Design Qualification Purified Water Storage & Distribution System/ PDF

Learn About the scope, responsibility, objective, acceptance criteria, Technical specification, Drawing, Checklist, Calibration, and Documents required for the Design Qualification Protocol of Purified Water Storage & Distribution System.

DESIGN QUALIFICATION:

NAME OF THE UTILITY / EQUIPMENT /SYSTEM / AREA	Purified water Storage & Distribution System
VENDOR’S NAME & ADDRESS	—
USER DEPARTMENT	XYZ Pharmaceuticals
DOCUMENT NUMBER	XYZ

TABLE OF CONTENTS:

S.N.	STAGE
1	OBJECTIVE & SCOPE
2	ACCEPTANCE CRITERIA
3	RESPONSIBILITIES
4	SYSTEM DESCRIPTION
5	BASIS OF DESIGN AND ASSUMPTION
6	TECHNICAL SPECIFICATION
6.01	STORAGE TANK
6.02	DISTRIBUTION PUMP
6.03	VENT FILTER
6.04	SANITARY PRESSURE GAUGE
6.05	TUBES AND FITTINGS
6.06	COMPOUND PRESSURE GAUGE
6.07	TEMPERATURE SENSOR
6.08	TEMPERATURE INDICATOR CUM CONTROLLER
6.09	CONDUCTIVITY SENSOR
6.10	CONDUCTIVITY INDICATOR CUM CONTROLLER
6.11	DIAPHRAGM VALVE
6.12	STEAM CONTROL VALVE
6.13	LEVEL TRANSMITTER
6.14	FLOW METER
6.15	3 WAY DIVERTOR VALVE (DUMPING)
6.16	ULTRA VIOLET PURIFIER
6.17	SHELL & TUBE HEAT EXCHANGER
6.18	CONTROL PANEL
7	DRAWINGS REQUIRED
8	CALIBRATION OF INSTRUMENTS
9	SUPPORTING UTILITIES
10	PRE-QUALIFICATION CHECKLIST
11	DOCUMENTS REQUIRED
12	DESIGN QUALIFICATION REPORT APPROVAL

1.0 OBJECTIVE AND SCOPE

1.1 Objective:

A) To prepare detailed specifications for all major components of Equipment/ instruments to ensure that the User Requirement Specifications are Achieved.

B) To design the equipment/instrument in conjunction with the design data in order to provide a basis for the vendor, manufacturer & / or design engineer to design the system when the project begins.

1.2 Scope:

Application to any equipment, system, facility, process, or software program.

a)  When subjected to new installation

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

c) When the existing system is subjected to up-gradation & / or modification.

d) When the existing system is relocated to another position

All URS 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.

2.0 Acceptance Criteria:

2.1 Equipment/ Utility system shall conform to specifications which are as per the user requirements.

2.2 The Equipment / Utility/system shall conform to the predetermined requirements and a certificate is issued by the projects / Engineering Department.

2.3 The following points are included in the design:

• Water quality is to be maintained as per the input feed quality at the user points.
• Gradient 1:100 to 1:200 for complete drainability.
• Velocity @ 2.2 m/s during non-peak load hours.
• Dead legs if any shall be <=3 D
• POU Pressure – 1.0 Kg/cm2
• Loop circulation Temp maintained at ambient temperature.
• Chloride free Insulation if any:
  • The system is CIP / SIP – for the storage tank and distribution loop
  • Orbital Weld Joints and Sanitary Tri-clamp joints

All contact parts (Material of construction) are as below–

3.0 Responsibilities:

• User Dept.: For providing user requirements (Technical and CGMP)
• Engineering: To review the specifications from installation and Maintenance aspects.
• QA: To review the specification from GMP Aspects
• Vendor: To review and agree upon the requirements.

4.0 System Description:

The Purified water generated shall be transferred to the Purified water storage tank of 2000 Liters (Client’s Scope). This Purified water from the storage tank is then re-circulated in a closed loop to various user points with the following features.

A- The storage tank assembly consists of:

• SS 316L wetted parts, Plain.
• Dished ends at bottom for complete drainability and at top to avoid stagnation.
• The spray ball located at the center nozzle (loop return) on the manhole for continuously wetting all the contact parts on the top surface of the tank including the manhole’s internal surfaces.
• Sanitary nozzles are for feed, re-circulation, vent, pressure gauge, level switch, spare nozzles on the top (manhole), and outlet at the bottom.
• The surface finish is less than 0.5 Ra inside, and the mat finish is on the outside surface.
• Sterile vent filter on the tank top.

