user requirement specifications sticker labelling machine

GOA ANTIBIOTICS AND. PHARMACEUTICAL LTD

Equipment Sticker labeling machine

of 13 Effective Date JUNE 2016

Revision No 00

ANNEXURE V

User Requirement Specifications Sticker Labelling Machine Capacity – 150 bottles / minute




Revision No 00

Table of Contents page no

1. APPROVAL SIGNATURES ……………………………………………………..03

2. INTRODUCTION………………………………………………………………….04

3. OVERVIEW………………………………………………………………………..04

4. PROCESS DESCRIPTION…………………………………………………….05

5. DESIGN REQUIREMENT………………………………………………………05

6. SAFETY REQUIREMENT……………………………………………………….08

7. TESTING AND DELIVERY………………………………………………………09

8. QUALIFICATION REQUIREMENT………………………………………….….10

9. TRAINING & TECHNICAL SUPPORT………………………………………...11

10. GOOD ENGINEERING PRACTICES …………………..…………………….11

11. CONSTRAINTS…………………………………………………………………...11

12. SCOPE OF SUPPLY……………………………………………………………..12

13. ABBREVIATIONS………………………………………………………………..13




Revision No 00

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, Maint. Engineer

Approved by


Mr. Govind R. Tilve, Manager Production

Authorized by


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




Revision No 00

2.0 INTRODUCTION

This document is 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 automatic Sticker labeling Machine that will place pressure sensitive labels on PET/ glass bottles. The User Requirements Specification (URS) is provided to aid the user through the important components, variables and options necessary to procure a functional labeler 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 labeler supply including the design and manufacture of the equipment.

This URS will 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.

3.0 OVERVIEW

3.1 This URS defines the automatic labeling machine to place pressure sensitive labels on pharmaceutical containers.

3.2 The labeling machine must be capable of continuous operation over 8 hour shift, in 3 shifts per day operation, but will be operated intermittently to satisfy the demands of Packaging Operations.

3.3 The machine shall be used primarily for:

3.3.1 Applying a pressure sensitive label to containers 3.3.2 Printing product information on the label 3.3.3 Inspecting pre-printed and printed characters on the label




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4.0 PROCESS DESCRIPTION

4.1 The equipment being defined is intended to receive product containers from an in feed conveyor, apply a label, Overprint batch coding details and discharge the container onto an out feed conveyor. The equipment will provide for container transport through the machine.

4.2 The labeler system will be operated adjacent to conveyor systems on an integrated packaging line and will be located in a designated operating area within a cGMP packaging operation.

5.0 DESIGN REQUIREMENT

5.1 Desired speed: 150 bottles/min �Yes �no 5.2 Input specifications: Container Size/ capacity : 10 ml to 500 ml Container Material : glass/ PET Container Shape : Round Container diameter : 28mm to 68 mm

Label length : 20 mm to 300mm

Label width : 10mm to 90 mm Gap between two label in roll : standard Label roll winding : clockwise and anticlockwise Label roll max diameter : standard 5.3 Vendor should give required specification for following

Label roll inner diameter ( core) Label roll max diameter Gap between two label in roll Grammage of label paper Grammage of base (release) paper of label roll Label roll winding Max. Weight of label roll Any other requirement




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5.4 Process Requirements 5.4.1 The products/containers being produced on the machine are liquid formulations.

5.4.2 The equipment will be used for the following application.

Glass Bottles �Yes �no Plastic ( PET) Bottles �Yes �no

5.4.1 Direction and Orientation of Container Travel : 90 DEGREE

5.4.2 Printing System: Inkjet printing �Yes �no

5.4.3 Label Inspection System

Inspect on web prior to placement. �Yes �no UV detection of label on container. �Yes �no

5.4.4 Conveyor: Sanitary- raised wear type �Yes �no

5.4.5 Label Supply

Shut down for label roll change �Yes �no

Label Dump Box �Yes �no

5.4.6 Machine Finish : Stainless steel �Yes �no

5.5 Process Control

Barcode or part number verification for positive label identification to ensure

proper label on the product container. �Yes �no

5.6 Printing system 5.6.1 Peferably laser printing �Yes �no

5.6.2 Inkjet printer ( optional) �Yes �no

5.6.3 Printer should be suitable for porous surfaces �Yes �no

5.6.4 Printing to be done on labels with and without varnish �Yes �no

5.6.5 Printing to be done from letter size 1 to 4mm, minimum 6 lines,

3 to 25 characters long �Yes �no

5.6.6 Printing quality: clear/ legible/quick drying/ permanent �Yes �no

5.6.7 Maintenance free printer with minimal cleaning requirement �Yes �no




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5.7 Specific requirement

5.6.1 No Container – No Label” – sensor – sensing device

to avoid wastage of labels. �Yes �no 5.6.2 Suitable label sensor �Yes �no

5.6.3 Digital speed indicator to show actual speed of machine along with digital counter �Yes �no 5.6.4 Stepper dispenser . �Yes �no 5.6.5 Label Roll End – machine stop system provided . �Yes �no 5.6.6 No / minimal Change Parts during change over of size. �Yes �no 5.6.7 Synchronized speed of Label Dispensing, Conveyor And Pressing Device �Yes �no 5.6.9 Self protected against any voltage fluctuations. �Yes �no

