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DQ for Purified Water System

BY PHARMACEUTICAL GUIDANACE ON JULY 2, 2016
OTHER, QUALIFICATION, VALIDATION & QUALIFICATION
NAME OF THE SYSTEM :PRETREATMENT & PURIFIED WATER GENERATION SYSTEM

TABLE OF CONTENTS
SR. NO.
STAGE
OBJECTIVE & SCOPE
ACCEPTANCE CRITERIA
RESPONSIBILITY
SYSTEM DESCRIPTION (SYSTEM AND SUB-SYSTEM)
BASIS OF DESIGN AND ASSUMPTION
TECHNICAL SPECIFICATIONS
DRAWINGS REQUIRED
SUPPORTING UTILITIES
PRE-QUALIFICATION CHECKLIST
10
LIST OF DOCUMENTS REQUIRED
11
DESIGN QUALIFICATION REPORT APPROVAL
12
ABBREVIATIONS
PAGE NO.
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1. OBJECTIVE AND SCOPE

OBJECTIVE
1. To prepare detailed specification for all major components of Equipment / instrument to ensure
that the User Requirement Specification and functional requirement specification are achieved.
2. 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.
SCOPE
Application to any equipment, system, facility, process & software programs.
1. When subjected for new installation
2. When the existing system is replaced with the new system.
3. When the existing system is subjected for up-gradation or modification.
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.
2. ACCEPTANCE CRITERIA
2. A) PURIFIED WATER GENERATION SYSTEM
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A.1 Equipment / Utility system shall confirm to specifications which are as per the user requirements/as
per USP 39.
A.2 The Equipment / Utility / system shall confirm to the predetermined requirements and a certificate is
issued by the projects / Engineering Department.
DESIGN BASIS
RAW WATER ANALYSIS
Sr.
Water Parameters
No.
Actual
Design Consideration
Parameters
Colour
< 5 CTU
< 5 CTU
pH
7.5
6.5 8.5
Conductivity (us/cm)
900
1200
Turbidity
1.8
Less than 5
SDI
Not check
< 3 assumed
Total Dissolved Solids
750 ppm
900 ppm
Total Alkalinity
120 ppm
120 ppm
Total Hardness
300 ppm
350 ppm
Calcium as CaCO3
100 ppm
125 ppm
10
Magnesium as CaCO3
200 ppm
225 ppm
11
Sodium as Na
36.11 ppm
50 ppm
12
Potassium as K
0.975ppm
5 ppm
13
Sulphate as SO4
43.68 ppm
50 ppm
14
Nitrates as NO3
2.3 ppm
10 ppm
15
Chlorides as Cl
92.3 ppm
100 ppm
16
Flouride
0.7 ppm
1 ppm
17
Colloidal Silica
5.6 ppm
10 ppm
18
Reactive Silica
5.6 ppm
10 ppm
19
TOC
1000 ppb
1000 ppb
20
Total Plate Count
79 CFU/ml
1000 CFU/ml
Pharmaceutical Guidance
Seguir
(Note. 1. Feed Water is free from pathogens like E- Coli, Pseudonymous, Salmonella)
2. B) PRETREATMENT & PURIFIED WATER GENERATION SYSTEM
FOR PRESSURE QUARTZ FILTER
END USE : SOFTENER
QUANTITY OF WATER : 7 m3/hr
TYPE OF OPERATION : MANUAL OPERATION
FOR SOFTENER
END USE : PURIFIED WATER GENERATION SYSTEM
QUANTITY : 3.8 m3/hr
OBR : 76 m3
NO OF HRS : 20 hrs
TYPE OF OPERATION : MANUAL OPERATION
FIRST PASS RO SYSTEM (Hot Water Sanitizable)
FEED FLOWRATE : 3800 LPH
REJECT FLOWRATE : 1100 LPH
PERMEATE FLOWRATE : 2700 LPH
OVER ALL RECOVERY : 70 %
TYPE OF OPERATION : FULLY AUTO & MANUAL OPERATION
SECOND PASS RO SYSTEM (Hot Water Sanitizable)
REJECT RECYCLE FLOWRATE : 500 LPH
92 seguidores

OVER ALL RECOVERY : 80 %
FOR EDI SYSTEM
REJECT FLOWRATE : 200 LPH
OVERALL RECOVERY : 90 %
TREATED WATER QUALITY
STAGE WISE TREATED WATER QUALITY AFETR RO:
(On basis of maximum feed water limiting condition)
Sr.
Water
Outlet of
Outlet of
Outlet of RO
Outlet of
No.
Parameter
Multi Grade
Softener
Pass I
RO Pass II
Filter
1.
2.
Ph
6 to 8.5
6 to 8.5
56
56
TSS
< 5 ppm
< 5 ppm
Nil
Nil
TDS /
1920 us/cm
1920 us/cm
200 us/cm
25 us/cm
350 ppm
Less than 5
Nil
Nil
Conductivity
3.
Total Hardness
( in ppm)
ppm
4.
SDI
<3
3.0 max
Nil
Nil
5.
TOC
1000 ppb
1000 ppb
500 ppb
200 ppb
6.
TVC
1000 CFU/ml
1000 CFU/ml
100 CFU/ml
50 CFU/ml
TREATED WATER QUALITY AFTER UF : ( as per Design Limits)
(PURIFIED WATER AS PER USP 39 std.)

Sr.
Water Parameters
USP 39
Action
Alert Limit
Limit
No.
Design
Limit
1.
Conductivity
1.25 s/cm
1.0 s/cm
0.8 s/cm
0.7 s/cm
2.
TOC in PPB
500 ppb
300 ppb
200 ppb
100 ppb
3.
TVC / TBC
100 CFU/ml
90 CFU/ml
70 CFU/ml
40 CFU/ml
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.
3. RESPONSIBILTY
User Dept
: For providing user requirement (Technical and cGMP)
Head-Operations
: To review the specification from installation andMaintenance aspects.
Head-Quality
: To review the specification from GMP Aspects
Vendor
: To review and agree upon the requirements.
4. SYSTEM DESCRIPTION (SYSTEM AND SUB-SYSTEM)

