeate flow.
Multi Media
Filtration
(MMF)
• used to help prevent fouling
• typically contains three layers of media consisting of
anthracite coal, sand and garnet, with a supporting
layer of gravel at the bottom (anthracite coal will be
on top and the heavier but smaller garnet will remain
on the bottom)
• A multi media filter is suggested when the Silt
Density Index (SDI) value is greater than 3 or
• when the turbidity is greater than 0.2 NTU
• It is important to have a 5 micron cartridge filter
placed directly after the MMF unit in the event that
the under drains of the MMF fail.(This will prevent
the MMF media from damaging downstream pumps
and fouling the RO system.)
2 Scaling • Occurs when certain
dissolved (inorganic)
exceed their solubility
limits and precipitate on
the membrane surface
as scale.
Microfiltration
(MF)
• removing colloidal and bacteria matter and has a
pore size of only 0.1-10µm.
• Microfiltration is helpful in reducing the fouling
potential for an RO unit.
• hollow fiber" type is the most commonly used
• Results a higher pressure drop across the system,
higher salt passage (less salt rejection), low
permeate flow and lower permeate water quality.

14. RO Treatment : Some of common problems an RO system
experiences due to lack of proper pre-treatment.
S/N PROBLEM REASON PREVENTION FUNCTION
3 Chemical
Attack
• Result of chemical attack on an RO
membrane is a higher permeate
flow and a higher salt passage.
• So microorganism growth on RO
membranes tends to foul RO
membranes so easily since there is
no biocide to prevent its growth.
Antiscalent
and Scale
Inhibitors
• to help reduce the scaling potential of the
feed water. Antiscalent and scale
inhibitors increase the solubility limits of
troublesome inorganic compounds..
4 Mechanical
Damage
• These can be addressed by using
variable frequency drive motors to
start high pressure pumps for RO
systems and
• by installing check valve(s) and/or
pressure relief valves to prevent
excessive back pressure on the
RO unit that can cause permanent
membrane damage.
Softening by
ion exchange
• to help prevent scaling in an RO system
by exchanging scale forming ions with
non scale forming ions
• it is important to have a 5 micron
cartridge filter placed directly after the
water softener in the event that the under
drains of the softener fail.

15. RO Treatment : some Pretreatment solutions for RO systems
that can help minimize fouling, scaling and chemical
attack.
Sodium Bisulphate (SBS) injection
• which is a reducer, to the water stream before an RO at the proper dose we can remove residual
chlorine
Granular Activated Carbon (GAC)
• is used for both removing organic constituents and residual disinfectants (such as chlorine and
chloramines)
• Activated carbon removes residual chlorine and chloramines by a chemical reaction that involves a
transfer of electrons from the surface of the GAC to the residual chlorine or chloramines.
• The chlorine or chloramines ends up as a chloride ion that is no longer an oxidizer.
• The disadvantage of using a GAC before the RO unit is that the GAC will remove chlorine quickly at
the very top of the GAC bed so eventually a GAC bed can become a breeding ground for bacteria
growth which can pass easily to the RO membranes

16. Reverse Osmosis: Performance Calculations
Design parameters
• In order to accurately measure the performance of an RO system we need the following operation parameters at a
minimum:
[Feed pressure / Permeate pressure / Concentrate pressure /Feed conductivity / Permeate conductivity / Feed flow /
Permeate flow / temperature]
S/N DESIGN PARAMETER DESCRIPTION
1 Salt Rejection %
• The higher the salt rejection, the better the system is performing. A low
salt rejection can mean that the membranes require cleaning or
replacement
2 Salt Passage %
• The lower the salt passage, the better the system is performing. A high
salt passage can mean that the membranes require cleaning or
replacement.
3 Recovery %
• If the recovery rate is 75% then this means that for every 100 gallons of
feed water that enter the RO system, you are recovering 75 gallons as
usable permeate water and 25 gallons are going to drain as
concentrate. Industrial RO systems typically run anywhere from 50% to
85% recovery depending the feed water characteristics and other
design considerations

