FOR PURIFIED WATER STORAGE & DISTRIBUTION SYSTEM
The Purified Water from the upstream generation System is stored in a Vertical Jacketed Storage tank From the storage tank the water is then supplied to various user points in the Production area. The Purified Water storage tank is controlled with the help of a capacitance-type level transmitter, which performs necessary actions to maintain sufficient water level in the tank. The distribution loop consists of a distribution pump, and online instruments for measuring conductivity, Temperature, Pressure, and level to monitor the level in the storage tank. All the user point valves are Manual Diaphragm valves. Whenever the circulation loop is to be sanitized for the destruction of bio-film formation or as per Validation requirements, the water is heated and circulated at elevated temperatures (i.e + 85 degrees Celsius) for a while. During sanitization, the inlet-actuated diaphragm valves feeding to the tank are closed so as not to allow additional fresh water until sanitization is over.
DESIGN QUALIFICATION PROTOCOL OF CONTENTS
- DESIGN QUALIFICATION PROTOCOL APPROVAL
- INTRODUCTION
- OBJECTIVE:
- SCOPE
- RESPONSIBILITY
- BASIS OF DESIGN
- SYSTEM DESCRIPTION
- SCOPE OF SUPPLY AND TECHNICAL SPECIFICATIONS
- PANEL INTERLOCKS AND OPERATIONAL LOGIC
- CRITICAL SAFETY REQUIREMENTS
- SAMPLING PLAN
- SANITISATION CYCLE
- LIST OF APPROVED MAKES
- DESIGN QUALIFICATION APPROVAL
INTRODUCTION
United States Pharmacopoeia (USP) has revised the water specification for purified water in their revised monograph USP for the 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 the 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 the 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
To achieve the above objective for the complete water system, the following shall be the responsibility of M/s. Supplier and Client.
M/s. Supplier:
- 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 the 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’s responsibility on their part shall be as follows:
- 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 the client’s scope.
- Ensures that all the utilities and materials required for the commissioning of the 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 the client before M/s. supplier commences supply to site / used for manufacturing at Vendor shops.
- Carry out Validation activities after the System is certified for intended operations.
BASIS OF DESIGN
The following are the main considerations for the design of the 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 considered as the basis for the design of the complete system:
Quality for Purified Water Specifications at point of use:
- Conductivity = <1.3 at 25ºC µs/cm
- Microbial Count = <100 Cfu/ml
- TOC = < 500 ppb
- pH – 5-7
Operational Limits at point of use:
- = <1.0 at 25ºC µs/cm ,Design Limits – > 0.9 at 25ºC ,Alert Limits – > 1.2 at 25ºC
- Microbial Count = <100 Cfu/ml
- TOC = < 500 ppb
- pH – 5-7
| Parameter | Unit | Design Limits | Alert Limits | Action Limits |
| Conductivity | µs/cm | NMT 1.0 at 25ºC | > 0.9 at 25ºC | > 1.2 at 25ºC |
| Microbial Count | Cfu/ml | NMT 25 | >50 | > 80 |
| TOC | ppb | NMT 300 | >350 | > 400 |
| pH | – | 5.0 – 7.0 | 5.5 – 6.5 | < 5.5 – > 6.5 |
User Point Requirements :
To formulate the best design for water distribution, User Requirement Specifications (URS) are prepared by M/s. client and the same is agreed upon (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:
| User point Name | Reactor Name/Tag |
| PRODUCTION BLOCK | |
| UP – 1 | FABRICATION – 3 |
| UP – 2 | FABRICATION – 2 |
| UP – 3 | FABRICATION – 1 |
| UP – 4 | PDL |
| UP – 5 | BIN WASHING |
| UP – 6 | EQUIPMENT WASH |
| UP – 7 | OINTMENT WASH AREA |
| UP – 8 | COATING – 3 |
| UP – 9 | COATING – 2 |
| RM STORE BLOCK | |
| UP – 10 | R.M STORE |
| PRODUCTION BLOCK | |
| UP – 11 | COATING – 1 |
| SOFT GELATIN BLOCK | |
| UP – 15 | SOFTGEL |
| UP – 16 | SOFTGEL ( IST FLOOR) |
| UP – 17 | SOFTGEL ( IIND FLOOR) |
| LIQUID SECTION | |
| UP – 23 | LIQUID MFG – I |
| UP – 24 | LIQUID MFG. – I |
| UP – 25 | LIQUID WASH – I |
| TOTAL PEAK CONSUMPTION | 2 m3/hr |
Based On the Above Information the Pump Sizing Is Calculated 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 :(Ref P&I Diagram – _____________________)
- Automation and Data Acquisition
Ambient Storage and Distribution System with Hot Water Sanitization
The Purified Water from the upstream generation System is stored in a Vertical Jacketed Storage tank. From the storage tank, the water is then supplied to various user points in the Production area. The Purified Water storage tank is controlled with the help of a capacitance-type level transmitter, which performs necessary actions to maintain sufficient water level in the tank. The distribution loop consists of a distribution pump, and online instruments for measuring conductivity, Temperature, Pressure, and level to monitor the level in the storage tank. All the user point valves are Manual Diaphragm valves. Whenever the circulation loop is to be sanitized for the destruction of bio-film formation or as per Validation requirements, the water is heated and circulated at elevated temperatures (i.e + 85 deg Celsius) for some time. During sanitization, the inlet-actuated diaphragm valves feeding to the tank are closed so as not to allow additional fresh water until sanitization is over. The signal to this actuated valve is given by a PLC-based control panel. Detailed control logic is described in a later chapter.
The control panel supplied for the Purified water system consists of Controllers for instruments and other ancillaries. The control panel controls the operation of all automatic valves and pumps with a predetermined logic. In normal operating conditions, 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:
| Equipment Description | MOC | Make |
| Storage Tank | SS 316L | Neela |
| Jacketed Vent Filter | ||
| Vent Filter Cartridge | PTFE | Pall/ Sartorius |
| Vent Filter Housing | SS 316L | Neela |
| Spray Ball | SS 316L | Neela |
| Cap. Type Level Transmitter | SS 316 | E & H /Emerson |
| Compound Pressure Gauge | SS 316L | Forbes Marshall |
| Temperature Transmitter | SS 316L | Radix |
| Syphon Type Pressure Gauge | SS 316L | Forbes Marshall |
| Conductivity Indicator Cum Controller | SS 316L | E & H / Emerson |
| Centrifugal Pump | SS 316 L | Alfa Laval |
| Pressure Gauge | SS 316L | Forbes Marshall |
| Ultra Violet | SS 316L | Alfa Water |
| Conductivity Indicator Cum Controller | SS 316L | E & H / Emerson |
| Flow Transmitter | SS 316L | E & H / Emerson |
| Temperature Transmitter | SS 316L | Radix |
| Manual Diaphragm Valve | SS 316L | Neela |
| Flow Divertor Valve | SS 316 L | Neela |
| Actuated Globe Valve | SS 304 | Neela |
| Back Pressure Valve | SS 316 | Neela |
| Manual Ball Valve | SS 304 | Neela |
| Non-Return Valve | SS 316 L | Neela |
| Steam Trap | SS 304 | Uniklinger/Spirax |
| SS Tubes | SS 316L | Sandvik |
| Control Panel | —– | Allen Bradley /ABB/ Messung |
TECHNICAL SPECIFICATIONS
Technical specifications for the major equipment and items required for the project are enclosed in the following pages.
PURIFIED WATER STORAGE TANK – Location: Purified Water Distribution Area
| Description | Specifications |
| Type | Vertical, Jacketed |
| Nominal Capacity | 2 KL |
| Process Fluid | Purified Water |
| Process Fluid Density | 1000 kg/m3 |
| Design Pressure – Shell Side | 1 Kg/cm2 |
| Design Pressure – Jacket Side | 3 Kg/cm2 |
| Design Temperature | 140 Deg Celsius |
| Hydrotest Pressure- Shell Side | 1.5 Kg/cm2 |
| Hydrotest Pressure – Jacket Side | 4.5 Kg/cm2 |
| Joint efficiency shell/Dish | 0.85/1.0 |
| Thickness Main Shell/Dish | Shell 5 Thk. /Top Dish 3 Thk Nom.,2 Thk. min./Bottom Dish 8 Thk Nom,7 Thk min. |
| Thickness Jacket Shell/Dish | Shell 3 Thk. / Dish end – 5 Thk Nom., 4 Thk. Min |
| Contact Part | SS 316L |
| Non-Contact Part | SS 304 |
| Internal Finish | 0.3 Ra. Electropolished |
| External Finish | Matt Finish |
| Radiography Shell / Dish | 10% + T / 100 % |
| Insulation | 50 mm THK, Glass wool |
| Cladding | SS 304, 2 mm Thk |
| Make | Neela |
JACKETED VENT FILTER: Location: On Top of Purified Water Tank
| Description | Specifications |
| Type | |
| Housing | Jacketed |
| Cartridge | Hydrophobic |
| Rating | 0.2 Micron |
| Construction Code | Code 7 |
| MOC1) Housing2) Cartridge | SS 316LPTFE |
| Gasket | Silicon |
| Working Condition | Ambient & Occasionally 85 deg. C |
| Housing End Connection | 1.5” TC |
| Housing Make | Neela |
| Filter Element | |
| Quantity | 1 No. |
| Size | 10” Long |
| Cartridge Make | Sartorius / Pall |
SPRAY BALL: Location – Inside the Purified Storage Tank
| Description | Specifications |
| Type | Rotary Capsule Type |
| MOC | SS 316L |
| Size | ¾” BSP(F) |
| Area of Coverage | 3600 |
| Make | Neela |
CAPACITANCE TYPE LEVEL TRANSMITTER: Location – On top of Purified Water Tank
| Description | Specifications |
| Type | Capacitance Type |
| Range | Zero – Full Scale |
| Measuring Parameter | Volume |
| Accuracy | < 1% for 1 m |
