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DESIGN QUALIFICATION FOR PURIFIED WATER STORAGE & DISTRIBUTION SYSTEM

TABLE OF CONTENTS

1.0       DESIGN QUALIFICATION PROTOCOL APPROVAL

2.0       INTRODUCTION

3.0       OBJECTIVE:

4.0       SCOPE

5.0       RESPONSIBILITY

6.0       BASIS OF DESIGN

7.0       SYSTEM DESCRIPTION

8.0     SCOPE OF SUPPLY AND TECHNICAL SPECIFICATIONS

9.0       PANEL INTERLOCKS AND OPERATIONAL LOGICS

10.0    CRITICAL SAFETY REQUIREMENTS

11.0    SAMPLING PLAN

12.0    SANITISATION CYCLE

14.0    LIST OF APPROVED MAKES

15.0    DESIGN QUALIFICATION APPROVAL

 

INTRODUCTION 

United State Pharmacopoeia (USP) has revised the water specification for purified water in their revised monograph USP-28 for Pharmaceutical Industry.

Conductivity                          :           < 1.3 Microsiemen / cm at 25 ° C

TOC                                        :           < 500 ppb

Total Bacterial Count          :           < 100 cfu / ml

However, the system is designed considering USP-40 as the basis for specified parameters as Maximum Allowable Parameters at user point with suitable Design Limits, Alert Limits and Action Limits as specified in the subsequent clauses.

OBJECTIVE:

The objective of preparing a Design Qualification Document is to prepare design data and detailed specifications for all major components of the equipment and system for the agreed scope of supply and performance to ensure Customer Requirements are achieved for the project as per agreed specifications. 

SCOPE

The Design Qualification is an essential part of the qualification process and will serve as a basic document for the validation activity. The scope of this document is to illustrate the complete design of an Integrated Scheme for Storage and Distribution of purified water as per the Relevant Standards, Agreed Technical Specifications, User Requirement Specification (URS) and other finalized terms and conditions.

RESPONSIBILITY

In order to achieve the above objective for the complete water system, following shall be the responsibility of M/s. Supplier and Client. 

M/s. Suppplier:

  1. The complete system is designed as per the Relevant Standards, Agreed Technical Specifications, and User Requirement Specifications (URS).
  1. Technical specifications of all the equipment, instruments, valves etc. are as per the offer and the Purchase Order Specifications.
  1. P & ID, As built Isometric drawings, Technical Specifications etc. as per requirements will be prepared and submitted to client.
  1. Control Philosophy shall be prepared for the complete system.
  1. Operational Manual for the Control Panel for the System as per Supplier shall be provided.
  1. Test Certificates for the various items used in the system along with calibration certificates for Conductivity meters and critical instruments included in the scope shall be provided. For non-critical instruments, vendors standard test certificates shall be provided.
  1. Isometric drawings for the distribution piping shall be provided.

M/s Clint responsibility on their part shall be as per following:

  1. To check and verify all the documents submitted as per above are in line with agreed specifications and scope and shall approve all the documents to signify that the vendor has complied with his commitment.
  2. To provide the necessary site clearance and complete the site activities covered in client scope.
  3. Ensures that all the utilities and material required for the commissioning of system as specified by M/s. Supplier in Design Qualification and other documents at site.
  4. Specify in writing the material required to be inspected by client before M/s. supplier commences supply to site / used for manufacturing at Vendors shops.
  5. Carryout Validation activities after the System is certified for intended operations.

BASIS OF DESIGN 

Following are the main consideration for the design of Purified Water Storage and Distribution System:

  • Out Put Capacities and Quality parameters
  • User Point Requirement (As Agreed by the client)

Output Capacities and Quality Parameters: 

Following are the design data consider as the basis for the design of complete system: 

  • Quality for Purified Water Specifications at point of use:

 

Sr. No. Parameter Unit Results
1
Conductivity µs/cm <1.3 at 25ºC
2
Microbial Count Cfu/ml <100
3 TOC ppb < 500
4.
pH 5-7

 Operational Limits at point of use:

 

Sr. No. Parameter Unit Design Limits Alert Limits Action Limits
1
Conductivity µs/cm NMT 1.0 at 25ºC > 0.9 at 25ºC > 1.2 at 25ºC
2
Microbial Count Cfu/ml NMT 25 >50 > 80
3 TOC ppb NMT 300 >350 > 400
4
pH 5.0 – 7.0 5.5 – 6.5 < 5.5 – > 6.5

 User Point Requirements : 

To formulate the best design of water distribution, User Requirement Specifications (URS) are prepared by M/s. client and the same are agreed (commented, as required) by us. Considering the same data & incorporating all the comments in due course of discussion, the system is designed.

