DQ for Purified Water System

Pharmaceutical Guidanace July 2, 2016 Validation & Qualification Comments Off on DQ for Purified Water System 5,848 Views

DQ for Purified Water System

NAME OF THE SYSTEM : PRETREATMENT & PURIFIED WATER GENERATION SYSTEM

TABLE OF CONTENTS

SR. NO.	STAGE
1	OBJECTIVE & SCOPE
2	ACCEPTANCE CRITERIA
3	RESPONSIBILITY
4	SYSTEM DESCRIPTION (SYSTEM AND SUB-SYSTEM)
5	BASIS OF DESIGN AND ASSUMPTION
6	TECHNICAL SPECIFICATIONS
7	DRAWINGS REQUIRED
8	SUPPORTING UTILITIES
9	PRE-QUALIFICATION CHECKLIST
10	LIST OF DOCUMENTS REQUIRED
11	DESIGN QUALIFICATION REPORT APPROVAL
12	ABBREVIATIONS

OBJECTIVE AND SCOPE

OBJECTIVE

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

When subjected for new installation
When the existing system is replaced with the new system.
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.

ACCEPTANCE CRITERIA

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. 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)

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 USP 39 std.)

Sr. No.	Water Parameters	USP 39	*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.

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.

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 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 39 Standards for Purified Water.

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. 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 USP 39 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)

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 than 50 ppm.

TECHNICAL SPECIFICATION:

Quantity : One

Flow rate : 7 m³/hr

Max. Working Pressure : 3.5 kg/cm²

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)

(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 : 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:

Normal Operation
Regeneration Operation
Slow Rinse Operation
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 m³OBR / 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)

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 Flow rate : 3.8 m³/hr

Conc. of Solution : 1 %

Dosing Pump flow rate: 1.52 LPH

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 : 3.8 m³/hr

Conc. of Solution : 2 %

Dosing Pump flow rate: 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:

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.

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

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.

TECHNICAL SPECIFICATION:

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

TECHNICAL SPECIFICATION:

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 μs/cm.

TECHNICAL SPECIFICATION:

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 : 45⁰C

Recovery : 70 %

Feed Water Flow Rate : 3800 m³/hr

Permeate Flow Rate : 2700 m³/hr

Reject Water Flow Rate : 1100 m³/hr

Sanitization Temp. : 85⁰C

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.

TECHNICAL SPECIFICATION:

No. of Housing : One

No. of Membranes in RO Housing : 4 Nos.

Make of Housing : HydroPure Systems

Material of Construction : SS 304

Diameter : 204 mm

Length : 4060 mm

Thickness : 2.5 mm

Surface Finish of RO Housing : Internally – < 0.4 Ra

Externally – mirror up to 180 grit

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.

TECHNICAL SPECIFICATION:

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 μs/cm.

TECHNICAL SPECIFICATION:

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 : 45⁰C

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.

TECHNICAL SPECIFICATION:

No. of Housing : One

Make of Housing : HydroPure Systems

Material of Construction : SS 316L

Diameter : 204 mm

Length : 2040 mm

Thickness : 2.5 mm

Surface Finish of RO Housing : Internally – < 0.4 Ra

Externally – mirror up to 180 grit

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.

TECHNICAL SPECIFICATION:

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

Max. Working Pressure : 2.5 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.

TECHNICAL SPECIFICATION:

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& 120^oC

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

TECHNICAL SPECIFICATION:

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

TECHNICAL SPECIFICATION:

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

6.B.1.2 PRESSURE GUAGES:

TAG NO: PG – 04 / 05 / 10

INSTRUMENT NAME: Pressure Gauges

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.