| Supply | 8 – 32 VDC |
| Wire | 2 wire |
| Output | 4-20 mA |
| MOC | SS 316 |
| End Connection | 2” TC End. |
| Probe Length | As per Tank Height |
| Make | E & H / Emerson |
COMPOUND PRESSURE GAUGE: Location – On The Top Of The Purified Water Storage Tank
| Description | Specifications |
| Type | Diaphragm Type |
| Size | 4” Dial |
| End Connection | Std. TC End |
| Range | -1 to 5 kg/cm2 |
| Diaphragm MOC | SS 316L |
| Liquid Filled | Glycerin |
| Make | FORBES MARSHALL |
TEMPERATURE TRANSMITTER: Location –On the Purified Water Storage Tank
| Description | Specifications |
| Type | PT100, 3 wire as per DIN 43760/ IEC 751 |
| No. Of Circuits | One (Simplex) |
| Accuracy | Class ‘B’+/- 0.3 at 0 deg. Cel & +/- 0.8 at 100 deg. cel |
| Sheath Dia | 6 mm |
| Sheath Length | 9” Long |
| Sheath Material | SS 316 |
| End Connection | ½” BSPT |
| Make | Radix |
SYPHON TYPE PRESSURE GAUGE: Location – At Steam Inlet To Jacket Of Tank
| Description | Specifications |
| Type | Diaphragm Type |
| Size | 4” Dial |
| End Connection | Std. TC End |
| Range | 0 to 7 kg/cm2 |
| Diaphragm MOC | SS 316L |
| Liquid Filled | Glycerin |
| Make | FORBES MARSHALL |
CONDUCTIVITY INDICATOR CUM CONTROLLER: Location – At Suction of Pump
| Description | Specifications |
| Type | Inline Type |
| Current Output | 4 – 20 mA |
| Sensor End Connection | TC End |
| Sensor MOC | SS 316L |
| Sensor Cell Constant | 0.01 |
| Sensor Range | 0-10 mS/cm. |
| Temperature | 0-105 deg. Cel. |
| Output | 4-20 mA |
| Input to the Meter | 230 VAC |
| Enclosure | IP65 |
| Make | Forbes Marshall / E & H |
| Model No. | — |
PURIFIED WATER DISTRIBUTION PUMP: Location – Purified Water Distribution Skid
| Description | Specifications |
| Type | Horizontal, Centrifugal |
| Capacity | 5.4 m³/hr. |
| Suction Head | Flooded |
| Discharge Head | 6 Kg/cm² |
| Max. Rated Speed | 2840 RPM |
| Liquid Handled | Water |
| Location | Indoor |
| M.O.C. | |
| Casing | SS – 316L |
| Impeller | SS – 316L |
| Shaft | SS – 316L |
| Base Frame | Not Reqd. |
| Seal | Mechanical Seal (Silicon Carbide Vs. Silicon Carbide.) |
| Prime Mover | A.C. Motor, 415 V, Three Phase, 50 Hz. |
| Power | 15 HP |
| Motor Make | Crompton |
| Drive Transmission | Direct |
| Quantity | 02 Nos. |
| Make | Alfa Laval |
| Model | ALC2 |
PRESSURE GAUGE: Location –At Discharge Of Pump
| Description | Specifications |
| Type | Diaphragm Type |
| Size | 4” Dial |
| End Connection | Std. TC End |
| Range | 0 to 14 kg/cm2 |
| Diaphragm MOC | SS 316L |
| Liquid Filled | Glycerin |
| Make | WAREE |
ULTRA VIOLET SYSTEM: Location: At Discharge Of PW Distribution Pump
| Description | Specifications |
| Flow Rate | 5 m3/hr |
| Arc Wave Length | 2537 Angstrom Units |
| Minimum Intensity At The End Of Life | > 30000 microwatt sec/cm² |
| Transmitting Medium | Quartz jacketed around each lamp |
| No. of High-Intensity UV Lamps | 4 Nos. |
| Length Of Each Lamp | 30” |
| Diameter of UV Lamp | 15 mm dia. |
| Model | AP-30 |
| Make | Alfa Water |
CONDUCTIVITY INDICATOR CUM CONTROLLER: Location –In Return Line Of Purified Water Distribution System
| Description | Specifications |
| Type | Inline Type |
| Current Output | 4 – 20 mA |
| Sensor End Connection | TC End |
| Sensor MOC | SS 316L |
| Sensor Cell Constant | 0.01 |
| Sensor Range | 0-10 mS/cm. |
| Temperature | 0-105 deg. Cel. |
| Output | 4-20 mA |
| Input to the Meter | 230 VAC |
| Enclosure | IP65 |
| Make | Forbes Marshall / E & H |
| Model No. | — |
FLOW TRANSMITTER: Location – In the Return line of the Purified Water Distribution system.
