PAGOpharma

The new standard for labelling systems

in the pharmaceuticalindustry

Page 4Labelling you can trust –Innovative concepts to meettomorrow’s safety standards

Page 6/7Everything under control – the technological guarantees forprocess and product security

Page 8/9PAGO System 214/221Labelling of pharmaceutical vignettesand tamper evidence labels for folding boxes

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C O N T E N T S

PAGOpharma

PAGO is a byword for secure pharmaceutical labelling

Decades of experiencePago is an experienced specialist in self-adhesive labelling for perfect, high-quality solutions and maximum labellingsecurity. Pago is also a general supplierbecause its interest is always in the entirelabelling process. From labels with theirspecific material and adhesive propertiesthrough printing to the labelling machine.From product decoration via identificationto process control. We have developedour expertise over decades and laid thegroundwork for our leading position todayin innovation and system expertise.

International synergiesCloser integration of markets and uniformstandards in the global village confront uswith new challenges every day. From theoutset, Pago has kept ahead of the trend. Our international structure of the group ofcompanies provides a stable basis for thispurpose. We have used that advantage toharmonise criteria profiles at an early dateand find innovative solutions that give ourcustomers an edge on markets which arebecoming tighter as they become morecompetitive.

In pharmaceutical labelling, where national security requirements have traditionally been high, finding answersfor the new international standards as they develop has become important. Multilevel answers which fit the bill – to satisfy maximum requirements and provide an economical solution for specific individual tasks.

Innovation based on partnership Close contact with our pharmaceuticalcustomers made us aware of the specialbackground conditions at an early stage,the emphasis being on absolute security,continuous control, verifiable identifi-cation, high labelling accuracy and thespecific innovative properties, whichlabels on pharmaceutical substances mustsatisfy. We have learnt from experience,accepted suggestions, thought themthrough and developed new concepts with our customers.

The PAGO PharmaTeam Today, this special know-how is combinedin the Pharma Team at Pago – a highlycreative competence centre which findsfar-sighted solutions for your particularapplications.

Page 10/11PAGO System 610 PharmaAbsolute precision and great versatility – all-round labelling with the rotary star

Page 12/13PAGO System 560 PharmaMaximum efficiency and economy – all-round labelling with wrapper strip Page 14/15

PAGO System 520 C PharmaPrecise front and back labelling ofshaped bottles on linear machines Page 16

PAGOmat Baureihe 6for economical inline labelling with attached automatic devices 3

Labelling you can trust – innovative concepts for tomorrow’s safety standards

PAGO represents a decisive stepforwards The modular thinking behind thePagopharma concept brings benefitsgoing beyond user-orientated perfectimplementation of our labelling technology in your production system.

With the add-on functions and units needed for your labelling process, it also permits customised economical solutions which remain open to futuremodifications and extensions.

PAGOpharma – the security breakthroughThe Pharma Team at Pago has followedthis approach to develop its basic PagoPharma standard. It provides importantfeatures for the right labelling technology.

Complete construction of machines in V2A high-grade steel, protection housingsin breakage-proof polycarbonate.

Easy cleaning due to cables sheltered byprotective conduits, covered screw headsand emergency stop switches mounted ina remote position.

High standard of programming security:– Fail-safe for reliable detection of sensor

errors– Positive logic to OK the product only

after all the relevant features have beenconfirmed

Validated software with ongoing amend-ments to meet GAMP 4 requirements.

Equipment with the latest automatic labelling devices suitable for pharma-ceutical products in Pagomat 6 series.

Basic safety devices are already fittedas standard:– Roll end detection and advance

warning – Label presence check with pneumatic

ejection and shaft

Full provision for efficient validationIn addition, all Pago systems built to the Pagopharma standard have beenspecially developed to satisfy pharma-ceutical criteria. Production is based onthe secure foundation of the GAMP 4and GMP principles. The basic package has CE/ISO certifi-cation; full machine documentation issupplied comprising the user manualand a one or two day functional testwith the presence of the customer onour premises (FAT, Factory AcceptanceTest).