The Fully Automated PLC based Purified Water Generation system generate 2 m3/hr. of Purified water as
Per USP 39 Standards.
SCHEME:
PRETREATMENT & PURIFIED WATER GENERATION SYSTEM:
PRE TREATMENT: (3800 LPH)
Pre Sodium Hypo Chlorite Dosing System
Raw Water Pumps
Multi Grade Filter
Softener Unit
FIRST PASS REVERSE OSMOSIS (HOT WATER SANITIZABLE) SYSTEM:
SMBS Dosing System
Antiscalent Dosing System
pH Correction System
5 Micron Cartridge Filter
ORP Analyzer and pH sensor along with auto Dumping Valve
RO High Pressure Pump
Reverse Osmosis Membranes along with High Pressure Housing
Conductivity Meter with Alarm
SECOND PASS REVERSE OSMOSIS (HOT WATER SANITIZABLE) SYSTEM:
Reverse Osmosis Membranes along with High Pressure Housing
Conductivity meter with Alarm
POST TREATMENT:
Hot Water Sanitizable Electro Deionization Unit
Conductivity meter with Alarm
SYSTEM DESCRIPTION:
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
(excess chlorine) present in the filtered water.
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.
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 39Standards for Purified Water.
5. BASIS OF DESIGN AND ASSUMPTION

FEED WATER SAMPLE:
The system design is based on the feed water analysis provided by the customer as per Annexure -A.
PRODUCT WATER QUALITY:
STAGE WISE TREATED WATER PARAMETER:
(On basis of maximum feed water limiting condition)
Sr.
Water
Outlet of
Outlet of
Outlet of RO
Outlet of
No.
Parameter
Multi Grade
Softener
Pass I
RO Pass II
Filter
1.
2.
Ph
6 to 8.5
6 to 8.5
56
56
TSS
< 5 ppm
< 5 ppm
Nil
Nil
TDS /
1920 us/cm
1920 us/cm
200 us/cm
25 us/cm
350 ppm
Less than 5
Nil
Nil
Conductivity
3.
Total Hardness
( in ppm)
ppm
4.
SDI
<3
3.0 max
Nil
Nil
5.
TOC
1000 ppb
1000 ppb
500 ppb
200 ppb
6.
TVC
1000 CFU/ml
1000 CFU/ml
100 CFU/ml
50 CFU/ml
TREATED WATER QUALITY AFTER UF: (as per Design Limits)(PURIFIED WATER AS PER USP 39 std.)
Sr.
Water Parameters
USP 34
Action
Alert Limit
Limit
No.
Design
Limit
1.
Conductivity
1.25 s/cm
1.0 s/cm
0.8 s/cm
0.7 s/cm
2.
TOC in PPB
500 ppb
300 ppb
200 ppb
100 ppb
3.
TVC / TBC
100 CFU/ml
90 CFU/ml
70 CFU/ml
40 CFU/ml
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.
5.3 FACILITY OPERATION:
The plant operation will be for 20 hrs/day,6 days/week,48 weeks/year
ANNEXURE A
Sr.
Water Parameters
No.
Actual
Design Consideration
Parameters
Colour
< 5 CTU
< 5 CTU
pH
7.5
6.5 8.5
SDI
900
1200
1.8
Less than 5
Total Alkalinity
Not check
< 3 assumed
Total Suspended Solids
750 ppm
900 ppm
Total Hardness
120 ppm
120 ppm
Calcium as CaCO3
300 ppm
350 ppm
Magnesium as CaCO3
100 ppm
125 ppm
10
Sulphate as SO4
200 ppm
225 ppm
11
Nitrates as NO3
36.11 ppm
50 ppm
12
Chlorides as Cl
0.975ppm
5 ppm
13
Silica as SiO2
43.68 ppm
50 ppm
14
Colloidal Silica
2.3 ppm
10 ppm
15
Reactive Silica
92.3 ppm
100 ppm
16
Total Chloride as CaCO3
0.7 ppm
1 ppm
17
Sulphate as CaCO3
5.6 ppm
10 ppm
18
TOC
5.6 ppm
10 ppm
19
TVC
1000 ppb
1000 ppb
(Note. 1. Feed Water is free from pathogens like E- Coli, Pseudonymous, Salmonella)
6. TECHNICAL SPECIFICATIONS
6.A MAJOR EQUIPMENTS OF PRETREATMENT & PURIFIED WATER GENERATION SYSTEM:
6.A.1 PRE SODIUM HYPOCHLORITE DOSING SYSTEM
TAG NO: NaOCl (DT-01 / DP-01)
EQUIPMENT NAME: Pre Sodium Hypo Chlorite Dosing system
EQUIPMENT LOCATION: After Bore Well Pump
FUNCTION: For Bacterial Disinfection in raw water. These will inhibit the bacterial growth.
Sodium Hypo chlorite dosed up to 2 ppm for disinfection.
TECHNICAL SPECIFICATION:
Quantity : One
Type : Positive Displacement Pump
Pump Capacity : 0.4 to 4 LPH
Max. Working Pressure : 5.5 kg/cm2
MOC of Dosing Tank : HDPE
Dosing Tank : 50 Liters Provided
Low Level Switch : Provided
Make : Milton Roy
Model : UC 11
DOSING CALCULATION:
Dosage required : 2 ppm
Feed Flow rate : 7 m3/hr
Conc. of Solution : 1 %
Dosing Pump flow rate : 1.4 LPH
Amount of dosing solution = 1.4 x 24 = 33.6 Ltrs.
6.A.2 RAW WATER PUMPS (1W + 1SB):
TAG NO: RWP-01 / 02
EQUIPMENT NAME: Raw Water Pumps
EQUIPMENT LOCATION: After Raw Water Storage Tank
FUNCTION: For pumping of Raw water to Pretreatment @ 7 m3/hr.
Quantity : Two (1W + 1SB)
Type : Horizontal Multistage pump
Flow rate : 7 m3/hr (7000 liter/hr)
Head : 35 mWC
Material of Construction : SS 304
Make : Nanfang
6.A.3 MULTI GRADE FILTER:
TAG NO: MGF-01
EQUIPMENT NAME: Multi Grade Filter
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.
Quantity : One
Flow rate : 7 m3/hr
Max. Pressure Drop : 0.5 kg/cm2
Diameter : 600 mm
Height : 1800 mm
Specific Velocity of Filtration : 25 m/hr.
Back Wash Time Required : 10-15 min.
Filter media : Pure Graded Silex Quartz of 1.5 to
2 mm Particle size.
Valve Type : Ball valve
MOC of Pressure Vessel : Fiber Reinforced Plastic (FRP)
Make of Pressure Vessel : M/s. Wave Cyber, USA / Pentair
Frontal Pipe Size : 38.1 mm
Pressure gauge : 100 mm Dial ( Inlet /Outlet )
MOC Piping : UPVC
Make of Piping : FIP
MOC of Valves : UPVC
Make of Valves : FIP
Inlet, Outlet, Drain Connection : 1.5 BSPF union ends
Operation:
1. Normal Operation
2. Back Wash 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)
(In Close Position: BV-07, BV-08 & BV-09)
2. Back Wash Operation:
WHEN & WHY BACKWASH
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 more than 0.5 kg/cm2.
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:
WHEN & WHY BACKWASH
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.
For changing from Back Wash operation to Rinse operation, the position of the Ball
Valves should be (In Open Position: BV-05 & BV-09)
6.A.4 SOFTENER:
TAG NO: SF-01
EQUIPMENT NAME: Softener Unit-01
EQUIPMENT LOCATION: After Multi Grade Filter
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.
Quantity : One
Type : Vertical Up Flow
Flow rate : 3.8 m3/hr
Max. Working Pressure : 4 kg/cm2
Max. Pressure Drop : 0.5 kg/cm2
Diameter : 600 mm
Height on straight : 1800 mm
Regeneration Time Required : 20-30 min.
Fast Rinse : 5-10 Minutes
Resin Quantity : 450 ltrs.
Make of Resin : M/s. Lenxess
Model of Resin : C 249
Regenerator (NaCl) : 72 Kgs.
Reg. Tank Capacity : 300 lts.
MOC of Reg .tank : HDPE
MOC of Softener : Fiber Reinforced Plastic (FRP)
Make of Vessel : M/s. Wave Cyber, USA / Pentair
Frontal Pipe Size : 38.1 mm
Valve : Ball valve
Pressure gauge : 100 mm Dial ( Inlet /Outlet )
Frontal Piping : UPVC
Make of Piping : FIP
Make of Valves : FIP
Operation:
1. Normal Operation
2. Regeneration Operation
3. Slow Rinse Operation
4. Fast Rinse 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..
2. Regeneration Operation:
WHEN & WHY REGENERATION
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
(In Open position: BV-12/13/14) & (In Close position: BV-10/11/15)
Allow the softener to backwash completely.
Allow the brine solution to get completely charged in the softener.
3. Slow Rinse Operation:
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.
(In Open position: BV-10/15) & (In Close position: BV-11/12/13/14)
6.A.5 SODIUM META BISULPHITE DOSING SYSTEM:

TAG NO: SMBS (DT-02 / DP-02)
EQUIPMENT NAME: Sodium Meta Bisulphate Dosing system
EQUIPMENT LOCATION: After Softener Unit
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)
Quantity : One
MOC of Dosing Tank : SS 304
Make : Milton Roy
Model : UC 11
DOSING CALCULATION:
Feed Flow rate : 3.8 m3/hr
Dosing Pump flow rate: 1.52 LPH
If we consider 3 shifts of 8 hrs. = 8 x 3 = 24 hrs.
6.A.6 ANTISCALENT DOSING SYSTEM:
TAG NO: ADS (DT-03 / DP-03)
EQUIPMENT NAME: Anti Scalent Dosing System
EQUIPMENT LOCATION: After SMBS Dosing System
FUNCTION: ADS (5 ppm) is dosed in soft water to avoid scaling in RO membrane.
Quantity : One
Make : Milton Roy
Model : UC 11
DOSING CALCULATION:
Feed Flow rate : 3.8 m3/hr
Dosing Pump flow rate: 0.95 LPH
If we consider 3 shifts of 8 hrs. = 8 x 3 = 24 hrs.
6.A.7 pH CORRECTION DOSING SYSTEM:
TAG NO: pHC (DT-04 / DP-04)
EQUIPMENT NAME: pH Correction Dosing System
EQUIPMENT LOCATION: After Anti-scalent dosing system

FUNCTION: To boost up the pH of RO feed water so as to convert the dissolved CO2 into
alkalinity and which can be rejected in RO Pass I.
Quantity : One
Make : Milton Roy
Model : UC 11
pH Correction Chemical : NaOH or Na2CO3
6.A.8 5-MICRON CARTRIDGE FILTER:
TAG NO: CF 01
EQUIPMENT NAME: 5 Micron Cartridge Filter
EQUIPMENT LOCATION: After SMBS / ADS / pHC Dosing Systems
FUNCTION: It filter all the suspended solids in water greater than 5 micron thus avoid
chocking in RO membrane.
No. of Unit : One
Type of Cartridge : Spun Bounded Type
Rating : 5 micron
Flow rate : 3800 LPH
No. of Cartridge : 2 nos. 20 long
MOC of Cartridge Housing : SS 304
MOC of Cartridge : PP ( Polypropylene)
Make of Cartridge : Kumar/Pratham
Make of Housing : HydroPure Systems
Surface Finish of Housing : Internally < 0.4 Ra
Externally mirror up to 180 grit
Type of Filter : Double open end filter
6.A.9 REVERSE OSMOSIS HIGH PRESSURE PUMP-I:

TAG NO: ROHP I
EQUIPMENT NAME: Reverse Osmosis High Pressure Pump- I
EQUIPMENT LOCATION: After 5-micron Cartridge Filter
FUNCTION: For pumping of water to RO pass-I system. @ 3.8 m3/hr
Quantity : One
Type : Vertical Multistage Pump
Flow rate : 3.8 m3/hr (3800 liter/hr)
Pressure : 12 kg / cm2
Material of Construction : SS 304 Wettable parts
Voltage Requirement : 415 Volts
Make : Grundfos
6.A.10 REVERSE OSMOSIS MEMBRANES:
EQUIPMENT NAME: Reverse Osmosis Membranes
EQUIPMENT LOCATION: Within the RO System
FUNCTION: RO membranes reduce the TDS & microbial load in the water. The semipermeable 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 s/cm.
No. of Membrane : 4 Nos.
Size of Membrane : 8 Dia. & 40 Long
Type of Membrane : Thin Film Composite
Type of Sanitization : Hot Water Sanitizable
Material of Construction : Polyamide
Make of Membrane : DOW.
Model : HSRO-390FF
Operating Temperature : 450 C
Recovery : 70 %
Feed Water Flow Rate : 3800 m3/hr
Permeate Flow Rate : 2700 m3/hr
Reject Water Flow Rate : 1100 m3/hr
Sanitization Temp. : 850 C
6.A.11 REVERSE OSMOSIS HOUSING:
TAG NO: RO PASS I
EQUIPMENT NAME: Reverse Osmosis Housing
EQUIPMENT LOCATION: After RO High Pressure I
FUNCTION: RO membranes are housed in the housing.
No. of Housing : One
No. of Membranes in RO Housing : 4 Nos.
Material of Construction : SS 304
Diameter : 204 mm
Length : 4060 mm
Thickness : 2.5 mm
Surface Finish of RO Housing : Internally < 0.4 Ra
Maximum Flow rate for housing : 4000 LPH
Permeate flow rate from RO Pass I is 2.7 m3/hr.
6.A.12 REVERSE OSMOSIS HIGH PRESSURE PUMP-II:
TAG NO: ROHP II
EQUIPMENT NAME: RO High Pressure Pump II
EQUIPMENT LOCATION: After RO pass I
FUNCTION: For pumping of water to RO pass II system.
Quantity : One
Type : Vertical Multistage Pump
Flow rate : 2.7 m3/hr (2700 LPH)
Pressure : 9 kg/cm2
Material of Construction : SS 316 wettable parts
Voltage Requirement : 415 volts
Make : Grundfos
6.A.13 REVERSE OSMOSIS MEMBRANES:
EQUIPMENT NAME: Reverse Osmosis Membranes
EQUIPMENT LOCATION: Within the RO Housing

FUNCTION: RO membranes reduce the TDS & microbial load in the water. The semipermeable 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 s/cm.
No. of Membrane : 2 Nos.
Size of Membrane : 8 Dia. & 40 Long
Type of Membrane : Thin Film Composite
Type of sanitization : Hot water
Temperature of sanitization : 850 C
Material of Construction : Polyamide
Make of Membrane : DOW.
Model : HSRO-390FF
Operating Temperature : 450 C
Recovery : 80-85 %
Feed Water Flow Rate : 2.7 m3/hr
Permeate Flow Rate : 2.2 m3/hr
6.A.14 REVERSE OSMOSIS HOUSING:
TAG NO: PWG-RO PASS II
EQUIPMENT NAME: Reverse Osmosis Housing
EQUIPMENT LOCATION: After RO High Pressure II
FUNCTION: RO membranes are housed in the housing.
No. of Housing : One
Material of Construction : SS 316L
Diameter : 204 mm
Length : 2040 mm
Thickness : 2.5 mm
Surface Finish of RO Housing : Internally < 0.4 Ra
Max Feed Flow rate : 3000 LPH
6.A.15 ELECTRO DEIONIZATION UNIT:
TAG NO: EDI 01
EQUIPMENT NAME: Electro De-Ionization System
EQUIPMENT LOCATION: After RO pass II
FUNCTION: EDI bring down the conductivity of RO treated water. The water generated
from the outlet of EDI will be as per USP 34.
No. of Unit : One
Type : Hot Water Sanitizable
Model No. : IP LXM 24 HI-3
Minimum Flow rate : 1400 ltrs/hr
Maximum Flow rate : 4200 Ltrs/hr
Normal Flow rate : 2800 ltrs/hr
End Connection : 1 TC
Operating Voltage DC : 150 250 V DC
Maximum Voltage : 300 V
Operating Current : 1 3 Amps
Maximum Current : 5 6 Amps.

Concentrate Flow rate (Reject) : 250 LPH
Pressure Drop across concentrate : 0.5 kg/cm2
Make of EDI : M/s. Ion Pure EDI, USA
Material of Construction of different parts:
Dilute Spacer : Polysulfone
Concentrate Spacer : Polysulfone
End Block : Polypropylene
Resin compartment O-rings : FDA-grade silicon
Anion exchange resin 1 : Styrene / DVB, strong base, type I
Anion exchange resin 2 : Styrene / DVB, strong base, type II
Cation exchange resin : Styrene / DVB, strong acid
Anion exchange membrane : Heterogeneous PE/AER
Cation exchange membrane : Heterogeneous PE/CER
Anode : Platinized Titanium
Cathode : SS 316
6.A.16 CIP TANK
TAG NO: CIP-ST
EQUIPMENT NAME: CIP Tank
EQUIPMENT LOCATION: Before CIP feed pump
FUNCTION: For Sanitization.
Quantity : One
Make : Hydro pure
Type : Plain Tank
Working Capacity : 200 Liters
Gross Capacity : 220 Liters
Tank Dia ID : 600 mm
Shell Height : 750 mm
Design Pressure & Tempe. : 3.5 Kg/cm2 & 120oC
Design Code : cGMP
Top & Bottom : Torispherical Dished end
M.O.C. of Shell : SS 316 L
Nozzles : Triclover end
Surface Finish : Internally electro polished to <0.4 micron Ra.
Externally buffed to mirror finish
6.A.17 CIP FEED PUMP:

TAG NO: CIP CIPFP
EQUIPMENT NAME: CIP Feed Pump
EQUIPMENT LOCATION: Trolley Mounted
FUNCTION: Pumps Purified water to RO system @ 2.5 m3/hr
Quantity : One
Type : Horizontal Multistage Pump
Flow rate : 2.5 m3/hr (2500 liter/hr)
Pressure : 2.9 kg / cm2
Material of Construction : SS 316 wettable parts
Voltage Requirement : 3 Phase, 415 volts
Make : Grundfos
6.B INSTRUMENTATION & OTHER ITEMS

6.B.1.1 PRESSURE GUAGES:
TAG NO: PG-01 / 02 / 03
INSTRUMENT NAME: Pressure Gauges
LOCATION: 1) Inlet of Multi Grade Filter
2) Outlet of Multi Grade Filter
3) Outlet of Softener
FUNCTION: To check the line pressure
Make :
Waaree
Size of Gauge :
100 mm Dial
Range : 0-7 kg/cm2

