This article describeshow packaging vendors can meet their part. Blow-fill-seal(BFS) products are quickly gaining ground as the preferred deliverymethod for many oral and ophthalmic treatmentsin the pharmaceuticalindustry. The acceptance of BFS has, however, created new requirements forproduct packaging systems.This article examines these requirementsand discusses how they can best be addressed. 
Key pointsReducingtime-to-market, optimizing the efficiency of asset usage and maximizingyields are all key concerns for today's pharmaceuticalcompanies. Yetthe processes of qualification and validation are becoming ever morestringent; a development that has thepotential to create costly delaysin the execution and commission of new systems. An attractiveand effective solutionto this conundrum is to consider theinstallation of over production lines, sourced from a singlesupplier, rather thanobtaining the diverse elements that build up theline from a variety of different sources. As many pharmaceuticalsuppliersare currently involved in the facility or specificationof packaging lines for BFS products, let us see how this holisticapproach might operate in a typical application of this type.Theexample we will consider handles the complete packaging process fromBFS cards in to packed cartons out. To provide thisfunctionality, theline will be made up of a flow wrapper together with deloadingfacilities for bulk packaging and bowl feedersfor product separation.Robots will be exploited to identify the BFS cards into the feeding chain of theflow wrapping. Secondarypackaging equipment will be a carton former, a top-loadingplatform, a tray closer and a case packer - alllocated at the end ofthe packaging line. To further reflect the world of moderninstallations, the stock will be configuredto handle several BFS cardformats as 1 or multiple packs, as good as various sizes of tray. Clearly,for applications in the pharmaceutical industry, verification ofprinted data, such as lot numbers and death dates,is an essentialrequirement. Fortunately, this can readily be achieved in this packagingline using vision systems. 
Modernvision systems are light to set up and use, as good as beingsurprisingly inexpensive. They can see all printed datawith ease,and can save an electronic log of the results. It is also relativelyeasy to do for packs with incorrect printeddata to be rejectedautomatically, ensuring that they never hit the final packagingprocess stages.Deloading bulk packagingInmany pharmaceutical manufacturing plants, cards of BFS vials are blown,formed, filled and certain in a procedure that isseparate from thepackaging line. Typically, the cards are made up of 4 or five vialscontaining the portioned pharmaceuticalinfusion liquid. Aftermanufacture, these cards are bulk stored with random orientation. Thefirst degree of the promotion process is, therefore, to deload the cardsby placing them on a transport conveyor that movesthem to a bowlfeeder; automatically stopping and start the conveyor system canreadily prevent overloading. 
Whilecentrifugal bowl feeders find frequent application in pharmaceuticalmanufacturing, their use with BFS packs imposesspecial requirements.In particular, guiding spirals designed specifically for thisapplication are essential if continuousfeeding is to be achieved, andadditional positioning controls may be required at the feeder exit.Vision to aid handlingWhenthe BFS cards allow the bowl feeder, they must so be placed andstacked precisely ready for flow wrapping. The highthroughput neededin today's installations means that a robot-based solution with pickingrates of at least 100 products/minis virtually essential. Letus not forget however, that the predilection of the BFS cards at thisstage is yet not uniform. A vision system is, therefore,needed tocapture an epitome of each product and determine its orientation. Withthis information, the robot system can workat maximum efficiency andwith the minimum risk of product damage. Conveniently,the same vision system can be exploited to verify key product parameters andinitiate the rejection of any productsthat fail to play the requiredspecifications. A separate project is captured for each and every product,which way that theproduct profile can be accurately verified bycomparing it with a stored reference shape. Alog of rejected profiles can likewise be retained and the reject ratecalculated in real-time. Should this rate exceed a presetvalue,arrangements will normally be in order to check the process of themachine so that the author of the problems can bedetermined andaddressed. The type ofrobot used for placing and stacking the BFS cards is important.Conventional multi-axes designs have limited flexibility,oftencombined with high inertia that limits operating speeds. An alternativedesign however, uses a structure based on jointedarms suspended belowthe operating mechanism. The arms meet at the gripper device, giving therobot an overall appearancesomewhat similar to a wanderer with its legsjoined at their tips. Thisarrangement allows arms with low mass to be used, so it has inherentlylow inertia, which way that high operating speedscan be achievedwith ease. It also provides the versatility needed to let the systemto handle multiple pack sizes and productstacking patterns. Flow wrappingBFSproducts are most often supplied in hermetically sealed packaging;making use of materials with low permeabilityfor oxygen and watervapour and additional functions such as light protection. Flowwrappers are readily available, but not all can offer an extendeddwell time for the sealing cycle while maintainingthe necessary highthroughput. Extended dwell time is highly desirable, if not essential,in pharmaceutical applications withthe highest requirements forsealing integrity and tightness. Furtherfeatures appropriate to the pharmaceutical industry that are providedby industry-orientated flow wrapping machinesinclude water-cooledcover plates for the longitudinal sealing section to protect theproduct, and gas flushing to facilitatethe use of modified andcontrolled atmosphere packaging. Cross-seal gusseting for multipacks isalso useful, as is onlineverification of sealing parameters to controlprocess reliability. Finally, in our example application, whichinvolves theuse of multiple packaging formats, a fully servo-drivenmachine will provide the welfare of fast, easy recipe changes. Carton forming and fillingFlow-packedBFS products are constantly supplied in cartons. Typically, in thepharmaceutical industry, these are designedwith a front flap closurethat is tucked in, with dust flaps to each side. Carton forming is arelatively straightforwardprocess, but 100% inspection is recommendedto ensure that the cartons are glued perfectly every time. Facilitiesfor insertinguser information leaflets can likewise be provided at thisstage. Loading theflow-packed products into the cartons is another process where robotsprovide an optimal solution. In this case,robots of relativelyconventional design can be used, but there are even a total of specialfeatures that aid productivityand flexibility. Forexample, the power of the loading system to pot the flow packsvertically or horizontally is invaluable, as is product-specifichandling design to set the current packs very tightly within the carton,thereby minimizing the sizing of carton needed for aparticular product. Afterbeing filled by the robot loading systems, the cartons require closing.An indispensable factor of this process is precisecarton control toensure that the dust flaps are folded inside, before the top flap isclosed and the front flap is tuckedin. With most packs, no glue isrequired, and facilities for changing the compact size without having tochange machine partsare highly desirable. In many cases, this is also aconvenient stage to cross the cartons with final production data bylasercoding, printing or labelling. The final stageThelast operation to be performed by our integrated packaging line is thepacking of the individual cartons into cases forshipping. A similarrobot system to that used for carton filling can conveniently be usedfor this process, complemented bya case closer that folds the caseflaps and seals them with tape. Qualifying the systemInthe pharmaceutical industry, there are clear demands for goodmanufacturing practice (GMP) and machine qualification procedures.Extensions to FDA regulations, including 21 CRF Part 11, have alsoplaced greater emphasis on proof and product traceability.Purchasers of packaging lines can cover all of these requirements bydrawing up detailed specifications but, in some cases,there may be afaster, easier and more cost-effective approach. Thisis to take good use of the application adjusted standard documentationsupplied by the system vendor, adding to it onlywhere necessary. Thisprocedure is considerably simplified when, as suggested in this article,the unit of the packaginginstallation is sourced from a singlesupplier.Naturally,relying on vendor documentation is merely an option when the systempurchaser can be entirely convinced that thisis dependable andcomprehensive. The mostenlightened suppliers to the pharmaceutical industry have addressedthese issues by, for example, developing basicstandard documents forfunctional design specification and design qualification, as well asinstallation qualification (IQ)and operational qualification (OQ)plans based on customer end-user requirement specifications (URS). Inthis process, adherenceto the V-model commonly used in thepharmaceutical industry is an advantage. Reducing time-to-marketAnotherdevelopment that suppliers of packaging machinery to the pharmaceuticalindustry have had to take in recent yearsis the urgent need oftheir customers to add new products to market quickly. This demand isnot only addressed by shorteneddelivery times, but likewise by achievingfull productivity as shortly as possible after installation. Carefuldesign of the installation plays a substantial part in this by ensuringthat the organisation is soft to establish and commission.Comprehensivepretesting and prequalification at the vendor's premises is anotherimportant element, but there is a furtherkey factor, which is easilyoverlooked. This is the character and union of the operatorinterface. Awell-designed operator interface, based on modern graphical display andtouchscreen technologies, greatly reduces the needfor operatortraining and the danger of errors during the other stages of operation.Similarly, the use of a common controltechnology for all sections ofthe packaging process such as feeding, handling, flow-wrapping andsecondary packaging ensuresa consistent feel and find that furtherreduces the demand for training. These are important ingredients inputting the installationto productive use in the shortest possibletime. BFS packagingcreates its own special demands. Attention to point at each stage ofthe packaging process, following the guidelinesdiscussed in thisarticle, provides a firm basis for satisfying these demands.Overall, however, the better solution isto adopt a holistic approach tothe specification, design and buying of the whole packaging system. Suchan approach not only guarantees that the stock components will functionoptimally with each other, but also simplifiesand speeds bothcommissioning and operator training. Finally, providing that a supplieris selected who is mindful of and responsiveto the specific needs ofthe pharmaceutical industry, the holistic approach can do much to reducethe cost and effort involvedin meeting the industry's stringenttechnical requirements. ConclusionTheeconomies in the system approach described are not entirely suitable forpacking blockbuster products with high volumes involved,but are alsorealizable for smaller production by leveraging system and productflexibility in the engineering phase. Suchan approach brings abouttime-to-market reductions, which is vital for both big pharma, smallpharma and subcontract manufacturers.The use of packaging systems,rather than discrete standalone equipment, reduces the validationprocess since the vendor canshare the responsibility for validatingits system.Partnering with a big a reputable supplier alsounderwrites this approachbecause there is confidence of continuity ofidentical spare parts and again a responsibility for the total system.Andreas Graf is product manager pharma, medical and healthcare at Bosch Packaging, Germany.
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