Packaging News 2003 (pdf) - Wipak

2003NovemberIn this issue:Page 2• Advanced medical packaging –a vital part of modern healthcarePages 2-3• Wihuri Group consolidatesits position as a centre ofexcellence for film technologyPage 4• Innovation throughknowledge sharingPage 5• Winpak´s benchmarkingprogramPage 7• Practical recommendationsand product newsPages 6, 8• Territorial news andreferences

Advanced medical packaging– a vital part of modern healthcareWipak´s corporate strategy isfully focused on our customers.The following 5 key elementsoutline our strategic directions.FOCUSWe focus our efforts on gaining and maintaininga leading position in clearly definedsegments. By consolidating our resourceswe intend to cater to your needs evenbetter than we have before.GROWTHContinual growth secures our strong positionin the market for flexible and semirigidfilms, and we want to use this strengthto build up a solid foundation upon whichour customers can develop real competitiveadvantages.INNOVATIONAs our customers expect us to provideinnovations in the form of new products,and we will do everything to satisfy theseexpectations. But we also regard innovationsto include progressive kinds of collaborationin areas such as technical andcommercial consulting.SERVICEProviding services related to our productsenhances their usefulness. The serviceswe provide can be considered comprehensiveas long as they meet or exceedthe requests and requirements of our customers.This can include services withina broader scope than just production itself,for instance assistance with graphic designing.GLOBAL APPROACHWipak and Winpak operate globally. Butacting and thinking globally includessupplying our nationally and internationallybased customers both locally andworldwide; and it means monitoring thevarious markets in which our customersare active; viewing both film and packagingrequirements holistically; exploitingsynergies for the benefit of our customers.As you see, we have clearly focused ourstrategy on our customers. We would beonly too pleased to discuss with you howWipak can contribute even more towardsyour company´s success - taking our strategicapproach a step further for evencloser co-operation.Harri PursiainenManaging DirectorWipak GroupWe are committedto customers´ benefitA frequent and critical look at our businessenvironment is worthwhile, inorder to pilot the company successfullyin an ever changing environment.I wish to share some thoughts andconsiderations from Wipak Medical´sstrategic analysis with you.Healthcare looksfor cost effectivenessThe growing use of healthcare consumablescontributes to constant cost reductions.The globalisation process, especiallyin Europe, will force economies to takemeasures in order to be competitive inthe intensifying international scenario.Governments will have to assign morepublic funds to the development of othersectors of society rather than healthcarewhile urging for national competitiveness.While hospitals have to run their operationsand cannot dramatically reduce theuse of disposable medical materials, thepressure to acquire them at lower costsis evident.A smaller global worldThe globalisation process is rapidly changingthe way we work with our customers.As many of our clientele run their operationspractically on all continents, we -as a materials supplier - have to be ableto satisfy needs globally. This requiressizeable production and service resourcesin different geographical areas. The managingof this international logistics chainrequires flexibility and wide experiencein business solutions.Good ethics in businessbecome valuableGlobalisation has generated so-calledglobal tenders. These tenders attract theparticipation of materials suppliers whilstsizeable volumes are in bid. The aggressivecharacter of some of these deals raiseconcern. We hope that tenders will continueto be awarded in line with goodbusiness ethics.Reinforced need forquality operationsHealthcare sector is forcing the medicalindustry to look for improved efficienciesand savings, and to lower costs whereverit is possible. Simultaneously, quality requirementsbecome more evident. Requirementsfor product standards and qualitysystems will force suppliers to invest inmaintaining the quality of their products,processes and services.Flexible and reliable servicesas a competitive edgeHealthcare sector and medical industrywere earlier characterized as a businesswith good prices and high margins. Thisencouraged some suppliers to expandtheir activities into medical applications.Most of these latecomers have been disappointed.Good prices and high marginsare history. Customers in healthcare institutionsand the medical device industryrequire flexible, precise and reliable ser-vices. This involves more costs than manycompanies anticipate in advance.Standards regulatedevelopmentThe healthcare business requires a deepunderstanding of the related regulatoryissues. Proper knowledge contributes tosuccessful business partnerships. As aspecialized medical supplier, Wipak activelyparticipates in the development ofthe medical regulatory framework.Commitment to successWhich medical companies will survive?A successful company needs to be bigenough in terms of volume, it must possessgood business expertise, run appropriatequality systems throughout all its functions,manage operations globally, provide acomprehensive range of medical packagingmaterials to large international companies,and last but not least, it needs tobe profitable and committed to the medicalbusiness. Commitment means acompany´s ability and readiness to developits activities.Corporate resources meetglobal customers needsThe global Wihuri Packaging Divisionoffers