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Sovereign Labelling Systems Limited Title: Functional Design Specification (FDS 00640) The Sovereign Monarch Round Bottle Labelling System with Outsert Application. Supplier: Sovereign Labelling Systems Ltd Unit 27 & 28 Morses Lane Industrial Estate Brightlingsea Essex CO7 0SF England Telephone: +44 (0)1206 304182 Fax: +44 (0)1206 306100 E-Mail [email protected] Document Reference: SLS 00640

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Sovereign Labelling Systems Limited

Title: Functional Design Specification (FDS 00640)

The Sovereign Monarch Round Bottle Labelling System with Outsert Application.

Supplier: Sovereign Labelling Systems Ltd Unit 27 & 28 Morses Lane Industrial Estate

Brightlingsea Essex

CO7 0SF England

Telephone: +44 (0)1206 304182 Fax: +44 (0)1206 306100

E-Mail [email protected]

Document

Reference:

SLS 00640

FUNCTIONAL DESIGN SPECIFICATION (FDS)

PROJECT: Sovereign Monarch Round Bottle Labelling System with Outsert Application

Doc Ref.: FDS Date:26 November 2008

Revision:1.0 Page 2 of 29

Table of Contents

1. INTRODUCTION…………………………………………………………….......................... 4 1.1 Purpose of Document …………………………………………………………………………………………. 4

1.2 Base Documentation …………………………………………………………………………………………… 4 1.3 Nomenclature …………………………………………………………………………………………………… 4

2. SYSTEM OVERVIEW …………………………………………………………………………… 5 Drawing no. 00640-001 ………………………………………………………………………………………. 5

2.1 Process Overview ……………………………………………………………………………………………….. 6 2.1.1 Outsert Tape Threading ……………………………………………………………………….. 7

2.1.2 Outsert Leaflet Loading (initial, not replenish) ………………………………………… 8

2.2 Sensor Overview ………………………………………………………………………………………………… 9 2.2.1 Fallen Bottle Detection …………………………………………………………………………. 9

2.2.2 Scroll Assembly ……………………………………………………………………………………. 9 2.2.3 Body Labeller ………………………………………………………………………………………. 9

2.2.4 Outsert Applicator ………………………………………………………………………………… 10 2.2.5 Inspection of Body Label on Product ……………………………………………………… 11

2.2.6 Inspection of Outsert on Product …………………………………………………………… 11

2.2.7 Reject Eject Sensor ………………………………………………………………………………. 12 2.2.8 Reject Product Management ………………………………………………………………….. 12

2.2.9 Outfeed Product Monitoring …………………………………………………………………… 12 2.2.10 Further Sensors ……………………………………………………………………………………. 13

2.3 Machine Construction ………………………………………………………………………………………….. 13

2.3.1 Conveyor Guarding System ……………………………………………………………………. 14 2.4 Service, Maintenance & Documentation ……………………………………………………………….. 14

2.5 Control System Overview …………………………………………………………………………………….. 14

3. SYSTEM FUNCTIONS AND FACILITIES …………………………………………………… 16 3.1 Modes of Operation ……………………………………………………………………………………………. 16

3.2 Machine Set-Up ………………………………………………………………………………………………….. 16

3.3 Conveyor and Reject System ……………………………………………………………………………….. 16 3.3.1 Automatic Operation …………………………………………………………………………….. 16

3.3.2 Alarms & Interlocks ………………………………………………………………………………. 19 3.4 Infeed Section ……………………………………………………………………………………………………..20

3.4.1 Automatic Operation …………………………………………………………………………….. 20

3.4.2 Alarms & Interlocks ………………………………………………………………………………. 21 3.5 Label Applicator ………………………………………………………………………………………………….. 22

3.5.1 Automatic Operation …………………………………………………………………………….. 22 3.5.2 Alarms & Interlocks ………………………………………………………………………………. 22

3.6 Outsert Application ……………………………………………………………………………………………… 23 3.6.1 Alarms & Interlocks ……………………………………………………………………………… 23

4. OPERATOR INTERFACE ……………………………………………………………………….. 24 4.1 Power Up Screen ………………………………………………………………………………………………… 24

4.2 Menu Screen ……………………………………………………………………………………………………… 24 4.3 Control Screen ……………………………………………………………………………………………………. 25

4.4 Counter Screen ………………………………………………………………………………………………….. 25

4.5 Machine Set-Up Screen ……………………………………………………………………………………….. 25 4.6 Engineering Screen …………………………………………………………………………………………….. 26

4.7 Recipe Screen ……………………………………………………………………………………………………. 26 4.8 Security …………………………………………………………………………………………………………….. 26

5. ALARM TEXT …………………………………………………………………………………….. 28

FUNCTIONAL DESIGN SPECIFICATION (FDS)

PROJECT: Sovereign Monarch Round Bottle Labelling System with Outsert Application

Doc Ref.: FDS Date:26 November 2008

Revision:1.0 Page 3 of 29

1. INTRODUCTION

1.1. Purpose of Document

The purpose of this document, the Functional Design Specification (FDS), is to clearly detail the operation of the Sovereign Monarch Body Labelling System with PCE Vision System and Outsert Applicator, which will be capable of attaching larger or smaller outserts. Maximum outsert size shall be 75mm high x 38mm wide x 12mm thick and minimum outsert size shall be 50mm high x 30mm wide 5mm thick.

This Functional Design Specification details all the controls associated with the system.