End Connection : 3/8 BSP (M)
MOC : SS Body with SS internals
TAG NO: PG 04 / 05 / 10
LOCATION: 1) Inlet of 5 micron Cartridge Filter
2) Outlet of 5 micron Cartridge Filter
3) Inlet line of EDI System
FUNCTION: To check the line pressure.
Make :
Size of Gauge :
Waaree
63 mm Dial
Range : 0 7 kg/cm2
End Connection : BSP (M)
Damping Liquid : Glycerin
Accuracy : 1.6 % of FS
TAG NO: PG 06 / 07 / 08 / 09
LOCATION: FOR TWO PASS RO-EDI SYSTEM
1) Feed line of RO pass I
2) Reject line of RO pass I
3) Feed line of RO pass II
4) Reject line of RO pass II
FUNCTION: To check the line pressure
Make :
Size of Gauge :
Waaree
63 mm Dial
Range : 0 21 kg/cm2
TAG NO: CIP-PG
LOCATION: Discharge line of CIP Feed Pump-1

FUNCTION: To check the line pressure.
Make :
Waaree
Size of Gauge :
63 mm Dial
Range : 0 7 kg/cm2
End Connection : BSP (M)
6.B.2 ROTAMETER:
TAG NO: RM-01 / 02 / 03 / 04 / 05 / 06
INSTRUMENT NAME: Rotameter
LOCATION: 1) Inlet line of Multi Grade Filter (1000 10000 LPH)
2) Potable Water Line (500 5000 LPH)
3) RO First Pass reject line (200 2000 LPH)
4) RO Second Pass reject line (100 1000 LPH)
5) EDI Feed line (400 4000 LPH)
6) Concentrate line of EDI I (30 300 LPH)
FUNCTION: To check the line flow rate.
Make :
George Fischer
End Connection : Tri Clover end

Type : Variable Area
Model : SK
MOC of float : SS 316
MOC of Measuring Tube : SS
MOC of end connection : Nylon 6
Accuracy class : 2.5
6.B.3 FLOW INDICATOR TOTALIZER:
TAG NO: FIT-01
INSTRUMENT NAME: Flow Indicator Totalizer
LOCATION: Outlet of Softeners
FUNCTION: To check the total line flow rate.
Make :
Aster Technology
Model : FT-650
Line Size : 38 mm
Type : Turbine Type
End Connection : Threaded
6.B.4 FLOATY LEVEL SWITCH:
TAG NO: FLS-01
INSTRUMENT NAME: Floaty Level Switches
LOCATION: Raw Water Tank
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.
Make :
Quantity :
Innovative Technologies
One
Type : Floaty type
MOC
PVC
6.B.5 LOW LEVEL SWITCH:

TAG NO: LLS-01 / 02 / 03 / 04 / 05
INSTRUMENT NAME: Low Level Switches
LOCATION:
1) NaOCl-01 Dosing Tank
2) Raw Water Tank
3) SMBS dosing system
4) ADS dosing system
5) pH correction system
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.
Make :
Innovative Technology
Quantity :
05 Nos.
Type : Magnetic
MOC
PP
6.B.6 FLOW SWITCHES:

TAG NO: FS-01
INSTRUMENT NAME: Flow Switches
LOCATION: Raw Water inlet line
FUNCTION: To check the line flow.
Make :
Quantity :
Dag Process
One
MOC
SS 316
Size
1.5
6.B.7 ORP SENSOR TRANSMITTER & CONTROLLER:

TAG NO: ORP 01
INSTRUMENT NAME: Oxidation Reduction Potential Analyzer
LOCATION: Inlet of RO pass I
FUNCTION: 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
chlorinated water for 300 secs. & even if the ORP value is not below the set point it will
trip the system.
Quantity :
One
Make :
Forbes Marshall
Range : +1000 to 1000 mV

End Connection : 1 TC end connection
MOC of Electrode : Glass
6.B.8.1 CONDUCTIVITY SENSOR TRANSMITTER & CONTROLLER:
TAG NO: CIC 01/02
INSTRUMENT NAME: Conductivity Indicator cum Controller
LOCATION: 1) Outlet of RO pass I 2) Outlet of RO pass II
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.
Quantity : Two
Make :
Emerson
Range : 0 200 s/cm for First Pass Permeate

0 100 s/cm for Second Pass Permeate
End Connection : 1 TC end connection.
MOC
SS 316 wettable parts
6B.8.2 CONDUCTIVITY SENSOR TRANSMITTER & CONTROLLER:

TAG NO: CIC 03
INSTRUMENT NAME: Conductivity Indicator cum Controller
LOCATION: 1) Outlet of EDI system
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.
Make :
Emerson
Range : 0 10 s/cm (EDI outlet)

End Connection : 1 TC end connection.
MOC
SS 316 wettable parts
6. B.9 HIGH PRESSURE SWITCH:

TAG NO: HPS 01 / 02
INSTRUMENT NAME: High Pressure Switch
LOCATION: 1) Outlet of RO High Pressure I
2) Outlet of RO High Pressure II
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.
Make :
Danfoss
Range : 1 to 16 bar
MOC
SS wettable parts
Type : Seamless Bellow type pressure switch

B.10 LOW PRESSURE SWITCH:
TAG NO: LPS 01 / 02 / 03
INSTRUMENT NAME: High Pressure Switch
LOCATION:
1) Inlet of RO High Pressure I
2) Inlet of RO High Pressure II
3) Inlet of EDI unit
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.
Make :
Danfoss
Range : 0 to 3 bar
MOC
SS wettable parts
Type : Seamless Bellow type pressure switch

6. B.11 LEVEL SWITCH for CIP Tank:
TAG NO: CIP LLS
INSTRUMENT NAME: Low Level Switch
LOCATION: CIP Tank

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.
Quantity : One
Make : Mahalaxmi
Model : SMT-16M 3 TC-AH
MOC :
SS 316
6. B.12 TEMPERATURE INDICATOR & TRANSMITTER

TAG NO: CIP TT
EQUIPMENT NAME: Temperature Transmitter
EQUIPMENT LOCATION: 1) CIP Feed Pump Discharge
FUNCTION: To check Temperature of system during Sanitization Process
Make : Wika
Wetted material : SS 316
Range : 0 to 2000 C
Input : PT 100 (RTD)
Accuracy : + / 0.5% of F.S.
Ambient Temp : 250 C
B.13 CONTROL VALVES
TAG NO: AV 01 / 02 / 03 / 04 / 05 / 06
EQUIPMENT NAME: Control Valves
LOCATION :
1) Raw Water Inlet line
2) Before RO High Pressure I (ORP Dump)
3) Reject line of RO pass I (Auto Rinse Valve)
4) Permeate line of RO pass I (CIC Dump)
5) Reject line of RO pass II (Auto Rinse Valve)
6) Permeate line of RO pass II (CIC Dump)
FUNCTION: To monitor the plant operation in Auto/Semi-Auto mode as per the pre-set
logic & time.
Make : Avcon
Type : Y- type Pneumatic operated ON-OFF
MOC : SS Wettable Parts
End Connection : TC end
Size : As per valve schedule
B.14 FLOW DIVERTER VALVE
TAG NO: FDV 01
EQUIPMENT NAME: Flow Diverter Valve
LOCATION: Outlet of EDI unit.
FUNCTION: To dump the high conductivity water at outlet of EDI unit.
Make : Kumar Process
MOC : SS 316L
End Connection : TC end
Size : 1
6.B.15 SAMPLING VALVE:
EQUIPMENT NAME: SP-05 to 11
EQUIPMENT LOCATION: RO-EDI Distribution Piping

