22 Pharmaceutical Technology August 2002 www.pharmtech.com

ow a part of the InternationalPharmaceutical Industry Con-gress, the 2002 Interphex phar-maceutical trade show was

stronger than ever, both in attendance andin content. Dozens of innovative packag-ing machines, containers, materials, andcomponents were displayed on locationat the Jacob K. Javits Convention Centerin New York City.

Blister packagingA compact 4.2 � 1.45 m domestic-builtmachine has low positioning of codingequipment and film–foil reels. The ma-chine’s nine servo drives and other com-ponents are contained in a pull-out rearcabinet, a configuration designed to im-prove hygienics, ergonomics, and main-tenance accessibility. The 300-blister/minstainless steel unit has a maximum form-ing area of 244 � 154 mm. Capabilitiesinclude accommodating nearly any typeof feeder, quickly changing over from coldto hot forming, and performing rotarysealing, perforating, and cutting. The ma-

chine’s design includes space to mountvision and NIR inspection systems. Therotary sealing function minimizes heattransfer to the product, and rotary perfo-rating and cutting reduce material usageand cost by narrowing the spacing be-tween blisters to �2 mm. An integratedcartoner responds to computer-based con-trols (B300, DT Packaging Systems,Leominster, MA).

A compact 2680 � 860 � 1630 mmblister packaging machine designed forclinical trials and low-volume production

operates at 30 cycles/min whether it is run-ning film or foil. The intermittent-motionmachine features balcony constructionand quick changeover without the needfor tools. The maximum blister size mea-sures 88 � 122 � 12 mm. However, themaximum pocket depth can be extendedfrom 12 to 22 mm (P.G. Clinipack, IMANorth America, Inc., Bristol, PA).

A blister card wallet production linegenerates �80 wallets/min with up to fourblister cards each. Integrated with a blis-ter machine or relying on manually loadedblister hoppers, the equipment creates atraditional paperboard wallet holder orchild-resistant–senior-friendly style in various size and dose-count formats. Tool-free changeover takes �30 min (New-Wallet, Dividella AG, Wareham, MA).

One established wallet pack has abroadened capability with the advent ofa coating that allows the paperboard toseal to Aclar, a material commonly usedfor the forming web of blister packs. Thewallet is child resistant, senior friendly,and compliance enhancing (Dosepak withPrintkote EasySeal Plus paperboard,MeadWestvaco Packaging ResourcesGroup, Stamford, CT).

Wallet formats also are available fromat least one contract packager who cancustom-design formats for compliancepacks, starter kits, and physician-dispensedsamples. Various paperboard and plasticmaterial combinations, perforations,diecuts, and literature pockets also areavailable (Carded Blisters, Sharp Corp.,Conshohocken, PA).

To enhance compliance, particularlyin clinical-trial situations, an active radiofrequency identification (RFID) tag thatis built into a blister card wallet recordsthe date and time as each dose is removed.This data is downloaded by a 13.56-MHzreader that is capable of scanning multi-ple tags simultaneously. Nearly one-halfthe size of a credit card, the 1.5-mm tagincorporates its own power source and achip-and-sensor grid that adapts to anyblister configuration. Alpha test trials forthe tag were planned for July 2002 withbeta testing scheduled for fall 2002. Inserting the RFID tag requires no spe-cial equipment and can be done by anypharmaceutical packaging converter(Med-ic Smart Package, Information Mediary Corp., Ottawa, ON).

The choice of materials for blister pack-aging is expanding and includes a high-

barrier alternative to foil consisting ofpolyvinyl chloride (PVC)–cyclo olefincopolymer (COC)–polyvinylidene chlo-ride (Pentapharm COC SD/02, KlöcknerPentaplast of America, Inc., Gordonsville,VA). For pharmaceutical packagers whoprefer vinyl-free structures, the companyoffers a polypropylene/COC/polypropy-lene laminate.

Developed for a four-week compliancepackage, a new PVC/Aclar/PVC structurefeatures a credit card size-PVC card. TheAclar sandwich structure presents advan-tages such as eliminating the need for anexpensive adhesive to seal the Aclar toPVC, operating with vinyl tooling and ma-chine settings, providing a flatter blister,and improving the pack’s moisture bar-rier by as much as 20%. The reduced curlsimplifies downstream handling for col-lating, bundling and cartoning, and bar-rier improvements offer the potential forreducing costs by downgauging the Aclarlayer (Aclar SO3 film, Klöckner Pentaplastof America, Inc.). DuraMed (Cincinnati,OH) is the first company to use the newmaterial.