  • List of Points of Use : 

Purified Water will be provided at the following Locations and respective rooms:

Sr. No. User point Name Reactor Name/Tag
PRODUCTION BLOCK
1 UP – 1 FABRICATION – 3
2 UP – 2 FABRICATION – 2
3 UP – 3 FABRICATION – 1
4 UP – 4 PDL
5 UP – 5 BIN WASHING
6 UP – 6 EQUIPMENT WASH
7 UP – 7 OINTMENT WASH AREA
8 UP – 8 COATING – 3
9 UP – 9 COATING – 2
RM STORE BLOCK
10 UP – 10 R.M STORE
PRODUCTION BLOCK
11 UP – 11 COATING – 1
XEED BLOCK
12 UP – 12 XEED COATING
13 UP – 13 XEED EQUIPMENT WASH
14 UP – 14 XEED FABRICATION
SOFT GELATIN BLOCK
15 UP – 15 SOFTGEL
16 UP – 16 SOFTGEL ( IST FLOOR)
17 UP – 17 SOFTGEL ( IIND FLOOR)
HERBAL BLOCK
18 UP – 18 HERBAL – FAB CAP.
19 UP – 19 HERBAL – BOWLING
20 UP – 20 HERBAL – FABRICATION
21 UP – 21 EQUIPMENT WASH.
22 UP – 22 OINT. – MFG.
  LIQUID SECTION
23 UP – 23 LIQUID MFG – I
24 UP – 24 LIQUID MFG. – I
25 UP – 25 LIQUID WASH – I
TOTAL PEAK CONSUMPTION 2 m3/hr

Based On the Above Information the Pump Sizing Is Calculated As Below

PUMP CALCULATION FOR PURIFIED WATER SYSTEM
TOTAL HEAD WORKING FOR PW DISTRIBUTION PUMP
TOTAL PIPE LENGTH 850 MTRS.
TOTAL ELEVATION 16 MTRS.
LINE SIZE 1.5″
INTERNAL DIAMETER OF PIPE 34.90 MM
EXTERNAL DIAMETER OF PIPE 38.10 MM
MIN. VELOCITY REQD. IN RETURN LINE 1 M/SEC.
TOTAL FLOW REQUIRED IN RETURN LINE 3.44 M3/HR
TOTAL PEAK LOAD 2.0 M3/HR
TOTAL PUMP OUTLET FLOW 5.44 M3/HR
TOTAL HEAD LOSS DUE TO FRICTION 13 MWC
TOTAL HEAD LOSS IN BENDS AND VALVES 10 MWC
TOTAL STATIC HEAD LOSS 16 MWC
TOTAL HEAD REQD. IN THE RETURN LINE 10 MWC
PUMP HEAD REQD. 49 MWC
PUMP RATING 15 H.P.
PUMP MAKE ALFA LAVAL
PUMP MODEL ALC-2

NOTE: Hence the Pump selected is 5.4 M3/Hr @ 60 MWC of slightly higher capacity w.r.t the head to anticipate any future increase in the piping.

SYSTEM DESCRIPTION

  1. Storage & Distribution System up to User Points
  2. Automation and Data Acquisition

Storage & Distribution system upto User Point:

(Ref P&I Diagram – ____________________________)

Ambient Storage and Distribution System with Hot Water Sanitization

The Purified Water from the upstream generation System is stored in 2 KL Vertical Jacketed Storage tank T-2101. From the storage tank the water is then supplied to various user points in Production area. The water level in the Purified Water storage tank is controlled with the help of capacitance type level transmitter, which performs necessary actions so as to maintain sufficient water level in the tank. The distribution loop consists of distribution pump, online instruments for measuring conductivity, Temperature, Pressure and level to monitor level in the storage tank. All the user point valves are Manual Diaphragm valves. Whenever the circulation loop is to be sanitized for destruction of bio-film formation or as per Validation requirements, the water is heated and circulated at elevated temperatures (i.e + 85 deg celcius) for a period of time. During sanitization the inlet actuated diaphragm valves feeding to the tank are closed so as not to allow any additional fresh water till sanitization is over. The signal to this actuated valve is given by a PLC based control panel. Detailed control logic is described in later chapter.

