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To design the equipment / instrument in conjunction with the design data in order to provide basis for
vendor, manufacturer & / or the design engineer for designing the system when the project begins.
To prepare detailed specification for all major components of Equipment / instrument to ensure that the
User Requirement Specification and functional requirement specification are achieved.
OBJECTIVE
SCOPE
All URS and FRS shall be defined by the user department in consultation with the engineering
department, which should be finalized and mutually discussed with the system supplier, vendor & or
manufacturer.
The design qualification is essential part of the qualification mechanism and will serve as a basic
document for the Validation Activity.
ABBREVIATIONS
Abbreviation Description
QA Quality Assurance
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pHC pH Correction
CF Cartridge Filter
RO Reverse Osmosis
EDI Electro-Deionization
TC Tri Clover
PG Pressure Gauge
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SS Stainless Steel
PP Poly-Propylene
ACCEPTANCE CRITERIA
Equipment / Utility system shall confirm to specifications which are as per the user requirements/as per
USP.
The Equipment / Utility / system shall confirm to the predetermined requirements and a certificate is
DESIGN BASIS
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NO OF HRS : 20 hrs
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OBR :76 m3
FOR SOFTENER
(Note. 1. Feed Water is free from pathogens like E- Coli, Pseudonymous, Salmonella)
OVERALL RECOVERY : 90 %
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STAGE WISE TREATED WATER QUALITY AFETR RO: (On basis of maximum feed water limiting
condition)
Sr. Outlet of Multi Outlet of Outlet of RO Outlet of RO
Water Parameter
No. Grade Filter Softener Pass I Pass II
Total Hardness ( in
3. 350 ppm Less than 5 ppm Nil Nil
ppm)
2. TOC in PPB 500 ppb 300 ppb 200 ppb 100 ppb
TVC / TBC
POST TREATMENT:
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Softener Unit
pH Correction System
Note: With the change in the incoming water parameters, the treated water quantity & quality may get
affected at different stages of the plant.
RESPONSIBILTY
The Fully Automated PLC based Purified Water Generation system generate 2 m3/hr. of Purified water as
Per USP Standards.
SCHEME:
SYSTEM DESCRIPTION:
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Raw water before Raw Water Tank is dosed with Sodium Hypochlorite 1 – 2 ppm. Raw water feed pump
will feed raw water from the raw water storage tank to Multi Grade Filter @ 7000 LPH.
Multi Grade Filter is a vertical down flow vessel containing pure graded silex quartz as a filtering media.
The vessel is fabricated in FRP. The water generated at the outlet of Multi Grade Filter will have
suspended solids less than 5 ppm. Multi Grade Filter is provided with Manual Backwash. We have
provided manual ball valves of for change over from normal operation to Backwash operation.
(Note that the inlet suspended solid load should not be more than 50 ppm).
The water from Multi Grade Filter is passed through Softener. Hardness after softener is less than 5
ppm. Soft Water after Softener unit is fed to Purified Water Generation System.
Sodium Metabisulphite (Na2S2O5) is then dosed in the chlorinated water to neutralize the free chlorine
Antiscalent Dosing System is then dosed in the soft water to avoid scale formation on the RO
Membranes.
pH Correction Dosing System is provided to adjust the feed pH of RO feed water as 6.5 – 8.5. The
treated water is then passed through 5 micron Cartridge Filter to trap the suspended solids. This will
avoid chocking of RO membranes due to suspended solids.
ORP Analyzer is provided so as to check the absence/presence of chlorine in the feed water to the RO
System. If free chlorine is sensed in the feed water it will give an indication on the panel & open the
dumping valve and dump the high ORP water for 300 secs. & Even if the ORP value is not below
the set point it will trip the system.
This soft water is then fed to the Reverse Osmosis First pass System by means of a High Pressure
Vertical multistage Pump with SS 304 wettable parts of M/s. Grundfos, Denmark. The First pass Reverse
Osmosis System will generate 2700 liters/hr water with an overall recovery of 70 %. The generated water
will have total dissolved solids less than 150 ppm. The semi-permeable reverse osmosis membrane has
molecular weight cut off less than 150 MWCO. The Reveres Osmosis membrane acts as positive barrier
to remove dissolved solids, organic compounds & bacteria.
The Reverse Osmosis System consists of thin film composite type Reverse Osmosis membrane of DOW.
The material of construction of the RO membrane is Polyamide. The RO membrane is housed in the High
Pressure SS 316L Wettable Parts Housing having TC end connection.
The outlet water of RO pass one is feed to RO pass two system. The Second pass Reverse Osmosis
System will generate 2200 liters/hr of water with an overall recovery of 80%. The generated water will
have total dissolved solids less than 15-20 ppm.
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The Reverse Osmosis System consists of thin film composite type Reverse Osmosis membrane of DOW.