17. Reverse Osmosis: Performance Calculations
S/N DESIGN PARAMETER DESCRIPTION
4 Concentration Factor
• if your feed flow is 100 gpm and your
permeate flow is 75 gpm, then the
recovery is (75/100) x 100 = 75%. To find
the concentration factor, the formula
would be 1 ÷ (1-75%) = 4.
A concentration factor of 4 means that
the water going to the concentrate
stream will be 4 times more concentrated
than the feed water is. If the feed water in
this example was 500 ppm, then the
concentrate stream would be 500 x 4 =
2,000 ppm.
• The concept is no different than that of a boiler or cooling tower.
They both have purified water exiting the system (steam) and
end up leaving a concentrated solution behind. As the degree of
concentration increases, the solubility limits may be exceeded
and precipitate on the surface of the equipment as scale.
5 Flux
• To find the flux (Gfd):
 If you had used Dow Filmtec LE-440i RO membranes in the
above example, then the flux would have been 14. So it is
important to factor in what type of membrane is used and to
try and keep the type of membrane consistent throughout the
system
 The flux is 16 Gfd.
This means that 16 gallons of water is passed through each
square foot of each RO membrane per day. This number could
be good or bad depending on the type of feed water chemistry
and system design. Below is a general rule of thumb for flux
ranges for different source waters and can be better
determined with the help of RO design software

18. Reverse Osmosis: Performance Calculations
Mass Balance :
We need to collect the following data from an RO system to perform a Mass Balance calculation:
• Feed Flow (gpm)
• Permeate Flow (gpm)
• Concentrate Flow (gpm)
• Feed Conductivity (µS)
• Permeate Conductivity (µS)
• Concentrate Conductivity (µS)
Example: Then the Mass Balance Equation would be: (7 x 500) = (5 x 10) + (2*1200)
3,500 =2,450
Then find the difference : (Difference / Sum) ∗ 100
((3,500 - 2,450) / (3,500 + 2,450)) * 100
= 18%
A difference of +/- 5% is ok.
A difference of +/- 5% to 10% is generally adequate.
A difference of > +/- 10% is unacceptable and calibration of the RO instrumentation is required
In the example above, the RO mass balance equation falls out of range and requires attention.
Permeate Flow 5 gpm
Feed Conductivity 500 µS
Permeate Conductivity 10 µS
Concentrate Flow 2 gpm
Concentrate Conductivity 1200 µS
(Feed flow1 x Feed Conductivity) = (Permeate Flow x Permeate Conductivity) + (Concentrate Flow*Concentrate Conductivity)

19. Desired Water Parameters
S/n Parameters pH Conductivity TDS Hardness Microbial
Count
Pathogen
1 Drinking Water 6.5-8.5 - 500 ppm 300 ppm - -
2 Domestic Water 6.5-8.5 NMT 500 μS/cm NMT 500 Mg/Litr NMT 300 Mg/Litr NMT 500
Cfu/ml
Absent
3 Chlorinated
water
6.5-8.5 NMT 1000 μS/cm NMT 500 Mg/Litr NMT 300 Mg/Litr NMT 250
Cfu/ml
Absent
4 MGF 6.5-8.5 NMT 500 μS/cm NMT 250 Mg/Litr NMT 150 Mg/Litr NMT 250
Cfu/ml
Absent
5 Softener 6.5-8.5 NMT 250 μS/cm NMT 125 Mg/Litr NMT 150 Mg/Litr NMT 250
Cfu/ml
Absent
6 UF 6.5-8.5 NMT 200 μS/cm NMT 100 Mg/Litr NMT 100 Mg/Litr NMT 100
Cfu/ml
Absent
7 RO I
(Potablewater)
6.5-8.5 NMT 150 μS/cm NMT 75 Mg/Litr NMT 100 Mg/Litr NMT 100
Cfu/ml
Absent
8 Ro II 6.5-8.5 NMT 150 μS/cm NMT 25 Mg/Litr NMT 25 Mg/Litr NMT 100
Cfu/ml
Absent
9 EDI
(Purifiedwater)
5.0-7.0 NMT 1.3 μS/cm NMT 10 Mg/Litr NMT 25 Mg/Litr - Absent
Drinking water specifications
pH 6.5-8.5
Total dissolved solids 500 ppm
Total hardness as CaCO3 300 ppm
Utility water specifications
Suspended matter Nil
Total hardness asCaCO3 NMT 2-5 ppm
pH 8.5-9.5
Total dissolved solids 600 ppm
Total alkalinity as CaCO3 70 ppm
Caustic alkalinity as CaCO3 70 ppm
Potable water specifications (RO water)
pH 6.0-6.5
Total hardness as CaCO3 Nil
Total dissolved solids Less than 10 ppm
Bacterial count NMT100 CFU/ml
Purified water specifications
Conductivity at 25°C 1.3 µS/cm
pH 5.0-7.0
Total Organic carbon NMT 500 ppb
Pathogens Absent
Bacterial endotoxin Less than 0.25 IU/ml