The control panel supplied for Purified water system consists of Controllers for instruments and other ancillaries. The control panel is controlling the operation of all automatic valves, pumps with a predetermined logic.

In normal operating condition, A minimum velocity of 1 m/s is maintained in the loop at peak consumption.

 

The Storage and distribution system design is suitable for meeting the requirements stated above and shall comply with the following:

  1. Material of Construction for Storage Tank :           SS – 316L
  2. Internal Finish :                                                           < 0.3 Ra
  3. Tubes for distribution :                                               SS – 316L
  4. Internal Finish (Electro polish) :                              < 0.3 Ra
  5. Welding  :                                                                       Orbital TIG Welding
  6. Original Mill Test Certificate   :                                 Required
  7. Triclover clamps With Silicon gaskets :                  As per Requirements
  8. Actuated Valves    :                                                      Contact Parts SS 316
  9. Manual Diaphragm Valves  :                                     Contact Parts SS 316L
  10. Diaphragm in Valves             :                                    EPDM

SCOPE OF SUPPLY AND TECHNICAL SPECIFICATIONS 

  • SCOPE OF SUPPLY: 
Sr. No. Equipment Description Tag. No MOC Make
1.0 Storage Tank T –2101 SS 316L Neela
2.0 Jacketed Vent Filter JVF-2101
Vent Filter Cartridge PTFE Pall/ Sartorius
Vent Filter Housing SS 316L Neela
3.0 Spray Ball SPB – 2101 SS 316L Neela
4.0 Cap. Type Level Transmitter CLT-2101 SS 316 E & H /Emerson
5.0 Compound Pressure Gauge CPG – 2101 SS 316L Forbes Marshall
6.0 Temperature Transmitter TT – 2101 SS 316L Radix
7.0 Syphon Type Pressure Gauge SPG – 2101 SS 316L Forbes Marshall
8.0 Conductivity Indicator Cum Controller CIC – 2101 SS 316L E & H / Emerson
9.0 Centrifugal Pump P – 2101/02 SS 316 L Alfa Laval
10.0 Pressure Gauge PG – 2101 SS 316L Forbes Marshall
11.0 Ultra Violet UV – 2101 SS 316L Alfa Water
12.0 Conductivity Indicator Cum Controller CIC – 2102 SS 316L E & H / Emerson
13.0 Flow Transmitter FT – 2101 SS 316L E & H / Emerson
14.0 Temperature Transmitter TT – 2102 SS 316L Radix
15.0 Manual Diaphragm Valve V – 2101 to 2103 , V – 2105 to V – 2131 V – 2131A to V – 2131C ,V-2132,V – 2134,V – 2139 SS 316L Neela
16.0 Flow Divertor Valve KV – 2101/03/04 SS 316 L Neela
17.0 Actuated Globe Valve KV – 2102 SS 304 Neela
18.0 Back Pressure Valve V – 2133 SS 316 Neela
19.0 Manual Ball Valve V – 2136 to V – 2138 SS 304 Neela
20.0 Non-Return Valve V – 2104 SS 316 L Neela
21.0 Steam Trap ST – 2101 SS 304 Uniklinger/Spirax
22.0 SS Tubes NA SS 316L Sandvik
23.0 Control Panel NA —– Allen Bradley /ABB/ Messung

TECHNICAL SPECIFICATIONS 

Technical specifications for the major equipments and items required for the project are enclosed in the following pages.

PURIFIED WATER STORAGE TANK
Tag No. Location
T-2101 Purified Water Distribution Area

 

Sr.

No.

Description Specifications
1. Type Vertical, Jacketed
2. Nominal Capacity 2 KL
3. Process Fluid Purified Water
4. Process Fluid Density 1000 kg/m3
5. Design Pressure – Shell Side 1 Kg/cm2
6. Design Pressure – Jacket Side 3 Kg/cm2
7. Design Temperature 140 Deg Celsius
8. Hydrotest Pressure- Shell Side 1.5 Kg/cm2
9. Hydrotest Pressure – Jacket Side 4.5 Kg/cm2
10. Joint efficiency shell/Dish 0.85/1.0
11. Thickness Main Shell/Dish Shell 5 Thk. /Top Dish 3 Thk Nom.,2 Thk. min./Bottom Dish 8 Thk Nom,7 Thk min.
12. Thickness Jacket Shell/Dish Shell 3 Thk. / Dish end – 5 Thk Nom., 4 Thk. Min
13. Contact Part SS 316L
14. Non Contact Part SS 304
15. Internal Finish 0.3 Ra. Electropolished
16. External Finish Matt Finish
17. Radiography Shell / Dish 10% + T /   100 %
18. Insulation 50 mm THK, Glass wool
19. Cladding SS 304, 2 mm Thk
20. Make Neela

 

JACKETED VENT FILTER
Tag No. Location
JVF – 2101 On Top of Purified Water Tank T – 2101

 

Sr.