FUNCTIONAL DESIGN SPECIFICATION (FDS)

PROJECT: Sovereign Monarch Round Bottle Labelling System with Outsert Application

Doc Ref.: FDS Date:26 November 2008

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FUNCTIONAL DESIGN SPECIFICATION (FDS)

PROJECT: Sovereign Monarch Round Bottle Labelling System with Outsert Application

Doc Ref.: FDS Date:26 November 2008

Revision:1.0 Page 5 of 29

2.1 Process Overview (in conjunction with drawing no. 00640-001 SHEET 3)

Products are deposited onto a slat conveyor at the infeed of the labelling system. Products on the slat conveyor progress in ‘block’ to a scroll pitching assembly. The rotation of the helical cut scroll spaces each product. At the exit of the scroll the product is securely gripped between the base slat conveyor and a top grip belt, applying pressure to the cap. The securely held product is then conveyed to the body labelling station. At the entry to the scroll device a product stop is situated. In the event of a control stop or low head of product being initiated, the product stop inhibits the flow of products into the scroll device. The scroll device uses a single helical cut tool for pitching the round products. The Sovereign Monarch labeller is configured to apply a 270° wrap body label to various circular products at application speeds up to 100BPM. A PCE (Pharmacontrol Electronic) vision system is provided to ‘read’ and confirm correct pre-printed label text and hot foil printing of: i) product lot number, ii) manufacturing date, iii) expiration date. Print confirmation is carried out prior to application of the label to the product. An ultraviolet sensor is provided to detect the presence of a label on the product. During the application of the body label (round products), the product is held in constant orientation and the label is suspended across the leading face of the product. Upon initial application the label/product combination is forced between two ‘saloon door’ type pivoting wipers, this achieves at least 50% of the ultimate label wrap. A product driven carousel of compliant rollers ‘chases’ the remaining 50% of label around the trailing face of the passing product. The product is consistently labelled with the 270° wrap equispaced about the face orientated to the labelling head and the un-labelled 90° area facing away from the label application station. With the body label applied and pressed onto the circular product, the ‘open’ area passes the outsert application station. The Sovereign Monarch outsert application system is capable of processing XXXX commercial bottle presentations, ranging from 40mm to 49mm diameter. The following is a list of the component specification numbers and component combinations of bottle presentations that will be packaged on the Outserter / Round Bottle Labeller Packaging line:

FUNCTIONAL DESIGN SPECIFICATION (FDS)

PROJECT: Sovereign Monarch Round Bottle Labelling System with Outsert Application

Doc Ref.: FDS Date:26 November 2008

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The Sovereign Monarch outsert application system comprises a 10 station vertical rotary magazine. Each station configured to accept a specially engineered tube capable of accepting a full box of outserts. The tubes are pre-loaded with outserts “off” the machine. The outfeed end of the tube is temporarily closed to inhibit egress of the outserts from the tube. A five position storage area is provided on the outside of the outsert guard where full tubes are stored, awaiting loading onto the rotary magazine. At the moment of loading a flexible and reusable seal is removed from the outfeed end of the tube, allowing the outsert to progress from the exit end of the tube. The arrangement of the 10 station vertical rotary magazine now ensures that the outserts are restrained until they are indexed to the “active” position.

Outsert leaflets progress from the ‘active’ packing tube, down a radial guide and along a short horizontal track to a gating star-wheel which separates individual outsert leaflets into radial pockets and conveys them towards the application point. Whilst the outserts are held within the star-wheel pockets, outsert tape (i.e. 3M “stripstick”) is attached to each outsert. The action of the outserts being conveyed by the star-wheel causes the outsert tape to be drawn from the full reel and be adhered to each successive leaflet. The outsert tape is pressed onto each outsert leaflet by spring steel ‘doctor’ blades. Immediately a firm adhesive bond has been achieved, the outsert tape backing is drawn away around a peeling blade to minimise ‘stringing’. With the backing removed, the adhesive loaded outserts are conveyed individually in their respective star-wheel pocket to the application point. The outsert backing tape is wound up on a motorised spool controlled by an ‘on demand’ spring-loaded dancing arm.

2.1.1 Outsert Tape Threading The outsert tape web path is defined by a guide roller, doctor blades and a peel blade. To simplify the threading of outsert tape, all ‘guides’ are retractable, resulting in a simple straight line pull of the tape and relocation of the guides.

2.1.2 Outsert Leaflet Loading (initial, not replenish)

From empty, 1 to 10 full tubes (dependant upon production quantity) are loaded to the magazine turret. A full tube is indexed to the ‘in use’ position and the machine is powered down. The machine operator will enter the access door and manually open a sliding trap-door/pressure plate to release the outserts. Access is provided just below the sliding trap door where the operator supports the ‘falling’ stack of leaflets and lowers at a controlled rate to the star-wheel.

FUNCTIONAL DESIGN SPECIFICATION (FDS)

PROJECT: Sovereign Monarch Round Bottle Labelling System with Outsert Application