General compliance with 21 CFR Part11 makes optional equipment of ourmachines to satisfy this standardstraightforward. Efficient and time-saving validation is ensured from theoutset by these principles.

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Exacting tasks…Labelling and identification of pharma-ceutical products are tasks which involvethe need to satisfy stringent standards.Statutory rules and standards are tendingto increase rather than decrease as pro-gress towards standardisation continues.The highest standard as the lowest common denominator is often regarded as a solution, but frequently by passes the real needs and economic realities.

…call for carefully thought outsolutionsPago therefore offers a multistage conceptfor perfect integration of the labelling process into your production line as theright response to the need for security andcleanness in fine chemical and pharma-ceutical labelling tasks. Our aim is to provide the right level of security for yourparticular pharmaceutical task – designedto satisfy your specific needs and all therelevant criteria in an economicaslly viable manner.

PAGOpharma

Pagopharma labelling systems readily permit the optional incorporation of allkinds of identification technologies fromhot embossing through thermal printing toan impression check with coloured markreader. Test devices, such as a pharma-code reader, monitoring cameras or product discharge by router or conveyorbelt can be fitted as required. Pago PMC(Pharma Management Centre) and PagoLSO (Label Sort Out) additionally increasesecurity for control or protection againstincorrect labelling.

21 CFR Part 11 PreparationWherever new demands are placed on the pharmaceutical industry, we make our contribution to professionalimplementation of standards in efficientand economical solutions.

Pagopharma supplies basic machines and attached extension stages including a full-scale labelling technology module(21 Part 11 ready) which satisfies all therelevant criteria to permit 21 CFR Part 11Compliance for your whole system.

PAGOpharma has the options you need

PAGOpharma

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Performance qualification (PQ)

Functional qualification (OQ)

Installation qualification (IQ)

Validation to PAGOpharma+ (GAMP 4) standard

Specification of the customer’s criteria

(detailed specifications)

Functional specification

Design specification

Manufacture

Reliable expertisePago Systems satisfy EU directives. Pago benefits from DIN EN ISO 9001 certification. We provide dependable service!

Two great benefits of PAGOpharma: better service – greater securityThe increasing demand for complete packages for reliable, smooth and time-saving implementation of our labelling systems into the environment of pharmaceutical production lines is satisfied by our multistage customer-orientated service concept.Two differentiated add-on stages extend our Pagopharma standard offer.

PAGOpharma PAGOpharma

PAGOpharma++As a further extension stage, Pago-pharma++ gives on site installation support and a two-day accompaniedcommissioning or factory acceptance bythe project manager and a specialisedtechnician from our Pharma Team.

During this attendance, we provide one day’s professional training for yourqualified staff, based on a defined training plan which is also part of thedocumentation.

Following an agreed period, subsequenttraining for your technicians is providedon site on two further days, including further machine verifications as part ofthe Pagopharma++ package.

Our contribution to smooth integration into your systemSystem expertise for pharmaceuticallabelling means competence for smoothand economical integration of the labelling process into the customer’s specific environment – to comply withyour particular criteria and security standards.

Let us discuss the best concept to solveyour particular labelling task.

PAGOpharma+Over and above the basic Pagopharmastandard, the Pagopharma+ standardensures full validation of the Pago systemand Change Control according to GAMP 4. As well as the project plan, the validationdocuments include functional specification(FS), installation qualification (IQ) and

operational qualification (OQ/ functiontest).

Throughout its life cycle, your project ishandled by an expert project managerfrom the Pago Pharma Team, who hasbeen specially trained to satisfy pharma-ceutical needs and criteria and is yourdirect contact person at all times.

If Pagopharma+ is chosen, the acceptancetest on our premises (FAT, FactoryAcceptance Test) is a three to four daysequence with direct advice from the projectmanager.

Verification

Verification

Verification

Verifica

tion

Everything under control – the guarantees of process and product security

of defective sensor signals so makingincorrect labelling impossible. The positive logic concept only approvesthe labelled product if all the test para-meters have been positively resolved.

