Complete Pharma Solution
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:
- The complete system is designed as per the Relevant Standards, Agreed Technical Specifications, and User Requirement Specifications (URS).
- Technical specifications of all the equipment, instruments, valves etc. are as per the offer and the Purchase Order Specifications.
- P & ID, As built Isometric drawings, Technical Specifications etc. as per requirements will be prepared and submitted to client.
- Control Philosophy shall be prepared for the complete system.
- Operational Manual for the Control Panel for the System as per Supplier shall be provided.
- 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.
- Isometric drawings for the distribution piping shall be provided.
M/s Clint responsibility on their part shall be as per following:
- 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.
- To provide the necessary site clearance and complete the site activities covered in client scope.
- 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.
- 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.
- 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
- Storage & Distribution System up to User Points
- 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:
- Material of Construction for Storage Tank : SS – 316L
- Internal Finish : < 0.3 Ra
- Tubes for distribution : SS – 316L
- Internal Finish (Electro polish) : < 0.3 Ra
- Welding : Orbital TIG Welding
- Original Mill Test Certificate : Required
- Triclover clamps With Silicon gaskets : As per Requirements
- Actuated Valves : Contact Parts SS 316
- Manual Diaphragm Valves : Contact Parts SS 316L
- 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. | MOC1) Housing2) Cartridge | SS 316LPTFE |
| 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” ODKV – 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/cm2Seat: 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
- UV system functions are very critical for the performance of the overall system and the required intensity is to be maintained.
- On compound pressure gauge showing less than zero kg/cm2, the cartridge of the vent filter to be replaced or sanitized.
- 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.