Doc Ref.: FDS Date:26 November 2008

Revision:1.0 Page 7 of 29

The sliding trap door/pressure plate is pneumatically operated by a double acting cylinder. A single 5/2 valve controls the open/closed state of the cylinder/trap-door. Reed switches mounted on the pneumatic cylinder provide cylinder position feedback to the control system such that the trap-door/pressure plate state is always in accordance with the system requirements, i.e. closed whilst positioning a full magazine of outserts, and open, lift and apply pressure to the top of the outsert stack when ‘encouraging’ outserts to progress to the star-wheel. A long stroke pneumatic cylinder mounted in the vertical plane lifts the trap-door/pressure plate arrangement to the uppermost outsert in the magazine whereupon it applies pressure (variable) to the full tube of outserts to ensure they travel smoothly from the magazine tube. The pressure exerted by the pneumatic cylinder slightly compresses the outsert stack causing a “compression spring” effect in the stack of outserts. This effect is particularly useful as the active tube empties and the rotary vertical magazine indexes a fresh tube of outserts. The slight compression ensures the outserts feed positively to the star-wheel. When the long stoke cylinder reaches its lowest point, a reed switch detects the low position of the cylinder and hence the empty state of the active magazine. This event causes a fresh/full magazine of outserts to be indexed into the active position. The pressure plate now becomes the trap-door providing support for the fresh stack of outserts as they are indexed into position. Immediately the full magazine in place the trap-door/pressure plate fully retracts, lifts higher than the outsert stack, out-strokes and lowers onto the top outsert to apply pressure to the stack. The position of the long stroke pneumatic cylinder is monitored not only to ensure its correct operation in conjunction with the machine control but also to provide machine operators with important information, as follows: - The outsert machine is surrounded by interlocked safety guards. The 10 station magazine is also protected by interlocked safety guards. Upon opening the access door that allows for the machine to be replenished with outserts the indexing of the magazine is disabled. Obviously, if the active stack runs out of outserts and the index function is disabled, the machine will be bought to a controlled stop through lack of outserts, therefore coloured status lights are illuminated to inform the operator when best to open the access door and replace the empty magazine tubes. Red light = index is about to occur, do not open door. Amber light = index will occur in 30 seconds (for example), Green light = system is suitable for replenishment. A passing product initiates a single index of the star-wheel causing an adhesive faced outsert to be bought into firm contact with the passing product. The outsert is attached to the label gap on the bottle. Fixed guides

FUNCTIONAL DESIGN SPECIFICATION (FDS)

PROJECT: Sovereign Monarch Round Bottle Labelling System with Outsert Application

Doc Ref.: FDS Date:26 November 2008

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ensure that the outsert is ejected from the star-wheel pocket as it is pressed onto the product. The labelled product progresses along the conveyor to a reject ejection station where its release from the top grip belt allows faulty products to be ejected from the conveyor. ‘Good’ product is conveyed by a slat conveyor and is transferred onto collection means (not within Sovereign scope of supply).

2.2. Sensor Overview 2.2.1 Fallen Bottle Detection

Positioned at the infeed of the machine, before the scroll unit, two sensors ‘look’ diagonally across the conveyor (stacked one above the other). The lowest is at a height from the slat top that is less than the diameter of the product to be processed. The uppermost is set higher than the diameter, but lower than the height of the product. If the lowest sensor detects a product whilst the highest does not, there is a fallen product fault alarmed.

2.2.2 Scroll Assembly The scroll is provided with a sensor which detects its rotational position. The sensor performs a second function in that it produces a momentary signal (pulse) for each revolution of the rotating scroll. The system monitoring of this pulse allows detection of a non-rotating scroll should a jam occur. A further use of this ‘pulse’ is that it ‘drives’ the shift registers which electronically track reject products to the ejection station.

2.2.3 Body Labeller

A label dispenser feeds on demand individual labels onto passing products. A sensor arrangement positioned across the full reel disc detects when the reel of labels is nearing depletion. The exact position of this ‘low reel’ sensor is end user adjustable, so as to allow the machine operator to prepare for a full label reel change. Immediately adjacent to the full reel is a sensor which detects the presence of the label web as it feeds from the full reel. Non-detection of label web denotes that the reel is empty or has broken. An Allen hot foil coder prints a code onto each label. A sensor detects the gaps between each and every label on the web. The purpose of this sensor is to halt the web feed and hence only feed (or index) one label per initiation.

FUNCTIONAL DESIGN SPECIFICATION (FDS)

PROJECT: Sovereign Monarch Round Bottle Labelling System with Outsert Application

Doc Ref.: FDS Date:26 November 2008

Revision:1.0 Page 9 of 29

Near to the position where the label ‘leaves’ the web and is applied to the product, a PCE vision system inspects each and every label for correct printed data. A web clamp cylinder will hold the web still while the camera is reading the printed data on the labels. Reject labels are dispensed as normal and finished onto a product, however, the reject label/product is tracked through the system and ejected from the conveyor at the appropriate reject station.

2.2.4 Outsert Applicator Provision for 10 full ‘tubes’ of outsert folded leaflets, in a vertical circular configuration, is provided as a buffer. The rotary magazine is indexed by an AC motor and controlled by the signal from a photo-electric sensor detecting indexing holes in the rotation body of the assembly. Stop position is fine adjusted electronically and locked in position by a pneumatically operated shot-bolt. An outsert present detection sensor ‘looking’ vertically into the tubes confirms the presence of leaflets in the tubes prior to tubes entering the ‘in use’ position. The purpose of the ‘outserts present in tubes’ sensor is to alert the machine operator to load fresh outserts. At the station where the outsert is released from the tube, the pneumatically operated pressure plate which serves to apply downward pressure to the outsert stack reaches the bottom of it’s travel and now becomes the sliding trap door and closes whilst the rotary magazine indexes, then opens quickly to ensure that the outsert ‘falls’ from the tube in a controlled manner and does not twist or jam. Having retracted the long stoke vertical pneumatic cylinder lifts the pressure plate/trap door to the top of the full magazine where upon the pressure plate pneumatically out-stroke to cover the uppermost outsert. The vertical variable pressure cylinder now lowers to apply downward force to the outsert stack. After leaving the magazine, the outsert leaflets follow a radial path to re-orientate them for application. At the top of the radial guide, a sensor detects the presence of outserts. When no outserts are present, an ‘end of outserts’ control stop is applied. Software safe-guards are provided so as to ensure a constant supply of outserts to the application head. Should the supply fail, the machine is bought to a controlled stop. The outsert ‘queue’ joins the gating star-wheel, where individual outserts are indexed from the end of the ‘queue’ enclosed in pockets cut into the star-wheel. The procession of star-wheel entrapped outserts is conveyed past the strip-stick tape. The strip-stick tape is drawn from a full reel by the movement of the outserts, to which the tape is adhered. Low reel detection is present on the full reel