20. Testing - setting specifications for
purified water or WFI

21. Block Diagram
S/n Equipments Critical parameters
1 Water tank  Desired Capacity to be selected
2 Chlorination  Total Bacterial Count 40 cfu/ml
 5 ppm 8 hr contact
3 MGF
 Total Suspended Solids ˂ 25
4 Softner (Cation Exchanger)  Total Hardness as CaCO3 101.5 mg CaCO3/L
5
5 micron filter
6 UF  Removing particulate and macromolecules from source
water
7 De chlorination  SMBS Dosing
8 pH correction  Antiscalent Dosing
9 RO  Desalination
10 EDI  Deionization
11 UV  Preventing the growth of microorganisms
Purified Water

22. Design Calculation
I. Pipe Size Selection (From Program):
1. Peak load : 750 LPH
2. Line Size : 50.8 mm OD SS316L (47.16 mm OD)
3. Minimum return velocity : 2 m/s
4. Minimum return flow rate required : 12671 LPH
5. Maximum feed flow rate @2.5 m/s :15838 LPH
Actual peak Load = Peak load + Minimum return flow rate = 750+ 12671= 13421 LPH
Therefore as per Program calculation Max velocity at actual peak load is 2.09 m/s
II. Pressure Drop (Pump Discharge pressure) Calculation :
1. Pipe size : 50.8mm OD
2. Type of Liquid : Water
3. Liquid temp : Ambient
4. Viscosity : 0.97
5. Max velocity : 2 .09 m/s
6. Pipe Length : 558 m
7. User points : 25
8. No. Of bends : 116
Total Pressure Drop = Drop in pipe line + Drop in bend + Drop in valves
a. Drop in pipe line having surface finish 0.4 Ra inside
= 4F X Total length of pipe X (velocity of fluid)2 / 2 X Gravity X Internal Dia in Mtr
b. Drop in bends = 0.2 mtrs X No. of bends
c. Drop in valves = 0.25 mtrs X No. of Valves (User points)
Pump Discharge Pressure = Total Pressure drop + Min pressure in return line (Appr 15 Mtrs)
= 50.45 + 15 = 65.45 Mtrs = 6.5 Kg/cm2

23. Design Calculation
Data to be Incorporated in program for pressure Drop in piping Calculations:
Data to be Incorporated Output
1. Peak load in m3/hr :
2. Pipe Line Size assumed ID in mm :
3. Pipe Line Size assumed OD in mm :
4. Flow rate in m3/hr :
5. Thickness of the pipe in mm :
6. Total length of the loop :
7. Total no. of user points :
8. Total no. of bends :
 Total Pressure drop in piping
 Pump Discharge pressure considering 1.5m min.
pressure in return line
 Finding Flow rates for Corresponding velocities &
Vice versa.
Water System Scheme for Various Applications
Applications Scheme
For Drinking Water 5 micron filtration.
Water for Cleaning equipment Softener
Water for Pharmaceutical use
(Purified Water)
Chlorination + MGF + Softener + 5 micron filter + UF
+ De chlorination + pH correction + Antiscalent
Dosing + RO + EDI + UV at the beginning of the
distribution loop is the best system

24. A EXAMPLE FOR WATER SYSTEM ELECTRICAL LOADS
S/N Equipment Load in
KW
Remarks
1 Dosing Chlorination system 2.5
2 Hydropnuematic system for raw water dist. 12
3
Feed Water Pump for MGF 2.5
Pretreatment
Common PLC panel -
supply to single panel.
Back flush Pump for MGF 2.5
Feed Water Pump for UF 2.5
Back flush Pump for UF 2.5
Dosing Pumps (03 Nos.) 0.6
Hydro pneumatic system for Domestic water distr. 12
Hydropnuematic system for Soft water distr. 12
Hydro pneumatic system for Potable water distr. 12
Remote IOS Control Panel for Pretreatment Unit 15 Remote IOS Control for
Pretreatment
4
Feed Water Pump for RO 1.5
Purified Water Generation,
Storage and Distribution
RO High Pressure Pump 3.5
Dosing Pumps (03 Nos.) 0.6
High Intensity UV (EDI Outlet & PW Distribution) 1
Heater with Regulator for sanitization tank 12
Purified Water Distribution Pump 22.5
Vent Filter Heater 1
Remote IOS Control Panel fot Ambient PW Generation,
Storage and Distribution
6 Remote IOS Control for PW
Approx. Total KW
120 Dosing Unit + Pretreatment +
Purified water Generation & Dist.

25. SUGGESTED VENDORS OF WATER SYSTEM
S/ N Manufacturer
1 M/s.Christ Nishotech Water System
2 M/s. Hydrocons Systems
3 M/s. Ion Exchange (I) Private Limited
4 Stillmas
M/s. ACE Technologies & Packaging
Systems Pvt Ltd
5 M/s. Praj HiPurity Systems Limited
6 M/s. Nilsan Nishotech Systems Pvt. Ltd.