the perfect environment to developour medical business. The Wipak-Winpakgroup of companies is a strong and profitablepartner with highly diversified andspecialized film-making capacities. Thenumerous world-wide manufacturingplants, coupled with an extensive networkof sales offices and partners provide anideal basis to develop our internationalactivities.Wipak offers a wide range and selectionof medical packaging products for theneeds of healthcare institutions and themedical devices industry. As a manufacturerwith large-scale volume, Wipak isable to achieve production cost efficienciesfor the benefit of its customers.An optimistic lookto the futureWe see excellent opportunities to developand maintain profitable business throughcontinued growth in existing and newmarket areas. We will continue to developproduct functions and features and theefficiency of the entire material flow andmanufacturing process. We have the bestpeople together with an extensive specialistpool of film-making machinery, equippedwith the newest process and technologicalinnovations.We are committed to develop our organizationand its structure to serve our medicalcustomers in an efficient and productiveway. We are excited by futurechallenges!Heikki WeijoManaging DirectorWipak Medical2

The centre of excellencefor thermoforming filmsWipak maintains its global position asthe leading manufacturer of flexiblethermoforming films. The work thatstarted in the early 1970s has continuedfor 30 years with increasingspeed of investments, R&D efforts andproduction development.In order to meet customer demands forhigher quality, better economy, new productsand improved machine productivity,challenges to the packaging materialsgrow steadily.Market expectations are transformed bythe marketing and sales organisation intheir strategic business plans into operationaltargets.Wipak-Winpak Success Factors• World-wide network of production units and skilled personnel• Co-operation with our excellent group of raw material and machine suppliers• Joint development projects with polymer research centresand universities• In-house pilot lines for film making and packaging machinesThe production and R&D people workclosely together to plan machine investmentsand to adapt the newest technologyto meet set targets. Today, our two coextrusionlines in North America representthe most modern technology with their13 extruders and 11-layer combinations.Productivity, process control and errorfree qualities are set targets for all productionoperators. Some of our most skilledand devoted personnel have worked withus for more than 25 years. Film makingskills are transferred from one generationto the next.Multiplant capacities are available throughour many production facilities in Europeand North America. Risk managementcalls for increasing attention from us andour customers.Our success in meeting customer demands and new challengesis based on many positive factors, such as:• A wide range of different production technologies including cast and blowncoextrusions, coating and lamination• High-volume production with one of the largest capacities in the marketAn “Iron Team” with a golden touch– continuously looking for the latest in production technologyAll our production managers assembleto regular meetings where production andproduction technology matters are discussed,analysed and decided on. Thisgroup has earned itself the nickname “ironteam” which we are rather proud of: itshows our determination to keep theWipak-Winpak Group ahead of the field.Our Iron Team also visits customers, machinesuppliers, exhibitions and othersources of information. The proper wayof approaching the difficult task of choosingthe right technology for the right unitand for the right product has already givenexcellent results.Wihuri was and is increasing investmentsin the packaging division for the advantageof medical business as well. While spendinga lot of our corporate financial resourceswe need to take care that wespend it well.Timo ToivolaTechnical DirectorWipak GroupNew flexo-printing press in NastolaState-of-the-art precision printing technologyand highly efficient peripheral systemsare what is required for top quality print.In 2003 a new eight-colour flexo printingpress came on stream to enhance thealready substantial printing capacity atWipak Nastola.With this new printing machine, Wipakinvested in cutting-edge technology assuringhigh quality as well as short changeoverand proofing times: the latest sleevetechnology for plate cylinders and aniloxrolls with closed inking circuits; automaticin-line wash-up system; automatic set-upsystem which sets the flexo plates andmachine elements at the right startingposition.The new line operates very accuratelyand with freely adjustable repeatlengths.High-performance extrusion linestarted in WalsrodeAt Wipak Walsrode a second highperformancecoextrusion line has recentlycome on stream for the production ofmultilayer film. This blown film linecomprises 9 extruders and enables ninelayerfilms to be produced. With the aidof appropriate feed systems, more than30 different types of resin can be processedinto a high-tech multilayer film. The newline not only increases capacity to meetdemand, but also enables Wipak to exceedcustomer expectations.Wipak Film Academy – Cast Coextrusion ProcessThe technical capabilities of Wipak and Winpak packaging groups include castfilm coextrusion lines with 5, 7 and up to 11 layers. One of the lines is installedin a clean room environment, allowing for the production of pharmaceuticalgrade high performance materials for primary infusion packaging.Cast film extrusion (also called flat filmextrusion or the chill-roll-method), is oneof the classic extrusion processes.It starts with raw materials, a polymerin the form of a granulate. 