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Project / Pretreatment & Purified Water Generation System
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DESIGN QUALIFICATION
DESIGN
QUALIFICATION
NAME OF THE UTILITY / EQUIPMENT / SYSTEM / AREA / PRETREATMENT & PURIFIED WATER GENERATION SYSTEM
ID. NO. OF THE UTILITY / EQUIPMENT / SYSTEM / AREA
VENDOR’S NAME & ADDRESS
DOCUMENT NUMBER
TABLE OF CONTENTS
SR. NO. / STAGE / PAGE NO.
1 / OBJECTIVE & SCOPE / 3
2 / ACCEPTANCE CRITERIA / 4
3 / RESPONSIBILITY / 8
4 / SYSTEM DESCRIPTION (SYSTEM AND SUB-SYSTEM) / 9
5 / BASIS OF DESIGN AND ASSUMPTION / 13
6 / TECHNICAL SPECIFICATIONS / 16
7 / DRAWINGS REQUIRED / 57
8 / SUPPORTING UTILITIES / 58
9 / PRE-QUALIFICATION CHECKLIST / 59
10 / LIST OF DOCUMENTS REQUIRED / 60
11 / DESIGN QUALIFICATION REPORT APPROVAL / 61
12 / ABBREVIATIONS / 62

1.OBJECTIVE AND SCOPE

1.1OBJECTIVE

A)To prepare detailed specification for all major components of Equipment / instrument to ensure that the User Requirement Specification and functional requirement specification are achieved.

B)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.

1.2SCOPE

Application to any equipment, system, facility, process & software programs.

a)When subjected for new installation

b)When the existing system is replaced with the new system.

c)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 34.

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. No. / Water Parameters / Actual Parameters / Design Consideration
1 / Colour / < 5 CTU / < 5 CTU
2 / pH / 7.5 / 6.5 – 8.5
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)

FEED FLOWRATE:2700 LPH

REJECT RECYCLE FLOWRATE:500 LPH

PERMEATE FLOWRATE:2200 LPH

OVER ALL RECOVERY:80%

TYPE OF OPERATION:FULLY AUTO & MANUAL OPERATION

FOR EDI SYSTEM

FEED FLOWRATE:2200 LPH

PERMEATE FLOWRATE:2000 LPH

REJECT FLOWRATE: 200 LPH

TYPE OF OPERATION:FULLY AUTO & MANUAL OPERATION

OVERALL RECOVERY:90%

TREATED WATER QUALITY

STAGE WISE TREATED WATER QUALITY AFETR RO:

(On basis of maximum feed water limiting condition)

Sr.No. / Water Parameter / Outlet of Multi Grade Filter / Outlet of Softener / Outlet of RO Pass I / Outlet of RO Pass II
1. / Ph / 6 to 8.5 / 6 to 8.5 / 5 – 6 / 5 – 6
TSS / < 5 ppm / < 5 ppm / Nil / Nil
2. / TDS / Conductivity / 1920 us/cm / 1920 us/cm / 200 us/cm / 25 us/cm
3. / Total Hardness ( in ppm) / 350 ppm / Less than 5 ppm / 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’)

(PURIFIED WATER AS PER USP34 std.)

Sr.
No. / Water Parameters / USP 34 / Action
Limit / Alert Limit / Design
Limit
1. / Conductivity / 1.25 µs/cm / 1.0 µs/cm / 0.8 µs/cm / 0.7 µs/cm
2. / TOC in PPB / 500 ppb / 300 ppb / 200 ppb / 100 ppb
3. / TVC / TBC
Microbial Count / 100 CFU/ml / 90 CFU/ml / 70 CFU/ml / 40 CFU/ml

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 and

Maintenance 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 2m3/hr. of Purified water as Per USP 34 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 Membranesalong with High Pressure Housing
  • Conductivity meter with Alarm

POST TREATMENT:

  • Hot Water Sanitizable Electro – Deionization Unit
  • Conductivity meter with Alarm

4.1 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.

SodiumMetabisulphite(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 304wettable parts of M/s. Grundfos, Denmark. The First pass Reverse Osmosis System will generate2700 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 ofDOW. The material of construction of the RO membrane is Polyamide. The RO membrane is housed in the High Pressure SS 316LWettable 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 15-20ppm.

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 perUSP 34Standards for Purified Water.

5.BASIS OF DESIGN AND ASSUMPTION

5.1FEED WATER SAMPLE:

The system design is based on the feed water analysis provided by the customer as per Annexure A.

5.2PRODUCT WATER QUALITY:

STAGE WISE TREATED WATER PARAMETER:

(On basis of maximum feed water limiting condition)

Sr.No. / Water Parameter / Outlet of Multi Grade Filter / Outlet of Softener / Outlet of RO Pass I / Outlet of RO Pass II
1. / Ph / 6 to 8.5 / 6 to 8.5 / 5 – 6 / 5 – 6
TSS / < 5 ppm / < 5 ppm / Nil / Nil
2. / TDS / Conductivity / 1920 us/cm / 1920 us/cm / 200 us/cm / 25 us/cm
3. / Total Hardness ( in ppm) / 350 ppm / Less than 5 ppm / 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’)

(PURIFIED WATER AS PER USP34 std.)

Sr.
No. / Water Parameters / USP 34 / Action
Limit / Alert Limit / Design
Limit
1. / Conductivity / 1.25 µs/cm / 1.0 µs/cm / 0.8 µs/cm / 0.7 µs/cm
2. / TOC in PPB / 500 ppb / 300 ppb / 200 ppb / 100 ppb
3. / TVC / TBC
Microbial Count / 100 CFU/ml / 90 CFU/ml / 70 CFU/ml / 40 CFU/ml

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. No. / Water Parameters / Actual Parameters / 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
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.
TECHNICAL SPECIFICATION:
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 than50 ppm.
TECHNICAL SPECIFICATION:
Quantity: One
Flow rate : 7 m3/hr
Max. Working Pressure: 3.5kg/cm2
Max. Pressure Drop:0.5 kg/cm2
Diameter: 600 mm
Height: 1800mm
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)
(In Close Position: BV-05, BV-06& BV-09)
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)
(In Close Position: BV-06, BV-07 & BV-08)

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.
TECHNICAL SPECIFICATION:
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: 600mm
Height on straight: 1800mm
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.5SODIUM 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)
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 : SS 304
Dosing Tank : 25 Liters Provided
Low Level Switch :Provided
Make:Milton Roy
Model :UC 11
DOSING CALCULATION:
Dosage required : 4 ppm
Feed Flowrate :3.8 m3/hr
Conc. of Solution:1 %
Dosing Pump flowrate:1.52LPH
If we consider 3 shifts of 8 hrs. = 8 x 3 = 24 hrs.
Amount of dosing solution = 1.52 x 24 = 36.48 Ltrs.

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.
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 : SS 304
Dosing Tank : 25 Liters Provided
Low Level Switch :Provided
Make:Milton Roy
Model :UC 11
DOSING CALCULATION:
Dosage required : 5 ppm
Feed Flow rate :3.8m3/hr
Conc. of Solution:2 %
Dosing Pump flowrate:0.95 LPH
If we consider 3 shifts of 8 hrs. = 8 x 3 = 24 hrs.
Amount of dosing solution = 0.95 x 24 =22.8 Ltrs.

6.A.7 pH CORRECTION DOSING SYSTEM: