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DQ for Purified Water System 0
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 PAGE NO.
1 OBJECTIVE & SCOPE
2 ACCEPTANCE CRITERIA
3 RESPONSIBILITY
4 SYSTEM DESCRIPTION (SYSTEM AND SUB-SYSTEM)

FACEBOOK
5 BASIS OF DESIGN AND ASSUMPTION
6 TECHNICAL SPECIFICATIONS

7 DRAWINGS REQUIRED
8 SUPPORTING UTILITIES
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9 PRE-QUALIFICATION CHECKLIST
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10 LIST OF DOCUMENTS REQUIRED
11 DESIGN QUALIFICATION REPORT APPROVAL
12 ABBREVIATIONS
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. FIND US ON GOOGLE PLUS
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
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 Actual Design Consideration

No. Parameters
Pharmaceutical Guidance
1 Colour < 5 CTU < 5 CTU
Seguir
2 pH 7.5 6.5 8.5
92 seguidores
3 Conductivity (us/cm) 900 1200
4 Turbidity 1.8 Less than 5
5 SDI Not check < 3 assumed
6 Total Dissolved Solids 750 ppm 900 ppm
7 Total Alkalinity 120 ppm 120 ppm
8 Total Hardness 300 ppm 350 ppm
9 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
(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
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. Ph 6 to 8.5 6 to 8.5 56 56
TSS < 5 ppm < 5 ppm Nil Nil
2. TDS / 1920 us/cm 1920 us/cm 200 us/cm 25 us/cm

Conductivity
3. Total Hardness 350 ppm Less than 5 Nil Nil

( 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 Design

No. Limit 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:
RO High Pressure Pump
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. Ph 6 to 8.5 6 to 8.5 56 56
TSS < 5 ppm < 5 ppm Nil Nil
2. TDS / 1920 us/cm 1920 us/cm 200 us/cm 25 us/cm

Conductivity
3. Total Hardness 350 ppm Less than 5 Nil Nil

( 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 Design

No. Limit 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 Actual Design Consideration

No. Parameters
1 Colour < 5 CTU < 5 CTU
2 pH 7.5 6.5 8.5
3 SDI 900 1200
4 Total Dissolved Solids 1.8 Less than 5
5 Total Alkalinity Not check < 3 assumed
6 Total Suspended Solids 750 ppm 900 ppm
7 Total Hardness 120 ppm 120 ppm
8 Calcium as CaCO3 300 ppm 350 ppm
9 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 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 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 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 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 : Waaree
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 : Waaree
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
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 : Innovative Technologies
Quantity : 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 : Dag Process
Quantity : 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

No.
1 Before Raw Water AV-01 32 mm Actuated Valve SS 304

Tank (NC)
2 ORP dump valve AV-02 25 mm Actuated Valve SS 304

(NC)
3 RO-I Reject line (Auto AV-03 20 mm Actuated Valve SS 304

Flushing) (NC)
4 RO-I Conductivity AV-04 20 mm Actuated Valve SS 304

dump valve (NC)
5 RO-II Reject line AV-05 20 mm Actuated Valve SS 304

(Auto Flushing) (NC)
6 RO-II Conductivity AV-06 20 mm Actuated Valve SS 304

dump valve (NC)
7 Suction line of RWP- BV-01 1.5 NB Manual Ball SS 304

01 Valve
8 Discharge line of BV-02 1.25 NB Manual Ball SS 304

RWP-01 Valve
9 Suction line of RWP- BV-03 1.5 NB Manual Ball SS 304

02 Valve
10 Discharge line of BV-04 1.25 NB Manual Ball SS 304

RWP-02 Valve
11 MGF Inlet 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 Manual Ball UPVC

outlet Valve
15 MGF drain 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 Manual Ball UPVC

water Valve
19 Softener-01 brine BV-13 d40DN32 Manual Ball UPVC

injection Valve
20 BV-14 d40DN32 UPVC

Softener-01 slow Manual Ball
Rinse outlet Valve
21 Softener-01 Fast BV-15 d40DN32 Manual Ball UPVC

Rinse outlet Valve
22 Diversion line 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 Non Return SS 304

Water Pump 01 Valve
26 Discharge line of Raw NRV-02 1.25 Non Return SS 304

Water Pump 02 Valve
27 Conc. Inlet EDI 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