1.Polymers may be inter-blended ormixed with certain additives to improveprocessability and performance.The granules pass through the extruder,where heat and friction turn theminto liquid melts. 3.The still separate melts are fed togetherinto the feed block. 4.Special plugs determine in what order themelt flows are combined, creating a coextrudedmultilayer film. The use of severaleasy-to-change plugs provides versatilyin terms of the final structure of the film.The melt is directed through a lineardie and meets the chill roll shortly afterleaving the die. 5.Contact with the chill roll leads to coolingand stabilizes the melt into a film, by“freezing” it into a solid state.2.1.2.3.1.2.5.3.Chill roll(I)1.2.3.4.3.Chill roll(II)1.2.3.The film is then fed over severalfurther rolls, across a thickness measuringunit. 6.Finally the film is trimmed to theworking width (by cutting the edges ofthe web) and wound on the motherrolls.1.2.7.6.1.Granulate feed2.Dosage/blending3.Melting transport4.Feed block5.Automatic die6.Control equipment7.Rewinding7.Automatic process controlThickness measurements are input forautomatic process control, which includesextrusion parameters such as the melttemperature, extruder speed, width of thedie gap and output etc.Controlling these parameters guaranteesthe constant high quality of the extrudedfilm.Advantages of the castcoextrusion process• high production speed = high productoutput = economical process• effective film cooling = excellent opticalproperties like transparency and clarity• fine adjustment of mechanical and filmsurface properties by controlling the extrusionparameters and chill roll temperatureAdditional equipment such as a recyclingunit for the edge trimmings makes theprocess even more economical or - as inthe case of a web cleaning unit – improvesproduct safety to meet the tough requirementsof medical packaging.Dr. Claudia MüllerManager, Medical R&DWipak, Nastola3

Wipak Medical – your global partnerfor advanced medical packagingSuitable forcommon usedpackaging machines• Thermoforming• Flow pack• 4-seal• PouchesSyringes and needlesCatheters and tubingsWoundcareGlovesIV and bloodtherapySteriking® PackagingMaterials & Systems aredeveloped for demandingpackaging applications• Flexible & Rigid forming films• Non-forming films• Lidding Webs, Papers and Tyvek®• Special Barrier Films for IV Solutions• Medical Pouches, Bags and Tubings• Heat-sealers, Chemical Indicators• Other Accessory ProductsOR-textiles, gownsRhenal therapyOperationand procedure setsInnovationthrough knowledge sharingResearch and development in the Wipakgroup is not only based on many years ofexperience in various production locationsand on a deep knowledge of applications,but also involves close co-operation withscientific polymer research organizations.Some of these, such as Muovipoli Ltd.,are geographically close - situated in thesame “polymer” valley of Finland as theWipak Nastola production plant. Researchexperts at Wipak and the VTT TechnicalResearch Centre of Finland work togetheron projects for the improved calculationof - packaging film properties underindustrial conditions of storage, transpor-Barrier Protection –EVOH in over wrap filmWipak is one of the major EVOH users inthe world. This knowledge and purchasingpower is transferred to critical barrier filmfor liquid packaging. Some of the latestinnovations have been patented.Steam sterilisation puts high requirementson EVOH and the barrier function. Handlingthe steam conditions and EVOH isno mean feat itself but our research hasmet the challenge.We can coextrude EVOH into combinationswith PP and PA, making combinationswhere total thickness and layer de-tation and usage, which, in turn, meansbetter features. Tampere Technical Universitysupports our R&D activities withtheir extensive knowledge of polymermaterials, providing a pilot line for fastpractical extrusion trials.New materials and film structures canthus be tested and investigated even faster.Development and validation processescan be substantially shortened. All theseefforts are focused on the latest developmentsin technology and materials resultingin cost and performance advantagesto our customers.signs are customer tailored. Caprolactanfree PA is available, as well as special tielayer qualities to withstand the hard steamsterilisation. Special PEEL sealing layercan be added for soft and easy opening.All EVOH based forming films are manufacturedto meet highest customer demandson strength, formability and sealability.The Wipak range also includes highbarrier lidding materials.Barrier over wrap materials are manufacturedon a special coextrusion line inclean room conditions.Biaxis doublesits BOPA capacityBiaxis was founded in 1995 as a jointventure between the Wihuri Groupand the Nichimen Corporation ofJapan.The first line was opened in North Americawith the name American Biaxis, followedby a second line in Finland which cameon stream this summer.Biaxis produces BOPA – biaxially orientedpolyamide – film which is generally usedin the food processing industry due to itsexcellent oxygen barrier properties andstability for high level print. Use in thehealthcare sector includes vacuum packedtextile products such as drapes and gownsor other oxygen or aroma sensitive products.All production lines are highly automated,run with superior line speed and complywith the highest quality assurance standards.The film is stretched in both themachine and crosswise directions.Wipak also uses a great deal of OPET inits healthcare product range. Polyesterfilm is frequently used in pouches