URS (USER REQUIREMENT SPECIFICATION) PROTOCOL FOR WASHING MACHINE
This is a specific document prepared for the sterile facility. Hence, this document before being effective shall be approved and authorized by Unit Head and accepted by Vendor/Supplier.
List of Content
- Front Page
- Index
- Approval
- Objective
- Responsibility
- Equipment description & Identification
- User Requirement
- Complementary aspects
- Safety and environmental Protection Cleaning
- Cleaning maintenance and service
- Rules and Regulation
- Scope of Delivery
- Installation, Commissioning and Tests
- Qualification/Validation
- Guarantee/Warrantee
Note: If any deviation in URS, Vendor/Supplier shall inform before acceptance of URS.
Objective: 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.
Responsibilities: In accordance with the document. Following functions shall be responsible for initiation and finalization of Equipment user requirement specification. When contract / consulting staff, all the work carry the work is to be performed Under the oversight of User department, user department head, Head QA.
Preparation of Document: User department to prepare the URS. Ensures that the document complies with current policies and procedures of cGMP regulations.
Ensures that the document is sufficient, clearly defined, technically sound and accurate.
It is a Guidance document to prepare the URS.
Review of Document: To be reviewed by Head of the user department and functional department Engineering & Quality assurance).
Approval of Document: Approval of document by Head Manufacturing/Head Engineering/Head Quality.
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……………..
Scope incorporates Understanding and documentation of critical requirements such as system requirements, cGMP requirements, safety requirements, documentation requirements and operational requirements.
Purpose: For the washing of vials in washing area.
User Requirements:
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: Vial washing machine with 20 track, feeding and loading attachment confirming 10 current CGMP requirements.
Capacity: 7.5 ml to 30 ml molded & tubular vials with Minimum 350 vials/minute
Potential Suppliers: Ambica
Contact parts (In case of Equipment): SS316L with mirror finish
Non-contact parts (In case of Equipment): SS304 with mat finish
Non-metallic contact parts (ln case of Equipment /Instrustn1ment):
Any material with food grade quality having no potential impact on the
Must be easily
Motor & Electrical installations (In case of Equipment /Instrument): Machine should be operated through PLC mounted on electrical control panel.
Machine assemblies (In case of Equipment instrument): Must be covered with SS 304 with mirror 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/Instruments): To be backed up by installed in-house DG set.
Gearbox specification (In case of equipment/instrument): As per cGMP model
Technical Description:
Machine should be operated by manual and auto mode on PLC.
21 CFR part 11-complaint software
Machine should be PLC based control.
Out feed lifter. pusher and out feed platform for vials provide in machine.
Pump, pipefittings (ss3J6with silicon pipe), pipe fitting for drain, tanks (ss316, minimum 50 liters).
Lifter device, Extra infeed conveyor, pre-inspection table, infeed conveyor, infeed lifter, loosening device, should be provide with machine.
Washing sequence-
1st Wash Compressed air
2nd Wash Re-circulated water
3rd Wash Re-circulated water
4th Wash compressed air
5th Wash Purified water
6th Wash compressed air
7th Wash Purified water
8th Wash compressed air
9th WFI Water
10th Wash compressed air
Complimentary aspects:
Training: The vendor Shall supply all available information for the adequate exploitation or equipment. For the Compliance or this purpose at the Job site and/ or at the Vendors Shop.
Vendor’s technical staff shall train customer’s personnel. The scope or the
Training will be agreed during the contract signature
The supplier is to include the personnel training activities. The contractor is to specify the foreseen time for:
- Operator/Supervisor training
- Manager Training
- Electrical maintenance training
- Mechanical Maintenance training
The contractor is to specify the personnel background needed for each of the operator’s maintenance.
Pre Delivery Qualification (FAT)
The System or its parts as provided for in the scope of supply shall be pre-installed at the vendors shop prior to delivery to customer site. Installation will be completed and documented including mechanical parts as well as electrical connections of all parts to facilitate taking over tests at Vendors shop prior to delivery.
Supplier Technical Documentation requirements:
Drawings: Equipment/Systems electrical drawing & Point to point wiring diagram
List:
- Equipment and instrument list with Component description.
- Electrical component parts list with Description.
- Function check list.
- Documentation list.
- Spare part list
Technical Manuals
- Operating handbook
- Trouble Shooting Guide
- Equipment Description
- Equipment specification
- Calibration Instruction
- Maintenance Instruction