Professional Documents
Culture Documents
DQ For Purified Water System - Pharmaceutical Guidance
DQ For Purified Water System - Pharmaceutical Guidance
OPEN
TABLE OF CONTENTS
SR.
STAGE PAGE NO.
NO.
2 ACCEPTANCE CRITERIA
3 RESPONSIBILITY
6 TECHNICAL SPECIFICATIONS
7 DRAWINGS REQUIRED
8 SUPPORTING UTILITIES
9 PRE-QUALIFICATION CHECKLIST
https://pharmaguidances.com/dq-for-purified-water-system/ 1/58
12/3/2020 DQ for Purified Water System - Pharmaceutical Guidance
12 ABBREVIATIONS
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
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
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
https://pharmaguidances.com/dq-for-purified-water-system/ 2/58
12/3/2020 DQ for Purified Water System - Pharmaceutical Guidance
OPEN
https://pharmaguidances.com/dq-for-purified-water-system/ 3/58
12/3/2020 DQ for Purified Water System - Pharmaceutical Guidance
(Note. 1. Feed Water is free from pathogens like E- Coli, Pseudonymous, Salmonella)
FOR SOFTENER
https://pharmaguidances.com/dq-for-purified-water-system/ 4/58
12/3/2020 DQ for Purified Water System - Pharmaceutical Guidance
OBR : 76 m3
NO OF HRS : 20 hrs
https://pharmaguidances.com/dq-for-purified-water-system/ 5/58
12/3/2020 DQ for Purified Water System - Pharmaceutical Guidance
OVERALL RECOVERY : 90 %
Total Hardness ( in
3. 350 ppm Less than 5 ppm Nil Nil
ppm)
https://pharmaguidances.com/dq-for-purified-water-system/ 6/58
12/3/2020 DQ for Purified Water System - Pharmaceutical Guidance
2. TOC in PPB 500 ppb 300 ppb 200 ppb 100 ppb
TVC / TBC
3. 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
The Fully Automated PLC based Purified Water Generation system generate 2 m3/hr. of Purified water as Per
USP 39 Standards.
SCHEME:
Softener Unit
https://pharmaguidances.com/dq-for-purified-water-system/ 7/58
12/3/2020 DQ for Purified Water System - Pharmaceutical Guidance
pH Correction System
5 – Micron Cartridge Filter
POST TREATMENT:
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
(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
https://pharmaguidances.com/dq-for-purified-water-system/ 8/58
12/3/2020 DQ for Purified Water System - Pharmaceutical Guidance
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
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
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
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
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.
https://pharmaguidances.com/dq-for-purified-water-system/ 9/58
12/3/2020 DQ for Purified Water System - Pharmaceutical Guidance
The Permeate water from RO system will be fed to the Electro Deionization Unit (EDI) having designed
The system design is based on the feed water analysis provided by the customer as per Annexure -A.
Total Hardness ( in
3. 350 ppm Less than 5 ppm Nil Nil
ppm)
TREATED WATER QUALITY AFTER UF: (as per ‘Design Limits’) (PURIFIED WATER AS PER USP 39
std.)
https://pharmaguidances.com/dq-for-purified-water-system/ 10/58
12/3/2020 DQ for Purified Water System - Pharmaceutical Guidance
2. TOC in PPB 500 ppb 300 ppb 200 ppb 100 ppb
TVC / TBC
Note: With the change in the incoming water parameters, the treated water quantity & quality may get
ANNEXURE – A
https://pharmaguidances.com/dq-for-purified-water-system/ 11/58
12/3/2020 DQ for Purified Water System - Pharmaceutical Guidance
(Note. 1. Feed Water is free from pathogens like E- Coli, Pseudonymous, Salmonella)
6. TECHNICAL SPECIFICATIONS
FUNCTION: For Bacterial Disinfection in raw water. These will inhibit the bacterial growth. Sodium Hypo
TECHNICAL SPECIFICATION:
Quantity : One
https://pharmaguidances.com/dq-for-purified-water-system/ 12/58
12/3/2020 DQ for Purified Water System - Pharmaceutical Guidance
Model : UC 11
DOSING CALCULATION:
Conc. of Solution : 1%
TECHNICAL SPECIFICATION:
Head : 35 mWC
Privacy & Cookies Policy
https://pharmaguidances.com/dq-for-purified-water-system/ 13/58
12/3/2020 DQ for Purified Water System - Pharmaceutical Guidance
Make : Nanfang
EQUIPMENT LOCATION: After Sodium Hypo-chlorite Dosing System, Piping and Raw Water Tank.