Dosing System
35 Inlet of Multi Grade SP-02 8 NB Sampling Valve SS 304

Filter
36 Outlet of Multi Grade SP-03 8 NB Sampling Valve SS 304

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

system
39 After ADS dosing SP-06 8 NB Sampling Valve SS 316

system
40 After pHC dosing SP-07 8 NB Sampling Valve SS 316

system
41 After 5-micron SP-08 8 NB Sampling Valve SS 316

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
1 X0 RWP-01 start/stop Y0 NaOCl-01
2 X1 RWP-01 trip Y1 SMBS-01
3 X2 RWP-02 start/stop Y2 ADS-01
4 X3 RWP-02 trip Y3 PHC-01
5 X4 LLS NaOCl-01 Y4 RWP-01
6 X5 FS-01 Y5 RWP-02
7 X6 HL Raw Water Tank Y6 ROHP-01
8 X7 ML Raw Water Tank Y7 ROHP-02
9 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-

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 Analog A/O description

Input Output
1 AI-1 PWG ORP 01 AO-1 PLP VFD
2 AI-2 PWG CIC 01
3 AI-3 PWG CIC 02
4 AI-4 PWG CIC 03
5 AI-5 PWD CIC 01
6 AI-6 PWD FT 01
7 AI-7 PWD TT 01
8 AI-8 PWD LIC
9 AI-9 CIP TIC
10 AI-10 EDI Current
6.C.3 System Description & Process Logics for Purified water Generation System
Sr. Interlock Description Action Taken Indication Audio

No. on MMI Visual
Alarm
1 High Level in Raw Will close Actuated Valve AV- YES YES
Water Tank 01
2 Medium Level in Raw Will open Actuated Valve AV- YES NA

Water Tank 01
3 Low Level in Raw Will stop RWP-01 / 02 YES YES

Water Tank
4 Medium Level in Raw Will start RWP-01 / 02 YES NA

Water Tank
5 Low Level in NaOCl- Will trip NaOCl-01 Dosing YES YES

01 Dosing Tank. Pump & will close AV-01
6 YES YES
Low flow in Raw Will trip NaOCl-01 Dosing
Water inlet line Pump & will close AV-01
7 High Totalized flow It Should give Alarm for YES YES

at outlet of softener Regeneration.
8 Emergency Stop Should Trip the System. YES YES
9 Low level in SMBS 1 RWP-01 will stop & RO-EDI YES YES
Dosing tank System will stop.
10 Low level in ADS RWP-01 will stop & RO-EDI YES YES
Dosing tank System will stop.
11 Low Level in pH RWP-01 will stop & RO-EDI YES YES

Correction Dosing System will stop.
tank
12 High ORP-01 Value. 1) Free chlorine will pass

through and ORP sensor will
sense free chlorine. Inturn the YES YES
ORP value will increase above
the set point. This will open
the ORP dumping valve AV-
02.
2) ORP comes down

within the desired limit. After
YES NA
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.
YES YES
3) If the ORP value is high

for more than 300 secs. it will
trip the plant.
13 Low Pressure at This will trip the ROHP 01 YES YES

ROHP 01 suction
14 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.
15 High Pressure at RO EDI system will trip. YES YES

ROHP 01 discharge
16 High Conductivity at 1) If the conductivity is YES YES

RO pass I outlet above the set point, it will
open the dumping valve AV-
04.
2) After 30 secs. of YES NA

consistent reading, below the
set value, it will close the AV-
04. Allow the water to feed to
the 2nd Pass of RO system.
The entire system will start
automatically.
YES YES
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

ROHP II
18 High Pressure in RO EDI system will trip. YES YES

ROHP II discharge

RO pass II outlet above the set point, it will
open the dumping valve AV-
06.
2) After 30 secs. of
consistent reading, below the
YES NA
set value, it will close the AV-
the EDI system. The entire
system will start
automatically.
YES YES
3) If the RO pass-II outlet
than 300 secs. it will trip the
plant.
20 Low pressure at EDI Low pressure at EDI inlet, will YES YES
inlet trip EDI unit.