TECHNICAL SPECIFICATION:

Make : Waaree

Size of Gauge : 63 mm Dial

Range : 0 – 7 kg/cm²

End Connection : ¼” BSP (M)

MOC : SS Body with SS internals

Damping Liquid : Glycerin

Accuracy : ± 1.6 % of FS

6.B.1.3 PRESSURE GUAGES:

TAG NO: PG – 06 / 07 / 08 / 09

INSTRUMENT NAME: Pressure Gauges

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

TECHNICAL SPECIFICATION:

Make : Waaree

Size of Gauge : 63 mm Dial

Range : 0 – 21 kg/cm²

End Connection : 1/4” BSP (M)

MOC : SS Body with SS internals

Damping Liquid : Glycerin

Accuracy : ± 1.6 % of FS

6.B.1.3 PRESSURE GUAGES:

TAG NO: CIP-PG

INSTRUMENT NAME: Pressure Gauges

LOCATION: Discharge line of CIP Feed Pump-1

FUNCTION: To check the line pressure.

TECHNICAL SPECIFICATION:

Make : Waaree

Size of Gauge : 63 mm Dial

Range : 0 – 7 kg/cm²

End Connection : ¼” BSP (M)

MOC : SS Body with SS internals

Damping Liquid : Glycerin

Accuracy : ± 1.6 % of FS

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.

TECHNICAL SPECIFICATION:

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.

TECHNICAL SPECIFICATION:

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.

TECHNICAL SPECIFICATION:

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.

TECHNICAL SPECIFICATION:

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.

TECHNICAL SPECIFICATION:

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.

TECHNICAL SPECIFICATION:

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.

TECHNICAL SPECIFICATION:

Quantity : Two

Make : Emerson

Range : 0 – 200 µs/cm for First Pass Permeate

0 – 100 µs/cm for Second Pass Permeate

End Connection : 1 ½” 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

TECHNICAL SPECIFICATION:

Make : Emerson

Range : 0 – 10 µs/cm (EDI outlet)

End Connection : 1 ½” TC end connection.

MOC : SS 316 wettable parts

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.

TECHNICAL SPECIFICATION:

Make : Danfoss

Range : 1 to 16 bar

End Connection : 3/8” BSP (M)

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.

TECHNICAL SPECIFICATION:

Make : Danfoss

Range : 0 to 3 bar

End Connection : 3/8” BSP (M)

MOC : SS wettable parts

Type : Seamless Bellow type pressure switch

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.

TECHNICAL SPECIFICATION:

Quantity : One

Make : Mahalaxmi

Model : SMT-16M 3” TC-AH

MOC : SS 316

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

TECHNICAL SPECIFICATION:

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.

TECHNICAL SPECIFICATION:

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.

TECHNICAL SPECIFICATION:

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.

TECHNICAL SPECIFICATION:

Quantity : 07 Nos.