A pneumatic multipacker collates andstretch-bands blisters or cartons in groupsof 4, 6, 8, or 10 while matching the speedof the blister packager or cartoner. Capa-ble of banding �50 bundles/min, theunit’s twin stretch applicators use stan-dard polyethylene stretch film. The flexi-ble machine also integrates with over-wrappers to serve as the collator (PSB 300Automatic Stretchwrapper/Bander, Mar-den Edwards Inc., Antioch, CA).

Filling innovationsFor solid dosage forms, a compact slatfiller with 48 slats features 6 funnels butcan be expanded to accommodate 10 or15. For easy cleaning and changeover,manifold disassembly requires turningonly two hand knobs. Depending on tabletcount and size, the unit can fill �100bottles/min (MPS 48-6, Modular Pack-aging Systems, Inc., Pine Brook, NJ). Thefiller can be integrated with a cottoner(Pharmafill CS2 Auto Cottoner, ModularPackaging).

To address a growing interest in thepouch format, which is less expensive thanblisters and requires only a single material,vertical form–fill–seal machines are beingdesigned for pharmaceutical requirements.Typical features include compatibility withany heat-sealable material and integrated

Packaging Advances Showcased Updated Equipment and Materials Displayed at Interphex

Hallie Forcinio

FORUMFORUMPa

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ing

Pack

agin

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ing

Pack

agin

g

Manufacturers and

suppliers rise to the

challenge that new

regulations and

obstacles impose

on today’s pharma-

ceutical packaging

processes.

Hallie Forcinio isPharmaceutical Technology’sPackaging Forum editor, 4708Morningside Drive, Cleveland, OH44109, tel. 216.351.5824, fax216.351.5684, editorhal@cs.com.

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The DT Packaging model B300blister packager has two servo-driven pinch rollers that controlforming film transport and preventfilm stretch in the preheating andforming stations.

24 Pharmaceutical Technology August 2002 www.pharmtech.com

coding and embossing. One new ma-chine with as many as four lanes createsfour-side-seal pouches at a speed of 90 cycles/min. The unit can process pouchesfrom 44–160 � 50–140 mm in size thatcontain products such as liquids, creams,powders, granules, tissues, and solid dosageforms (LA-160 Vertical Pouch Packer,Klöckner Medipak, Clearwater, FL).

A compact tube fillerwith hot-air sealing jawscan process polyethyl-ene, metal, or laminatetubes and is compatiblewith any style of prod-uct-feeding hopper. Abalcony design posi-tions the mechanicaland electrical compo-nents in the same cabi-net for improved acces-sibility and hygiene, andcam-controlled timingand programmable-logic controllers (PLC)ensure accuracy andconsistency. Dependingon the height of thetube and how far thefilling nozzles dive, theunit can fill and seal�80 tubes/min (Kalish

K-80, DT Packaging Systems). For conventional liquid filling, change-

over is simplified and reduced to 5 minby a portable product-handling sectionwith remote clean-in-place capability. Tochange over, nozzles slide out and areplaced in temporary holders on the dock-able filling system. One lever then releasesthe trolley, which is rolled away and re-

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IMA’s Sterifill F200 filling–stoppering unit wasshown as part of a complete aseptic line,which also included a washer and sterilizationtunnel.

Circle/eINFO 19

placed with another unit. Clean nozzlesthen are set in place, and the new batchcan begin. Filling is governed by flow me-ters or lobe pumps that are arranged inpairs of 4, 6, 8, 10, 12, or more. Fill vol-umes currently range from 50 mL to liters,but eventually will be designed for vol-umes as low as 5 mL. A twelve-head ma-chine fills �300 containers/min with 0.5%

To enhance

compliance, an

active radio

frequency identifi-

cation (RFID) tag

records the date and

time as each dose is

removed.

26 Pharmaceutical Technology August 2002 www.pharmtech.com

accuracy (Filamatic Series DFS Filler, Na-tional Instrument, Inc., Baltimore, MD).

Parenteral packagingA small all-servo filling–stoppering machine designed especially for clinicaltrials relies on a peristaltic pump for fill-ing and requires no change parts. Capa-ble of simultaneously handling one, two,or four containers, the unit can output�120 containers/min (model 1331, FPDevelopments, Inc., Williamstown, NJ).A sister machine that is integrated with atray loader incorporates dual nested traysso the outer tray can be loaded while con-tainers from the inner tray are being filled(Model 1377, FP Developments).