A sharp eyeOptional camera monitoring (top) orcode reader as part of the Pagopharma standard – only thelatest verification technology is used inPagopharma systems.

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PAGO Pharma Management CenterAs an option, all Pagopharma systemscan be equipped with a Pago PMC main central control. This permits convenient equipment operation via a single unit and combinesall the intelligent assemblies such as themonitoring, identification and safety devices. Your database and online support permit very simple product conversion. In addition, improved diagnostics are provided with the possibility of online assistance.

When verification is essentialTo guarantee maximum product dependability which the pharmaceuticalindustry requires in respect of the labellingprocess, all Pagopharma systems havecomplete verification devices.

1 Label presence check and ejector stationLuminescence scanners check for the presence of labels in the production run.When an initial monitoring functionreports an error, the product concerned is discharged by an electro-pneumaticsystem. Confirmed security is ensured by a second check on ejection.

Sophisticated control securityThe sophisticated Pagopharma securityconcept is already embodied in the user-orientated standard control. Its fail-safe programming guarantees detection

Highly precise stable adjusting deviceswith precise adjustment scales permit simple and accurate setting of all theunits.

Specialised security: optionsIndividual security measures must alwaysbe taken to satisfy the highly specific security criteria applicable to pharma-ceutical products. We offer various options for this purpose, with smooth integration into the overall line control.

2 Code monitoringThe extended dispensing device of theautomatic Pagomat labelling units is fitted as standard with a Pharmacodemonitoring reader/detection system. This initiates immediate tracing/rejection if a fault is detected or activates label sort out (optional).

3 Individual product identificationVariable high quality imprints can beapplied using a thermal printer (as illustrated) or hot foil embosser in theongoing labelling process to mark the products with codes, information or batchnumbers. The units used by us for this purpose are integrated as standard withall the relevant parameters into the facilitysecurity monitoring.

4 Monitoring camerasFor opto-electronic detection of all kinds of product features, various recordingsystems are available on request.

5 Colour cap checkColour sensors check at the machineinfeed whether the infusion bottles havethe right colour coding. Depending onwhether the colour cap, the knurled ringor printed information is to be checked –the product can only pass the labellingtest as fault free when the signals from all the verification devices have been positively confirmed.

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In conjunction with the appropriate monitoring devices and computer links,Pago PMC naturally also satisfies standard 21 CFR Part 11 in respect of verified user management and recording of modifications (audit trail).

6 Precaution against incorrectlabelling: the Label Sort OutSystem PAGO LSODefective labels previously necessitatedcost-intensive product follow-up, ejectionand special treatment of the product.

Pago LSO prevents labels detected as being defective fromreaching the product. They areautomatically rejected from theprocess and collected separately.

Label errors detected by the code checkand batch print monitoring units on thedispenser tongue result are followed bytargeted disposal of the label. As soon as the defective label reaches a dispensing position, it is rejected andremoved via a take-up roll. The unlabelledproduct is returned to the labelling systemafter a short stop or ejected in the case ofa linear production system. No unlabelledbottles reach the line delivery end.However, for security reasons, a label presence check with an ejector station isgenerally fitted.

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The Pago System 214/221 is a labellingsystem which applies vignettes and tamperevidence labels to the pharmaceutical pro-ducts. Proper labelling is checked directly.Defective labelling is immediately recogni-sed and the corresponding productsrejected.

Consistent accuracyThe aligning system on the machine entryside ensures precise alignment of the folding boxes on the conveyor belt. Side belts and an upper retaining beltguarantee safe guidance for labelling purposes. The central transport unit driveensures absolute synchronisation. This enables the label position on the productto be precisely defined and reproduced.

Dead accurate – 300 times a minuteThe high performance Pagomat 6 auto-matic labelling machine applies 300labels per minute in conjunction with thealigning station. Without the aligning station up to 400 labels can be appliedeach minute.