and in4-seal machines for its stability and hightemperature resistance.Wipak enters theBOPP marketby acquiringWalothen GmbHWipak is increasing its market share inthe biaxially oriented film market. In 2003,the packaging division of Wihuri oncemore joined up with Bayer AG, the globalpharmaceutical company, to took overWalothen GmbH with 250 employees. In2001 the acquisition of the Bayer subsidiaryand packaging company Covexxwas finalised; this unit now operates successfullyunder the name Wipak Walsrode.Walothen is a leading producer of BOPP– biaxially oriented polypropylene – film.The in-house production of BOPP providesWipak with new products and prospectsfor steam sterilisation applications includingsolution packaging business.Antti Aarnio-Wihuri(left) receives fromDr. Herzog of theWolff Board thesymbolic film reelsigned by the personnelof Walothen;with Dr. Brauer,Managing DirectorWalothen (right).Matt-finished filmsas a temporary skinThe new Covexx WF PE matt can be usedas a base film for adhesive tapes andsticking plasters. These polyethylene basedfilms are moisture-proof, contain no slipagents, have a very low tendency to curl,and are highly resistant to tear initiationand tear propagation. The matt surfacegives the effectof skin bothvisually andhaptically.ECOTOP WHITEPEEL – the refined topfilm for irradiationThis 100 % polyethylene films is the solutionwhen looking for a non-curling,coextruded, printable and an economicalfilm to form an all film pack.Irradiation is becoming a more widelyused sterilisation method, not requiringporous material for penetration. Gammaor Beta sterilisation is not affecting thisfilm like medical papers, which are loosingpart of their strength.ECOTOP can be used on thermoformingmachines with our recommended bottomfilm MLA, which is equipped with specialsealing layer for a wide process window.MLE TF PEEL filmsseal well to uncoatedTyvek®The new TF PEEL films are sealing andpeeling against uncoated Tyvek® qualitiesthus offering an economical use. Thiswell-known DuPont material is directlysupplied to Wipak´s converting units.The MLE TF PEEL films are high qualitythermoformingfilms,that offergood machineperformanceand awide sealingwindow.Walotape® Tear TapesWho would think that a tear tape couldhelp detect counterfeit products?Walotape® tear tapes can be providedwith multicolour images and texts withup to 10 ink colours, even 0,3 mm microtypewhich is perceived by the naked eyemerely as a line. As an anti-counterfeitsecurity measure, Walotape® tear tapescan be supplied with a hologram or withthermochromicor photochromicfeatures: ata certain temperatureor underUV light thematerial changescolour.4

Winpak Benchmarking programhelping North American customers to savingsOften, when medical device manufacturersstart looking for cost saving opportunitiesthey look at their currentmaterials pricing and develop a RequestFor Quote or Bid Package. Althoughthis may produce some savingson materials cost, it often doesnot deal with the entire cost picture.Winpak has developed a very thoroughbenchmarking program for current andpotential customers to help identify savingsopportunities:1.Analysis of packagingcomponents andoperating performanceThe benchmarking starts with an analysisof the current packaging components andoperating performance. Current filmsare analyzed.• Dynamic mechanical analyzer• Differential scanning calorimeter• Gas chromatograph• Infrared spectrometer• M.V.T.R. verification• O.T.R. analysis• Flex crack• Tear testing• Drop testing• Tensile Testing• Seal Strength• Coefficient of Friction (C.O.F.)• Interlayer bond• Thickness profiling• Microscopy• Digital microscopy2. Analysis of packagecontents and dimensionsOnce the physical properties of the packagingmaterial are fully understood, thepackage contents and dimensions areanalyzed. This enables Winpak to matchthe product requirements to film performance.3.Analysis of the equipmentNext, the equipment itself is analyzed tosee if there are any output restrictions.Are there pre-heaters, plug assists or otheroperating components on the machinethat will enhance or restrict the speed ofoperation or throughput?4. Mini-trial runThe recommended Winpak film is thenchosen and a mini-trial is run on theWinpak lab Horizontal or Vertical FormFill and Seal equipment. This step in theprocess often confirms that a down-gaugedfilm performs well on customer equipmentand results in lower material costs, as wellas faster cycle times.5. Customer reviewThe proposed film packaging solution andtotal performance advantage is outlinedfor the customer for their review. If thecustomer agrees with the approach, amachine trial on the customer’s equipmentis arranged.Total packaging savings,seamless transitionThis approach has proven beneficial tomany Winpak customers. Not only hasthis Benchmarking led to total packagingsavings, but also to a seamless transitionfor the customer.Bob DuffyProduct ManagerMedical PackagingWinpak DivisionWinpak’s HeatSealableMembranesfor Pharmaceutical andPersonal Care MarketsWinpak’s Heat Seal business unit basedin Montreal is the industry leader in manufacturingheat sealable membranes forthe food processing, pharmaceutical, beverage,dairy, personalcare and closure linermarkets. With over 32years of expertise inthe lidding market,Winpak is the premierdie-cut lidmanufacturerin NorthAmerica.Winpak’sbroad productoffering includescombinationsof paper/foil/filmlids which arehighly resistant topuncture, tear, and flex-cracking. Thesepackaging structures have excellent sealintegrity for all packages including PVC,Aclar®, Barex®, PVDC, PP and APET.Product applications include pharmaceuticalblister packaging push-through