FUNCTIONAL DESIGN SPECIFICATION (FDS)

PROJECT: Sovereign Monarch Round Bottle Labelling System with Outsert Application

Doc Ref.: FDS Date:26 November 2008

Revision:1.0 Page 10 of 29

and an end of reel sensor is also incorporated into the control system to prevent outsert application/adhesive failure. The indexing of the outsert star-wheel is initiated by a conveyor mounted sensor, and is powered by an AC brushless servo. Stopping position is controlled by an indexing mark machined into the star-wheel. Electronic fine adjustment of stopping position is present. In summary, each single index of the star-wheel collects an outsert from the infeed queue, applies an adhesive patch to one outsert and applies one outsert to a passing product. The target speed of the outserter application is 100 bottles per minute (nominal) and so should empty the 10 tubes of outserter leaflets in 10 minutes (nominal).

2.2.5 Inspection of Body Label on Product As described in System Overview, a reject label will have been identified and ‘tracked’ from the label application station. Whilst the product is still firmly captivated by top and base belts, further inspection is carried out. A photo-electric sensor detects the presence of a passing product and causes the control system to momentarily (snap-shot) monitor the status of an ultraviolet varnish on the body labels and thereby confirms the presence of a body label. This technique does not confirm the acceptable label finish, but merely the presence of an ultraviolet florescent at the point on the product body where the ultraviolet sensor is aimed.

2.2.6 Inspection of Outsert on Product A gating sensor is utilised to trigger the PCE vision system for the outsert verification. Any failed outserts are ejected at the reject station.

FUNCTIONAL DESIGN SPECIFICATION (FDS)

PROJECT: Sovereign Monarch Round Bottle Labelling System with Outsert Application

Doc Ref.: FDS Date:26 November 2008

Revision:1.0 Page 11 of 29

2.2.7 Reject Eject Sensor

The product ‘tracking’ method is open loop. Provided no forces dislodge a product as it progresses through the label application process, its position can be accurately predicted to within tenths of a millimetre. To further enhance product tracking, a photo-electric sensor is provided to initiate the pneumatically operated reject eject arm. Initiation of this arm relative to product position is critical. To ensure perfect ejection of a reject product, the signal from the photo-electric sensor is preferred to the ‘predicted’ product position. Actual product position and predicted product position are monitored and compared to confirm product position (e.g. a product identified as reject and which must be ejected does not pass the ‘reject eject sensor’ as predicted causes immediate system shut down).

2.2.8 Reject Product Management

The amalgamation of all the inspection results determines whether each unique product is pass or fail. Fail products are to be ejected from the production line. This is carried out at the moment the product is released from the top grip belt. Failed products are mechanically removed from the production line by a pneumatically operated deflecting arm. The product is forced from the conveyor into a collection bin. A photo-electric sensor at the entrance of the bin confirms that the reject product has progressed into the bin.

2.2.9 Outfeed Product Monitoring ‘Pass’ products progress from the labelling machine and are further processed (packed) which is not within Sovereign scope of supply. To maintain the successful operation of all proceeding processes, the completed products are monitored for outfeed back up and fallen product. Two photo-electric sensors ‘look’ diagonally across the conveyor (stacked one above the other). The lowest is at a height from the slat top that is less than the diameter of the product to be processed. The uppermost is set higher than the diameter, but lower than the height of the product. If the lowest sensor detects a product whilst the highest does not, there is a fallen product fault alarmed.

FUNCTIONAL DESIGN SPECIFICATION (FDS)

PROJECT: Sovereign Monarch Round Bottle Labelling System with Outsert Application

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Revision:1.0 Page 12 of 29

2.2.10Further Sensors

Synchronisation of the labelling system is maintained by two sensors. Mounted to the conveyor drive shaft is an encoder that produces a fine electrical pulse stream. Pulse stream frequency is directly related to conveyor speed and each pulse represents a known movement distance of the product transport conveyor. As previously described, a sensor detecting complete revolutions of the scroll drive (one pulse per revolution = one pulse per product). This ‘pulse’ signal ‘drives’ software shift registers and so makes it possible to ‘track’ reject products through the labelling machine. As the system is ‘open loop’, guards are provided to inhibit the outside manipulation of products in the system.

2.3. Machine Construction The machine is constructed primarily in 304 grade finished stainless steel. The support frame is a space frame design and is manufactured from 50mm square box section with all joints fully welded. The conveyor side plates are 3mm thick laser cut stainless steel with HDPE chain running channels. All shafts, brackets, fasters and bearings are also stainless steel.

The equipment design will ensure that the equipment is easy to clean and should eliminate all possible traps for product and packaging materials where possible. The guarding is constructed from 25mm square 304 stainless steel box section with 6mm clear PetG infill panels which are mounted to the frame work using glazing extrusions. The electrical control cabinets are also manufactured is 304 grade stainless steel. Materials of construction must be non-corrosive, non-toxic and non-abrasive. Other GMP materials shall be used provided they are suitable for use. Certification will be provided. Filler-less run in welds will be polished. Hidden flush welds shall be ground and polished. All external lubricants used in the system will be food grade. Certification will be provided.