The Pago System 214/221 is a multi-purpose machine combining vignettelabelling with tamper evidence labellingon both sides. The vignettes are applied tothe top of the folding box. The tamper evidence labels are dispensed at the sideand deflected over the folding box edge.

Monitored securityAll labelling processes can be reliablychecked by an intelligent monitoring stati-on. Faults are detected immediately andthe products concerned removed through

the ejector station. The ejection checkcompletes the pharma security conceptand ensures the presence of a continuousverification chain.

Product-specific identificationThe Pago System 214/221 satisfies allspecial pharmaceutical requirements.Code readers to check the vignette codeson the dispenser tongue can be fitted as options together with thermal printers or hot foil embossing devices.Codes, information or batch identificationscan be printed or checked before thelabelling process. An additional cameracan read comparative data or check for presence of labels as required. Thelabelling capacity is adapted to the required performance range.

Simple operationThe Pago System 214/221 is fitted with a clear and convenient control and auto-matic pre-warning of approaching labelroll end. Optionally, a Pago PMC controlwith touch screen panel can be fitted.

Compact modular structureThe Pago System 214/221 has a modular design for box handover andattachment of further components (such as a protective housing). Its compact structure supports smooth integration into the production line.

PAGO System 214/221Labelling of pharmaceutical vignettes and

tamper evidence labels for folding boxes

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Precise alignmentThe products are aligned precisely in theside conveyor belt in feed.

Light barrier fork...for precise label scanning in the high performance range.

Vignette applicationUp to 300 vignettes per minute can be accurately positioned on the folding box.

Tamper evidence labelling (left fig.) The labels are dispensedon both sides and deflected to thebox edges. Sensors check proper application.

Comparison check (center fig.)A camera on the discharge sidereads the data on the appliedvignette for reconciliation with the database.

Ejection station (right fig.)Products with defective labellingare detected immediately andseparated in the ejector station.

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Notes on standard equipmentof the Pagopharma machinesand the many availableoptions will be found on pages 4 to 7.

PAGO System 610 PharmaMaximum precision and versatility – all-round labelling

with the rotary star system

Precise axial alignmentThe perfect all-round labelling of cylindrical products on fast-running production lines is a technical challenge.Especially when double labels (two labelsper product) or target labels (to be placedat a particular position on the product) are needed. Pago system 610 Pharmahandles these labelling needs easily withits rotary star system. The stable three-point product support during labellingguarantees optimum precision without spiral effects and a perfect label fit.

Fast peripheral labellingis generally effected by the Pago System610 Pharma in high performance modeusing a wrapper strip. The peripheral areacan be labelled partially or with an accu-rate visual gap or overlapping alignmentwith the edges.

For difficult special tasksSpecial requirements such as double labelling with front and back labels (arranged alternately on the roll, includingthe possibility of different label lengths) or wrapped labelling with multi-layer information labels, can be handled perfectly by the Pago System 610 Pharma– depending on the needs in an operatingcycle in conjunction with a driven pressdown roll or in continuous mode with the wrapper strip.

Stable structure and plenty of roomfor options - PAGOmat PharmaThe Pagomat System 610 Pharma with thePagomat Pharma is ideal for stringentidentification and monitoring requirementswith its innovative drive technology andan extended dispenser tag. Ample spaceis available for the attachment of labelpresence checks, thermal printers or hot foil embossers, batch pressure andpharma code check. Perfectly preciseimprint of variable information is thereforeassured. For the application of multilayerPago media labels or Pago inforoll wrapped labels, the Pagomat Pharma can be ideally equipped. Maximum labelling accuracy is guaranteed by thehighly stable double suspension for thebase plate.

All-round or front/backlabelling with a precisevisual gapThe Pago System 610 Pharma is suitable for all kinds of applications and can also handle multiple Pagoinforollwrapped labels.

PAGOmat Pharma Robust labelling technology fortough use in continuous high performance production: thePagomat Pharma combines thisbasic virtue of our automaticlabelling machines with a highly vibration-resistant doublesuspension and a vary longdispensing tongue. Ample spaceis available on this machine forthe various identification andmonitoring devices as well as theautomatic label sort out.