No.

Description Specifications
1. Type
a. Housing Jacketed
b. Cartridge Hydrophobic
2. Rating 0.2 Micron
3. Construction Code Code 7
4. MOC

1)    Housing

2)    Cartridge

 

SS 316L

PTFE

5 Gasket Silicon
6 Working Condition Ambient & Occasionally 85 deg. C
7 Housing End Connection 1.5” TC
8 Housing Make Neela
9 Filter Element
a. Quantity 1 No.
b. Size 10” Long
c. Cartridge Make Sartorius / Pall

 

SPRAY BALL
Tag No. Location
SPB – 2101 Inside the Purified Storage Tank T – 2101

 

Sr.

No.

Description Specifications
1 Type Rotary Capsule Type
2. MOC SS 316L
3. Size ¾” BSP(F)
4. Area of Coverage 3600
5. Make Neela

 

CAPACITANCE TYPE LEVEL TRANSMITTER
Tag No Location
CLT-2101 On top of Purified Water Tank T – 2101

 

Sr.

No.

Description Specifications
1. Type Capacitance Type
2. Range Zero – Full Scale
3. Measuring Parameter Volume
4. Accuracy < 1% for 1 m
5. Supply 8 – 32 VDC
6. Wire 2 wire
7. Output 4-20 mA
8. MOC SS 316
9. End Connection 2” TC End.
10. Probe Length As per Tank Height
11. Make E & H / Emerson

 

COMPOUND PRESSURE GAUGE
Tag No. Location
CPG – 2101 On The Top Of The Purified Water Storage Tank T – 2101

 

Sr.

No.

Description Specifications
1. Type Diaphragm Type
2. Size 4” Dial
3. End Connection Std. TC End
4. Range -1 to 5 kg/cm2
5. Diaphragm MOC SS 316L
6. Liquid Filled Glycerin
7. Make FORBES MARSHALL

 

TEMPERATURE TRANSMITTER
Tag No Location
TT – 2101 On the Purified Water Storage Tank T – 2101

 

Sr.

No.

Description Specifications
1. Type PT100, 3 wire as per DIN 43760/ IEC 751
2. No. Of Circuits One (Simplex)
3. Accuracy Class ‘B’+/- 0.3 at 0 deg. Cel & +/- 0.8 at 100 deg. cel
4. Sheath Dia 6 mm
5. Sheath Length 9” Long
6. Sheath Material SS 316
7. End Connection ½” BSPT
8. Make Radix

 

SYPHON TYPE PRESSURE GAUGE
Tag No Location
SPG – 2101 At Steam Inlet To Jacket Of Tank T – 2101

 

Sr.

No.

Description Specifications
1. Type Diaphragm Type
2. Size 4” Dial
3. End Connection Std. TC End
4. Range 0 to 7 kg/cm2
5. Diaphragm MOC SS 316L
6. Liquid Filled Glycerin
7. Make FORBES MARSHALL

 

CONDUCTIVITY INDICATOR CUM CONTROLLER
Tag No. Location
CIC – 2101 At Suction of Pump P – 2101 /02

 

Sr.

No.

Description Specifications
1. Type Inline Type
2. Current Output 4 – 20 mA
3. Sensor End Connection TC End
4. Sensor MOC SS 316L
5. Sensor Cell Constant 0.01
6. Sensor Range 0-10 mS/cm.
7. Temperature 0-105 deg. Cel.
8. Output 4-20 mA
9. Input to the Meter 230 VAC
10. Enclosure IP65
11. Make Forbes Marshall / E & H
12. Model No.

 

PURIFIED WATER DISTRIBUTION PUMP
Tag No Location
P – 2101/02 Purified Water Distribution Skid

 

Sr.

No.