The material of construction of the RO membrane is Polyamide. The RO membrane is housed in the High
Pressure SS 316L Wettable Parts Housing having TC end connection.
The Permeate water from RO system will be fed to the Electro Deionization Unit (EDI) having designed
capacity of 2000 LPH. The EDI system has a recovery of 90%.
The water generated from the outlet of EDI will be as per USP Standards for Purified Water.
The system design is based on the feed water analysis provided by the customer as per Annexure A..
STAGE WISE TREATED WATER PARAMETER: (On basis of maximum feed water limiting condition)
Total Hardness ( in
3. 350 ppm Less than 5 ppm Nil Nil
ppm)
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2. TOC in PPB 500 ppb 300 ppb 200 ppb 100 ppb
TVC / TBC
Microbial Count
Note: With the change in the incoming water parameters, the treated water quantity & quality may
get affected at different stages of the plant.
FACILITY OPERATION:
ANNEXURE – A
Sr.
Water Parameters Actual Parameters Design Consideration
No.
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(Note. 1. Feed Water is free from pathogens like E- Coli, Pseudonymous, Salmonella)
TECHNICAL SPECIFICATIONS
FUNCTION: For Bacterial Disinfection in raw water. These will inhibit the bacterial growth. Sodium Hypo
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TECHNICAL SPECIFICATION:
Quantity : One
Model : UC 11
DOSING CALCULATION:
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Conc. of Solution : 1 %
TECHNICAL SPECIFICATION:
Head:35 mWC
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Make : Nanfang
EQUIPMENT LOCATION: After Sodium Hypo-chlorite Dosing System, Piping and Raw Water Tank.
FUNCTION: It filters the suspended solids in the Raw water up to 5 ppm with the help of Multi Grade
Filter in the vessel, the inlet suspended solids should be less than 50 ppm.
TECHNICAL SPECIFICATION:
Quantity : One
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Diameter : 600 mm
Height : 1800 mm
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Operation:
1.Normal Operation
3.Rinse Operation
1. Normal Operation:
Since MGF is a Vertical Down Flow Vessel the Suspended Solids are removed by passing through
Filtering Media which is been 60% filled. For normal operation position of Ball valves which are mounted
on MGF should be (In Open Position: BV-05 & BV-06)
Back Wash is used to remove the Suspended Matter which is entrapped in the filter Media Top Layer
during Normal Operation. Back Wash is done after 20 hr OR if the differential pressure across the filter is
For changing from normal operation to backwash operation, the position of the Ball Valves should be (In
Open Position: BV-07 & BV-08)
3. Rinse Operation:
Rinse Operation is done after Back Wash. Rinse is done to remove the Suspended Solid which is
entrapped in the Filter Media during Backwash Operation.
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For changing from Back Wash operation to Rinse operation, the position of the Ball Valves should be (In
Open Position: BV-05 & BV-09)
(In Close Position: BV-06, BV-07 & BV-08)
SOFTENER:
FUNCTION: It will replace the hardness causing Ca & Mg ions with Na ions. This will soften the raw water
and will avoid scale formation. Treated Water at the outlet of softener-II will have hardness less than 5
ppm. Flow totalizer will be provided at the outlet of softener unit to indicate the amount of soft water
generated and give indication after pre define quantity of soft water is generated.
TECHNICAL SPECIFICATION:
Quantity :One
Diameter : 600 mm
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Operation:
Normal Operation
Regeneration Operation
1. Normal Operation:
Since Softener is a Vertical UP Flow Vessel the Hardness causing Ions are removed by passing through
Resin Media (Cation and Anion) which is been 92% filled of the Total Volume. For normal operation the
position of the Ball valves should be:
(In Open position: BV-10, BV-11) & (In Close position: BV-12/13/14/15)
After 12 hrs of operation of the softening plant OR after 72 m3 of OBR the softener should go under
regeneration mode or the hardness does not get maintain within its limit.. Privacy & Cookies Policy
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2.Regeneration Operation:
Regeneration is used to recharge the Resin to regain its absorbing properties of hardness. Regeneration
is done if the Hardness at the Outlet of Softener Unit is above 5 ppm OR after 72 m3 OBR / 12 hrs of
Operation of plant whichever is earlier. Flow Totalizer will be provided at the outlet of each softener unit to
indicate the amount of soft water generated and give indication of Regeneration after pre define quantity
of soft water generation.