FUNCTION: It filters the suspended solids in the Raw water up to 5 ppm with the help of Multi Grade Filter
in the vessel, the inlet suspended solids should be less than 50 ppm.
TECHNICAL SPECIFICATION:
Quantity : One
Diameter : 600 mm
Height : 1800 mm
2 mm Particle size.
https://pharmaguidances.com/dq-for-purified-water-system/ 14/58
12/3/2020 DQ for Purified Water System - Pharmaceutical Guidance
Operation:
1. Normal Operation
3. Rinse Operation
1. Normal Operation:
Since MGF is a Vertical Down Flow Vessel the Suspended Solids are removed by passing through Filtering
Media which is been 60% filled. For normal operation position of Ball valves which are mounted on MGF
should be (In Open Position: BV-05 & BV-06)
Back Wash is used to remove the Suspended Matter which is entrapped in the filter Media Top Layer
during Normal Operation. Back Wash is done after 20 hr OR if the differential pressure across the filter is
For changing from normal operation to backwash operation, the position of the Ball Valves should be (In
https://pharmaguidances.com/dq-for-purified-water-system/ 15/58
12/3/2020 DQ for Purified Water System - Pharmaceutical Guidance
3. Rinse Operation:
Rinse Operation is done after Back Wash. Rinse is done to remove the Suspended Solid which is
For changing from Back Wash operation to Rinse operation, the position of the Ball Valves should be (In
6.A.4 SOFTENER:
FUNCTION: It will replace the hardness causing Ca & Mg ions with Na ions. This will soften the raw water
and will avoid scale formation. Treated Water at the outlet of softener-II will have hardness less than 5 ppm.
Flow totalizer will be provided at the outlet of softener unit to indicate the amount of soft water generated
and give indication after pre define quantity of soft water is generated.
TECHNICAL SPECIFICATION:
Quantity : One
Diameter : 600 mm
https://pharmaguidances.com/dq-for-purified-water-system/ 16/58
12/3/2020 DQ for Purified Water System - Pharmaceutical Guidance
Operation:
1. Normal Operation
2. Regeneration Operation
1. Normal Operation:
Privacy & Cookies Policy
https://pharmaguidances.com/dq-for-purified-water-system/ 17/58
12/3/2020 DQ for Purified Water System - Pharmaceutical Guidance
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:
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
For changing from normal operation to regeneration mode, the valve position should be
Slow Rinse is used to get properly mix up with Salts & Resins.
https://pharmaguidances.com/dq-for-purified-water-system/ 18/58
12/3/2020 DQ for Purified Water System - Pharmaceutical Guidance
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
Model : UC 11
DOSING CALCULATION:
Conc. of Solution : 1%
https://pharmaguidances.com/dq-for-purified-water-system/ 19/58
12/3/2020 DQ for Purified Water System - Pharmaceutical Guidance
6.A.6 ANTISCALENT DOSING SYSTEM:
TECHNICAL SPECIFICATION:
Quantity : One
Model : UC 11
DOSING CALCULATION:
Conc. of Solution : 2%
https://pharmaguidances.com/dq-for-purified-water-system/ 20/58
12/3/2020 DQ for Purified Water System - Pharmaceutical Guidance
FUNCTION: To boost up the pH of RO feed water so as to convert the dissolved CO2 into alkalinity and
TECHNICAL SPECIFICATION:
Quantity : One
Model : UC 11
TAG NO: CF – 01
Privacy & Cookies Policy
https://pharmaguidances.com/dq-for-purified-water-system/ 21/58
12/3/2020 DQ for Purified Water System - Pharmaceutical Guidance
FUNCTION: It filter all the suspended solids in water greater than 5 – micron thus avoid chocking in RO
membrane.
TECHNICAL SPECIFICATION:
Rating : 5 micron
https://pharmaguidances.com/dq-for-purified-water-system/ 22/58
12/3/2020 DQ for Purified Water System - Pharmaceutical Guidance
TECHNICAL SPECIFICATION:
Quantity : One
Pressure : 12 kg / cm2
Make : Grundfos
FUNCTION: RO membranes reduce the TDS & microbial load in the water. The semi-permeable reverse
osmosis membrane has molecular weight cut off less than 150 MWCO. The Reveres Osmosis membrane
acts as positive barrier to remove dissolved solids, organic compounds & bacteria. Membranes consist of
thin film composite type. It will bring down the conductivity less than 200 μs/cm.