tabletfoil, as well as induction and conductioncap liner materials and tamper-proof membranesfor cosmetics.Winpak Heat Seal is a vertically integratedsupplier with custom equipment to coat,laminate, print, emboss, slit and die-cut.These capabilities allow Winpak to providean infinite number of material combinationsto meet the ever-changing demandsof the pharmaceutical and medicalmarkets.Wipak and Healthmark growwith joined forces in the U.S. hospital marketHealthmark Industries, founded in1969, specializes in products for theCSSD since its inception. The currentproduct line is focused on InfectionControl and Sterilization products.The whole U.S.A. asan marketing areaThe U.S. is a geographically large market.The healthcare sector has decreased somewhatin size in recent years – fromabout 8.000 hospitals in the mid 1980sto about 5.000 in 2003. Healthmark isheadquartered in St. Clair Shores (MI) andit markets Steriking® packaging throughoutthe U.S.A.Sales and marketing are managed througha variety of resources, including directmail (over 200.000 items per year), tradejournal advertising, attendance at tradeshows, telemarketing, and direct sales via30+ salespeople in the field.Contracts with GPOsPurchases of most disposable/consumableproducts in the U.S.A. healthcare marketare managed through Group PurchasingOrganizations (GPOs). These organizationsrepresent a large group of hospitalsin order to secure the best possible priceby committing to purchase high volumesof products. The GPO environment is aSales Channel - Steriking® Pouches & RollsWholesale distributorsProductPaymentdifficult minefield, but Healthmark hasmanaged to negotiate its way though itand secure some regional and nationalcontracts for Steriking®.Professionalcustomer serviceHealthmark ships most Steriking® productsthrough this distribution environment, butalso directly to the hospitals themselves.RebatesGPOs% ofRebateGPOmemberhospitalsPriceNegotiationMembershipDuesThe local sales representatives are veryknowledgeable about sterilization packagingand are able to provide a completeafter-sales service to ensure that customersare happy with their choice.The U.S.A. is a highly competitive marketfor sterilization packaging dominated byat least five major companies. Pricingpressure has been significant, with theaverage prices almost 15 % lower thanThe distribution part of the GPOenvironment has eliminated all butthe specialty distributors from localhospitals, but has helped the consumerhealthcare market to more closelyresemble the distribution systemfor the drug industry. In both casespricing and marketing are directedto the end user, but the product isshipped and billed through a localdistribution warehouse. The wholesaledistributors negotiate a separatecontract with the GPO or hospitalsand work on razor-thin margins.seven years ago. Steriking® is a newcomerto the market, but with Wipak quality andHealthmark market knowledge Steriking®has been able to make significant in-roadsin a highly competitive market.Mark D. BasilePresidentHealthmark Industries Inc.5

Japanese choose prime qualityPrize-winningenvironmental contributionWipak ´s sustained and systematicinvestment in environmentalfriendly systems is rewarded.Wipak Nastola is adapting its environmentalmanagement systems to comply withISO 14001. Production waste is recycledback into the manufacturing process ordisposed of by incineration with energyrecovery. Landfill waste is reduced to aminimum and air pollution is avoided byminimizing VOC compounds in the manufacturingprocesses. During past fiveyears Wipak has reduced its landfill wasteto one tenth.Wipak won the Nastola Environmental Practiceof the Year award in 2002. Quality manager LeenaHovi proudly presents the certification.Clean room facility expanded in SittardTOP is also a manufacturer of disposable medical products and they go for high quality in their ownproduction. “We feel that the excellent quality image of Steriking® contributes to building up TOP´squality image and visa versa”, says Mr. Shin-ichi Sato, Manager of TOP´s import section.With a population of 120 million peopleand a comprehensive healthcare system,Japan is one of the most interesting marketsin the Pacific region. Japan is a wellknownhigh quality market where consumersdo not usually settle for secondbest. This applies in healthcare as elsewhere.In purchasing decisions safety,quality, service and operational economyare important. Among foreign packagingbrands, Steriking has been the marketleader for more than 15 years.TOP Corporation is an expert in localconditions and their extensive sales networkhas made the Steriking® successstory possible. In Japan customer preferencesin packaging are slightly differentto those in Europe and therefore stronglocal knowledge is needed to customizethe product to meet end-user demands.Education is a vital factor in the packagingbusiness. TOP Corporation believes inthorough education and delivers continuoustraining sessions to salesmen anddistributors. Knowledgeable and motivatedsales personnel can in turn enlighten endusers on the quality and safety aspects ofSteriking® products.Outi Lindholm-OllikainenArea Sales ManagerWipak Medical, HongkongWipak BV in Sittard, Netherlands, startedconverting medical products in 1990 innew, controlled clean premises. It alsoserves as a Logistics Center for the Beneluxcountries. Customer proximity, flexibility,delivery reliability – well, personnel aregeared to these demands. Quality is notonly paramount in production, but is alsoa top priority in customer service.Wipak BV is certified to ISO 9001:2000and is audited frequently by key customers.Mr Andreas Remer of Medicalis Medizintechnologie,remarked