OBJECTIVE of URS for Colloid Mill
The purpose of this document is to ensure that all the critical aspects of the Equipment, cGMP & Safety features have been considered in designing the equipment/instrument and is properly documented. The objective of URS for Colloid Mill is to provide the appropriate design, operational and performance requirements for procurement of equipment including major ancillary component or fabrication of the area so as to meet the in-house requirements as well as compliance with cGmP.
The User Requirement Specifications (URS) is written to support the prospective supplier to identify organization needs and propose a design to the organization.
CONTENTS
| Sr. No. | Title | Page No. |
| APPROVAL | ||
| OBJECTIVE | ||
| RESPONSIBILITY | ||
| EQUIPMENT DESCRIPTION & IDENTIFICATION | ||
| USER REQUIREMENTS | ||
| TECHNICAL DESCRIPTION | ||
| COMPLEMENTARY ASPECTS | ||
| SUPPLIER TECHNICAL DOCUMENTATION REQUIREMENTS | ||
| SAFETY AND ENVIRONMENTAL PROTECTION | ||
| CLEANING MAINTENANCE AND SERVICE | ||
| SCOPE OF DELIVERY | ||
| EXPECTED DOCUMENTATION | ||
| MAINTANANCE REQUIREMENTS | ||
| OTHER REQUIREMENT | ||
| REFERENCE | ||
| ABBREVIATIONS |
APPROVAL of of URS for Colloid Mill:
PREPARED BY:
| Department | Name | Signature | Date |
| Production (Officer/Executive) |
REVIEWED BY:
| Department | Name | Signature | Date |
| Production (Executive/Manager) | |||
| Quality Assurance (Executive/Manager) | |||
| Engineering (Executive/Manager) |
APPROVED BY:
| Department | Name | Signature | Date |
| Quality Assurance (Head QA) |
RESPONSIBILITY:
The User department comprising of representatives from each of the following departments should be responsible for the overall compliance with this URS:
| Department | Responsibility |
| User Department | Preparation of User Requirement Specifications (URS).Ensures that the document is in compliance with current policies and procedures of cGMP regulations. Ensures that the content is sufficient, clearly defined, technically sound and accurate. It is a Guidance document to prepare the URS. |
| User/Project/Engineering | The Department Head or Designee shall be responsible to review the URS. |
| Quality Assurance | The Department Head or Designee shall be responsible to review and approve the URS. |
EQUIPMENT DESCRIPTION & IDENTIFICATION:
SCOPE:
This document covers all aspects of Users requirements for the Equipment along with all Attachment, Spare Parts, Change Parts and Accessories to be used in Colloid Mill 5 HP, at company The following item (s) intended for use as part of pharmaceutical manufacture.
Scope incorporates understanding and documentation of critical requirements such as system requirements, cGMP requirements, safety requirements, documentation requirements and operational requirements.
PURPOSE:
Purpose of equipment is used in production area for mixing of Liquid of material used in formulation of solid dosages.
USER REQUIREMENTS of URS for Colloid Mill
| SYSTEM COMPONENTS | SYSTEM REQUIREMENTS |
| Identification (In case of Equipment /Instrument) | Details of Make, Name, Serial. No., Capacity, Model and Year of manufacture should be available |
| Model/Type | As per cGMP model (Colloid Mill.) |
| Capacity | 5 HP |
| Potential Suppliers | SAMS TECHNO MECH PVT. LTD. |
| Contact parts (In case of Equipment) | SS316 with Mirror finish |
| Non contact parts (In case of Equipment) | SS304 with matt finish |
| Non metallic contact parts (In case of Equipment /Instrument) | Any material with food grade quality having no Potential impact on the products.Durable.Must be easily cleanable. |
| Motor & Electrical installations (In case of Equipment /Instrument) | As per machine requirement |
| Machine assemblies (In case of Equipment /Instrument) | Must be covered with SS 316 with matt finish. |
| Machine adjustments (In case of Equipment /Instrument) | Setting with Zero clearance with good accuracy. |
| Packaging & Transport | Should be packed and transported in such a way to avoid any damage during transportation. |
| No. of requirements | 01 |
| Requirements for any power failure backup’s (In case of Equipment /Instrument) | To be backed up by installed in-house DG set. |
TECHNICAL DESCRIPTION:
| SPECIFICATION | SYSTEM REQUIREMENTS |
| Colloid Mill | YES |
| Capacity 5 HP | YES |
| Dimension ( L-1070 mm W-475 mm, Ht-1310 mm) | YES |
| Start Push Button | YES |
| Stop Push Button | YES |
| Phase (3 Phase) | YES |
| Voltage (415 Volts) | YES |
| Frequency (50 Hz) | YES |
| Total HP (5 HP) | YES |
| Total KW (3.7 kW) | YES |
COMPLEMENTARY ASPECTS
| Specification | SYSTEM REQUIREMENTS |
| The vendor Shall supply all available information for the adequate exploitation of equipment. For the Compliance of this purpose at the Job site and/ or at the Vendors Shop. Vendor’s technical staff shall train customer’s personnel. The scope of the Training will be agreed during the contract signature. | YES |
| The supplier is to include the personnel training activities. The contractor is to specify the foreseen time for: Operator/Supervisor trainingManager TrainingElectrical maintenance trainingMechanical Maintenance training | YES |
| The contractor is to specify the personnel background needed for each of the operators maintenance. | YES |
SUPPLIER TECHNICAL DOCUMENTATION REQUIREMENTS:
| COMPONENTS | REQUIREMENTS |