B- The distribution pump consists of the following features:

• SS 316 wetted parts
• Mono-block, Centrifugal type
• Sanitary with zero hold-up volume

C- Distribution loop consisting of the following features:

• SS 316L, laser welded Bead removed tubes, Electro-polished.
• Internal surfaces finish less than 0.5 Ra.
• Outside Mirror Polish.
• Installed at a slope of 1:100 for complete drainability.
• Properly supported with SS304 contact parts.
• Dead legs of not more than 3D.
• No hold-up volume in case of shutdown.
• Normal velocity of 2.2 m/s and during peak load velocity of min. 1.2m/s shall be maintained.
• All possible joints shall be orbital welded; the remaining shall be sanitary tri-clamp type.

D- Apart from the above major items, the system has the following features:

• The complete storage and distribution system shall have provision for hot water sanitization by applying steam to the shell of shell and tube heat exchanger in loop supply. The Sanitization process is semi-automatic.
• Have the necessary pressure gauges Viz at the pump outlet, loop return, and Compound pressure gauge on a tank top.
• Conductivity controllers in feed supply & loop supply.
• Temperature sensors in tank and loop return.
• Level controller on a tank for pump controlling and feed control.
• Metal tube flow meter in loop return to monitor flow rate/velocity.
• Auto Dumping valve in loop supply for high conductivity.
• The Back Pressure Valve in the Loop returns to regulate pressure and flow.
• The electrical control panel shall control the complete system.

5. Basic of Design And Assumption:

5.1 Feed Water Sample:

Generation of PURIFIED water shall be as per the USP standards (Client’s scope).

5.2 Product Water Quality:

The product water quality at the point of use (POU) shall comply with PURIFIED water Specifications. Microbial Limits shall be as follows:

Allowable limit	100 CFU / ml
Acceptable limit	75 CFU / ml
Action limit	50 CFU / ml
Alert limit	25 CFU / ml

Assumption: The feed water quality is as per PURIFIED tare Standards.

5.3 Facility Operation:

The plant operation will be for 8-16 hours/day and the PURIFIED water system will re-circulate 24 hours/day to avoid stagnation. The system shall be run at ambient temperature.

5.4 Water Demand at Point of Use:

The system is being designed on the basis of Water Consumption Profile provided by the Customer. The peak load of the loop shall be not more than 1400 LPH at any given time.

5.5 System Pressure and Temperature:

The Purified water re-circulation is designed to deliver PURIFIED water to various user points at a Pressure of 1.5 Kg. /cm².

5.7 System Sanitization:

The Storage and Distribution system is sanitized at 80-85°C in 45 min cycle. The frequency of hot water sanitization shall be determined during validation but normally would be once every week.

5.8 SKID Mounted / Modular Approach:

The entire system is designed on a modular basis and is skid-mounted so as to facilitate Validation as per current international norms. This means that individual Equipment/Instruments shall be assembled in the factory, which shall reduce site work and will help in ensuring achieving design specifications.

5.9 Control Philosophy:

The complete PURIFIED water system shall be monitored and controlled on a timely basis from a electrical Control panel. This is a semi-automatic control system, that will monitor critical on-line parameters like conductivity, level, and temperature and will not provide data logging.

5.10. cGMP Compliance:

The following points are included in the design:

• Gradient 1:100 to 1:200 for complete trainability.
• Differential Pressure in a loop heat exchanger between stream and process line.
• Velocity @ 2.2 m/s during non-peak load hours.
• POU are Zero dead leg Valves.
• Dead legs<=3 D
• Orbital welded joints wherever possible and Tri-clamp joints.
• Loop circulation Temp maintained at ambient temperature.
• System is CIP / SIP – for the storage tank and distribution loop.

All contact parts (Material of construction) are as below:

Material of Construction:

Component	Specified
1. Storage Tank	SS 316L
2. Cartridge (0.2) micron)	PTFE
3. Vent Filter Housing	SS 316L
4. Cartridge	PTFE
5. Manual Diaphragm Valve	SS 316
6. Pressure Gauge	SS 316
7. Temperature sensing element (thermo well)	SS 316L
8. Level Transmitter	SS 316 / PTFE
9. Actuated control valve	SS 316
10. Pump	SS 316
11. Piping	SS 316L
12. Conductivity Sensor	SS 316
13. UV Housing	SS 316L
14. Gasket	EPDM/PTFE/VITON/SILICON

Flow statistics:

Normal flow rate	3100 LPH (2.2 m/s)
Peak load	1400 LPH
Flow rate during peak load	1700 LPH (1.2 m/s)

 Pressure statistics:

Loop return pressure (Min. Required)	1.5 Bar
Pressure drop across the loop (Considering 180 mtr. Of length)	3.7 Bar
Pump pressure (Min. Required)	5.2 Bar
Pump Selected	3500 LPH @ 55MWC

Temperature statistics:

Normal temperature	Ambient.
Sanitization	>80 deg. Cel.