in his quality auditreport : “It was quite clear to me thatWipak not only has a quality managementsystem, but also implements it in a fantasticway, and this deserves praise of thehighest kind. The entire Wipak operationcertainly gave the impression of beingvery well organized.”The production environmentis undergoing furtherexpansion and upgradingand will comply withClass 8 (100.000) forimproved safety andcleanness of the products.Peter Smits is responsiblefor pouch making sinceinception.Wihuri family committed to culture and scienceOur corporate founder Antti Wihuri wasborn on October 9th in 1883 in the archipelagodistrict of Kustavi. He set out tosea at the early age of twelve. After havingsailed the seas in steamers for many years,he decided to stay on dry land, workingas a supervisor for a stevedoring companyand as a ship broker before starting hisown shipping company in 1916.In the 1940s, Antti Wihuri started to expandhis business to other sectors. In time,he came to own several companies, whichhe actively managed up until his death in1962. Antti Wihuri was a far-seeing manwith exceptional talent. He was hardworking,modest and kind-hearted.Soon after the war broke out in 1939,Antti Wihuri donated considerableamounts of money for the defence of thecountry. This period was a turning pointin the life of this practical man. He tookone of the most important decisions ofhis life - to build a foundation. This wasa clear indication of the Wihuri family'scommitment to culture.The Wihuri fund donated7 million euros this yearAir AmbulanceServicewhen speed countsfor medical careDue to Finland's geographical locationas the closest western neighbour to Russia,Helsinki is a real gateway between theEast and West.Wihuri Aviation Jetflite Ltd. is the largestprivate business aviation company inScandinavia. Euro-Flite Air Ambulance isthe most experienced western serviceprovider in the area of the former SovietUnion where it operates from more than140 different locations.Finland's high quality hospital networkoffers the closest western medical servicesas an alternative to the Russian healthcaresystem for foreigners who live and workin Russia but are not satisfied with localhealthcare facilities or cannot be treatedby them.Antti Wihuri and his wife Jenny Wihuristarted a general-purpose cultural foundationin 1942. The foundation gives outscholarships for promoting science, artand civic activities. The purpose is toadvance the spiritual and economicaldevelopment of mankind. Over 61 years,the total amount of awards and scholarshipsamounts to € 124,2 million.Wihuri International award was donated to the world famous Finnish composer Jean Sibeliusin 1953. Here Antti Wihuri (left) congratulates the composer.6

[Enduser´s view on sterilisation packaging choice]Keywords: Safety of use, economy – pros and consThe feasability analysis focuses onmedical packages which follow EN868-2 and EN 868-8 standards. Thepackaging materials and methods forsterilising vary from country to countrydue to the different methods and criteriaused. I am comparing single-usewraps and reusable containers, theirpros and cons, and costs of acquisitionand use from the viewpoint of asterile supplies manager.When reviewing these two package concepts,I addressed questions which remainto be satisfactorily answered in Finland.When I was in charge of the CSS departmentin a central hospital with 600+ beds,I faced this question more than once becausepersonnel in operating rooms werein favour for the use of containers.A container system is a capital investmentwhich involves considerable running costsduring the period of use.There are time and material related costsinvolved in making a device ready fornext use (so called turn-around time). Theeffective service time for device maintenanceis an important factor from theviewpoint of the operating room staff.When the turn-around time increases, itmeans instruments are not in their intendedlocation in time for proper use. Thismeans that more instruments need to beacquired for sterile supply availability.An optimal choice of a correct packagingsystems require that sub-processes relatedto their use and practicality are analyzedat the investment planning stage of thehealthcare facility:• transportation equipment and itssuitability• capacity of washing machines andsuitability of their drying system• applicability of automatic conveyorbelts• adequacy of packaging tables• autoclave capacities (turn-around times)• applicability of unloading devices• adequacy and suitability of storagespaceThere are additional cost factors to betaken in account, such as:Unloading used devices out of containersand cleaning them (double sorting andcleaning costs for one set of devices),washing the containers, emptying thewashing machines and drying, checkingand maintenance of containers, replacingsingle-use filters and checking mechanicalfilters (double costs for checking andmaintenance).Container use also involves running costsfrom cold and warm water used, disinfectingagents, energy, labels, fillers and innerpackaging materials.Cost feasability at the detailed level shallconsider also purchase prices for materialsand wages and social security costs ofpersonnel and utility costs.ConclusionsA healthcare facility planning introductionof a container system must take this choiceinto consideration at the stage of structuralplanning for a sterile supply center. Containerpackages are usable, but changingover to this method is not possible withoutmajor modifications and investments.In Finland, single-use packages are preferred.Only a few hospitals use containers.In the light of my long career in this field,I am in favour of single-use