Description Specifications
1. Type Horizontal, Centrifugal
2. Capacity 5.4 m³/hr.
3. Suction Head Flooded
4. Discharge Head 6 Kg/cm²
5. Max. Rated Speed 2840 RPM
6. Liquid Handled Water
7. Location Indoor
8. M.O.C.
    A.        Casing SS – 316L
    B.        Impeller SS – 316L
    C.        Shaft SS – 316L
    D.        Base Frame Not Reqd.
9. Seal Mechanical Seal (Silicon Carbide Vs. Silicon Carbide.)
10. Prime Mover A.C. Motor, 415 V, Three Phase, 50 Hz.
11. Power 15 HP
12. Motor Make Crompton
13. Drive Transmission Direct
14. Quantity 02 Nos.
15. Make Alfa Laval
16. Model ALC2

  

PRESSURE GAUGE
Tag No. Location
PG – 2101 At Discharge Of Pump P – 2101/02

 

Sr.

No.

Description Specifications
1. Type Diaphragm Type
2. Size 4” Dial
3 End Connection Std. TC End
4 Range 0 to 14 kg/cm2
5 Diaphragm MOC SS 316L
6 Liquid Filled Glycerin
7 Make WAREE

 

ULTRA VIOLET SYSTEM
Tag No Location
UV-2101 At Discharge Of PW Distribution Pump P – 2101/02

 

Sr.

No.

Description Specifications
1. Flow Rate 5 m3/hr
2. Arc Wave Length 2537 Angstrom Units
3. Minimum Intensity At The End Of Life > 30000 micro watt sec/cm²
4. Transmitting Medium Quartz jacketed around each lamp
5. No. of High Intensity UV Lamps 4 Nos.
6. Length Of Each Lamp 30”
7. Diameter of UV Lamp 15 mm dia.
8. Model AP-30
9. Make Alfa Water

  

CONDUCTIVITY INDICATOR CUM CONTROLLER
Tag No. Location
CIC – 2102 In Return Line Of Purified Water Distribution System

 

Sr.

No.

Description Specifications
1. Type Inline Type
2. Current Output 4 – 20 mA
3. Sensor End Connection TC End
4. Sensor MOC SS 316L
5. Sensor Cell Constant 0.01
6. Sensor Range 0-10 mS/cm.
7. Temperature 0-105 deg. Cel.
8. Output 4-20 mA
9. Input to the Meter 230 VAC
10. Enclosure IP65
11. Make Forbes Marshall / E & H
12. Model No.

 

FLOW TRANSMITTER
Tag No. Location
FT – 2101 In Return line of Purified Water Distribution system

 

Sr.

No.

Description Specifications
1. Type Vortex Type
2. Sensor End Connection Flanged
3. Sensor MOC SS 316
4. Sensor range 0.8 to 8 m3/hr
5. Accuracy 0.75% of Operating range
6 Max. Temperature 175 Deg Celsius
7 Output 4-20 mA
8 End Connection 1.5” TC
9. Input to the Meter 24 VDC Loop Powered
10 Make E & H / Emerson

 

TEMPERATURE TRANSMITTER
Tag No Location
TT – 2102 In Return line of Purified Water Distribution System

 

Sr.

No.

Description Specifications
1. Type PT100, 3 wire as per DIN 43760/ IEC 751
2. No. Of Circuits One (Simplex)
3. Accuracy ‘Class ‘B’+/- 0.3 at 0 deg. Cel & +/- 0.8 at 100 deg. cel
4. Sheath Dia 6 mm
5. Sheath Length 50 mm Long
6. Sheath Material SS 316
7. End Connection 1 ½” TC End
8. Make Radix

 

MANUAL DIAPHRAGM VALVE
Tag No Location
As per P & ID As per Annexure below

 

Sr. No. Description Specifications
1. Type Diaphragm Type
2. Internal Finish Pharma Finish ,Electro-polished
4. Diaphragm Grade EPDM
5. End Connection TC End
6. Body SS 316 L
7. Bonnet SS 304
8. Handle SS 304
9. Make NEELA
10. Size As Per Attached Annexure

ANNEXURE 

Sr No. Tag No Size Location
1. V – 2101 1” OD At Tank T – 2101 Drain
2. V – 2102 3” OD At Suction Of Pump P-2101/02
3. V – 2103 ½” OD Sampling Point At Discharge Of Pump P-2101/02
4. V – 2105 1 ½” OD At Inlet Of UV System UV-2101
5. V – 2106 ½” OD Sampling Point At Inlet Of UV-2101
6. V – 2107 ½” OD Sampling Point At Outlet Of UV-2102
7. V – 2108 to V – 2131 ¾” OD At User Points
8. V – 2131A to V – 2131C ¾” OD At User Points
9. V – 2132, V – 2139 ½” OD Sampling point in return line & At UV outlet respectively.
10. V – 2134 1 ½” OD On Top Of Tank T – 2101