EDI outlet above the set point, it will
open the dumping valve FDV-
01.
2) After 30 secs. of
consistent reading below the
YES NA
set value, it will close the FDV-
the purified water tank. The
entire system will start
automatically.
YES YES
3) If the EDI outlet
than 300 secs. it will trip the
plant.
22 Low temperature at Ceramic Heater will be ON. YES NA

CIP supply line
23 High temperature at Ceramic Heater will be OFF. YES NA

CIP supply line
24 Low Level in CIP Should trip the Heater & CIP YES YES
Tank Feed Pump.
25 Emergency Stop RO-EDI System will trip. YES YES
7. DRAWINGS REQUIRED
SR. NO. DESCRIPTION DRAWING NO. REV

1 P&ID for Pretreatment & Purified HPS/PR150/PWG/DR01 0
Water Generation & Distribution
System
2 Skid Drawings HPS/PR150/PWG/DR02 0
3 Isometric for Pretreatment System HPS/PR150/PWG/DR03 0
4 Isometric for RO-EDI System HPS/PR150/PWG/DR04 0
5 Control Panel Drawing HPS/PR150/PWG/DR05 0
6 CIP Tank Drawing HPS/PR150/PWG/DR06 0
8. SUPPORTING UTILITIES
SR. Equipments / Location Utilities Specification Scope

NO. Instruments
1 Pretreatment PW Raw Water 7000 LPH ZCHL

Plant Generation
Plant
Control Panel RO Plant Power 3 phase, 430V, 50 ZCHL

2 Room Hz
3 RO Plant RO Plant Compressed MOC of tube is ZCHL

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
A Manufacturers Manuals Preventive Maintenance (O.M.)
B MOC Certificate
C Leak Test Reports / Hydro Test Report
D Sanitization Reports
E Cleaning / Flushing Reports
F Manufacturers Catalogue
G Test Certificate
H Guarantee / Warranty Certificate
I Basis of Design
11. DESIGN QUALIFICATION REPORT

APPROVAL
Approved / Not Approved
Signature
Approved By
Vendor Executive name
Client Engineering
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 RO High Pressure Pump
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 Total Dissolved Solids
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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September 7, 2016 LATEST NEWS SOP on Acceptable Quality Level (AQL) During Product Inspection for p... Search...

FOR FREE UPDATE

DQ for Purified Water System 0

BY PHARMACEUTICAL GUIDANACE ON JULY 2, 2016 OTHER, QUALIFICATION, VALIDATION & QUALIFICATION

NAME OF THE SYSTEM :PRETREATMENT & PURIFIED WATER GENERATION SYSTEM

SR. NO. STAGE PAGE NO.

1 OBJECTIVE & SCOPE

4 SYSTEM DESCRIPTION (SYSTEM AND SUB-SYSTEM)

5 BASIS OF DESIGN AND ASSUMPTION

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11 DESIGN QUALIFICATION REPORT APPROVAL

1. OBJECTIVE AND SCOPE

3. When the existing system is subjected for up-gradation or modification.

Sr. Water Parameters Actual Design Consideration

4 Turbidity 1.8 Less than 5

5 SDI Not check < 3 assumed

6 Total Dissolved Solids 750 ppm 900 ppm

7 Total Alkalinity 120 ppm 120 ppm

8 Total Hardness 300 ppm 350 ppm

9 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

TYPE OF OPERATION : MANUAL OPERATION

Sr. Water Outlet of Outlet of Outlet of RO Outlet of

TSS < 5 ppm < 5 ppm Nil Nil

2. TDS / 1920 us/cm 1920 us/cm 200 us/cm 25 us/cm

3. Total Hardness 350 ppm Less than 5 Nil Nil

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)

Sr. Water Parameters USP 39 Action Alert Limit Design

1. Conductivity 1.25 s/cm 1.0 s/cm 0.8 s/cm 0.7 s/cm

3. TVC / TBC 100 CFU/ml 90 CFU/ml 70 CFU/ml 40 CFU/ml

Sr. Water Outlet of Outlet of Outlet of RO Outlet of

TSS < 5 ppm < 5 ppm Nil Nil

2. TDS / 1920 us/cm 1920 us/cm 200 us/cm 25 us/cm

3. Total Hardness 350 ppm Less than 5 Nil Nil

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

Sr. Water Parameters USP 34 Action Alert Limit Design

1. Conductivity 1.25 s/cm 1.0 s/cm 0.8 s/cm 0.7 s/cm

3. TVC / TBC 100 CFU/ml 90 CFU/ml 70 CFU/ml 40 CFU/ml

Sr. Water Parameters Actual Design Consideration

1 Colour < 5 CTU < 5 CTU

2 pH 7.5 6.5 8.5

3 SDI 900 1200

4 Total Dissolved Solids 1.8 Less than 5

5 Total Alkalinity Not check < 3 assumed

6 Total Suspended Solids 750 ppm 900 ppm

7 Total Hardness 120 ppm 120 ppm

8 Calcium as CaCO3 300 ppm 350 ppm

9 Magnesium as CaCO3 100 ppm 125 ppm