User Requirement Specifications

Transcription

1 Page 1 of 13 ANNEXURE III User Requirement Specifications MACHINE :Linear Bottle Washing CAPACITY: 120 Bottles/ minute

2 Page 2 of 13 Table of Contents 1.0 APPROVAL SIGNATURES INTRODUCTION OVERVIEW PROCESS DESCRIPTION DESIGN REQUIREMENT SAFETY REQUIREMENT TESTING & DELIVERY QUALIFICATION REQUIREMENT TRAINING & TECHNICAL SUPPORT GOOD ENGINEERING PRACTICES CONSTRAINTS SCOPE OF SUPPLY ABBREVIATIONS...13

3 Page 3 of APPROVAL SIGNATURES This document has been prepared and reviewed by the technical team of project management and approved by following officials of GAPL. Prepared by Name/ Designation Signature Date Mrs Priyanka yeshi, AM production Checked by Name/ Designation Signature Date Mr. B. Demello, Maintenance Engineer Approved by Name/ Designation Signature Date Mr. Govind R. Tilve, Manager Production Authorized by Name/ Designation Signature Date Mr. D.N. Shetty, DGM CQA/RA

4 Page 4 of INTRODUCTION This document was generated under the authority of the GOA ANTIBIOTICS AND PHARMACEUTICALS LTD.( A SUBSIDIARY OF HLL LTD)for the purpose of specifying the user requirement for an linear bottle washing Machine that will clean empty GLASS / PET bottles required for liquid product filling. The User Requirements Specification (URS) is provided to aid the user through the important components, variables and options necessary to procure a functional bottle washer that meets the users needs in the most cost-effective method possible. The URS shall be provided to the Supplier to provide a price quote for machine supply including the design and manufacture of the equipment. This URS shall be recognized as an integral part of the procurement agreement with the selected equipment vendor. The equipment supplier or vendor will abide by the information and conditions set forth by this document as well as the standard purchasing term and conditions of the Company. The machine shall be installed and operated adjacent to existing conveyor systems as an integrated bottle filling line and will be located in a designated operating area of liquid oral filling and packing facility at production department. 3.0 OVERVIEW 3.1 Project Standard The facilities, upon completion, shall be in compliance with the cgmp requirement of Drugs And Cosmetic Act-1940/ WHO and also the GAPL s internal quality standards. The liner bottle washing machine must be capable of continuous operation over a 8 hour shift, in 3 shifts basis. 3.2 Equipment description The Linear Bottle Washing machine will be used for washing of empty PET/Glass bottles to be used for filling of Liquid formulation. The equipment should provide. loading: bottles will be loaded to feeding tray and manually pushed. washing: bottles to be carried by suitable carrier pockets moving in Linear indexing motion over a several washing stations where they are washed through a series of water jets/ compressed air from inside and external surface of the bottle in a tunnel type arrangement. unloading: washed bottles to be unloaded on the turntable of existing filling line Standard guidelines for equipment The equipment should comply with the current Good Manufacturing Practice for Pharmaceuticals

5 Page 5 of PROCESS DESCRIPTION 4.1 Bottles loaded on machine through feeding tray manually. 4.2 These bottle will be transferred in neck down position over spray nozzles through suitable carrier system. 4.3 Bottles will be washed by water pressure jets though spray nozzles from inside and outside 4.4 Inside wash Spray nozzles deliver water jets or compressed air to flush internal surface of bottles. 4.5 Bottles pass through a series of wash cycles 4.6 Duly washed bottles are than delivered to out feed with neck upward position and transfer through suitable conveyer to filling line turn table. 5.0 DESIGN REQUIREMENT 5.1 Capacity Desired speed: 120 bottles/minute Loading of bottles on machine through feed tray which shall be transferred by suitable conveyer system on machine to washing stations Facility for transfer of washed bottles from machine to turntable should be provided. Machine to operate with minimal/no change parts for different bottle sizes with similar neck diameter Bottles to be washed internally as well as externally on completion of washing cycle. Bottle washing should be achieved uniformly. 5.2 Input specifications MOC of infeed bottles: PET/ Glass/ Nylon size : 20 ml to 500 ml neck diameter ( od) : 25 mm /22mm base diameter : mm height : mm