For changing from normal operation to regeneration mode, the valve position should be
Slow Rinse is used to get properly mix up with Salts & Resins. (In Open position: BV-12/14) & (In Close
position: BV-10/11/13/15)
4. Fast Rinse Operation: Fast Rinse is used to remove excess Salts from the resins.
FUNCTION: 1 ppm of chlorine needs 2 ppm SMBS dosing. We have considered 2 ppm of chlorine so we
have assumed 4 ppm of SMBS dosing. 6 ppm SMBS is dosed in soft water to neutralize the free chlorine
in soft water. (Note: ORP analyzer is provide with dumping valve to check & dump the high chlorinated
water)
TECHNICAL SPECIFICATION:
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Quantity : One
Model : UC 11
DOSING CALCULATION:
Conc. of Solution : 1 %
TECHNICAL SPECIFICATION:
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Quantity:One
Model :UC 11
DOSING CALCULATION:
Conc. of Solution : 2 %
FUNCTION: To boost up the pH of RO feed water so as to convert the dissolved CO2 into alkalinity and
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TECHNICAL SPECIFICATION:
Quantity : One
Mode : UC 11
TAG NO: CF – 01
FUNCTION: It filter all the suspended solids in water greater than 5 – micron thus avoid chocking in RO
membrane.
TECHNICAL SPECIFICATION:
Rating : 5 micron
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TECHNICAL SPECIFICATION:
Quantity : One
Pressure : 12 kg / cm2
Make : Grundfos
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FUNCTION: RO membranes reduce the TDS & microbial load in the water. The semi-permeable reverse
osmosis membrane has molecular weight cut off less than 150 MWCO. The Reveres Osmosis membrane
acts as positive barrier to remove dissolved solids, organic compounds & bacteria. Membranes consist of
thin film composite type. It will bring down the conductivity less than 200 μs/cm.
TECHNICAL SPECIFICATION:
Model : HSRO-390FF
Recovery : 70 %
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TECHNICAL SPECIFICATION:
Diameter : 204 mm
Length : 4060 mm
Thickness : 2.5 mm
TECHNICAL SPECIFICATION:
Quantity : One
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Pressure : 9 kg/cm2
Make : Grundfos
FUNCTION: RO membranes reduce the TDS & microbial load in the water. The semi-permeable reverse
osmosis membrane has molecular weight cut off less than 150 MWCO. The Reveres Osmosis membrane
acts as positive barrier to remove dissolved solids, organic compounds & bacteria. Membranes consist of
thin film composite type. This will bring down the conductivity less than 25 μs/cm.
TECHNICAL SPECIFICATION:
Model : HSRO-390FF
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Recovery : 80-85 %
TECHNICAL SPECIFICATION:
Diameter : 204 mm
Length : 2040 mm
Thickness : 2.5 mm
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FUNCTION: EDI bring down the conductivity of RO treated water. The water generated from the outlet of
EDI will be as per USP
TECHNICAL SPECIFICATION:
End Connection : 1” TC
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Cathode : SS 316
CIP TANK
TECHNICAL SPECIFICATION:
Quantity :One
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TECHNICAL SPECIFICATION:
Quantity : One
Make : Grundfos
PRESSURE GUAGES:
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3) Outlet of Softener
TECHNICAL SPECIFICATION:
Make:Waaree
PRESSURE GUAGES:
TAG NO: PG – 04 / 05 / 10
LOCATION:
TECHNICAL SPECIFICATION:
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Make : Waaree
Range : 0 – 7 kg/cm2
Accuracy :± 1.6 % of FS
PRESSURE GUAGES:
TAG NO: PG – 06 / 07 / 08 / 09
TECHNICAL SPECIFICATION:
Make : Waaree
Range : 0 – 21 kg/cm2
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Accuracy : ± 1.6 % of FS
PRESSURE GUAGES:
TECHNICAL SPECIFICATION:
Make :Waaree
Range : 0 – 7 kg/cm2
Accuracy : ± 1.6 % of FS
ROTAMETER:
LOCATION:
3) RO First Pass reject line (200 – 2000 LPH) Privacy & Cookies Policy
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TECHNICAL SPECIFICATION:
Model : SK
TECHNICAL SPECIFICATION:
Model : FT-650
Line Size : 38 mm
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FUNCTION: To check the Level in the tank. If the level in the tank is below the desired level the system
will give indication on the panel & will trip the system.
TECHNICAL SPECIFICATION:
Quantit : One
MOC : PVC
LOCATION:
5) pH correction system
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FUNCTION: To check the Level in the dosing tank. If the level in the tank is below the desired level the
system will give hooter & after settable time will trip the system.
TECHNICAL SPECIFICATION:
Quantity : 05 Nos.
Type : Magnetic
MOC : PP
FLOW SWITCHES:
TECHNICAL SPECIFICATION:
Quantity : One
MOC : SS 316
Size : 1.5”
FUNCTION: ORP Analyzer is provided so as to check the absence/presence of chlorine in the feed
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water to the RO System. If free chlorine is sensed in the feed water it will give an indication on the
panel & open the dumping valve and dump the high chlorinated water for 300 secs. & even if the
ORP value is not below the set point it will trip the system.