Water quality

The water quality at the inlet of the storage tank shall be maintained throughout the storage and distribution system with once-a-week sanitization of the system. However, the period of sanitization shall be determined during validation.

6. Technical Specification:

ANNEXURE A – TECHNICAL SPECIFICATIONS FOR PURIFIED WATER SYSTEM:

6.01  Distribution pump:

Type	Sanitary, Centrifugal, and Monoblock
MOC	SS 316 for contact parts
Rating	5 HP
Capacity	3500 LPH @ 55MWC
Make	Make Name

6.02  Vent filter:

Type	Code-7, Jacketed
Ratings	0.2 Micron absolute
MOC of cartridge	PTFE
MOC of Housing	SS316L
Size/no. Of element	10” / 1
Make	Make Name

6.03 Sanitary Pressure Gauges:

Type	Sanitary, Chemical seal, Glycerin filled
Chemical seal	SS 316 Diaphragm with silicon oil
Dial size	4.0”
MOC	SS 316L wetted parts, Rest SS304
Make	Make Name
Range	0 to 10 Kg/cm2

6.04 Tubes & Fittings:

Type	Laser welded, Bead removed, Electro-polished
MOC	SS 316L
Thickness	16 Swg
Size	1.0”
Internal / External Finish	Less than 0.5 Ra / Mirror Finish

6.05 Sanitary Compound Pressure Gauges:

Type	Sanitary, Chemical seal, Glycerin filled
Chemical seal	SS 316 Diaphragm with silicon oil
Dial size	4.0”
MOC	SS 316L wetted parts, Rest SS 304
Make	Make Name
Range	-1 to 5 Kg/cm2

6.06 Temperature sensor:

Make	Make Name
Type	PT-100, Simplex
MOC	Contact parts of SS 316L
Range	0-150°C

6.07 Temperature Indicator cum Controller:

Make	Make Name
Type	Display with set points and 4-20mA outputs
Supply	230 VAC
Mounting	Panel mounted
Model	Model Name

6.08 Conductivity Sensor:

Make	Make Name
Type	Sanitary
End connection	Welded Tri-clamp, SS316L
MOC	Contact parts of SS316, PTFE Insulators, Viton ‘O’ ring
Max. Temperature	125 deg. Cel
Mounting	Online, flow through

6.09  Conductivity Indicator cum controller:

Make	Make Name
Inputs	Conductivity sensor
Outputs	Relay output
Display	3.5 digits
Range	0-10 mS/cm
Temperature compensator	Automatic

6.10  Diaphragm Valves:

Make	Make Name
Type	Diaphragm
MOC  Body / Bonnet	SS316L / Epoxy Bonnet
Diaphragm	EPDM grade 325
End connection	Tri-clamp

  6.11 Steam ON / OFF Valve:

Make	Make Name
Type	Pneumatic, Single-acting
Media type	Plant steam
Operating temperature	150 deg. Cel.
End connection	1 ½” Tri-clover
Control action	Normally close, slow opening
Valve type	Angular Globe type
Valve size	1.5”
Wetted parts	SS304

 6.12 Level Switch:

Make	Make Name
Type	Magnetic Float type
MOC	All contact parts SS316
End connection	Tri-clamp
Display	None
No. of Floats	Two
No. of set points	Four
Length	As per tank height
Outputs	4 nos. Relay O/P

6.13 Flow Meter:

MAKE	Make Name
TYPE	Metal tube rotameter
RANGE OF MEASUREMENT	400 to 4000 LPH
PROCESS END CONNECTION	1.5” TRICLOVER SS 316,
WETTED PARTS	SS316

6.14 3-WAY Diverter Valve:

MAKE	Make Name
MODEL	3-way diverter valve
TYPE	Pneumatic, Single Acting
PROCESS END CONNECTION	Tri-clover SS 316 L welded
WETTED PARTS (diaphragm)	SS 316 L
SEALING MATERIAL	EPDM
APPLICATION STANDARD	Sanitary, Steam Sterilizable
TOTAL PORT	3 nos, Port 1 –inlet, Port2 & 3 – outlets