Another tray loader with dual trays is aservo-driven unit that requires no tools orchange parts to change over. This machineis capable of processing �400 vials/min.Loading patterns include straight, alter-nate, or N-1 (ATLl-500S Servo-DrivenVial Tray Loader, Chase-Logeman Corp.,Greensboro, NC).

A vial filler for volumes �100 mLcheckweighs parenteral products that arehigh-value or critical-dose and require ex-treme fill accuracy. Presented with pistonpumps, but compatible with other fillingmechanisms, this vial filler operates at 120vials/min and checkweighs containers in

pairs, checking both tare and fill weightswithout slowing down the filler. With100% in-process weight measurement, thesystem can record fill data for each vial and provide documentation. The systemaccepts glass or plastic vials and can insertrubber stoppers or tip inserts and applyaluminum or screw caps (MLF 3002 VialFiller, Bosch Packaging Technology,Minneapolis, MN).

A completely integrated parenteral lineincludes washing capability, a steriliza-tion oven, filling and closing stations, andcomputer-based control and software for21 CFR Part 11 compliance. Vials with 13-

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Speed combined

with small size

describes a next-

generation wipe-

on label applicator.

Circle/eINFO 21

Top: Markem’s SmartDate 3 thermal-transfer printer has various ribbon-saving options that reduceribbon usage and consumables costs.Above: The small size and variable position output lens of Markem’s SmartLase SL carbon dioxidelaser coder make it easy to install on most packaging lines.

28 Pharmaceutical Technology August 2002 www.pharmtech.com

or 20-mm neck finishes begin at thewasher, which can clean �300 vials/min(FAU6000 washer, Bausch & Stroebel,Clinton, CT). Next, vials pass through a sterilization tunnel with three sections:infeed and heating, a sterilization zonewith temperatures 300–350 �C, and cool-ing (DHT3670 Laminar Flow SterilizationTunnel, Bausch & Stroebel). Cooled con-tainers move to the filling and stopperingunit, which features a rotary piston pumpcapable of a filling accuracy of �0.1%, in-process checkweighing, and rotary stop-pering (FFV6024 Vial Filler/Closer, Bausch& Stroebel). Carrier-type holders trans-port containers by the neck throughoutthe system. Because containers don’t slide,particulate generation is minimized. Thecarriers also enable necks to be accuratelycentered for filling and sealing.

Another complete aseptic line includesa washer and vapor hydrogen peroxide(VHP) sterilization tunnel integrated toan in-line filling and stoppering machine.The washer can be configured to handlevarious glass and plastic containers, in-cluding oval or elliptical shapes, and vari-ous infeed and outfeed options (LibraHydra washing machine, IMA). From thewasher, containers proceed to a VHP ster-ilization tunnel with a dry-heat chamberfor depyrogenation (Libra Blue GalaxyVHP sterilization tunnel, IMA). Con-tainers then transfer to the Class 100 fill-ing area where they are processed four ata time. The system can accommodate fillvolumes �500 mL at 320 vials/min (Steri-fill F200 filling/stoppering unit, IMA).

A filler for sterile vials exposes containeropenings for less than 8 in. of travel. Usingpresterilized containers and a Class 100enclosure, this unit removes stoppers, fillsvials, and then replaces the same stopperit removed. Final steps include applica-tion of a crimp or screw cap (modelP1540, M&O Perry Industries, Inc.,Corona, CA).

For large i.v.-solution bags, a fillingmodule transports premade bags hori-zontally and centers the port for filling.After filling, the port is closed. The sys-tem is compatible with several fillingmethods and can be integrated with a bag-making module (BFV5060, Bausch &Stroebel).

Bags constructed of one ply of uncoatedTyvek and one ply of high-density poly-ethylene or other see-through sterilizablefilm protect presterilized supplies such asstoppers and vials as the components aretransferred to an isolator-equipped fillingline. The bags feature wrinkle-free, per-manent seals and are compatible with eth-ylene oxide or steam sterilization meth-ods (Isotech Bags, Tolas Health CarePackaging, Feasterville, PA).

Quality controlLines that require multiple inspection op-erations or that run at high speed oftenneed multiple cameras to confirm qual-ity. Typically, one vision system that sup-

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Top: Industrial Dynamics’s Lasetec Phase II coder can change serialized codes during productionand is easily adjustable to align the coding head for different containers. Above: A metal 276 carousel outsert feeder from NJM/CLI provides at least a one-hour supply ofoutserts, eliminates the need to dedicate an operator to the labeler, reduces labor costs, andimproves worker ergonomics.

ports up to two boards of four cameraseach is mounted on a labeler or cartonerto ensure that all packaging componentsare present and correct. The inspectionsystem includes computer-based control,a stainless steel enclosure, a flat-paneltouch-screen operator interface, and anuninterruptable power supply (Vision-scape I-Pak, RVSI, Canton, MA).