TECHNICAL SPECIFICATION:
https://pharmaguidances.com/dq-for-purified-water-system/ 23/58
12/3/2020 DQ for Purified Water System - Pharmaceutical Guidance
Model : HSRO-390FF
Recovery : 70 %
TECHNICAL SPECIFICATION:
Diameter : 204 mm
Length : 4060 mm
Thickness : 2.5 mm
https://pharmaguidances.com/dq-for-purified-water-system/ 24/58
12/3/2020 DQ for Purified Water System - Pharmaceutical Guidance
TECHNICAL SPECIFICATION:
Quantity : One
Pressure : 9 kg/cm2
Make : Grundfos
FUNCTION: RO membranes reduce the TDS & microbial load in the water. The semi-permeable reverse
Privacy & Cookies Policy
https://pharmaguidances.com/dq-for-purified-water-system/ 25/58
12/3/2020 DQ for Purified Water System - Pharmaceutical Guidance
osmosis membrane has molecular weight cut off less than 150 MWCO. The Reveres Osmosis membrane
acts as positive barrier to remove dissolved solids, organic compounds & bacteria. Membranes consist of
thin film composite type. This will bring down the conductivity less than 25 μs/cm.
TECHNICAL SPECIFICATION:
Model : HSRO-390FF
Recovery : 80-85 %
TECHNICAL SPECIFICATION:
Privacy & Cookies Policy
https://pharmaguidances.com/dq-for-purified-water-system/ 26/58
12/3/2020 DQ for Purified Water System - Pharmaceutical Guidance
Diameter : 204 mm
Length : 2040 mm
Thickness : 2.5 mm
FUNCTION: EDI bring down the conductivity of RO treated water. The water generated from the outlet of
TECHNICAL SPECIFICATION:
https://pharmaguidances.com/dq-for-purified-water-system/ 27/58
12/3/2020 DQ for Purified Water System - Pharmaceutical Guidance
End Connection : 1” TC
Cathode : SS 316
https://pharmaguidances.com/dq-for-purified-water-system/ 28/58
12/3/2020 DQ for Purified Water System - Pharmaceutical Guidance
TECHNICAL SPECIFICATION:
Quantity : One
https://pharmaguidances.com/dq-for-purified-water-system/ 29/58
12/3/2020 DQ for Purified Water System - Pharmaceutical Guidance
TECHNICAL SPECIFICATION:
Quantity : One
Make : Grundfos
3) Outlet of Softener
https://pharmaguidances.com/dq-for-purified-water-system/ 30/58
12/3/2020 DQ for Purified Water System - Pharmaceutical Guidance
TECHNICAL SPECIFICATION:
Make : Waaree
TAG NO: PG – 04 / 05 / 10
TECHNICAL SPECIFICATION:
Make : Waaree
Range : 0 – 7 kg/cm2
Accuracy : ± 1.6 % of FS
Privacy & Cookies Policy
https://pharmaguidances.com/dq-for-purified-water-system/ 31/58
12/3/2020 DQ for Purified Water System - Pharmaceutical Guidance
TAG NO: PG – 06 / 07 / 08 / 09
TECHNICAL SPECIFICATION:
Make : Waaree
Range : 0 – 21 kg/cm2
Accuracy : ± 1.6 % of FS
https://pharmaguidances.com/dq-for-purified-water-system/ 32/58
12/3/2020 DQ for Purified Water System - Pharmaceutical Guidance
TECHNICAL SPECIFICATION:
Make : Waaree
Range : 0 – 7 kg/cm2
Accuracy : ± 1.6 % of FS
6.B.2 ROTAMETER:
TECHNICAL SPECIFICATION:
https://pharmaguidances.com/dq-for-purified-water-system/ 33/58
12/3/2020 DQ for Purified Water System - Pharmaceutical Guidance
Model : SK
TECHNICAL SPECIFICATION:
Model : FT-650
Line Size : 38 mm
https://pharmaguidances.com/dq-for-purified-water-system/ 34/58
12/3/2020 DQ for Purified Water System - Pharmaceutical Guidance
FUNCTION: To check the Level in the tank. If the level in the tank is below the desired level the system will
TECHNICAL SPECIFICATION:
Quantity : One
MOC : PVC
LOCATION:
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:
Quantity : 05 Nos.