FUNCTIONAL DESIGN SPECIFICATION (FDS)

PROJECT: Sovereign Monarch Round Bottle Labelling System with Outsert Application

Doc Ref.: FDS Date:26 November 2008

Revision:1.0 Page 13 of 29

2.3.1 Conveyor Guarding System

An interlocked guarding system is provided to prevent products being removed from the conveyor system during normal operation. The guards have access doors, which hinge or slide open and are fitted with interlocking dual channel safety switches linked to the machine emergency stop system. To allow the products to be viewed as they pass through the conveyor system, 6mm clear Acrylic infill panels are used.

2.4. Service, Maintenance and Documentation

The handover documentation will include but not be limited to: 1. Suggested details of annual maintenance requirements and intervals. 2. Recommended preventative maintenance frequencies and associated

procedures for the XXXXXX’s operational requirements. 3. List of Materials of Construction. 4. Installation, Operating and Maintenance Manuals. 5. Certificates for Materials of Construction.

2.5 Control System Overview

The control system consists of a Siemens S7 200 Series Programmable Logic Controller (software program 00640 ver4) and Siemens Touch Panel Operator Display (software program 00640 ver3). These form the heart of the control system and the interface to the operator. The conveyor, scroll, label waste rewind unit, outsert magazine and outsert tape rewind motors are controlled by Siemens MM420 Inverters. Adjustment to the speed is displayed on the Siemens Operator Display (HMI). The application of the body label over-head belt and outsert leaflet are controlled via discreet Panasonic Servo Controllers. These units interface with the Siemens PLC via digital I/O. Body label and outsert leaflet visual inspections are carried out by two PCE - OCR camera systems which interface with the PLC via digital I/O. The required part number Code is programmed into the units for each label and outsert. These are used to verify the correct code.

FUNCTIONAL DESIGN SPECIFICATION (FDS)

PROJECT: Sovereign Monarch Round Bottle Labelling System with Outsert Application

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The PLC utilises digital I/O to interface with the sensors. Time critical sensors and interrupts are wired directly to the PLC input. The control system has in excess of 10% digital inputs and outputs spare capacity, to allow for future expansion.

FUNCTIONAL DESIGN SPECIFICATION (FDS)

PROJECT: Sovereign Monarch Round Bottle Labelling System with Outsert Application

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3. SYSTEM FUNCTIONS AND FACILITIES

This section of the Functional Design Specification details the operation of the Sovereign Body Label and Outsert Applicator, and all the associated control functions. All the alarms are detailed by number. The text displayed on the Human Machine Interface (HMI) is detailed by number. The alarm message to be displayed on the machine is included within Appendix A of this document.

3.1 Modes of Operation

There are three modes of operation related to the Labelling Machine. These are…

i. Automatic Mode ii. Prime Mode iii. Through mode

The mode of operation is selected by the Operator from the HMI and the selected mode clearly displayed on the screen. In Automatic Mode the system applies a body label and outsert leaflet with the security fully operational. Prime Mode is designed to allow the operator to load labels, outserts or outsert tape. In this mode the main conveyors do not run. The label head is enabled and can be cycled via a local push button. The outsert applicator can also be cycled but with guards in place. In Through Mode products can pass through the machine, but the labelling head and security devices are disabled.

3.2 Machine Set-up

The machine is required to be set-up for each product, body label and outsert combination. The Outserter will be capable of attaching the smaller outsert for the Viread Brazil market as well as larger outserts for the US Viread, Truvada and Atripla markets. Change parts will be supplied which, in various combinations will be suitable for processing the range of outsert sizes. Each change part is uniquely

FUNCTIONAL DESIGN SPECIFICATION (FDS)

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identified so as to allow for specification on XXXXXX manufacturing control records. A recipe system in the HMI will be required to be loaded by the operator along with mechanical adjustments. The recipe includes the positions for the mechanical settings of the machine. Changes to the recipe can only be made by a user with a Level 2 Engineering Password.

3.3 Conveyor and Reject System

The conveyor system comprises of a single/continuous straight running section of 100mm (4”) wide slat band conveyor (overall conveyor body width 128mm). Product stability during label application is enhanced by a top grip belt conveyor 20mm wide of compliant high-grip material. The top grip belt applies pressure to the caps of all products as they exit the pitching scroll. The grip is maintained through the entire label’s application process and releases at the moment where ejection of reject product takes place.

3.3.1 Automatic Operation The labeller is controlled via a Start and Stop push-button on the control panel. When the Start push-button is pressed the conveyor system starts and the label applicators are enabled. When the Stop push-button is pressed, ingress of product to the scroll pitching unit is inhibited by the pneumatically operated product stop. The conveyor continues to run for a preset distance to allow all the products from the infeed to be cleared of the machine. The machine then stops. A facility exists on the HMI to perform an immediate stop. This has been included for machine set up and critical device checks. In normal operating conditions conveyor and top belts run continuously. These convey the product through the system. The reject eject system comprise an air operated pivoter which is utilised to mechanically remove faulty products from the line, into a reject chute. The removal of faulty products from the line is confirmed by a sensor at the entry to the reject collection chute.

FUNCTIONAL DESIGN SPECIFICATION (FDS)

PROJECT: Sovereign Monarch Round Bottle Labelling System with Outsert Application

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All sensors relating to the reject system are designed to operate in a fail safe manner. All sensor failures, which relate to product quality, are checked via the PLC and individual alarms raised if a sensor is detected as failed. The sensors relating to product quality are as follows:-

Sensor Description

S-06 PCE Camera – detects and verifies the presence of print on the body label (run condition monitored).

