Innovations for 2012

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P A C K A G IN G F O R U M

I n n o v a t i o n s f o r 2 0 1 2Hallie Forcinio

Packaging innovations boost p roductivity, meetregulatory requirements, and protect p roducts.

A new year is a good time to lookforward as well as backward. Newdevelopments in 2012 will supportthe 10 major trends of 2011, which in-clude increased automation, particularlyfor quality-control functions; implemen-tation of serialization and traceabilitytechnology; adoption of anticounter-feiting measures; new choices in blistermaterial; braille on labels; improvem entsin cold-chain practices; greater use ofprefiUed syringes and single-use product-contact parts; rising interest in stickpacks; and stronger emphasis on sustain-able processes, packaging, and logistics(see "Sustainability O utside the Box" inthe October 2011 issue of Pharm aceuticalTechnology).A u t o m a t i o nServo technology and software are bring-ing a new level of automation to p harma-ceutical packaging. Software not only au-tomates functions, but also simplifies thework of packaging line operators as wellas the collection and analysis of produc-tivity data. One new software productoversees multiple quality-control systemson a single packaging line or multiplelines in one or mo re facilities. A dash-board system and color-coded m achineicons on the operator interface qu icklyalert operators and management to qual-ity problems in real time so remedial ac-tion can be taken and downtime can be

Hallie Forciniois PharmaceuticalTechnology'sPackaging Forumeditor, 4708Morningside Drive,Cleveland, OH 44109,

minimized or eliminated. Remote setupprevents unauthorized changes to set-tings and errors and supports consistentoperation across lines and facilities. Theprogram currently oversees checkweigh-ers, metal detectors, and X-ray inspec-tors and will accommodate machine-vision systems in 2012 (ProdX software,Mettler-Toledo).

Software's poten tial to simplify ope r-ation is particularly evident in m achinevision, a technology w ith a reputationfor being difficult to set up, operate, andchange over. In one system, Windows-based software oversees as man y as fourcolor or monochrome cameras andperforms tasks, including inspectinglabels, caps, containe rs, an d fill levels,confirming the presence and conditionof a tamper ring, and verifying date andlot codes and one- and two-dimensionalbarcodes. Capable of checking 2000metal, glass, or plastic containers eachminute, the system includes an inte-grated reject system (TotalVu Sensorvision system w ith Teledyne Daisa cam-eras, Teledyne TapTone).

S e r i a l i z a t i o n a n d t r a c e a b i l i t yWith pedigree regulations looming oralready in place in some countries, in-terest is high in implementing serializa-tion systems that generate the supportingdata. One serialization-ready p rinte r-ap -plicator prints a two-dimensional Data-Matrix code and human-readable dataon a label before applying it. A built-incamera verifies print quality (BL400V-TEXL label printer and application,Marchesini Group). Data transm ission,aggregation, and storage is provided byintegrated hardware and software (Sys-

PharmTech.com/pack

A n t i c o u n t e r f e i ti n g m e a s u re sAlthough the pharmaceutical indushas had some success in countering coterfeiters w ith multilevel overt and cosecurity features, fake or diverted pructs continue to endanger consumworldwide. Because counterfeiters cduplicate what they can't see or readdetect, covert features, such as tiny tgants, rank as an essential anticounfeiting tool.

One taggant-based technology enasmooth adoption by blending the tgants in ink, varnish, thermal-tranribbon, resin, or film. In its latest itetion, taggants are combined w ith inink that's invisible under visible ortraviolet light. Detection ofthe alphameric characters or barcode prin ted wthe taggant-equipped ink is only posswith a programmable handheld reawhich provides authentication in sonds. Tight oversight ofthe supply chensures secure handling of taggant c

W e ' l l b e s e e in g m o r e . . . Au tomat ion Serialization and traceability Anticounterfeit ing measures Blister innovations Braille on labels Improvements in

cold-chain pract ices Prefilled syringes Single-use product-

contact parts Emphasis on sustainable pro-

cesses, packaging, and logistic


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P a c k a g i n g F o r u m

Meda uses Sleever International'sbraille labels for its Betadinedisinfectant sold in Italv.

l o d o poSPECIAUT MEDICINALE >KONSOGGETTAAPRER a c o n e tiW Blw i -100 ml rontengofilO*ii*))g10. Eccipie(iti:G' M o , Sodio fosfato bibasico '* punta.

rier materials (Traceless AD inkjet in kand reader, Eastman Kodak).Blister innovations

runs on existing thermoforming equip-ment with only minor adjustments. At152.4 |xm, thefilmmeasures 50% thickerand improves water-vapor-transmissionbarrier properties 50% compared withprevious offerings. The enhanced bar-rier properties allow moisture-sensitivemedicines to withstand the hottest andmost humid environments, includingClimatic Zon es IVA and IVB as definedby the World Health Org anization. Withthis material, pharmaceutical companiescan standardize packaging worldwide.The clearfilmprovides product visibilityand reduces package size as much as 55%versus cold-formed foil, the traditionalbarrier material for ultrasensitive prod-ucts (Aclar UltRx 60 00 film, HoneywellSpecialty Materials).