FUNCTION: To take a Sample for RO Water Analysis.
Quantity : 07 Nos.
Make : Kumar Process
Type : Milipore Design
Size : 8 NB
M.O.C. : SS 316L
6.B.16 VALVE SCHEDULE
Sr.
Location of Valve
Tag No.
Size
Type
MOC
Before Raw Water
AV-01
32 mm
Actuated Valve
SS 304
No.
1
Tank
2
ORP dump valve
(NC)
AV-02
25 mm
Actuated Valve
SS 304
(NC)
3
RO-I Reject line (Auto
AV-03
20 mm
Flushing)
4
RO-I Conductivity
RO-II Reject line
AV-04
20 mm
RO-II Conductivity
AV-05
20 mm
Suction line of RWP-
AV-06
20 mm
Discharge line of
BV-01
1.5 NB
Suction line of RWP-
BV-02
1.25 NB
Discharge line of
BV-03
1.5 NB
MGF Inlet
SS 304
Manual Ball
SS 304
Manual Ball
SS 304
Manual Ball
SS 304
Valve
BV-04
1.25 NB
RWP-02
11
Actuated Valve
Valve
02
10
SS 304
Valve
RWP-01
9
Actuated Valve
(NC)
01
8
SS 304
(NC)
dump valve
7
Actuated Valve
(NC)
(Auto Flushing)
6
SS 304
(NC)
dump valve
5
Actuated Valve
Manual Ball
SS 304
Valve
BV-05
d40DN32
Manual Ball
UPVC
Valve
12
MGF outlet
BV-06
d40DN32
Manual Ball
UPVC
Valve
13
MGF back wash inlet
BV-07
d40DN32
Manual Ball
UPVC
Valve
14
MGF back wash
BV-08
d40DN32
outlet
15
MGF drain
Manual Ball
UPVC
Valve
BV-09
d40DN32
Manual Ball
UPVC
Valve
16
Softener-01 Inlet
BV-10
d40DN32
Manual Ball
UPVC
Valve
17
Softener-01 Outlet
BV-11
d40DN32
Manual Ball
UPVC
Valve
18
Softener-01 power
BV-12
d25DN20
water
19
Softener-01 brine
UPVC
Valve
BV-13
d40DN32
injection
20
Manual Ball
Manual Ball
UPVC
Valve
BV-14
d40DN32
UPVC
21
Softener-01 slow
Manual Ball
Rinse outlet
Valve
Softener-01 Fast
BV-15
d40DN32
Rinse outlet
22
Diversion line
Manual Ball
UPVC
Valve
BV-16
d40DN32
Manual Ball
UPVC
Valve
23
Discharge ROHP-01
BV-17
25 mm
Manual Ball
SS 304
Valve
24
Discharge ROHP-02
BV-18
25 mm
Manual Ball
SS 304
Valve
25
Discharge line of Raw
NRV-01
1.25
Water Pump 01
26
Discharge line of Raw
Conc. Inlet EDI
SS 304
Valve
NRV-02
1.25
Water Pump 02
27
Non Return
Non Return
SS 304
Valve
DV-01
DN 20
Diaphragm
SS 316
Valve
28
CIP Tank drain valve
CIP-DV-01
DN 20
Daiphragm
SS 316
Valve
29
CIP Suction Valve
CIP-DV-02
DN 20
Daiphragm
SS 316
Valve
30
CIP Discharge Valve
CIP-DV-03
DN 20
Diaphragm
SS 316
Valve
31
ORP needle valve
NV-01
Needle valve
SS 304
32
Reject line RO-01
NV-02
20 mm
Needle Valve
SS 304
33
Reject line RO-02
NV-03
20 mm
Needle Valve
SS 304
34
After NaOCl-01
SP-01
8 NB
Sampling Valve
SS 304
SP-02
8 NB
Sampling Valve
SS 304
SP-03
8 NB
Sampling Valve
SS 304
Dosing System
35
Inlet of Multi Grade

Filter
36
Outlet of Multi Grade

Filter
37
Outlet of Softener-01
SP-04
8 NB
Sampling Valve
SS 304
38
After SMBS dosing
SP-05
8 NB
Sampling Valve
SS 316
SP-06
8 NB
Sampling Valve
SS 316
SP-07
8 NB
Sampling Valve
SS 316
SP-08
8 NB
Sampling Valve
SS 316
system
39
After ADS dosing

system
40
After pHC dosing

system
41
After 5-micron
Cartridge Filter
42
After RO pass-I
SP-09
8 NB
Sampling Valve
SS 316
43
After RO pass-II
SP-10
8 NB
Sampling Valve
SS 316
44
After EDI system
SP-11
8 NB
Sampling Valve
SS 316
6. C.1 PLC PANEL:

TAG NO.: PLC Panel
INSTRUMENT NAME: MCC cum PLC panel.
LOCATION: Mounted on the SKID
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.
MOC of Panel : SS 304 with matt finish
Digital Input and Output Card
Make : Mitsubishi
Model : FX3G 60MR+FX2N 8ER
Digital Input : 40, 24VDC input
Digital Output : 28, 230VAC output
Analog Input/Output Card
Make : Mitsubishi
Model : FX2N 8AD + 5A
Analog Input : 12 Nos.
Analog Output : 01 No.
MMI ( Monochrome)
Make : Mitsubishi
Catalogue No. : E 1043
Communication Port : RS-232 (DF1)
Printer Port : RS-232
Display : Touch Screen
Size : 3.5
6.C.2 PLC INPUT/OUTPUT DETAILS:
Sr.No
D/Input
Input Description
D/Output
Output description
X0
RWP-01 start/stop
Y0
NaOCl-01
X1
RWP-01 trip
Y1
SMBS-01
X2
RWP-02 start/stop
Y2
ADS-01
X3
RWP-02 trip
Y3
PHC-01
X4
LLS NaOCl-01
Y4
RWP-01
X5
FS-01
Y5
RWP-02
X6
HL Raw Water Tank
Y6
ROHP-01
X7
ML Raw Water Tank
Y7
ROHP-02
X10
LL Raw Water Tank
Y10
EDI
10
X11
ROHP 1 start/stop
Y11
PLP-01
11
X12
ROHP 1 trip
Y12
PLP-02
12
X13
ROHP 2 start/stop
Y13
HIUV
13
X14
ROHP 2 trip
Y14
PWST Heater
14
X15
EDI start/stop
Y15
CIPFP
15
X16
EDI trip
Y16
CIP Heater
16
X17
CIPFP start/stop
Y17
AV-01
17
X20
CIPFP trip
Y20
AV-02
18
X21
CIP HTR Start / Stop
Y21
AV-03
19
X22
LLS SMBS-01
Y22
AV-04
20
X23
LLS ADS-01
Y23
AV-05
21
X24
LLS-pHC-01
Y24
AV-06
22
X25
LPS-01 ROHP-01
Y25
FDV-01
23
X26
LPS-02 ROHP-02
Y26
PWD-FDV-01
24
X27
LPS-03 EDI
Y27
PWD-AV-01
25
X30
HPS-01 ROHP-01
Y30
VF HTR
26
X31
HPS-02 ROHP-02
Y31
Hooter
27
X32
LLS CIPT
Y32
Spare
28
X33
PLP 1 start / stop
Y33
Spare
29
X34
PLP 2 start / stop
30
X35
PLP 1/2 trip
31
X36
PWST Ceramic Heater
32
X37
Auto Manu. Switch for RO-
Analog
A/O description
EDI
33
X40
Auto Manu. Switch for

Purified Water Distribution
System
34
X41
EMERGENCY
35
X42
ACCEPT
36
X43
Air Pressure Switch
37
X44
Spare
38
X45
Spare
39
X46
Spare
40
X47
Spare
Sr.No
Analog
A/I description
Input
Output
AI-1
PWG ORP 01
AI-2
PWG CIC 01
AI-3
PWG CIC 02
AI-4
PWG CIC 03
AI-5
PWD CIC 01
AI-6
PWD FT 01
AI-7
PWD TT 01
AI-8
PWD LIC
AI-9
CIP TIC
10
AI-10
EDI Current
AO-1
PLP VFD
6.C.3 System Description & Process Logics for Purified water Generation System
Sr.
Interlock Description
Action Taken
No.
Indication
Audio
on MMI
Visual
Alarm
High Level in Raw
Will close Actuated Valve AV-
Water Tank
01
YES
YES
Medium Level in Raw
Will open Actuated Valve AV-
Water Tank
01
YES
NA
Low Level in Raw
Will stop RWP-01 / 02
YES
YES
Will start RWP-01 / 02
YES
NA
Low Level in NaOCl-
Will trip NaOCl-01 Dosing
YES
YES
01 Dosing Tank.
Pump & will close AV-01

YES
YES
Water Tank
4
Medium Level in Raw

Water Tank
Low flow in Raw
Will trip NaOCl-01 Dosing
Water inlet line
Pump & will close AV-01
High Totalized flow
It Should give Alarm for
at outlet of softener
Regeneration.
Emergency Stop
10
11
YES
YES
Should Trip the System.
YES
YES
Low level in SMBS 1
RWP-01 will stop & RO-EDI
YES
YES
Dosing tank
System will stop.
Low level in ADS
YES
YES
Dosing tank
System will stop.
Low Level in pH
YES
YES
Correction Dosing
System will stop.
YES
YES
YES
NA
YES
YES
This will trip the ROHP 01
YES
YES
Repeated Low
After ROHP 01 trips for 4
YES
YES
Pressure at ROHP
times in a minute. This will
01 suction
trip the entire plant.
High Pressure at
RO EDI system will trip.
YES
YES
High Conductivity at
1) If the conductivity is
YES
YES
RO pass I outlet
above the set point, it will
YES
NA
YES
YES
tank
12
High ORP-01 Value.
1) Free chlorine will pass

through and ORP sensor will
sense free chlorine. Inturn the
ORP value will increase above
the set point. This will open
the ORP dumping valve AV02.
2) ORP comes down

within the desired limit. After
30 secs. of consistent
reading, below the set value it
will close the AV-02. Allow the
water to feed to the RO
system. The entire system
will start automatically.
3) If the ORP value is high

for more than 300 secs. it will
trip the plant.
13
Low Pressure at
ROHP 01 suction
14
15
ROHP 01 discharge
16
open the dumping valve AV04.
2) After 30 secs. of
consistent reading, below the
set value, it will close the AV04. Allow the water to feed to
the 2nd Pass of RO system.
The entire system will start
automatically.
3) If the RO pass-I outlet

conductivity is high for more
than 300 secs. It will trip the

plant.
17
Low Pressure at
This will trip the ROHP II
YES
YES
RO EDI system will trip.
YES
YES
YES
YES
RO pass II outlet
YES
NA
YES
YES
YES
YES
YES
YES
YES
NA
YES
YES
Ceramic Heater will be ON.
YES
NA
Ceramic Heater will be OFF.
YES
NA
Low Level in CIP
Should trip the Heater & CIP
YES
YES
Tank
Feed Pump.
Emergency Stop
RO-EDI System will trip.
YES
YES
ROHP II
18
High Pressure in
ROHP II discharge
19
open the dumping valve AV06.
consistent reading, below the
set value, it will close the AV06. Allow the water to feed to
the EDI system. The entire
system will start
automatically.
3) If the RO pass-II outlet

than 300 secs. it will trip the
plant.
20
21
Low pressure at EDI
Low pressure at EDI inlet, will
inlet
trip EDI unit.
EDI outlet

open the dumping valve FDV01.
consistent reading below the
set value, it will close the FDV01. Allow the water to feed to
the purified water tank. The
entire system will start
automatically.
3) If the EDI outlet

than 300 secs. it will trip the
plant.
22
Low temperature at
CIP supply line
23
High temperature at
CIP supply line
24
25
7. DRAWINGS REQUIRED
SR. NO.
DESCRIPTION
DRAWING NO.
REV
P&ID for Pretreatment & Purified
HPS/PR150/PWG/DR01
Water Generation & Distribution

