User Requirement Specifications MACHINE :Linear Bottle

GOA ANTIBIOTICS AND. PHARMACEUTICAL LTD

Equipment Linear Bottle washing machine

Page 1 of 13 Effective Date JUNE 2016

Revision No 00

ANNEXURE III

User Requirement Specifications MACHINE :Linear Bottle Washing CAPACITY: 120 Bottles/ minute




Revision No 00

Table of Contents 1.0 APPROVAL SIGNATURES ……………………………..……………………..03

2.0 INTRODUCTION…………………………………………….…………………..04 3.0 OVERVIEW…………………………………………………………………..……04

4.0 PROCESS DESCRIPTION………..……………………………………………05

5.0 DESIGN REQUIREMENT ………………………………………………..……..05

6.0 SAFETY REQUIREMENT …………………………………………….………..08 7.0 TESTING & DELIVERY…………………………………………………………09

8.0 QUALIFICATION REQUIREMENT…………………………………..……..…10

.. 9.0 TRAINING & TECHNICAL SUPPORT………………………………………..11

10.0 GOOD ENGINEERING PRACTICES ………………….………………...…11

11.0 CONSTRAINTS………………………………………………………………....11 12.0 SCOPE OF SUPPLY……………………………………………………….....12 . 13.0 ABBREVIATIONS……………………………………………………………....13




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1.0 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


Mr. B. Demello, Maintenance Engineer

Approved by


Mr. Govind R. Tilve, Manager Production

Authorized by


Mr. D.N. Shetty, DGM CQA/RA




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2.0 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. 3..3 Standard guidelines for equipment

The equipment should comply with the current Good Manufacturing Practice for Pharmaceuticals




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4.0 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 �Yes �no

Loading of bottles on machine through feed tray which shall be transferred by suitable conveyer system on machine to washing stations �Yes �no

Facility for transfer of washed bottles from machine to turntable should be provided. �Yes �no

Machine to operate with minimal/no change parts for different bottle sizes with similar neck diameter �Yes �no

Bottles to be washed internally as well as externally on completion of washing cycle. �Yes �no

Bottle washing should be achieved uniformly. �Yes �no

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 : 26 -80 mm

height : 58-190 mm




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5.3 Material of construction

Machine main structure of SS304. �Yes �no

Machine external finish :mirror finish �Yes �no

Water Tanks & trays made from SS 316 mirror finish. �Yes �no

Water contact parts and jet spray nozzles strictly of SS 316L �Yes�no

Welding: argon arc type. �Yes�no

Water transfer pump: SS 316 with mechanical seal( TC toTC) �Yes�no

All Parts coming in contact with washing zones/jet to be made from

SS316. �Yes�no

SS filter housing : SS 316. �Yes�no

Other Exposed parts SS304.r

Preferred makes for Motor:Kirloskar /Compton Greaves/ Siemens �Yes �no

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. �Yes �no

Provision for recirculation of water at initial washing stations �Yes �no

Pumps and tanks required to be preferably inbuilt �Yes �no

Appropriate filter of NLT 20 µ ( preferably pp filter cartridge) to be provided

to water storage tanks �Yes �no

Minimum 3 wash cycles with water from inner side , one on outside of the bottle and one wash with filtered air provision �Yes �no

Each wash station to be provided with separate circuit to prevent mixing of two different waters �Yes �no

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 �Yes �no




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5.5 Quality requirement

No water stagnation in any part of the machine at any given time during

operation /non-operation �Yes �no

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. �Yes �no

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 �Yes �no

Machine shall be safe from an Operator and environmental standpoint. The equipment shall have proper safeguards

Control System Requirements Manual/automatic �Yes �no

5.8 Cleaning and Maintenance

Filters & spray nozzles should be easy to dismantle & clean whenever required. �Yes �no

Vendor to give information on the cleaning procedure for the machine . �Yes �no

The equipment shall be easily accessible for cleaning the non-product contact part at maintenance side of the equipment. �Yes �no

Vendor shall provide special tools for maintenance of the equipment. �Yes �no

Vendor shall give recommended spare parts list. �Yes �no




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6.0 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. �Yes �no

Noise level below 75 db at a distance of 1 m from the equipment �Yes �no

Emergency stop function on all accessible areas �Yes �no

Appropriate failure detection / alarm notification �Yes �no

5.1.5 Appropriate closure of all the rotating parts. �Yes �no

5.1.6 Proper earthing of the equipment. �Yes �no

5.1.7 All electrical/ wirings properly insulated and cancelled �Yes �no 6.2 Power failure and recovery

On power failure equipment shall come to rest, to protect operator, equipment

the material and surroundings. �Yes �no

On power resumption machine shall operate only after manual starting not directly �Yes �no

6.3 Failure mode detection Equipment shall be capable to detect the following failure, notify the operator with alarm:

6.2.1. pressure drop at washing stations �Yes �no

6.2. 2 Feed water tank level low �Yes �no




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7.0 TESTING AND DELIVERY

7.1 In order to verify labeler performance, the User shall witness the execution of the

Factory Acceptance Test (FAT) procedures. �Yes �no

7.2 Vendor shall prepare FAT and SAT protocol and get approved from GAPL. �Yes �no 7.3 Delivery

The labeler, with all options, equipment, and the documentation listed below, shall be delivered to the User’s receiving bay.

7.3.1 Documentation

Installation, operation, and maintenance instruction documentation for the labeling machine shall be developed

7.3.2 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


Equipment Linear Bottle washing machine Page 10 of 13 Effective Date JUNE 2016

Revision No 00

8.0 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). �Yes �no 8.1.2 Vendor shall support client in execution of all the qualification phases. �Yes �no 8.2 Desired documents

8.2.1 Supply package

Following documents, but not limited to these, are expected from the vendor as part of the supply package

Filled in URS �Yes �no

Equipment layout drawing fitted in the room layout block �Yes �no

Detail technical offer that support the compliance of the URS �Yes �no

Critical list of major component, devices and instruments with their specific functions, specifications data sheet �Yes �no

Schematic diagram of the equipment. �Yes �no 8.2.2 Post ordering

Functional design specification and technical specification, that should contain the following:

• Equipment descriptions and its function �Yes �no • Equipment operation steps �Yes �no • List of failure indications �Yes �no • List of input/outputs and its functions �Yes �no

8.2.3 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. �Yes �no

Installation instructions/ guideline for equipment. �Yes �no

Detailed drawing marking clearly all the necessary dimensions and locations of

utilities along with requirement of utilities on the drawing along with the offer.

�Yes �no

Spare and/ or change parts list with ordering information. �Yes �no

Types of Lubricants used for lubrication and specification. �Yes �no

Instrument calibration certificates. �Yes �no

Guaranty/ warranty certificates for each equipment. �Yes �no

MOC certificates for S316 material used for the machine. �Yes �no



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9.0 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 �Yes �no 10.4 All material of construction should have test certificates. �Yes �no 11.0 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



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12.0 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



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13.00 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

Documents

User Requirement Specifications MACHINE :Linear Bottle