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Top performance of all componentsPago System 610 Pharma sets the pacewith its capacity of up to 350 articles perminute in continuous operating mode.Even in the cycled mode for double or target labelling, up to 100 pieces perminute can be handled. The machine isinfinitely variable from zero to the maxi-mum speed with automatic speed adjust-ment for all the functional assemblies.

Short reset times and simple format changeThe modular design and convenientassemblies ensure flexibility and short set-up and adjustment times. For formatconversion, the rotary star is simply changed without a tool using its three-star handle.

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Label Sort Out – for additionalsecurity and economyAs an option, an LSO system protects thepassing containers against expensivelabelling errors. Only labels which havebeen checked and found to be correctreach the bottle.

Defective labels are registered by themonitoring devices on the dispenser tongue, followed up carefully and disposed of or dispensed at the extremityon a separate take-up roller. The otherwiseusual complex recording and isolationwhen faults occur is unnecessary.

Only a very short production delay occurswithout unlabelled or defectively labelledbottles occurring. A label presence checkwith a discharge station on the machinedelivery side is, however, advisable forsecurity reasons.

Details of the standard equipment of Pagopharmamachines and the variousoptions will be found onpages 4 to 7.

PAGO System 560 PharmaEfficiency and economy –

all-round labelling with wrapper strip

The Pago System 560 Pharma combinesconvincing flexibility with universal use. Itprovides a technologically secure basis forfast and economical labelling of all kindsof cylindrical plastic and glass packages.

Reliable technologyAll the functional and auxiliary assembliesare mounted on the base plate in a clearlayout for easy use. The assembly deviceto mount the Pagomat automatic labellerhas a strong double tubular design.Height adjustment is effected by means ofa spindle with a hand wheel. A digitalpositioning display facilitates adjustmentand reproduction of the values. The PagoSystem 560 Pharma is infinitely adjusta-ble. The conveyor belt, isolating screwand wrapper strip are centrally driven.

Powerful in every respectFor continuous operation or in the highperformance mode with labelling capacities of up to 300 per minute!

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Control and operationLike all the Pago systems, the Pago System560 Pharma in its standard version isequipped with a Siemens S 7, Allen-Bradley or FlexiLogix stored programme control and also incorporates a 16 bitmicrocompressor control to monitor and programme the Pagomat 6 automaticlabelling unit which is driven by a stepper motor.The operating console is clearly laid outand contains the operating and displayelements for the Pagomat and the terminalfor the equipment functions.

Naturally, the equipment – like allPagopharma systems – can be optionallyfitted with a Pago Pharma ManagementCenter. Details of the standard equipment ofPagopharma machines and the manyavailable options will be found on pages4 to 7.

Precise identificationTo print individual product data, all kinds of hotfoil embossers or thermal printers are available.All production-relevant properties such as temperature etc are monitored.

PAGO Label Sort OutFor linear running systems, like the PagoSystem 560 Pharma, an effective and economical prevention of incorrect labelling is available as an option in theshape of the label sort out technique.Defective labels are already detected onthe dispensing tongue of the Pagomat, followed through to the end of the tongueand dispensed and disposed of on aseparate take-up roller. They do not reachthe product. The unlabelled product isdetected by the subsequent label presencecheck and eliminated at the ejector station. Production remains uninterrupted.

Simple and easy product changePago System 560 Pharma offers extremeflexibility in respect of the choice or chan-ge of products to be labelled as the screwis the only format element that has to bechanged.

Ejector stationUnlabelled or defective products are eliminated from the production process by an electropneumatic ejector unit.

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Details of the standard equipment of thePagopharma machines and the manyavailable options will be found on pages4 to 7.

PAGO System 520 C PharmaPrecise front and back labelling

of shaped bottles on linear machines

With its sophisticated linear technologyand modular design, the Pago System520 C Pharma is ideal for perfect labelling of shaped bottles. Its develop-ment was based on our extensive experi-ence in the highly demanding cosmeticindustry. The simple change of the few format pieces without the use of specialtools makes this equipment a flexible multipurpose solution.

