(DQ)DESIGN QUALIFICATION FOR PURE STEAM GENERATION SYSTEM
DQ- The Author signature indicates that this document has been prepared in accordance with existing cGMP standards and adequately reflects the tasks and deliverables necessary for qualification of the equipment.
REVIEWED BY: The reviewer’s signature indicates that, this document has been reviewed, and it accurately and completely reflects the tasks and deliverables necessary for the qualification of the equipment and that the documentation and information included complies with applicable regulatory requirements and current Good Manufacturing practices.
APPROVED BY: The approver’s signature indicates that the documentation and information contained herein complies with applicable regulatory requirements and current Good Manufacturing Practices.
The approver’s signature indicates that the documentation and information contained herein complies with applicable regulatory requirements and current Good Manufacturing Practices
- Introduction
- Scope
- Responsibility
- System Description
- Instruments Governing the Product Quality and Quantity
- Technical Specifications of Main Components
- Technical Specifications of Instruments
- Technical Specifications of Valves
- Technical Specifications of Pipes & Pipe Fittings
- Commencing & Qualification
- Utilities
- Supporting Documents
- Summary & Conclusion
- Abbreviation
- DQ approval
INTRODUCTION: United State Pharmacopoeia (USP) has revised the water specification for PSG in their current USP for Pharmaceutical Industry.
The maximum allowable limits for various parameters specified in current USP are as following:
- pH : 5 – 7
- Conductivity: < 1.3 μS / cm at 25 ° C
- TOC : < 500 ppb
- Total Bacterial Count : < 10 cfu / 200 ml
However, the system is designed considering current USP 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.
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 mechanism 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 Pure Steam Generator 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 PSG, following shall be the responsibility of Vendor and Party.
The complete system is designed as per the Relevant Standards, Agreed Technical Specifications, and User Requirement Specifications to comply with the regulatory Requirements.
Technical specifications of all the equipment, instruments, valves etc. are as per the offer, the Purchase Order, and the plant Requirements.
P & ID, General Arrangement Drawing, layout drawings, Technical Specifications) as per requirements will be prepared and submitted to plant before installation commence.
Documents for Installation Qualification shall be submitted.
Ensure all the components used, certification and documentation provided is in compliance with plant.
Requirements and/or with the standards specified in the plant Specifications.
Training on the system to be provided to operation staffs those are involved in water system.
Support for Performance Qualification Documents shall be provided after completion of Operational Qualification.
Plant responsibility on their part shall be as per the following:
To check and verify all the documents submitted are in line with agreed specifications and scope. Plant shall comment on the documents to signify that the vendor has complied with his commitment.
To provide the necessary site clearance, free access to installation site and completion of the site activities covered in plant scope.
Ensures that all the utilities and material required for the commissioning of system as specified by Vendor in Design Qualification and other documents at site.
Specify in writing the material required to be inspected by party before vendor commences supply to site / used for manufacturing at Vendors shops.
Carryout Operation qualification after the plant is certified for intended operations.
List of utilities to be provided by Plant Power: 415 V AC, 50HZ, three phase
Water: Purified/WFI Water up to inlet termination points.
Chemicals as per list given by Vendor
Unloading, Storage at site to be done at site.
Work permit, Heat permit to be provided for the erection of pipe work regarding (Environment, Health and Safety) EHS requirements if applicable.
SYSTEM DESCRIPTION:
Pure Steam Generator up to User Point: The Pure steam is generated from Pure Steam generator in Cylindrical, vertical, insulated, cladded single column equipped with double tube sheet Heat Exchanger. From steam column the pure steam is then supplied to various user points.
The help of level transmitter, which performs necessary actions to maintain sufficient water level in the HE, and avoids dry running of Purified water transfer pumps, shall control the water level in the purified water heat exchanger.
The system consists of transfer pump (sanitary construction), online instruments for measuring flow, pressure, temperature at return line, and level sensor for monitoring level in the HE.
The control panel supplied for Pure Steam Generator 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 1.2 m/s is maintained in the return loop.
The Pure Steam Generator design is suitable for meeting the requirements stated above.