S-05 PCE Gate Sensor – detects the label gap and causes the PCE camera to ‘snap shot’ to inspect for printed particulars.

S-28 Reject Gate Sensor – detects the product to be rejected.

S-08 Reject Confirmation Sensor – verifies that the reject product has been removed from the line.

S-21 Scroll Rotation Sensors – used to synchronise scroll and monitor for jams

S-13 PCE Gate Sensor – detects a product with an outsert applied and causes the PCE camera to ‘snap shot’ to inspect for outsert particulars .

S-12 PCE Camera – detects and verifies printed features on the outsert label (run condition monitored).

S-27 U/V camera checks presence of UV fluorescence (label) on product.

S-29 detects a passing product and causes the UV camera to ‘snap shot’ to inspect for UV fluorescence (label).

FUNCTIONAL DESIGN SPECIFICATION (FDS)

PROJECT: Sovereign Monarch Round Bottle Labelling System with Outsert Application

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3.3.2 Alarms and Interlocks

The following alarms are associated with the conveyor and reject system of the labeller. Note that the individual reject alarms are detailed within the local section.

Alarm No. Description Type

0001 Machine stopped N/A

0003 Controlled stop. Machine is stopping. N/A

0004 No recipe loaded. The machine set-up has not been loaded to the PLC.

Machine will not start

0006 Low air pressure. The air pressure supplying the reject station is detected as low.

1

0007 Part number not confirmed. 1

0008 Three consecutive rejects. 1

0009 Missing label reject. 4

0010 Missing part number reject. 1

0011 Missing print reject. 4

0012 Outsert reject. 4

0018 UV sensor 1 fault. 1

0019 Outsert PCE not ready. 1

0020 Outfeed full. 1

0027 Reject confirmation sensor fault. 1

0028 No reject confirmation fault. 1

0029 Reject failed to reach reject station. 1

0032 Reject gate sensor fault. 1

0041 Outfeed fallen bottle. 1

The following table details the action for each alarm type…

Type Action

1 Immediate Stop. Audible alarm sounds for 5 Seconds, Beacon flashes. Alarm is latched until acknowledged by the operator and must be reset before the machine can be restarted.

2 Controlled Stop, machine runs clear clamping at the infeed. Audible alarm sounds for 5 Seconds, Beacon Flashes. Alarm is latched until acknowledged by the operator and must be reset

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before the machine can be restarted.

3 Emergency stop circuit is activated, machine stops immediately. Audible alarm sounds for 5 Seconds, Beacon Flashes. The cause of the emergency stop is displayed on the message display until cleared (e.g. Guard Open). At this point alarm 0002 is displayed until the emergency stop circuit is reset (via the start push-button). The machine will only restart once the start push-button) is pressed.

4 Machine continues to run, message only displayed for 5 seconds, product tracked to the reject station and removed from the line.

3.4 Infeed Section

The infeed section of the Labeller controls the flow of products into the machine.

3.4.1 Automatic Operation

Upon machine start up, the preceding equipment delivers products onto the machine conveyor. Product progresses along the conveyor, passing the fallen product detection sensors (S-01 & S-02) and arrives at the infeed of the scroll (not yet rotating). Successive products accumulate at the infeed to the scroll and form a queue. Eventually the queue extends back to the fallen product detection sensor arrangement and the lower of the sensors becomes permanently covered. The control system monitors the duration of continued sensor input and after a pre-set delay (configurable in Engineering settings), starts the scroll rotation motor/s. The rotation of the scroll causes the product to be guided along the variable pitch helical groove and so be spaced or ‘pitched’. Near the outfeed of the scroll, the pitch of the helical groove becomes constant and so the products are now travelling at a constant velocity. Each successive product is now acted upon by the ‘top hold’ top grip belt, which captivates it during all label/outsert application. The rotation of the scroll is monitored by a sensor (S-21) detecting the passing of a ‘drive’ mounted ‘flag’ that produces a momentary pulse each and every revolution. A product jam will cause the scroll to stop and therefore the absence of the signal will result in a scroll jam fault being activated.

FUNCTIONAL DESIGN SPECIFICATION (FDS)

PROJECT: Sovereign Monarch Round Bottle Labelling System with Outsert Application

Doc Ref.: FDS Date:26 November 2008

Revision:1.0 Page 20 of 29

3.4.2 Alarms and Interlocks

The following alarms are associated with the infeed section of the labeller.

Alarm no. Description Type

0016 Fallen bottle infeed fault. 1

0024 Scroll sensor fault. 1

0031 Infeed conveyor low of bottles. 4

The following table details the action for each alarm type…

Type Action

1 Immediate Stop. Audible alarm sounds for 5 Seconds, Beacon Flashes. Alarm is latched until acknowledged by the operator and must be reset before the machine can be restarted.

2 Controlled Stop, machine runs clear clamping at the infeed. Audible alarm sounds for 5 Seconds, Beacon Flashes. Alarm is latched until acknowledged by the operator and must be reset before the machine can be restarted.

3 Emergency stop circuit is activated, machine stops immediately. Audible alarm sounds for 5 Seconds, Beacon Flashes. The cause of the emergency stop is displayed on the message display until cleared (e.g. Guard Open). At this point alarm 0002 is displayed until the emergency stop circuit is reset (via the start push-button). The machine will only restart once the start push-button) is pressed.

4 Machine continues to run, message only displayed for 5 seconds, product tracked to the reject station and removed from the line.