| Description | Specifications |
| Type | Vortex Type |
| Sensor End Connection | Flanged |
| Sensor MOC | SS 316 |
| Sensor range | 0.8 to 8 m3/hr |
| Accuracy | 0.75% of Operating range |
| Max. Temperature | 175 Deg Celsius |
| Output | 4-20 mA |
| End Connection | 1.5” TC |
| Input to the Meter | 24 VDC Loop Powered |
| Make | E & H / Emerson |
TEMPERATURE TRANSMITTER: Location –In the Return line of the Purified Water Distribution System
| Description | Specifications |
| Type | PT100, 3 wire as per DIN 43760/ IEC 751 |
| No. Of Circuits | One (Simplex) |
| Accuracy | ‘Class ‘B’+/- 0.3 at 0 deg. Cel & +/- 0.8 at 100 deg. cel |
| Sheath Dia | 6 mm |
| Sheath Length | 50 mm Long |
| Sheath Material | SS 316 |
| End Connection | 1 ½” TC End |
| Make | Radix |
MANUAL DIAPHRAGM VALVE: Location – As per P & ID
| Description | Specifications |
| Type | Diaphragm Type |
| Internal Finish | Pharma Finish, Electro-polished |
| Diaphragm Grade | EPDM |
| End Connection | TC End |
| Body | SS 316 L |
| Bonnet | SS 304 |
| Handle | SS 304 |
| Make | NEELA |
| Size | As Per the Attached Annexure |
ANNEXURE
| Size | Location |
| 1” OD | At Tank T – 2101 Drain |
| 3” OD | At Suction Of Pump P-2101/02 |
| ½” OD | Sampling Point At Discharge Of Pump P-2101/02 |
| 1 ½” OD | At Inlet Of UV System UV-2101 |
| ½” OD | Sampling Point At Inlet Of UV-2101 |
| ½” OD | Sampling Point At Outlet Of UV-2102 |
| ¾” OD | At User Points |
| ¾” OD | At User Points |
| ½” OD | Sampling point in return line & At UV outlet respectively. |
| 1 ½” OD | On Top Of Tank |
FLOW DIVERTER VALVE: Location – At tank inlet, at the inlet of UV system & in the return line of Purified Water Distribution System respectively
| Description | Specifications |
| Type | 3-way valve |
| End connection | TC End |
| MOC | |
| Body | SS 316 |
| Seat | PTFE |
| Body Seal | PTFE |
| Max. Pressure | 15 Kg/cm2 |
| Make | Neela |
| Size | KV – 2101 – 1” ODKV – 2103/04 – 1 ½” OD |
ACTUATED GLOBE VALVE: Location – Steam inlet to the Jacket of Purified Water Storage tank
| Description | Specifications |
| Body Form | Investment Casting |
| Construction | Pc. Design |
| End Connection | Flanged End |
| Body Material | SS304 |
| Stem Material | SS304 |
| Seat | PTFE |
| Max Pressure | 15 kg/cm2 |
| Make | Neela |
| ACTUATOR DETAILS | |
| Type | S.A. Pneumatic Rotary Actuator |
| M.O.C. – Body | Aluminium |
| Seat | PTFE |
| Seal | PTFE |
| Action | Normally Close |
| Rotation | 0 – 90 Degrees |
| Operating Pressure | 5-6 kg/cm2 |
BACK PRESSURE VALVE: Location – In Return Line Of Purified Water Distribution System
| Description | Specifications |
| Type | Self Actuated |
| MOC, Main Body | SS 316 |
| Centre Rod Assembly | SS 316 |
| Seal Material | Silicon |
| Top Body | SS 316 |
| Max. Temperature | 120 Deg. C |
| Max. Operating Pressure | 6 Kg / cm2 |
| Set Pressure | 1 to 3 Kg / cm2 |
| Size | 1.5” TC |
| Inlet Connection | TC End |
| Outlet Connection | TC End |
| Make | Neela |
MANUAL BALL VALVE: Location – Steam Trap assembly
| Description | Specifications |
| Type | Single pc Design |
| End Connection | Screwed End |
| BODY MOC | SS 304 |
| Ball MOC | SS 304 |
| Spindle | SS 304 |
| Seat | PTFE |
| Max Pressure | 12 kg/cm2 |
| Make | NEELA |
| Size | ¾” OD |
NON-RETURN VALVE: Location – Pump P – 2101/02 Discharge
| Description | Specifications |