TECHNICAL SPECIFICATION:
Quantity :One
FUNCTION: To check the conductivity in the water, if the conductivity in the feed water is sensed high
above a settable value then it will give an indication on the panel & open the dumping valve and dump the
high conductivity water.
TECHNICAL SPECIFICATION:
Quantity : Two
Make : Emerson
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FUNCTION: To check the conductivity in the water, if the conductivity in the feed water is sensed high
above a settable value then it will give an indication on the panel & open the dumping valve and dump the
TECHNICAL SPECIFICATION:
Make :Emerson
LOCATION:
FUNCTION: To check the feed pressure to the RO system, if the line pressure in the feed water is sensed
high above a settable value then it will trip the entire RO-EDI system.
TECHNICAL SPECIFICATION:
Make : Danfoss
Range :1 to 16 bar
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LOCATION:
FUNCTION: To check the pressure in the water, if the line pressure in the feed water is sensed low below
the settable value then it will trip the entire RO-EDI system.
TECHNICAL SPECIFICATION:
Make : Danfoss
Range : 0 to 3 bar
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FUNCTION: To check the Level in the CIP tank. If the level in the tank is below the desired level the
system will give indication on the panel & will trip the system.
TECHNICAL SPECIFICATION:
Quantity :One
Make : Mahalaxmi
MOC : SS 316
TECHNICAL SPECIFICATION:
Make : Wika
Range : 0 to 2000 C
CONTROL VALVES
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LOCATION :
FUNCTION: To monitor the plant operation in Auto/Semi-Auto mode as per the pre-set logic & time.
TECHNICAL SPECIFICATION:
Make : Avcon
TECHNICAL SPECIFICATION:
MOC : SS 316L
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Size : 1”
SAMPLING VALVE:
TECHNICAL SPECIFICATION:
Size : 8 NB
M.O.C.: SS 316L
VALVE SCHEDULE
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valve
13 MGF back wash inlet BV-07 d40DN32 Manual Ball Valve UPVC
14 MGF back wash outlet BV-08 d40DN32 Manual Ball Valve UPVC
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PLC PANEL:
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FUNCTION: To operate all Pumps, drives, control valves and instrumentation. To operate predefined
operational logic of the plant. To operate the plant with predefine interlock logic for safety and trouble free
operation. To collect predefine process parameter for equipment validation.
TECHNICAL SPECIFICATION:
Make : Mitsubishi
Make :Mitsubishi
MMI ( Monochrome)
Make : Mitsubishi
Size : 3.5”
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6 X5 FS-01 Y5 RWP-02
HL – Raw Water
7 X6 Y6 ROHP-01
Tank
ML – Raw Water
8 X7 Y7 ROHP-02
Tank
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PWST Ceramic
31 X36
Heater
34 X41 EMERGENCY
35 X42 ACCEPT
37 X44 Spare
38 X45 Spare
39 X46 Spare
40 X47 Spare
6 AI-6 PWD – FT 01
7 AI-7 PWD – TT 01
System Description & Process Logics for Purified water Generation System
Audio
Sr. Indication on
Interlock Description Action Taken Visual
No. MMI
Alarm
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6 Low flow in Raw Water Will trip NaOCl-01 Dosing Pump & YES YES
Low level in ADS Dosing RWP-01 will stop & RO-EDI System
10 YES YES
tank will stop.
12 High ORP-01 Value. 1) Free chlorine will pass through YES YES
YES YES
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13
Low Pressure at ROHP
This will trip the ROHP – 01 YES YES
– 01 suction
YES
YES
NA
2) After 30 secs. of consistent
reading, below the set value, it will YES
close the AV-04. Allow the water to
High Conductivity at RO
16
pass – I outlet feed to the 2nd Pass of RO system.
The entire system will start
automatically.
YES
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YES
YES
AV-06.
YES
YES
YES
Low pressure at EDI inlet, will trip EDI
20 Low pressure at EDI inlet YES
unit.
21 High Conductivity at EDI 1) If the conductivity is above the set YES YES
outlet point, it will open the dumping valve
FDV-01.
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YES YES
DRAWINGS REQUIRED
SR.
DESCRIPTION DRAWING NO. REV
NO.
SUPPORTING UTILITIES
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2
Control Panel RO Plant Room Power 3 phase, 430V, 50 Hz
DOCUMENTATION CHECK
INTERLOCK CHECKS
OPERATIONAL CHECKS
B MOC Certificate
D Sanitization Reports
F Manufacturer’s Catalogue
G Test Certificate
I Basis of Design
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Approved By Signature
Engineering
Client
Head-Operations
(Zydus Cadila Healthcare Ltd.)
Head-Quality
Pharma Editor
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