At least two blister-material convertersproduce laminations with one layer of theultrahigh-barrier PCTFE. One is a two-layer PCTF F-polyvinyl chloride (PVC)lamination (Pentapharm Aclar PA600/02barrierfilm,Klckner Pentaplast Group).

For a stronger moisture barrier, thePCTFE can be lam inated to polypropyl-ene, cyclic olefin copolymer (COC), poly-ethylene terephthalate glycol, polyethyl-ene, or ethylene vinyl alcohol. In fact, onestructure, consisting of PCTFE laminatedto a ply of coextruded CO C is claimed toboost barrier properties as much as 80%compared with current high-barrierPCTFE -PVC lam inations (Aclar UltRx600 0 laminations, Tekni-Plex). A foil-freePVC with barrier properties an d a foil-like, light-blocking appearance is anotheralternative to cold-formed foil and alumi-num strip packaging (Alu-Look blisterfilms, Tekni-Plex).Braille on labelsWhen European 2004/27/CE directivetook effect on Jan. 1,2006, it mad e braillelabeling ma ndatory on all new ph arma-ceutical packaging. Since then, a growingnumber of options have been introducedto help pharm aceutical packagers comply.

To overcome a lack of harm oniza tionin the con figuration of braille messages,one produ cer of shrink-sleeve labels has

dots, their width, their height, the ditance between each group of six do(which corresponds to a letter) and interlines. A proprietary marking methoand morphing tool ensure characters aformed in compliance with parameteand do not become distorted du ring thheat-shrinking process (Sleever BraillSleever International).Better cold-chain practicesThe expanding num ber of temperatursensitive biologic products and increaseregulatory insistence on proper handling across the supply chain is keepinthe spotlight on packaging comp onenthat protect products from temperatuexcursions. A flat, USB-equipped wterproof label about the size of a sugpacket monitors temperature conditionat the pallet, ca rton, or item level. Suface readings provide a more accuratime or temperature record than thambient readings taken by conventiontime and temperature loggers. Whethe product reaches its destinatiolight-emitting diodes on the label flasif temperatures exceeded parameterPlugging th e label's USB connection ina computer uploads the trip's time antemp erature h istory (XpressPDF LabePakSense).Prefilled syringesPrefilled syringes are gaining markshare over traditional vials becauthey offer great dose accuracy, simpliadministration, and eliminate overfiamong other reasons (1). As a result, thpackaging format, particularly autoinjetor versions, often is selected for producdestined for self-injection. One off-thshelf, disposable autoinjector shown INTERPHEX 2011 hides the needle bfore, during, and after the injection anis designed to be han dled by people wilimited dexterity. The initial offering,1-mL long syringe with a 0.5-in. stakeneedle, is available in push-to-activaand press-button-push-to-activate cofigurations. Both designs provide visuand audible feedback of activation an


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P a c k a g i n g F o r u mThe XpressPDF Label uploads time andtemperature data directly to a personalcomputer through its USB port.

BlOmedXpressPAKSENSE

T U 1 5 C - P A K 1 0 - 1 5 D a y 1 0 1 K N 3

V OK 30MM S OHNUNOER (VER

Pharma Tech Industries has installed aStik Pak S/N 307 torm -crim p-fill-se almachine trom Ropak.

Single-use product-contact partsAttendees at INTERPHEX 2011 alsohad a chance to explore the poss ibilityof convert ing to single-use product-ontact parts. A single-use fluid pathnsures pur ity, sim plif ies val id at ion,nd expedites changeover on h i g h -

hroug hput peristaltic fill ing and cap-ing systems (AsepticSU single-useflu id path technology, Flexicon Liqu id

Fil l ing) .Pharmaceutical packagers switch-

ing to disposable product paths have arowing number of pump choices, in-luding 6- and 50-cm ' peristaltic pum pss well as a rol l in g diaphrag m pum p

(PreVAS Single-use Dosing System,obert Bosch Packaging Technology).

ludes ease of op en ing , ease of dis -

dispensing. In response to rising inter-est in this f lexible packaging format,Pharma Tech Industr ies, a contractman ufacturer and packag er of powderproducts, installed a machine that forms,crim ps, fills, and seals the slender, cy lin -dric al packs (Stik Pak S/N 307 machine,Ropak M anufactur ing).

Set up to handle 10 lanes simu ltane -ously, the machine produces 6 00 stickpacks /min and features in-line collationand cartoning, as we ll as a color tou ch-

screen operator interface. S ervo-drivencontinuous m otio n corrects deviations.A n adjustable dos ing system allows tool-less changeover of dosing -specific com -ponents.Reference

1 K. Abdelkader, R.M. Akers, and M. J. Akers,"Sterile Prefilled Syringes: Market Dy nam -ics & Curre nt Issues in Man ufacturin g &Control," in Prefilled Syringes, Innovationsthat Meet Growing Demand (ONd ru g De-livery, Newtimber, UK, 2005), p. 4 . P T

O v e r6,000P r o d u c t s

' Chromatography viuiWu^Di^mtuio,' Spectroscopys p e c t r u m

chemicals & laboratory products *

' Sample Preparation P e r k i n E l m e rFor the Bet te r

chemicals & laboratory products L a DFeaturing Chromatography & Spectroscopy Consumables from PerkinElmer


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Innovations for 2012