6 Page 6 of Material of construction Machine main structure of SS304. Machine external finish :mirror finish Water Tanks & trays made from SS 316 mirror finish. Water contact parts and jet spray nozzles strictly of SS 316L Yesno Welding: argon arc type. Yesno Water transfer pump: SS 316 with mechanical seal( TC totc) Yesno All Parts coming in contact with washing zones/jet to be made from SS316. Yesno SS filter housing : SS 316. Yesno Other Exposed parts SS304.r Preferred makes for Motor:Kirloskar /Compton Greaves/ Siemens Other mechanical parts/ Motors: non corrosive material 5.4 Design specification Pressure guages to be provide at all washing stations to detect pressure of washing jets. Provision for recirculation of water at initial washing stations Pumps and tanks required to be preferably inbuilt Appropriate filter of NLT 20 µ ( preferably pp filter cartridge) to be provided to water storage tanks Minimum 3 wash cycles with water from inner side, one on outside of the bottle and one wash with filtered air provision Each wash station to be provided with separate circuit to prevent mixing of two different waters Provision for washing of bottles with height, neck, base diameter more/less than that mentioned in our input specifications to be available for the machine if required

7 Page 7 of Quality requirement No water stagnation in any part of the machine at any given time during operation /non-operation There should be no water leakage through machine except for drain water. Appropriate provision to be made for draining off all the rinse water from the interior of the bottles is to ensure that there is no residual rinse water left in the bottle prior to sending for product filling. 5.6 Utility requirement Vendor should state the utilities required for the normal operation of the machine Vendor should provide consumption details for Electricity, water, Compressed air and Other utilities o Cables, air tubes, etc required from the point (single utility point) to equipment is in scope of vendor. 5.7 Operation Single operator is expected to operate the machine Machine shall be safe from an Operator and environmental standpoint. The equipment shall have proper safeguards Control System Requirements Manual/automatic 5.8 Cleaning and Maintenance Filters & spray nozzles should be easy to dismantle & clean whenever required. Vendor to give information on the cleaning procedure for the machine. The equipment shall be easily accessible for cleaning the non-product contact part at maintenance side of the equipment. Vendor shall provide special tools for maintenance of the equipment. Vendor shall give recommended spare parts list.

8 Page 8 of SAFETY REQUIREMENT 6.1 General Following facilities must be provided to protect personnel, article and equipment: In the event of equipment malfunction or loss of utilities, the unit must contain all necessary protection devices to ensure that the equipment and the article remain in a safe condition. Noise level below 75 db at a distance of 1 m from the equipment Emergency stop function on all accessible areas Appropriate failure detection / alarm notification Appropriate closure of all the rotating parts Proper earthing of the equipment All electrical/ wirings properly insulated and cancelled 6.2 Power failure and recovery On power failure equipment shall come to rest, to protect operator, equipment the material and surroundings. On power resumption machine shall operate only after manual starting not directly 6.3 Failure mode detection Equipment shall be capable to detect the following failure, notify the operator with alarm: pressure drop at washing stations Feed water tank level low

9 Page 9 of TESTING AND DELIVERY 7.1 In order to verify labeler performance, the User shall witness the execution of the Factory Acceptance Test (FAT) procedures. 7.2 Vendor shall prepare FAT and SAT protocol and get approved from GAPL. 7.3 Delivery The labeler, with all options, equipment, and the documentation listed below, shall be delivered to the User s receiving bay Documentation Installation, operation, and maintenance instruction documentation for the labeling machine shall be developed Document format shall comply with the following requirements. User Requirements Specification Functional Specification/Requirements Design Specifications Controls Test Hardware Installation Test Operational Test Factory Acceptance Test Operator, Maintenance and Service Manuals Process and Instrumentation Diagram (P&ID) Control Schematics Control Panel Assembly Drawings Equipment Assembly Drawings Spare Parts List other relevant documents