Precise separation and alignmentProduct separation is effected behind ablocking zone by means of an isolatingscrew with indexing designed for the particular labelling task. The robust structure swivels and allows fast ex-change for product changes. The productalignment for precise labelling is effectedby means of eccentric jaws which act onboth sides and follow the linear productflow.

250 accurate labels per minuteWith this high capacity and constant highdelivery quality, the Pago System 520 CPharma sets new standards.

For precise labelling, perfect productfixing by AIR-PRESS-Technology togetherwith stable, precise and rapid changeassembly devices set the standard. Therobust automatic labelling unit in thePagomat 6 series is your guarantee of perfect label application.

Special requirementsThe machine also permits accurate labelling of shaped containers with complex product shapes. In such cases,the labels are additionally set to the correct position by means of an optionalpost-printing station. Various additionalassemblies are available for this purposedepending on the particular task and are synchronised with the machine running. The application of multilayer Pagomedia labels or Outserts and three-sided labelling across the corners are possible.

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monitoring units and with the optionalPago Pharma Management Center createthe high level control for perfect overview,continuous security and guaranteed ejection of defective products.

Pharma Management CenterPAGO PMCWith its combination of all the intelligentassemblies in a central operating unit,Pago PMC makes the labelling processcontrol extremely simple, even with themost stringent monitoring requirements. 21 CFR Part 11 requirements are satisfiedand can be easily achieved in combina-tion with the necessary monitoring andcomputer units. With the database andonline support, product conversions areeasily implemented by Pago PMC.

Fast product changePago PMC with its memory functions andthe tool-free exchange of the small numberof format parts create flexibility for fastproduct changes. Only the isolating screwand the shaped jaws of the alignment station and possibly the optional post-printing station need replacement.

Details of the standard equipment ofPagopharma machines and the many options will be found on pages 4 to 7.

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For reliable seating: eccentric post-printing stationSpecial labelling materials or productforms frequently require additional labeldimension checks. The eccentric post-printing station with shaped jaws for thespecific products is an optional extraassembly supplied for this purpose.

Perfect control and continuousmonitoringThe Pago System 520 C Pharma also per-mits the integration of all pharmaceuticallyrelevant monitoring and coding devices.All the current monitoring systems usingcameras for testing the imprint, presenceand positions of the labels through to printquantity sensors and print mark checkersare available as options. We integrate the

Pago Ltd. • Labels • Labelling systemsCentenary House • Gilberd CourtSeveralls Industrial ParkGB-Clochester, Essex CO4 4WN

Tel. 01 206 75 52 06Fax 01 206 75 52 10sales@pago.co.uk

www.pago.co.uk

Pago AGLabels • Labelling systemsWerdenstr. 85CH-9472 Grabs SG

Tel. +41(0)81 772 35 11Fax +41(0)81 772 36 55admin@pago.ch

www.pago.com • www.pago.ch16

Incorporation of the PAGOmatinto your production lineAttached automatic devices like thePagomat 6HS offer an efficient andeconomical possibility of effecting price sticker labelling directly in thedischarge belts of the cardboard boxpreparation machines on pharma-ceutical production lines. The high performance labelling machine adjustsautomatically to every cardboard boxmachine. The electrical lift column ensures ultra-simple operation andheight adjustment.Our automatic attached units can ofcourse be fitted with optional monito-ring devices. The intelligent control concept guarantees ideal communi-cation with previous and subsequentequipment. The installation length of the automaticattached unit is generally immaterialand its modular design makes for perfect solutions even when space is at a premium.

PAGOmat 6For economical in line labelling

Pago Etikettiersysteme GmbHLabels • Labelling systemsGutenbergstr. 972631 Aichtal • Germany

Tel. +49 (0) 71 27 58 01-0Fax +49 (0) 71 27 5 78 73pago@pagoaich.de

www.pagoaich.de