| Type | Lift Check Spring Loaded Type |
| Size | 1.5“ OD |
| End Connection | Flanged End |
| Body MOC | SS 316 L |
| Internal Finish | Pharma Finish |
| Hydro Test Pressure | Body: 10 kg/cm2Seat: 3.5 kg/cm2 |
| Make | NEELA |
STEAM TRAP: Location – Steam Trap Assembly
| Description | Specifications |
| Type | Thermodynamic |
| Ends | Screwed to BSPT |
| Cap | AISI 420 |
| Rating | 800 # |
| Disc | AISI 420 |
| Element Holder | SS 410 |
| Packing | CAF |
| Strainer Screen | SS 316 |
| Pressure Operating | 10.5 kg. /cm2 |
| Operating Temperature | 180 deg. C |
| Max. Operating Temperature | 200 deg. C |
| Max. Operating Pressure | 20 kg/cm2 |
| Utility | Steam |
| Make | Uniklinger / Spirax |
| Model No. | ——- |
| Size of Trap | ¾” |
SS TUBES: Location – Distribution. Network
| Description | Specification |
| Type | Laser welded Bead Removed |
| Standard | ASTM A 270 TP 316L |
| Internal finish | < 0.3 micron |
| External finish | Sanitary Finish |
| Make | Sandvik |
PANEL INTERLOCKS AND OPERATIONAL LOGICS:
Integration with Purified Water Storage and Distribution System:
- REF.ATTACHED P& I DRAWING
- REF. ATTACHED CONTROL LOGIC DOC.
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 the 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: At the drain of Tank T-2101
S2: : At the outlet of Pump P-2101/02
S3: At the inlet of UV – 2101
S4: At the outlet of UV – 2101
S5: : User Points
S6: : User Points
S7: In return line after FT – 2101
SANITISATION CYCLE
PURIFIED WATER DISTRIBUTION SYSTEM:
The Sanitization of the Purified Water Distribution System shall be established based on Performance Validation. Storage and Distribution System shall be sanitized by Hot Water at 80-900C. It is preferable to sanitize the system once a week or as established during Performance Validation.
The complete system is designed for periodic sanitization.
Bio-film formation in the 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 the 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 feeding to the tank should be in the closed position so as not to allow additional fresh water until sanitization is over. 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 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 the OFF position and the 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 to bring down the complete system to ambient temperature. Flush water from all sample and user points of the 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 systems covered in the system shall be offered for inspection at the works as per the agreed schedule and inspection requirements for Dimensional checkups and surface Finishes.
- Distribution piping shall be offered for inspection, if required, before dispatch for a 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 of -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
| Item Description | Makes |
| CAP. TYPE LEVEL TRANSMITTER | E&H/EMERSON |
| CENTRIFUGAL PUMPS | ALFA LAVAL |
| COMPOUND PRESSURE GAUGE | FORBES MARSHALL |
| PRESSURE GAUGE | FORBES MARSHALL |
| ULTRA VIOLATE SYSTEM | ALFA WATER |
| TEMPERATURE TRANSMITTER | RADIX |
| FLOW TRANSMITTER | E & H / EMERSON |
| CONDUCTIVITY SENSOR | E & H / FORBES MARSHALL |
| SS PIPING | SANDVIK |
| SS FITTINGS | NEELA |
| 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.