Privacy & Cookies Policy
https://pharmaguidances.com/dq-for-purified-water-system/ 35/58
12/3/2020 DQ for Purified Water System - Pharmaceutical Guidance
Type : Magnetic
MOC : PP
TECHNICAL SPECIFICATION:
Quantity : One
MOC : SS 316
Size : 1.5”
FUNCTION: ORP Analyzer is provided so as to check the absence/presence of chlorine in the feed 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
TECHNICAL SPECIFICATION:
Quantity : One
Privacy & Cookies Policy
https://pharmaguidances.com/dq-for-purified-water-system/ 36/58
12/3/2020 DQ for Purified Water System - Pharmaceutical Guidance
FUNCTION: To check the conductivity in the water, if the conductivity in the feed water is sensed high
above a settable value then it will give an indication on the panel & open the dumping valve and dump the
TECHNICAL SPECIFICATION:
Quantity : Two
Make : Emerson
https://pharmaguidances.com/dq-for-purified-water-system/ 37/58
12/3/2020 DQ for Purified Water System - Pharmaceutical Guidance
FUNCTION: To check the conductivity in the water, if the conductivity in the feed water is sensed high
above a settable value then it will give an indication on the panel & open the dumping valve and dump the
TECHNICAL SPECIFICATION:
Make : Emerson
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
https://pharmaguidances.com/dq-for-purified-water-system/ 38/58
12/3/2020 DQ for Purified Water System - Pharmaceutical Guidance
LOCATION:
FUNCTION: To check the pressure in the water, if the line pressure in the feed water is sensed low below
the settable value then it will trip the entire RO-EDI system.
TECHNICAL SPECIFICATION:
Make : Danfoss
Range : 0 to 3 bar
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:
Privacy & Cookies Policy
https://pharmaguidances.com/dq-for-purified-water-system/ 39/58
12/3/2020 DQ for Purified Water System - Pharmaceutical Guidance
Quantity : One
Make : Mahalaxmi
MOC : SS 316
TECHNICAL SPECIFICATION:
Make : Wika
Range : 0 to 2000 C
LOCATION :
https://pharmaguidances.com/dq-for-purified-water-system/ 40/58
12/3/2020 DQ for Purified Water System - Pharmaceutical Guidance
FUNCTION: To monitor the plant operation in Auto/Semi-Auto mode as per the pre-set logic & time.
TECHNICAL SPECIFICATION:
Make : Avcon
TECHNICAL SPECIFICATION:
MOC : SS 316L
https://pharmaguidances.com/dq-for-purified-water-system/ 41/58
12/3/2020 DQ for Purified Water System - Pharmaceutical Guidance
Size : 1”
6.B.15 SAMPLING VALVE:
TECHNICAL SPECIFICATION:
Quantity : 07 Nos.
Size : 8 NB
M.O.C. : SS 316L
https://pharmaguidances.com/dq-for-purified-water-system/ 42/58
12/3/2020 DQ for Purified Water System - Pharmaceutical Guidance
valve
13 MGF back wash inlet BV-07 d40DN32 Manual Ball Valve UPVC
14 MGF back wash outlet BV-08 d40DN32 Manual Ball Valve UPVC
26 Discharge line of Raw Water NRV-02 1.25” Non Return Valve SS 304
https://pharmaguidances.com/dq-for-purified-water-system/ 43/58
12/3/2020 DQ for Purified Water System - Pharmaceutical Guidance
Pump – 02
https://pharmaguidances.com/dq-for-purified-water-system/ 44/58
12/3/2020 DQ for Purified Water System - Pharmaceutical Guidance
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
TECHNICAL SPECIFICATION:
Make : Mitsubishi
Make : Mitsubishi
MMI ( Monochrome)
Make : Mitsubishi
https://pharmaguidances.com/dq-for-purified-water-system/ 45/58
12/3/2020 DQ for Purified Water System - Pharmaceutical Guidance
Size : 3.5”
Output
Sr.No D/Input Input Description D/Output
description
6 X5 FS-01 Y5 RWP-02
HL – Raw Water
7 X6 Y6 ROHP-01
Tank
ML – Raw Water
8 X7 Y7 ROHP-02
Tank
https://pharmaguidances.com/dq-for-purified-water-system/ 46/58
12/3/2020 DQ for Purified Water System - Pharmaceutical Guidance
PWST Ceramic
31 X36
Heater
34 X41 EMERGENCY
35 X42 ACCEPT
https://pharmaguidances.com/dq-for-purified-water-system/ 47/58
12/3/2020 DQ for Purified Water System - Pharmaceutical Guidance
37 X44 Spare
38 X45 Spare
39 X46 Spare
40 X47 Spare
6 AI-6 PWD – FT 01
7 AI-7 PWD – TT 01
6.C.3 System Description & Process Logics for Purified water Generation System
Audio
Sr. Indication on
Interlock Description Action Taken Visual
No. MMI
Alarm
https://pharmaguidances.com/dq-for-purified-water-system/ 48/58
12/3/2020 DQ for Purified Water System - Pharmaceutical Guidance
Low Level in NaOCl-01 Will trip NaOCl-01 Dosing Pump & will
5 YES YES
Dosing Tank. close AV-01
Low flow in Raw Water Will trip NaOCl-01 Dosing Pump & will
6 YES YES
inlet line close AV-01
Low level in ADS Dosing RWP-01 will stop & RO-EDI System
10 YES YES
tank will stop.