packagingmaterials because of their overall ease ofuse and processing, economy and safety.Katariina OrhaSurgical instruments, Hospital Supplies,CSSD and Infection Control ExpertSpecialised Nurse in Surgery (RN) (CSSD andoperating theatre), Surgical Nursing (SRN),Operating theatre nursing (ORN)CE Marking – Protection, Performance and Safety firstEuropean legislation aims to provideall patients and users with high levelsof protection. It aims to ensure that theperformance levels claimed by manufacturershave actually been reached.From June 1998, all medical devices governedby the Medical Device Directive(MDD 93/42) are carrying the CE mark.To apply CE marking, manufacturers mustmeet the statutory requirement that productssold in European markets complywith the Essential Requirements of MDD.Standard series EN 868European standards with requirements forparticular materials and preformed sterilebarrier systems are available and knownas the EN 868 series, developed to showcompliance with the relevant EssentialRequirements of MDD.There is an ongoing process to harmonizeand to unify the EN and international ISOstandards.IIIIIIGeneral requirementsPerformance &Test MethodsInformationto be suppliedDifferent procedures applyto different classes of devices.For lower risk devices – such as Class 1sterilization packaging – the manufacturerhas sole responsibility for assessing compliance.• Quality & Documentation systems• Sterilization process compability• Toxicity• Bioburden• Packaging design• Compability with the labeling system• Sterility preservation• Permeability/impermeability• Closure or seal integrity• Tortuous path• Microbial barrier• Aseptic opening• Batch traceability• Single-use/Multi-use• Restrictions on use• Storage and handling recommendation• Shelf life• CE ConformityEssential RequirementsThe long list of requirementsincludes minimum safety andperformance levels for devices inrelation to the risks and benefitsthey represent for patients and users.[FACTS!]Reliable product performancecontributes to cost savingsA middle sized hospital uses annually some200.000 pouchesat a failure level of 2 % it sums up to4.000 failed packsthat corresponds to some 20 failed packs a daywhen re-packing takes about 3 minutesthis labours daily one person for an hour extra!Steriking®Health Care ProductsSee-through pouches & rollsSpecial pouches, bags & rollsSteriking® Lot code serves as a key for traceabilityPaper & nonwoven wrapping sheetsThe packaging system shall be designedto minimize the safety hazard to user orpatient under the intended specified use.Wipak´s design, manufacture and materialrecords contribute to validation, processcontrol or other quality decision-makingprocesses. The source, history and traceabilityof all materials is known and controlledto ensure that the finished productwill consistently meet the requirementslaid down for each specific product.The sampling plan used for selection andtesting of Steriking products is based ona statistically valid rationale. The frequentsampling program prevents the risk ofdefective manufacturing in a batch frombeing delivered to customers. If requestedby customers, label data is used to traceand screen product details.WipakpackinglistOrder Confirmation no+ item line no• Customer• ProductDelivery index noLot number / pallet noPouch makingbatch numberLot numberEach Steriking Pouch/Rollhas a code imprint(e.g. OY9 – Year & Month)DATABASELot numberSTERIKINGCARTONLABELLot numberEvery Steriking® product bears the GMP manufacturing code enabling raw materials andproduction history to be traced. Customer and shipping details are recorded upon deliveryin the IT data file.Chemical indicator products & tapesEquipment & other accessory productswww.steriking.fi7

A new member inour winning teamVenutek Medika began representingWipak in the Philippines only two yearsago. The Philippines is not an easymarket to penetrate because of itsgeographical complexity. Thousandsof islands can only be reached throughan extensive distribution network,which is one of Venutek´s strengths.Success throughteamworkAccording to Jennifer de Guzman,Venutek´s Steriking product manager, therecipe for success is rather simple. AtVenutek all personnel work as a team andsales representatives support one anotherand train each another, reaching clearlydefined goals. Venutek has also madeheavy investments in training, as the topmanagement believes in the importanceof technical skills. Venutek and Wipakhave jointly organised professional scientificseminars to increase the awarenessof hospital infections and to emphasisethe importance of good sterilisation practisesas part of infection control.Tough financiesurge to efficiencyThe Philippines is a geographicly fragmentedmarket. Throughout the countryhospitals are facing difficult economicconditions and therefore all products haveto be effective in relation to price, qualityand performance. Despite tough economicconditions, several hospitals are systematicallyraising their standards and applyingfor ISO accreditation. Steriking® has beenchosen as packaging system in these hospitals,since it efficiently meets customerneeds in every respect.Premium quality honouredVenutek is greatly contributing to theimprovement of sterilisation practises.Jennifer de Guzman is sure that Venutek– Wipak is the winning team in her country.Venutek is very eager to put in more hardwork and dedication to further strengthenthe Steriking® market presence.Outi Lindholm-OllikainenArea Sales ManagerWipak Medical, HongkongMEDICA DüsseldorfMedtec StuttgartMedTec tradeshow has an important rolewithin the Medical Device Industry inEurope. Stuttgart, in the middle of newEurope, has established