FUNCTIONAL DESIGN SPECIFICATION (FDS)

PROJECT: Sovereign Monarch Round Bottle Labelling System with Outsert Application

Doc Ref.: FDS Date:26 November 2008

Revision:1.0 Page 21 of 29

3.5 Label Applicator

From the infeed, the products travel on the conveyor to the body label application head.

3.5.1 Automatic Operation

The labels are fed from a full reel. A sensor (S20) detects each product as it approaches the label applicator. A label dispensed from the backing web into the path of each product. A sensor (S-05) detects the gap between labels and stops the web feed, so ensuring only one label is delivered per product. Sensor (S-05) also initiates two further operations; i) Coder signal to code once, ii) PCE print inspection vision system to perform one inspection cycle.

3.5.2 Alarms and Interlocks

The following alarms are associated with the body label applicator section of the labeller.

Alarm no. Description Type

0005 Label head servo fault 1

0014 End of label reel 1

0015 Low label reel 4

0017 Label product sensor fault 1

0022 Label PCE not ready 1

0025 Label waste rewind fault 1

0026 Label web index fault 1

Note A missing label on web is detected firstly by the label gap position sensor (S-05). The web feed system performs an ‘open loop’ fixed distance move to compensate for the missing label. This web feed over-ride is performed so that the missing label does not effect preceding label/s application.

When a gap (missing label on web) indexes to the vision system station, two faults are detected; incorrect over print and incorrect pre-printed label detail. The PCE Vision System is configured to produce two discreet output signals pertaining to each fault type; i) overprint fault, ii) body label code fault.

FUNCTIONAL DESIGN SPECIFICATION (FDS)

PROJECT: Sovereign Monarch Round Bottle Labelling System with Outsert Application

Doc Ref.: FDS Date:26 November 2008

Revision:1.0 Page 22 of 29

The following table details the action for each alarm type.

Type Action

1 Immediate Stop. Audible alarm sounds for 5 Seconds, Beacon Flashes. Alarm is latched until acknowledged by the operator and must be reset before the machine can be restarted.

2 Controlled Stop, machine runs clear clamping at the infeed. Audible alarm sounds for 5 Seconds, Beacon Flashes. Alarm is latched until acknowledged by the operator and must be reset before the machine can be restarted.

3 Emergency stop circuit is activated, machine stops immediately. Audible alarm sounds for 5 Seconds, Beacon Flashes. The cause of the emergency stop is displayed on the message display until cleared (e.g. Guard Open). At this point alarm 0002 is displayed until the emergency stop circuit is reset (via the start push-button). The machine will only restart once the start push-button) is pressed.

4 Machine continues to run, message only displayed for 5 seconds, product tracked to the reject station and removed from the line.

3.6. Outsert Application

Products from the body labellers conveyor progress along the conveyor still captivated between the slat conveyor and the ‘top hold’ top grip belt. The detection (S-07) of an approaching product causes the outsert star-wheel to index and release an outsert onto the passing product. If for whatever reason, no outsert is applied, the product progresses to the inspection area where appropriate action is taken. A sensor (S-15) stops the rotation of the star-wheel after the index of one outsert pocket.

3.6.1 Alarms & Interlocks

Alarm no. Description Type

0012 Outsert reject 4

0019 Outsert PCE not ready 1

0042 Outserts low 4

0043 Outsert magazine empty 1

0046 Outsert disk index fault 1

0047 Outsert Magazine turret fault 1

0048 Outsert product sensor fault 1

0051 End of outsert supply 1

FUNCTIONAL DESIGN SPECIFICATION (FDS)

PROJECT: Sovereign Monarch Round Bottle Labelling System with Outsert Application

Doc Ref.: FDS Date:26 November 2008

Revision:1.0 Page 23 of 29

4. OPERATOR INTERFACE

The operator interface is provided via push-buttons and a Siemens Touch Panel (TP170B) housed on the front of the control panel. The push-buttons are utilised to start and stop the machine. The Siemens Touch Panel provides text displays to the operator for the set-up of the machine, reporting of alarms and display of the machine statistics. The following screens are provided on the panel.

i. Power up screen ii. Menu Screen iii. Control Screen iv. Counters v. Machine Set-up screen vi. Recipe Screen vii. Engineering Screen

4.1 Power up Screen

The power up screen is displayed when the unit is powered up and can be accessed from the Menu Screen. This screen displays the current date and time and contact information for Sovereign Labelling Systems.

4.2 Menu Screen

The Menu Screen provides access to the following screens.

i. Control Screen ii. Machine Set-up screen iii. Counters iv. Engineering Screen

This screen also displays the Set-Up selected, the total number of products and the total number of rejects.

FUNCTIONAL DESIGN SPECIFICATION (FDS)

PROJECT: Sovereign Monarch Round Bottle Labelling System with Outsert Application

Doc Ref.: FDS Date:26 November 2008

Revision:1.0 Page 24 of 29

4.3 Control Screen

The Control Screen allows the operator to select the following functions.

i. Mode of operation ii. Immediate stop iii. Empty out

The mode of operation is selected via a slider. The operator is required to drag the slider using the touch screen to select either automatic or prime mode. The facility exists to perform an immediate stop of the machine. This is via a push-button on the screen when pressed the labeller stops. The empty out facility is used to halt the product at the infeed (pneumatic cylinder) and allow any products held at the scroll to be run through the machine, active only while running in automatic operation.

4.4 Counter Screen

The total good and rejected products are displayed on this screen. Each individual fault is displayed along with the number of rejects for each count. The facility exists for a user with Level 1 password to reset the Counters.