Make : Kumar Process

Type : Milipore Design

Size : 8 NB

M.O.C. : SS 316L

6.B.16 VALVE SCHEDULE

Sr. No.	Location of Valve	Tag No.	Size	Type	MOC
1	Before Raw Water Tank	AV-01	32 mm	Actuated Valve (NC)	SS 304
2	ORP dump valve	AV-02	25 mm	Actuated Valve (NC)	SS 304
3	RO-I Reject line (Auto Flushing)	AV-03	20 mm	Actuated Valve (NC)	SS 304
4	RO-I Conductivity dump valve	AV-04	20 mm	Actuated Valve (NC)	SS 304
5	RO-II Reject line (Auto Flushing)	AV-05	20 mm	Actuated Valve (NC)	SS 304
6	RO-II Conductivity dump valve	AV-06	20 mm	Actuated Valve (NC)	SS 304
7	Suction line of RWP-01	BV-01	1.5” NB	Manual Ball Valve	SS 304
8	Discharge line of RWP-01	BV-02	1.25” NB	Manual Ball Valve	SS 304
9	Suction line of RWP-02	BV-03	1.5” NB	Manual Ball Valve	SS 304
10	Discharge line of RWP-02	BV-04	1.25” NB	Manual Ball Valve	SS 304
11	MGF Inlet	BV-05	d40DN32	Manual Ball Valve	UPVC
12	MGF outlet	BV-06	d40DN32	Manual Ball Valve	UPVC
13	MGF back wash inlet	BV-07	d40DN32	Manual Ball Valve	UPVC
14	MGF back wash outlet	BV-08	d40DN32	Manual Ball Valve	UPVC
15	MGF drain	BV-09	d40DN32	Manual Ball Valve	UPVC
16	Softener-01 Inlet	BV-10	d40DN32	Manual Ball Valve	UPVC
17	Softener-01 Outlet	BV-11	d40DN32	Manual Ball Valve	UPVC
18	Softener-01 power water	BV-12	d25DN20	Manual Ball Valve	UPVC
19	Softener-01 brine injection	BV-13	d40DN32	Manual Ball Valve	UPVC
20	Softener-01 slow Rinse outlet	BV-14	d40DN32	Manual Ball Valve	UPVC
21	Softener-01 Fast Rinse outlet	BV-15	d40DN32	Manual Ball Valve	UPVC
22	Diversion line	BV-16	d40DN32	Manual Ball Valve	UPVC
23	Discharge ROHP-01	BV-17	25 mm	Manual Ball Valve	SS 304
24	Discharge ROHP-02	BV-18	25 mm	Manual Ball Valve	SS 304
25	Discharge line of Raw Water Pump – 01	NRV-01	1.25”	Non Return Valve	SS 304
26	Discharge line of Raw Water Pump – 02	NRV-02	1.25”	Non Return Valve	SS 304
27	Conc. Inlet EDI	DV-01	DN 20	Diaphragm Valve	SS 316
28	CIP Tank drain valve	CIP-DV-01	DN 20	Daiphragm Valve	SS 316
29	CIP Suction Valve	CIP-DV-02	DN 20	Daiphragm Valve	SS 316
30	CIP Discharge Valve	CIP-DV-03	DN 20	Diaphragm Valve	SS 316
31	ORP needle valve	NV-01	¼ ”	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 Dosing System	SP-01	8 NB	Sampling Valve	SS 304
35	Inlet of Multi Grade Filter	SP-02	8 NB	Sampling Valve	SS 304
36	Outlet of Multi Grade Filter	SP-03	8 NB	Sampling Valve	SS 304
37	Outlet of Softener-01	SP-04	8 NB	Sampling Valve	SS 304
38	After SMBS dosing system	SP-05	8 NB	Sampling Valve	SS 316
39	After ADS dosing system	SP-06	8 NB	Sampling Valve	SS 316
40	After pHC dosing system	SP-07	8 NB	Sampling Valve	SS 316
41	After 5-micron Cartridge Filter	SP-08	8 NB	Sampling Valve	SS 316
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

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.

TECHNICAL SPECIFICATION:

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 Input	A/I description	Analog Output	A/O description
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. No.	Interlock Description	Action Taken	Indication on MMI	Audio Visual Alarm
1	High Level in Raw Water Tank	Will close Actuated Valve AV-01	YES	YES
2	Medium Level in Raw Water Tank	Will open Actuated Valve AV-01	YES	NA
3	Low Level in Raw Water Tank	Will stop RWP-01 / 02	YES	YES
4	Medium Level in Raw Water Tank	Will start RWP-01 / 02	YES	NA
5	Low Level in NaOCl-01 Dosing Tank.	Will trip NaOCl-01 Dosing Pump & will close AV-01	YES	YES
6	Low flow in Raw Water inlet line	Will trip NaOCl-01 Dosing Pump & will close AV-01	YES	YES
7	High Totalized flow at outlet of softener	It Should give Alarm for Regeneration.	YES	YES
8	Emergency Stop	Should Trip the System.	YES	YES
9	Low level in SMBS 1 Dosing tank	RWP-01 will stop & RO-EDI System will stop.	YES	YES
10	Low level in ADS Dosing tank	RWP-01 will stop & RO-EDI System will stop.	YES	YES
11	Low Level in pH Correction Dosing tank	RWP-01 will stop & RO-EDI System will stop.	YES	YES
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 AV-02. 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.	YES YES YES	YES NA YES
13	Low Pressure at ROHP – 01 suction	This will trip the ROHP – 01	YES	YES
14	Repeated Low Pressure at ROHP – 01 suction	After ROHP – 01 trips for 4 times in a minute. This will trip the entire plant.	YES	YES
15	High Pressure at ROHP –01 discharge	RO – EDI system will trip.	YES	YES
16	High Conductivity at RO pass – I outlet	1) If the conductivity is above the set point, it will open the dumping valve AV-04. 2) After 30 secs. of consistent reading, below the set value, it will close the AV-04. Allow the water to feed to the 2^nd 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.	YES YES YES	YES NA YES
17	Low Pressure at ROHP – II	This will trip the ROHP – II	YES	YES
18	High Pressure in ROHP – II discharge	RO – EDI system will trip.	YES	YES
19	High Conductivity at RO pass – II outlet	1) If the conductivity is above the set point, it will open the dumping valve AV-06. 2) After 30 secs. of consistent reading, below the set value, it will close the AV-06. Allow the water to feed to the EDI system. The entire system will start automatically. 3) If the RO pass-II outlet conductivity is high for more than 300 secs. it will trip the plant.	YES YES YES	YES NA YES
20	Low pressure at EDI inlet	Low pressure at EDI inlet, will trip EDI unit.	YES	YES
21	High Conductivity at EDI outlet	1) If the conductivity is above the set point, it will open the dumping valve FDV-01. 2) After 30 secs. of consistent reading below the set value, it will close the FDV-01. Allow the water to feed to the purified water tank. The entire system will start automatically. 3) If the EDI outlet conductivity is high for more than 300 secs. it will trip the plant.	YES YES YES	YES NA YES
22	Low temperature at CIP supply line	Ceramic Heater will be ON.	YES	NA
23	High temperature at CIP supply line	Ceramic Heater will be OFF.	YES	NA
24	Low Level in CIP Tank	Should trip the Heater & CIP Feed Pump.	YES	YES
25	Emergency Stop	RO-EDI System will trip.	YES	YES

DRAWINGS REQUIRED

SR. NO.	DESCRIPTION	DRAWING NO.	REV
1	P&ID for Pretreatment & Purified Water Generation & Distribution System	HPS/PR150/PWG/DR01	0
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

SUPPORTING UTILITIES

SR. NO.	Equipments / Instruments	Location	Utilities	Specification	Scope
1	Pretreatment Plant	PW Generation Plant	Raw Water	7000 LPH	ZCHL
2	Control Panel	RO Plant Room	Power	3 phase, 430V, 50 Hz	ZCHL
3	RO Plant	RO Plant Room	Compressed Filtered regulated Air	MOC of tube is PU, Press – 6 kg/cm²	ZCHL

PRE-QUALIFICATION CHECK LIST

9.1 HYDRAULIC PRESSURE TEST

9.2 DOCUMENTATION CHECK

9.3 INTERLOCK CHECKS

9.4 OPERATIONAL CHECKS

LIST OF DOCUMENTS REQUIRED FOR GENERATION SYSTEM

CODE	DOCUMENTS REQUIRED
A	Manufacturer’s Manuals – Preventive Maintenance (O.M.)
B	MOC Certificate
C	Leak Test Reports / Hydro Test Report
D	Sanitization Reports
E	Cleaning / Flushing Reports
F	Manufacturer’s Catalogue
G	Test Certificate
H	Guarantee / Warranty Certificate
I	Basis of Design

DESIGN QUALIFICATION REPORT

APPROVAL

Approved / Not Approved

Approved By		Signature
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

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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About Pharmaceutical Guidanace

Ms. Abha Maurya is the Author and founder of pharmaceutical guidance, he is a pharmaceutical Professional from India having more than 18 years of rich experience in pharmaceutical field. During his career, he work in quality assurance department with multinational company’s i.e Zydus Cadila Ltd, Unichem Laboratories Ltd, Indoco remedies Ltd, Panacea Biotec Ltd, Nectar life Science Ltd. During his experience, he face may regulatory Audit i.e. USFDA, MHRA, ANVISA, MCC, TGA, EU –GMP, WHO –Geneva, ISO 9001-2008 and many ROW Regularities Audit i.e.Uganda,Kenya, Tanzania, Zimbabwe. He is currently leading a regulatory pharmaceutical company as a head Quality. You can join him by Email, Facebook, Google+, Twitter and YouTube

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