10 Page 10 of QUALIFICATION REQUIREMENT 8.1 General 8.1.1Equipment shall be qualified for design phase (DQ), installation phase (IQ), Operational phase (OQ) and the performance phase (PQ) Vendor shall support client in execution of all the qualification phases. 8.2 Desired documents Supply package Following documents, but not limited to these, are expected from the vendor as part of the supply package Filled in URS Equipment layout drawing fitted in the room layout block Detail technical offer that support the compliance of the URS Critical list of major component, devices and instruments with their specific functions, specifications data sheet Schematic diagram of the equipment Post ordering Functional design specification and technical specification, that should contain the following: Equipment descriptions and its function Equipment operation steps List of failure indications List of input/outputs and its functions Delivery of the equipment Vendor shall provide the following documents in the delivery package Operation and maintenance manuals, preventive maintenance schedule for equipment major component as well as the operating system. Installation instructions/ guideline for equipment. Detailed drawing marking clearly all the necessary dimensions and locations of utilities along with requirement of utilities on the drawing along with the offer. Spare and/ or change parts list with ordering information. Types of Lubricants used for lubrication and specification. Instrument calibration certificates. Guaranty/ warranty certificates for each equipment. MOC certificates for S316 material used for the machine.

11 Page 11 of TRAINING & TECHNICAL SUPPORT 9.1 User training shall consist of minimum 2 days of Operator training and 1 day of Maintenance training. 9.2 Technical support shall be provided by personnel visit via telephone / electronic media for a period of one years following the completion of validation activities. 9.3 A recommended replacement parts list including normal lead times shall be provided for the machine 10.0 GOOD ENGINEERING PRACTICES 10.1 Equipment must be fabricated following all Good Engineering Practices. The vendor s Quality System must follow applicable national standards 10.3 All sensors, controllers, PLC, indicators and will have to be calibrated, Original calibration certificate to be submitted by the vendor 10.4 All material of construction should have test certificates CONSTRAINTS Equipment location and available space at GAPL 11.1 This equipment will be installed in the existing available area - L X B X H: 2500 X 1500 X 2000 mm Conveyer height: 860 mm (to be verified by the vendor before fabrication of the machine). Floor: Ground Floor Department: Liquid oral (Production) location : Bottle washing room 11.2 Site visit preferred for the confirmation of exact location for new installation of the machine

12 Page 12 of SCOPE OF SUPPLY 1. The supply, installation, commissioning and validation has to be done by the supplier at Goa Antibiotics & Pharmaceuticals Ltd. Tuem -pernem Goa. However FAT will be perform by GAPL team at manufacture site. 2. Vender shall depute their technical person for installation, commissioning and validation of machine. 3. Adjusting Conveyer height of the machine to match the existing bottle packing line at GAPL is in the scope of supplier 4. All utility points such as electrical, compressed air line shall be provided by GAPL. 5. Utilities such as vaccum is in scope of the manufacturer 6. All the cabling, electrical fittings, transfer pipes etc., up to the functional point ( single utility point) is in the scope of GAPL and from functional point to the respective machine shall be in the scope of manufacturer. 7. Proper Concealing/ aesthetics of all electrical cables used for the machine is in the scope of manufacturer/supplier 8. Vendor shall prepare FAT protocol and get approved from GAPL. 9. Vendor shall prepare qualification document protocol and get approved from GAPL. 10. Calibration of instruments/ components is in the scope of vendor. 11. Vendor shall provide necessary test certificates at the time of installation. 12. Warrantee - 12 months from the date of commissioning. 13. Proper earthing to the machine is in the scope of the manufacturer/ supplier 14. DQ/IQ/OQ is in the scope of manufacturer/ supplier 15. Specific requirement for motor - Kirloskar / Compton Greaves/ Remi / Bharat Bijlee

13 Page 13 of ABBREVIATIONS 01. GAPL : Goa Antibiotics and Pharmaceutical Ltd. 02. HLL : Hindustan Life Care Limited 03. URS : User Requirement Specifications 04. cgmp : Current good manufacturing practices 05. PET : Polyethelyne terephthalate 06. UV : Ultra Violet 07. FAT : Factory Acceptance test 08. SA : Site acceptance Test 09. DQ : Design Qualification 10. OQ : Operational Qualification 11. PQ : Performance Qualification 12. IQ : Installation Qualification 13. WHO : World health Organization 14. SS : Stainless Steel 15. TC : Technetium 16. µ : Micron 17. NLT : Not Less Than 18. PLC : Programmable Logic Controller 19. SAT - Site Acceptance Test