its position as thevenue. Naturally, Wipak Medical, is participatingin MedTec.Swissaccuracyand reliabilityAs one of the leading companies inthe Swiss medical market, HausmannSpital bedarf AG provides hospitals,clinics and nursing homes with a widerange of products from renownedmanufacturers, promoted within OR,Care units, and CSSDs.MEDICA, the world's largest medicaltradeshow, together with the MEDICACongress and integrated thematic shows,attracts over 130.000 visitors and 3.600exhibitors from over 50 countries. TheMedica Tradeshow provides us with anexcellent annual venue to meet our globalclientele and sales networks.Wiki – the greatSteriking® promoterhas been travellingaround the worldOn behalf of the entire Venutek Steriking® team, Jennifer de Guzman says it is an honour to be associatedwith a product like Steriking®, which is premium quality and well known all over the world.WINPAK PRODUCTION FACILITIES Canada: Toronto, Ontario- Montreal, Quebec - Winnipeg, Manitoba USA: Senoia, Georgia- Bristol, Pennsylvania - San Bernardino, California - Chicago,Illinois WIPAK PRODUCTION FACILITIES Finland: Nastola, LahtiFrance: Bousbecque Germany: Walsrode United Kingdom:Welshpool Netherlands: Sittard WIPAK SALES OFFICES Germany:Heinsberg Sweden: Stockholm Norway: Oslo Hungary: BudapestRussia: Moscow Czech Republic: Prague Poland: WarsawSwitzerland: Zürich Spain: Barcelona China: Shanghai STERIKINGAGENTS & DISTRIBUTORS Argentina: Buenos Aires Australia:Sydney, Adelaide Austria: Wien, Thalgau Belgium: Brussels Brazil:Sao Paulo Canada: Bramalea, Calgary, Edmonton, Halifax, Montreal,Regina, Winnipeg, Vancouver China: Hong Kong Chile: Santiago Czech & Slovak Republics: PragueColombia: Bogota, Medellín Croatia: Zagreb Cuba: Havana Denmark: Roskilde Ecuador: Quito Estonia:Tallinn Finland: Helsinki Germany: Hamburg, Berlin, Dresden, Duisburg, Garbsen, Göttingen, Leverkusen,Leipzig, Münster, Mülheim, München, , Sulzbach, Wedemark, Wiesbaden, Wupperdal, Ahlen, Hofheim,Oldenburg, Saarbrücken Greece: Athens Hungary: Budapest Iceland: Reykjavik India: Mumbai Indonesia:Jakarta Iran: Tehran Ireland: Dublin Israel: Petah Tikva, Mazkeret Batia Italy:Milan Japan: Tokyo Jordan: Amman Korea: Seoul Lebanon: Beirut Lithuania:Vilnius Latvia: Riga Malaysia: Kuala Lumpur, Sebarang Perai Mexico: MexicoCity New Zealand: Auckland Norway: Gjerdrum Pakistan: Karachi Panama:Panama City Peru: Lima Philippines: Manila Poland: Bialystok, Bydgoszsz,Gdansk, Warsaw Portugal: Lisboa Romania: Bucharest Russia: Moscow, St.Petersburg Saudi Arabia: Jeddah - Singapore Slovenia: Ljubljana South Africa:Capetown Spain: Madrid Suriname: Paramaribo Sweden: Stockholm Switzerland:Wil Thailand: Bangkok Turkey: Istanbul U.A.E: Dubai United Kingdom: HighWycombe, Bucks Uruguay: Montevideo USA: St. Clair Shores (Detroit) Venezuela:CaracasOne of the company´s main focuses isthe CSSD where we represent world leadersin packaging and monitoring products.Co-operation with Wipak dates back tothe 70‘s. Our customers appreciate thehigh quality standards of Steriking® whichprovide them with maximum efficiencyand security.For us the key factors to success ofSteriking® in Switzerland are:• quality, which results in optimum functioning,safety and time savings in dailyuse• availability, which makes us a reliablesupplier• readiness to put in extra effort to gainan advantage over the competition.The Know-How of Wipak’s product expertshelps us to build and maintain agood reputation in our market. In additionto these “hard“ factors, there are also“soft“ factors such as the excellent humanrelations between people in both companies,which create the feeling of beingpart of the global Steriking® family. Theaim of any business is profit but it is somuch more rewarding when you can alsohave fun together.Ralph BachmannManaging DirectorHausmann Spitalbedarf AGLast July Wiki was promoting our products at theEFHSS (European Federation of Hospital SterilizationSupply) Winterthur exhibition in Switzerland at theHausmann stand. Wiki has attracted interest latelyin Tübingen (Germany), for example at the annualDGSV (Deutsche Gesellschaft für Sterigulversorgunge.V.) congress.Wipak StarMountain Bike TeamThe “Wipak Star Bike Team” that completed in theNova Cup race in October was made up of WipakCzech customers and employees. They had to tackle59 kilometers of by-roads and mountain trails witha difference in altitude of 507 meters. The Wipakteam came in 45th (out of 75 teams). All the teammembers were very pleased and plan to take partagain next year.www.wipak.comFranceGermanyUnited KingdomFinlandNetherlandsUSA & CanadaChinaWipak Gryspeert S. A.B. P. 6, Zone des BoisF-59166 BousbecqueTel. +33 320 115 656Fax +33 320 115 670E-mail: info.france@wipak.comWipak Walsrode GmbH & Co KGPostfach 1661D-29656 WalsrodeTel. +49 5161 44-3903Fax +49 5161 44-143903E-mail: info.germany@wipak.comWipak UK Ltd.Unit 3, Buttington Business Park,Welshpool, Powys SY21 8SLTel. +44 1938 555 255Fax +44 1938 555 277E-mail: info.uk@wipak.comWihuri Oy WipakP.O. Box 45, Wipaktie 2FIN-15561 NastolaTel. +358 3 468 311Fax +358 3 468 3333E-mail: info.finland@wipak.comWipak B.V.Nieuwstadterweg 17NL-6136 KN SittardTel. +31 46 420 2999Fax +31 46 458 1311E-mail: info.benelux@wipak.comWinpak Division Medical Packaging219 Andrews ParkwaySenoia, GA, USA 30276Tel. +1 770 599 4666Fax +1 770 599 8387info@winpak.com, www.winpak.comWipak ShanghaiRm 3604 B, Nan Zheng Bldg.580 Nanjing (W) Rd.P.R. CHINA, ShanghaiTel. +86 21 5234 0675Fax +86 21 5234 0677info.china@wipak.com/ Esaprint / 11/03WIPAK MEDICAL PACKAGING NEWS editorial team • Anne Lehtovuori, e-mail: anne.lehtovuori@wipak.com • Peter Rasmussen, e-mail: peter.rasmussen@wipak.com