above the set point. This will open the YES YES
ORP dumping valve AV-02.
https://pharmaguidances.com/dq-for-purified-water-system/ 49/58
12/3/2020 DQ for Purified Water System - Pharmaceutical Guidance
YES YES
13
Low Pressure at ROHP –
This will trip the ROHP – 01 YES YES
01 suction
https://pharmaguidances.com/dq-for-purified-water-system/ 50/58
12/3/2020 DQ for Purified Water System - Pharmaceutical Guidance
YES YES
valve AV-06.
https://pharmaguidances.com/dq-for-purified-water-system/ 51/58
12/3/2020 DQ for Purified Water System - Pharmaceutical Guidance
YES YES
YES
Low pressure at EDI inlet, will trip EDI
20 Low pressure at EDI inlet YES
unit.
YES YES
valve FDV-01.
YES YES
https://pharmaguidances.com/dq-for-purified-water-system/ 52/58
12/3/2020 DQ for Purified Water System - Pharmaceutical Guidance
24 Low Level in CIP Tank Should trip the Heater & CIP Feed YES YES
Pump.
25 Emergency Stop RO-EDI System will trip. YES YES
7. DRAWINGS REQUIRED
8. SUPPORTING UTILITIES
SR. Equipments /
Location Utilities Specification Scope
NO. Instruments
PW Generation
1 Pretreatment Plant Raw Water 7000 LPH ZCHL
Plant
https://pharmaguidances.com/dq-for-purified-water-system/ 53/58
12/3/2020 DQ for Purified Water System - Pharmaceutical Guidance
Compressed ZCHL
MOC of tube is PU,
3 RO Plant RO Plant Room Filtered regulated
Press – 6 kg/cm2
Air
B MOC Certificate
D Sanitization Reports
F Manufacturer’s Catalogue
G Test Certificate
I Basis of Design
https://pharmaguidances.com/dq-for-purified-water-system/ 54/58
12/3/2020 DQ for Purified Water System - Pharmaceutical Guidance
APPROVAL
Approved By Signature
Engineering
Client
Head-Operations
Head-Quality
Abbreviation
Description
QA Quality Assurance
https://pharmaguidances.com/dq-for-purified-water-system/ 55/58
12/3/2020 DQ for Purified Water System - Pharmaceutical Guidance
pHC pH Correction
CF Cartridge Filter
RO Reverse Osmosis
EDI Electro-Deionization
TC Tri Clover
12. ABBREVIATIONS
PG Pressure Gauge
RM Rotameter
Privacy & Cookies Policy
https://pharmaguidances.com/dq-for-purified-water-system/ 56/58
12/3/2020 DQ for Purified Water System - Pharmaceutical Guidance
SS Stainless Steel
PP Poly-Propylene
https://pharmaguidances.com/dq-for-purified-water-system/ 57/58
12/3/2020 DQ for Purified Water System - Pharmaceutical Guidance
Pharmaceutical Guidanace
Mr. Shiv Kumar is the Author and founder of pharmaceutical guidance, he is a pharmaceutical Professional from India having more than 14 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
https://pharmaguidances.com/dq-for-purified-water-system/ 58/58