5.8 Utility requirement

5.8.1 Vendor should state the utilities required for the normal operation of the machine and provide consumption details for Electricity, Compressed air and Other utilities

5.7.2 Cables, air tubes, etc required from the point (single utility point) to equipment is in

scope of vendor. �Yes �no

5.9 Operation

5.9.1 Operator interaction is expected to be minimal following the set-up of the labeler. 5.9.2 Labeler operation shall be safe from an Operator and environmental standpoint. The

equipment shall have proper safeguards 5.9.3 Control System Requirements

Manual/automatic �Yes �no

5.10 Cleaning/maintenance

5.10.1 The equipment shall be easily accessible for cleaning the non-product contact

part at maintenance side of the equipment. �Yes �no

5.10.2 Equipment contact parts shall be easily dismantle and cleanable. �Yes �no

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

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

5.10.5 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: 6.1.1 In the event of equipment malfunction the unit must contain all necessary protection

devices to ensure that the equipment and the article remain in a safe condition. �Yes �no

61.2 Noise level below 75 db at a distance of 1 m from the equipment

�Yes �no 6.1.3 Emergency stop function

The labeler shall have an E-Stop string designed to stop all physical movement of the machinery immediately. �Yes �no

6.1.4 Appropriate covering of all the rotating parts. �Yes �no

6.1.5 Proper earthing of the equipment. �Yes �no 6.1.7 All electrical/ wirings properly insulated and concealed. �Yes �no 6.2 Power failure and recovery 6.2.1 On power failure equipment shall come to rest, to protect operator, equipment itself and the product �Yes �no .

6.2..2 The labeler will stop automatically upon loss of electricity, air, or other major utility and will require operator intervention to re-start. �Yes �no

6.3 Use of lubricants

6.3.1 Any lubricant, used in the equipment must be of food grade and non-toxic. �Yes �no 6.3.2 Vendor to state the lubricants to be used on the machine. � 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

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 Sticker labeling machine of 13 Effective Date JUNE 2016

Revision No 00

8.0 QUALIFICATION REQUIREMENT 8.1 General

8.1.1 Equipment 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 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 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 interlocks �Yes �no • List of input/outputs and its functions �Yes �no

8.2.3. Specifications Remarks

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

• Schematic diagram of the equipment. �Yes �no 8.2.4. 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

Operation and maintenance manuals for the bought out items. �Yes �no

Installation instructions/ guideline for equipment. �Yes �no

Final as-built drawing 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 Lubricant and Lubrication instructions. Food grade Certificate. �Yes �no

Instrument calibration certificates. �Yes �no

Guaranty/ warranty certificates for each equipment and major bought-out items. �Yes �no



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9.0 TRAINING & TECHNICAL SUPPORT 9.1 User training shall consist of minimum 2 days of Operator training/ till the fluency of

the operator on the machine and 1 day of Maintenance training. �Yes �no

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. �Yes �no

9.3 A recommended replacement parts list including normal lead times shall be provide for the machine. �Yes �no

. 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 for fine finish. �Yes �no

10.3 For all sensors, controllers, indicators original calibration certificate to be submitted by the vendor �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: 1800 mm x 1200mm x 2000 mm

Conveyer height: 860 mm (to be verified by the vendor before fabrication of the

machine).

Floor: Ground Floor

Department: Liquid orals (Production)

location : Bottle packing line.

11.2 Site visit preferred for the confirmation of exact location for new installation to

fabricate and design the machine accordingly.



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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



Revision No 00

13.0 ABBREVIATIONS

1. GAPL : Goa Antibiotics and Pharmaceutical Ltd.

2. HLL : Hindustan Life Care Limited

3. URS : User Requirement Specifications

4. cGMP : Current good manufacturing practices

5. PET : Polyethelyne terephthalate

6. UV : Ultra Violet

7. FAT : Factory Acceptance test

8. SAT : Site acceptance Test

9. DQ : Design Qualification

10. OQ : Operational Qualification

11. PQ : Performance Qualification

12. IQ : Installation Qualification

user requirement specifications sticker labelling machine

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