 

FLOW DIVERTOR VALVE
Tag No. Location
KV – 2101/2103/2104 At tank inlet , at inlet of UV system & in return line of Purified Water Distribution System respectively

 

Sr. No. Description Specifications
1. Type 3 way valve
2. End connection TC End
3. MOC
a. Body SS 316
b. Seat PTFE
c. Body Seal PTFE
4. Max. Pressure 15 Kg/cm2
5. Make Neela
6. Size KV – 2101 – 1” OD

KV – 2103/04 – 1 ½” OD

 

ACTUATED GLOBE VALVE
Tag No Location
KV – 2102 Steam inlet to the Jacket of Purified Water Storage tank T – 2101

 

Sr.

No.

Description Specifications
1. Body Form Investment Casting
2. Construction Pc. Design
3. End Connection Flanged End
4. Body Material SS304
5. Stem Material SS304
6. Seat PTFE
7. Max Pressure 15 kg/cm2
8. Make Neela
ACTUATOR DETAILS
9. Type S.A. Pneumatic Rotary Actuator
10. M.O.C. –                                                     Body Aluminium
Seat PTFE
Seal PTFE
11. Action Normally Close
12. Rotation 0 – 90 Degrees
13. Operating Pressure 5-6 kg/cm2

 

BACK PRESSURE VALVE
Tag No. Location
V – 2133 In Return Line Of Purified Water Distribution System

 

Sr. No. Description Specifications
1. Type Self Actuated
2. MOC , Main Body SS 316
4. Centre Rod Assembly SS 316
5. Seal Material Silicon
6. Top Body SS 316
7. Max. Temperature 120 Deg. C
8. Max. Operating Pressure 6 Kg / cm2
9. Set Pressure 1 to 3 Kg / cm2
10 Size 1.5” TC
11 Inlet Connection TC End
12 Outlet Connection TC End
13. Make Neela

 

MANUAL BALL VALVE
Tag No Location
V – 2136 to V – 2138 Steam Trap assembly

 

Sr.

No.

Description Specifications
1. Type Single pc Design
2. End Connection Screwed End
3. BODY MOC SS 304
4. Ball MOC SS 304
5. Spindle SS 304
6. Seat PTFE
7. Max Pressure 12 kg/cm2
8. Make NEELA
9. Size ¾” OD

 

NON RETURN VALVE
Tag No. Location
V – 2104 Pump P – 2101/02 Discharge

 

Sr.

No.

Description Specifications
1. Type Lift Check Spring Loaded Type
2. Size 1.5“ OD
3. End Connection Flanged End
4. Body MOC SS 316 L
5. Internal Finish Pharma Finish
6. Hydro Test Pressure Body: 10 kg/cm2

Seat: 3.5 kg/cm2

7. Make NEELA

 

STEAM TRAP
Tag No Location
ST – 2101 Steam Trap Assembly

 

Sr.

No.

Description Specifications
1. Type Thermodynamic
2. Ends Screwed to BSPT
3. Cap AISI 420
4. Rating 800 #
5. Disc AISI 420
6. Element Holder SS 410
7 Packing CAF
8 Strainer Screen SS 316
9 Pressure Operating 10.5 kg. /cm2
10 Operating Temperature 180 deg. C
11 Max. Operating Temperature 200 deg. C
12 Max. Operating Pressure 20 kg/cm2
13 Utility Steam
14 Make Uniklinger / Spirax
15 Model No. ——-
16 Size of Trap ¾”

 

SS TUBES
Tag No Location
——- Dist. Network

 

Sr.

No.

Description Specification
1. Type Laser welded Bead Removed
2. Standard ASTM A 270 TP 316L
3. Internal finish < 0.3 micron
4. External finish Sanitary Finish
5. Make Sandvik

 PANEL INTERLOCKS AND OPERATIONAL LOGICS: 

Integration with Purified Water Storage and Distribution System:

  • REF.ATTACHED P& I DRAWING NO.:- NIPL – PAN – AS – GEN – PI – 01 – R0
  • REF. ATTACHED CONTROL LOGIC DOC.: – NS – PAN – DOC – 01 – R0 

CRITICAL SAFETY REQUIREMENTS 

  1. UV system functions are very critical for the performance of the overall system and the required intensity is to be maintained.
  1. On compound pressure gauge showing less than zero kg/cm2, the cartridge of the vent filter to be replaced or sanitized.
  1. Periodic Sanitization of the system is very critical for the performance of the overall system and the required Frequency is to be maintained.