| Drawings Equipment/Systems electrical drawing.Point to point wiring diagram | Pre Installation Requirements will be supplied by Vendor |
| LIST. Equipment and instrument list with Component description.Electrical component parts list with Description.Function check list.Documentation list.Spare part list | List of spares required for smooth operation will be provided by the Vendor at the time of ordering. |
SAFETY AND ENVIRONMENTAL PROTECTION:
| Specification | Requirements |
| All motors have to be thermally Protected. | YES |
| All the Installation must be in accordance with the cGMP. | YES |
| The cGMP concerning safety must be applied. | YES |
CLEANING MAINTENANCE AND SERVICE:
| Specification |
| In accordance with cGMP guidelines the units must be easy to clean, to disinfect, and where necessary, to sterilize. |
| The Supplier should guarantee that, if required, a service team can be on site within one working day. |
| The design should be such as to allow mechanical cleaning of the surface and that the cleanliness of the surface can be checked easily. |
| All machine parts, in particular instrumentation, should be constructed so that they can be easily removed and calibrated. |
| All special tools required for running and maintenance should be best. |
| A spare parts delivery guarantee with in time. |
SCOPE OF DELIVERY:
| Specification | Requirements |
| Units described in the specific system requirements including all necessary controls and instrumentation. | YES |
| The complete mechanical and electrical installation. | YES |
| The Connections to all the necessary utilities, exhaust, and waste lines necessary for its operation. | YES |
| All piping and cabling of the units itself. | YES |
| Wiring and cable run: all wiring and cable run is part of the supply. We will supply the main power switches to be located in correspondence to the electrical and control cabinets delivered by the equipment supplier. | YES |
| All internal contacts of the supplied equipment for the required utilities. | YES |
| Unload on site of the equipment: the supplier is required to define all the necessary handling devices required to the unloading operation. The supplier will inform at least 4 weeks in advance the day of delivery and the list of required handling devices. | YES |
| Assembling operation: the required consumable, the internal transportation, the assembling tools and the required personal are part of the supply. | YES |
| A complete set of commissioning spare parts. | YES |
EXPECTED DOCUMENTATION of URS for Colloid Mill:
The Vendor shall provide documents needed for preliminary review of the equipment initially. Documents reflecting ‘as-built’ condition shall be provided along with the final consignment delivery. The following documents shall be provided by the suppliers during the procurement life cycle:
| Document Details | Required (P / O ) | Requirement | Format |
| Design Specifications | R | Should Provide | Paper or PDF |
| Functional Specifications | R | ||
| Piping and Instrumentation Diagram (P&ID) | Q | ||
| Instrument Listing | R | ||
| Control Panel Assembly Drawings | R | ||
| Machine Assembly Drawings | R | ||
| Bill of Materials | R | ||
| Operator, Maintenance and Service Manuals | R | ||
| Spare Parts List | R | ||
| MOC Certificates | R | ||
| Calibration Certificates of Instruments | R | ||
| Test Certificates of Components/Test Devices | R | ||
| Weld Certificates (Optional) | Q | ||
| ‘As-built’ P&ID | Q | ||
| GA Drawing | R | ||
| Isometric Drawing | Q | ||
| Electrical / Control Wiring Drawings | R | ||
| Component Cut Sheets (Optional) | Q | ||
| PLC Program Printouts and Disk File (Optional) | R | Electronic Downloadable | |
| HMI Configuration Printout and Disk File (Optional) | R | ||
| Other (Specify) product contact surfaces area | R | Vendor DQ/IQ/OQ | Stamp with Signed Hard Copy/Soft Copy |
MAINTANANCE REQUIREMENTS:
(Accessibility for easy maintenance, equipment side to be kept open able to the service area for maintenance activity, required spares, etc. shall be mentioned in details).
Approved Operational and Preventive Maintenance SOP’s should be available.
OTHER REQUIREMENTS:
All Vendors Documents like DQ, IQ, OQ, Operation Manuals, Calibration Certificate and Components Certificates etc. shall be in English Language.
REFERENCE:
| Title | Document No. | Location |
| Manual | N.A. | Validation Document Cell |
ABBREVIATIONS:
| Abbreviations | Description |
| cGMP | Current Good, Manufacturing Practice. |
| URS | User Requirement Specification |
| 0C | Degree Centigrade |
| PLC | Programmable Logic Control |
| mm | Millimeter |
| HMI | Human Machine Interface |
| V | Voltage |
| Hz | Hertz |
| MMI | Man Machine Interface |
| RH | Relative Humidity |
| NMT | Not More Than |
| HVAC | Heating Ventilation and Air Conditioning |
| CFM | Cubic Feet per Minute |
| LOD | Loss of Drying |
| RPM | Revolution Per Minute |
| MOC | Material of Construction |
| GMP | Good Manufacturing Practices |
| GA | General Assembly |
| P & ID | Piping & Instrumentation Drawing |
| PO | Purchase Order |
| Portable Document Format | |
| SCADA | Supervisory Control And Data Acquisition |
| NLT | Not Less Than |
| FAT | Factory Acceptance Test |
| DQ | Design Qualification |
| IQ | Installation Qualification |
| OQ | Operational Qualification |
| SOP | Standard Operating Procedure |
| VFD | Variable Frequency Drive |
| MCB | Miniature Circuit Breaker |
| PLM | Planetary Mixer |