INSTRUMENTS GOVERNING THE PRODUCT QUALITY AND QUANTITY
The instruments and indicators that shall be incorporated in the system are categorized as critical (C) i.e. the instruments whose performance shall directly affect the quality attributes of the processed material, current calibration status shall be listed for these instruments only. Monitor (M) i.e. the instrument whose performance failure would not affect product quality and which are used for process control.
| Instruments/Indicators/Sensors | Category |
| Pressure gauges | M |
| Rotameter | M |
| Temperature Sensor | M |
| Level Sensor | C |
| Low- & high-pressure switch | C |
ACCEPTANCES CRITERIA: The Pure Steam Generation System design confirms to ordered specifications as per USP. PSG should have
- Conductivity: Less than 1 μ Siemens / cm at 20ºC
- TOC: Less than 500 ppb
- Microbial Count: Less than 10 cfu/100 ml
- Colour, Taste and Odour – Clear
- All other parameters will comply USP, BP standards
TECHNICAL SPECIFICATIONS OF MAIN COMPONENTS:
Technical specifications for the major equipment’s and items required for the project are enclosed in the following pages.
- PSG COLUMN
- PW FEED PUMP
- PREHEATER UNIT
- SAMPLER
- TECHNICAL SPECIFICATIONS OF INTRUMENTS: AIR LOW PRESSURE SWITCH
- HIGH PRESSURE SWITCH
- GLASS TUBE ROTAMETER
- PRESSURE TRANSMITTER
- PRESSURE GAUGE
- TEMPERATURE SENSOR
- CONDUCTIVITY METER TRANSMITTER
- A CONDUCTIVITY SENSOR
- B CONDUCTIVITY TRANSMITTER
- LEVEL SENSOR
- STEAM TRAP
TECHNICAL SPECIFICATIONS OF VALVES:
- MANUAL DIAPHRAGM VALVE
- AUTO DIAPHRAGM VALVE
- BALL VALVE
- AUTO ANGLE SEAT VALVE
- SAMPLING VALVE
TECHNICAL SPECIFICATIONS OF PIPES & PIPE FITTINGS:
- SS TUBES & FITTINGS
- PIPES
- BENDS
- TEE
- PIPE HOLDER ASSEMBLY
- TC LINER
- TC CLAMP
COMMENCING AND QUALIFICATION: Due to the nature of the products to be manufactured, the system shall be subjected to qualification. The design shall follow the proper procedures required and GDP to allow such qualification. The validation of Pure Steam Generation System consists of DQ, FAT, IQ and OQ of the system.
DQ will be approved before manufacturing of the system.
Stage wise commissioning will be done by Vendor.
IQ/OQ will be performed at the installation site.
After completion of system installation IQ & OQ shall be performed.
The Vendor is responsible for the IQ & OQ protocols & execution.
Komal industries will perform training for operators, service and maintenance personnel and supervisors, covering set-up, operation and maintenance troubleshooting. Training shall be documented with a certificate of training for each person.
THE PROGRAMMABLE LOGIC CONTROLLER (PLC) : The key salient features are as follows: –
- Three level password protection for process security.
- RS 232 port for data communication.
- In-built Real Time Clock with date and time function.
- Battery backup for automatic restart in case of power failure.
HUMAN – MACHINE INTERFACE (HMI): Touch screen HMI is mounted on control panel. This is for on-line monitoring and control of the process through different customized screens with direct access via predefined function keys on the operator console.
PNEUMATIC CONTROLS: Consists of AFRL units mounted inside the panel connected to manifold units to which pilot solenoid valves and coils are fixed. The PLC outputs are connected to the coils and the pneumatic out-put shall be field terminated.
AUTO PURGING FACILITY: To prevent build-up of impurities in the columns an auto purging facility is provided wherein feed water from the last column is purged at pre-defined time interval.
ACCESS CONTROL MANAGEMENT DETAILS :
OPERATOR: ONLY ABLE TO ACCESS P&ID, AUTO MODE AND INPUT/OUTPUT STATUS.
SUPERVISOR: WILL ABLE TO OPERATE ENGINEERING SETTINGS, REVIEW FUNCTIONS IF ANY
ADMIN: WILL HAVE ALL THE ABOVE ACCESS AND ALSO THE TEST MODE (MAINTENANCE MODE FOR CHECKING THE OUTPUTS)
CONTROL PANEL DETAILS: Panel / PLC / HMI
Following are the utilities required for Multi Column distillation plant: Sr. No.
- Compressed Air
- PW from Loop
- Raw Steam Inlet
- PSG Outlet
- Recirculate to Chilled Water
- Chilled Water Inlet
- Drain Line
- Electricity
- Steam Consumption
SUPPORTING DOCUMENTS:
- Documents Attached with Design Qualification
- P & I Diagram
- Documents shall be provided with Installation Qualification
- As Build P & I Diagram
- Test / Calibration Certificates of Instruments
DESIGN QUALIFICATION REPORT APPROVAL
This design qualification report document is studied and approved by the Undersigned Authorized Personnel.