System
2
Skid Drawings
HPS/PR150/PWG/DR02
Isometric for Pretreatment System
HPS/PR150/PWG/DR03
Isometric for RO-EDI System
HPS/PR150/PWG/DR04
Control Panel Drawing
HPS/PR150/PWG/DR05
CIP Tank Drawing
HPS/PR150/PWG/DR06
8. SUPPORTING UTILITIES
SR.
Equipments /
NO.
Instruments
Location
Utilities
Specification
Scope
Pretreatment
PW
Raw Water
7000 LPH
ZCHL
Plant
Generation
Power
3 phase, 430V, 50
ZCHL
Plant
Control Panel
RO Plant
Room
RO Plant
Hz
RO Plant
Compressed
MOC of tube is
Room
Filtered
PU, Press 6
regulated Air
kg/cm2
9. PRE-QUALIFICATION CHECK LIST

9.1 HYDRAULIC PRESSURE TEST
9.2 DOCUMENTATION CHECK
9.3 INTERLOCK CHECKS
9.4 OPERATIONAL CHECKS
10. LIST OF DOCUMENTS REQUIRED FORGENERATION SYSTEM
CODE
DOCUMENTS REQUIRED
Manufacturers Manuals Preventive Maintenance (O.M.)
MOC Certificate
Leak Test Reports / Hydro Test Report
Sanitization Reports
Cleaning / Flushing Reports
Manufacturers Catalogue
Test Certificate
Guarantee / Warranty Certificate
Basis of Design
11. DESIGN QUALIFICATION REPORT

APPROVAL
Approved / Not Approved
Signature
Approved By
Vendor
Executive name
Client
Engineering
ZCHL
Head-Operations
Head-Quality
Abbreviation
Description
URS
User Required Specification
FRS
Functional Required Specification
cGMP
Current Good Manufacturing Practice
QA
Quality Assurance
USP
United States Pharmacopoeia
WHO
World Health Organization
ROHP
CIPFP
CIP Feed Pump
SMBS
Sodium Meta bisulfate
ADS
Antiscalent dosing System
pHC
pH Correction
CF
Cartridge Filter
RO
Reverse Osmosis
EDI
Electro-Deionization
CIP
Cleaning In Place
Ppm
Mg/Ltrs OR Parts Per Million
NTU
Neblometric Turbidity Unit
MWCO
Molecular Weight Cut-Off
CFU/ml
Colony Forming Unit per ml
TSS
Total Suspended Solids
TDS
TOC
Total Organic Carbon
TVC
Total Viable Count
TBC
Total Bacterial Count
TC
Tri Clover
P&ID
Process Flow & Instrumentation Diagram
LPH
Liters Per Hour
12. ABBREVIATIONS
PG
Pressure Gauge
RM
Rotameter
LLS
Low Level Switch
PLC
Programmable Logical Controls
MMI
Manual Machine Interface
ORP
Oxidation Reduction Potential
CIC
Conductivity Indicator cum Controller
HPS
High Pressure Switch
LPS
Low Pressure Switch
MOC
Material Of Construction
CPVC
Chlorinated Poly-Vinyl Chloride
SS
Stainless Steel
PP
Poly-Propylene
FRP
Fiber Reinforced Plastic
HDPE
High Density Poly Ethylene
HOS
Height Of Shell
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DKD R 5 7 e Calibración de Cámaras Climaticas

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DKD R 5 7 e Calibración de Cámaras Climaticas

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September 7, 2016

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Validation & Qualification

Validation & Qualification

Media And Video

DQ for Purified Water System

FOR FREE UPDATE

DQ for Purified Water System

OTHER, QUALIFICATION, VALIDATION & QUALIFICATION

NAME OF THE SYSTEM :PRETREATMENT & PURIFIED WATER GENERATION SYSTEM

OBJECTIVE & SCOPE

SYSTEM DESCRIPTION (SYSTEM AND SUB-SYSTEM)

BASIS OF DESIGN AND ASSUMPTION

LIST OF DOCUMENTS REQUIRED

DESIGN QUALIFICATION REPORT APPROVAL

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1. OBJECTIVE AND SCOPE

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Total Dissolved Solids

Total Plate Count

PERMEATE FLOWRATE : 2200 LPH

TREATED WATER QUALITY AFTER UF : ( as per Design Limits)

(PURIFIED WATER AS PER USP 39 std.)

: For providing user requirement (Technical and cGMP)

: To review the specification from installation andMaintenance aspects.

: To review the specification from GMP Aspects

: To review and agree upon the requirements.

4. SYSTEM DESCRIPTION (SYSTEM AND SUB-SYSTEM)

5. BASIS OF DESIGN AND ASSUMPTION

Total Dissolved Solids

Total Suspended Solids

Total Chloride as CaCO3

6.A.5 SODIUM META BISULPHITE DOSING SYSTEM:

EQUIPMENT LOCATION: After Anti-scalent dosing system

6.A.9 REVERSE OSMOSIS HIGH PRESSURE PUMP-I:

EQUIPMENT LOCATION: Within the RO Housing

Maximum Current : 5 6 Amps.

6.A.17 CIP FEED PUMP:

6.B INSTRUMENTATION & OTHER ITEMS

Range : 0-7 kg/cm2

LOCATION: Discharge line of CIP Feed Pump-1

End Connection : Tri Clover end

Type : Floaty type

6.B.5 LOW LEVEL SWITCH:

6.B.6 FLOW SWITCHES:

6.B.7 ORP SENSOR TRANSMITTER & CONTROLLER:

Range : +1000 to 1000 mV

Range : 0 200 s/cm for First Pass Permeate

SS 316 wettable parts

6B.8.2 CONDUCTIVITY SENSOR TRANSMITTER & CONTROLLER:

Range : 0 10 s/cm (EDI outlet)

SS 316 wettable parts

6. B.9 HIGH PRESSURE SWITCH:

Type : Seamless Bellow type pressure switch

Type : Seamless Bellow type pressure switch

LOCATION: CIP Tank

6. B.12 TEMPERATURE INDICATOR & TRANSMITTER

EQUIPMENT LOCATION: RO-EDI Distribution Piping

Before Raw Water

ORP dump valve

RO-I Reject line (Auto

RO-II Reject line

Suction line of RWP-