6.15 ULTRA Violet Purifier (3000 LPH):

SERVICE	D.M.WATER / ULTRA FILTERED WATER
MODEL NO.	Model Name
MAKE	Make Name XYZ
MAXIMUM OUTPUT EFFICIENCY	99.9%
MAXIMUM FLOW RANGE	3000 LTRS/ HR
TRANSMITTING MEDIUM	QUARTZ JACKET AROUND EACH LAMP
NO.OF HIGH-INTENSITY UV LAMPS	02 NOS
WAVELENGTH OF UV LAMP	2537-ANGSTROM UNITS OR 254 NM
NOMINAL WATTAGE OF THE LAMP	39W
ULTRAVIOLET OUTPUT OF THE LAMP	13.8W
UV DOSAGE	25000 µ W-s/cm2
LIFE OF THE UV LAMP	7000 WORKING HOURS
VESSEL CONSTRUCTION	SS 316L STAINLESS STEEL VESSEL CONTAINING 2 LAMPS, EACH ENCLOSED IN QUARTZ GLASS        WITH SINGLE END STAINLESS STEEL FLANGED END
WIPER ASSEMBLY	PROVIDED
SUPPLY VOLTAGE	230 V SINGLE-PHASE
INLET/OUTLET CONNECTION	1.5” TRI-CLOVER ENDS
INSTRUMENTATION	RUNNING TIMER METER, UV OPERATING, INDICATOR, INTENSITY METER
LAMPS MAKE	Make Name
LAMP MODEL	Model Name

6.16 Shell & Tube Heat Exchanger:

6.17 Control Panel:

Type	ELECTRICAL, Semi-Automatic
Mounting	Wall Mounted
Fabrication and Finish	MS Powder coated
Capacity	12 HP, 440V 3 Phase, 5 Wire
PLC & HMI	None
Power Supplies AC/DC	440/220 500 VA Isolation Transformer
Panel Mounted Instruments	Temperature Ind. Cum Controller – 2 Nos.Conductivity ind. Cum controller – 2 Nos.Level Ind. Cum controller – 1 Nos.Hooter – 1 Nos.
Operator Controls/Mimic/AnnunciationAll Switchgear & control push-buttons & Indicator will be L & T make	1. E Stop Mushroom Push Button2. Control on indication3. R, Y, B Supply indication4. Other controls as listed
Instrument Wiring	Shielded Cables, isolated from other wiring with separate grounding bus
Termination	Bottom

 7. Drawings Required:

S. NO	DESCRIPTION	DRAWING NO.	REV.
1	P & I DIAGRAM FOR PURIFIED WATER SYSTEM	XYZ	0

8. Calibration of Instruments:

Sr. No	Components	Make	Qty	Size	Purpose
1.	Conductivity Sensor	Make Name	2	0-10Us/cm	To measure conductivity
2.	Conductivity indicator cum controller – Dual Channel	Make Name	2	0-10Us/cm	Relay Output and 4-20 mA output for each channel
3.	Temp Sensor	Make Name	2	0-150*C	To measure temperature
4	Temp. Indicator cum controller	Make Name	2	0-150*C	Relay outputs and 4-20 mA output
5	Compound pressure Gauge	Make Name	1	-1 to 5 bar	To measure pressure
6	Pressure gauge	Make Name	2	0 to 10 bar	To measure pressure
7	Steam pressure gauge	Make Name	1	0 to 10 bar	To measure pressure
8	Flow Meter	Make Name	1	400-4000 LPH	To measure Flow

9. Supporting Utility:

SR. NO	EQUIPMENTS / INSTRUMENTS	LOCATION	UTILITIES	SPECIFICATION	SCOPE
1	Heat exchanger	Skid #1	Steam or Super Heated Water	3 bar, 60 Kg/hr   250 LPH @ 140 deg. C	Client
2	Control Panel	Equip. Room	Air	6 bar	Client
3	Control Panel	Equip. Room	Power	3 phase, 440V, 50 Hz, 10KW	Client
4	For all Skid	Equip. Room	Drain Line	6” Common Header	Client

10. Pre-Qualification:

10.1 Hydraulic Pressure Test

10.2 Documentation Check

10.3 Interlock Checks

10.4 Operational Checks

11. List of Documents Required for Distribution Loop:

CODE	DOCUMENTS REQUIRED
A	Manufacturer’s Manuals – Preventive Maintenance (O.M.)
B	MOC Certificate
C	Leak Test Reports / Hydro Test Report
D	Surface Finish Report
E	Passivation Reports
F	Cleaning / Flushing Reports
G	Pump Performance Curves
H	Filter Test Reports
I	Engineering Specifications
J	Assembly Drawing
K	Manufacturer’s Catalogue
L	SEALS / Gasket-MOC
M	Test Certificate
N	Calibration Certification with traceability to National Standards
O	Basis of Design
P	Performance Certificate
Q	Validation Guide

12 Design Qualification Approval:

FOR XYZ PVT. LTD.  (DQ Preparation and review)

NAME	SIGNATURE	DATE

FOR XYZ PHARMACEUTICALS LIMITED

Reviewed By 

NAME	SIGNATURE	DATE

Approved By

NAME	SIGNATURE	DATE