4.5 Machine Set-Up Screen

For the different product sizes that run through the machine a recipe system is utilised. The recipe includes data required for the machine to run such as label length and whether outserts are required. The recipe also includes machine settings, which must be set manually before the machine is started. These settings are approximate settings, which will require engineering set-up during change over of products. The facility exists for the operator to select and download the recipe to the PLC; this must be performed before the labeller can be run. The recipe cannot be edited from this screen, only viewed and downloaded to the PLC.

FUNCTIONAL DESIGN SPECIFICATION (FDS)

PROJECT: Sovereign Monarch Round Bottle Labelling System with Outsert Application

Doc Ref.: FDS Date:26 November 2008

Revision:1.0 Page 25 of 29

4.6 Engineering Screen

The engineering screen is a menu system for engineers to alter configurations. From this screen a user with a Level 2 password can access the screen where the recipe can be modified. A user with a Level 2 password can access the reject system status. This is a tool which displays the status of the label on the web for missing Label and Missing Reject Confirmation. A supervisor can use this screen to access the Password Protection system to update user passwords.

4.7 Recipe Screen

This screen can only be accessed by a user with a Level 2 (Engineering) password. It is accessed via the Engineering Screen. This screen allows the user to view, edit and download the machine set-up data recipe.

4.8 Security

There are three levels of security configured for this system. The levels are defined as follows. Level 1 – Operator Level 2 – Engineer Level 9 – System Administrator These levels operate in a hierarchical fashion, that is level 2 has all the access rights of Level 1 and Level 2, while access Level 9 (third configured level) has all the access rights of Level 1, Level 2 and Level 9. Under normal operating conditions, no security access is required for operating the machine. Alarms can be acknowledged by the operator the mode changed etc. without entering a password. Level 1 is required to verify that the operator has the rights to reset counters. Level 2 is required by engineers for configuring machine settings (recipe) and viewing machine set up.

FUNCTIONAL DESIGN SPECIFICATION (FDS)

PROJECT: Sovereign Monarch Round Bottle Labelling System with Outsert Application

Doc Ref.: FDS Date:26 November 2008

Revision:1.0 Page 26 of 29

Level 9 is the default level for system administrator. This is used by the administrator to add and remove passwords from the system. Password set-up is via a screen on the operator interface. Only the system administrator has access to this screen. All passwords time out after 2 minutes if no action is taken.

FUNCTIONAL DESIGN SPECIFICATION (FDS)

PROJECT: Sovereign Monarch Round Bottle Labelling System with Outsert Application

Doc Ref.: FDS Date:26 November 2008

Revision:1.0 Page 27 of 29

5. ALARM TEXT

The following table lists all the alarms associated with the Labeller.

Number Text

0001 MACHINE STOP ACTIVE

0002 MACHINE EMERGENCY STOP ACTIVE

0003 CONTROLLED MACHINE STOP

0004 NO RECIPE LOADED

0005 LABEL HEAD SERVO FAULT

0006 LOW AIR SUPPLY PRESSURE

0007 PART NUMBER NOT CONFIRMED

0008 THREE CONSECUTIVE REJECTS

0009 MISSING LABEL REJECT

0010 MISSING PART NUMBER REJECT

0011 MISSING PRINT REJECT

0012 OUTSERT REJECT

0013 PRODUCT SPACING FAULT

0014 END OF LABEL REEL

0015 LOW LABEL REEL

0016 FALLEN BOTTLE INFEED FAULT

0017 LABEL PRODUCT SENSOR FAULT

0018 UV SENSOR 1 FAULT

0019 OUTSERT PCE NOT READY

0020 OUTFEED FULL

0021 PRINTER NOT READY

0022 LABEL PCE NOT READY

0023 NO RECIPE LOADED

0024 SCROLL SENSOR FAULT

0025 LABEL WASTE REWIND FAULT

0026 LABEL WEB INDEX FAULT

0027 REJECT CONFIRMATION SENSOR FAULT

0028 NO REJECT CONFIRMATION FAULT

0029 REJECT FAILED TO REACH REJECT STATION

0030 MISSING LABEL GATE SENSOR FAULT

0031 INFEED CONVEYOR LOW OF BOTTLES

0032 REJECT GATE SENSOR FAULT

0033 ESTOP NO 1 ACTIVE

0034 ESTOP NO 2 ACTIVE

0035 ESTOP NO 3 ACTIVE

0036 ESTOP NO 4 ACTIVE

0037 ESTOP NO 5 ACTIVE

0038 DOOR NO 1 OPEN

0039 DOOR NO 2 OPEN

0040 DOOR NO 3 OPEN

0041 OUTFEED FALLEN BOTTLE

0042 OUTSERTS LOW

0043 OUTSERT MAGAZINE EMPTY

0044 STRIPSTICK WEB LOW

0045 STRIPSTICK REEL END

FUNCTIONAL DESIGN SPECIFICATION (FDS)

PROJECT: Sovereign Monarch Round Bottle Labelling System with Outsert Application

Doc Ref.: FDS Date:26 November 2008

Revision:1.0 Page 28 of 29

0046 OUTSERT DISK INDEX FAULT

0047 OUTSERT TURRET FAULT

0048 OUTSERT PRODUCT SENSOR FAULT

0049 DOOR NO 4 OPEN

0050 DOOR NO 5 OPEN

0051 END OF OUTSERT SUPPLY

0052 OUTSERT TURRET DOOR OPEN

0053 STRIPSTICK REWIND FAULT

0054 PRIME MODE ACTIVE