SAMPLING PLAN 

Sampling Points as per following are provided: 

S1: V – 2101                                  :  At the drain of Tank T-2101

S2: V – 2103                                  :  At the outlet of Pump P-2101/02

S3: V – 2106                                 :         At inlet of UV – 2101

S4: V – 2107                                  :  At outlet of UV – 2101

S5: V – 2108 to V – 2131             :  User Points

S6: V – 2131A to V – 2131C      :  User Points

S7: V – 2132                                  :  In return line after FT – 2101

SANITISATION CYCLE

PURIFIED WATER DISTRIBUTION SYSTEM:  

The Sanitization of Purified Water Distribution System shall be established on the basis of Performance Validation.

Storage and Distribution System shall be sanitized by Hot Water at 80-900C.

It is preferable to sanitize the system once in a week or as established during Performance Validation. 

The complete system is designed for periodic sanitization.

Bio-film formation in Distribution loop is an unavoidable phenomenon. As and when the microbial count is found to be exceeding the permissible limits, sanitization of the system shall be performed.

Whenever the circulation loop is to be sanitized for destruction of bio-film formation or as per Validation requirements, the panel should be operated in the SANITIZATION MODE. The purified water tank is filled up to 1/3rd of its capacity.

During sanitization the inlet valve KV – 2101 feeding to the tank should be in closed position so as not to allow any additional fresh water till sanitization is over. The Low Pressure steam is used to heat this water. The LPST is passed through the jacket of the tank. Since the loop will be under continuous re-circulation, restricts the temperature to rise gradually. The water is heated up to 80-85 deg and then maintained at that temperature for an hour. Sanitization temperature and the time, both are settable parameters. Steam inlet actuated globe valve KV-2102 opens and closes, depending upon the return line temperature sensor TT-2102. After the set time of sanitization is over, the water is circulated till it reaches to appropriate safe temperature by natural cooling. Then this water is drained out. Keep the sanitization mode switch in OFF position and PLC control system from Auto mode to Manual mode and charge enough fresh water in the tank to re-circulate through the Loop for 30 minutes so as to bring down the complete system to ambient temperature. Flush water from all sample and user points of distribution loop as mentioned above in section 10.0 for 5 minutes. Completely drain the water from the Distribution Loop. Keep the PLC control system from Manual mode to Auto mode.

Now the system is sanitized and ready for usage.

FACTORY ACCEPTANCE TEST: 

  • All the equipment and system covered in the system shall be offered for inspection at the works as per the agreed schedule and inspection requirements for Dimensional checkups, Surface Finishes.
  • Distribution piping shall be offered for inspection, if required, before dispatch for physical check up for dimensions, workmanship, specification compliance etc.
  • Prior approval for Inspection shall be given for the items required to be inspected. In case Non -feasibility of inspection, the waiver of inspection shall be provided authorizing the dispatch.

After FAT the approved and accepted material shall be dispatched for site erection.

 LIST OF APPROVED MAKES

 

Sr. No. Item Description Makes
1. CAP. TYPE LEVEL TRANSMITTER E&H/EMERSON
2. CENTRIFUGAL PUMPS ALFA LAVAL
3. COMPOUND PRESSURE GAUGE FORBES MARSHALL
4. PRESSURE GAUGE FORBES MARSHALL
5. ULTRA VIOLATE SYSTEM ALFA WATER
6. TEMPERATURE TRANSMITTER RADIX
7. FLOW TRANSMITTER E & H / EMERSON
8. CONDUCTIVITY SENSOR E & H / FORBES MARSHALL
9. SS PIPING SANDVIK
10. SS FITTINGS NEELA
11. SS VALVES NEELA

DESIGN QUALIFICATION APPROVAL:

This design qualification document is studied and approved by the Undersigned Authorized Personnel.

 

This approved Design Qualification supersedes all the previously agreed documents.

The system is now READY FOR INSTALLATION QUALIFICATION.

 

 

 

About 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

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