A lower cost two-camera system isavailable for less-stringent requirements.It requires only 35 microseconds to lo-cate a randomly oriented eight-charactercode on a moving container and cancheck a two-dimensional code even faster,in slightly less than 15 microseconds. Be-cause this system uses the same computercontrol and flat-panel touch-screen op-erator interface as the multi-camera unit,no retraining is needed for operators whoswitch from one system to the other. Op-tical character verification algorithms adjust to acceptable variations in pre-printed or overprinted codes to reducefalse rejects. The system supports a vari-ety of camera models and offers onboarddigital input–output for triggering, strobecontrol, and other interfacing functions(Visionscape I-Pak Express, RVSI).

A vision system designed specificallyfor vial inspection relies on bright lightfrom a multifiber-optic system and high-luminance light sources to examine theentire surface of the container. Compar-ing the captured image with a learned example, the unit detects glass defects; con-tamination in cake powder; level varia-tions; and stopper and cap presence, po-sition, and flaws. The system can processvials measuring 15–33 mm in diameterand 30–70 mm in height at speeds�180/min (Kanebo VVIS-SXX Vial VideoInspecting System, DJK-Global Group,Itasca, IL).

A digitally controlled photoelectric sen-sor monitors labels, rollstock, or otherprinted packaging materials for registra-tion marks that will trigger labelers,form–fill–seal machines, or other pack-aging equipment. Internal controls storesettings within the sensor, including auto-matic contrast tracking, which adjusts theunit as conditions change. An associatedcontrol panel allows an operator to adjust,configure, and monitor sensor operationby clicking on stored settings or featureicons (Smarteye DCS, Tri-Tronics Co.,Inc., Tampa, FL).

A faster, more accurate checkweigherenables 100% quality control with in-motion weighing through starwheel in-dexing. Mounted above existing convey-ors, the customizable system relies onelectromagnetic forced compensationweighing technology and can be inte-grated with a reject system. The unit also isequipped with 21 CFR Part 11–compliantsoftware (HC-IS Indexing Checkweigher,OCS Checkweighers, Inc., Snellville, GA).

RFID technology that resides in acredit-card-size label is available for moni-toring shipping conditions. Placed in the

30 Pharmaceutical Technology August 2002 www.pharmtech.com

enable one unit to incorporate all of itselectronics within the coding head. Thisdesign eliminates the need for a cabinetand only slightly increases the size of thehead. Operators can change the font styleand size from 1 to 50 mm without changeparts. When various package sizes are run,an optional servo-controlled adjustmentsystem automatically repositions the print-head. The laser coder matches productionline speeds while applying and verifyingcodes to passing packaging (Lasetec PhaseII Laser Printer, Industrial Dynamics, Tor-rance, CA).

An enlarged aperture provides a largetarget area and fast throughput for a lasercoder capable of printing as many as fourlines of text or graphics in an 8.2-cm2 areaat a rate of �400 characters/s. Networkingsoftware allows this coder to be integratedinto the packaging line without a separatecomputer (SmartLase SL, Markem).

Labels and labelingFast speed combined with small size de-scribes a next-generation wipe-on labelapplicator capable of processing �181 mm–wide label stock at a speed of �6350 cm/min. The machine includes a streamlinedinterior with all-electronic components,a self-prompting display, a choice of fivelanguages, and automatic setup (Model3125 Wipe-on Labeler, Label-Aire, an Im-paxx company, Fullerton, CA).

Another label printer–applicator thatis compatible with any printer on the mar-ket includes a rotatable operator interfacewith a two-line digital display and fullerror messaging. With all new electron-ics, the PLC-based machine’s interiorcomponent count has been reduced by

and vaccination passports, detachable sec-tions to provide information to both thecaregiver and the patient, multiple pagesprinted in various languages, and integrateddesigns for clinical trials (Extended-text labels, Schreiner Pharmaceutical Labels).

Capping and closuresSkewed caps are eliminated with a rotarycap placer that sets the cap straight downon the bottle finish. With a processingspeed of 300 caps/min, the unit can beintegrated with a traditional spindle cap-per. The device can process most capstyles, including continuous thread, childresistant, and metal in container sizes30–1500 cc (NERCAE Rotary Cap Place-ment System, New England Machinery,Inc., Bradenton, FL).

A press-and-turn, child-resistant metalcap with a translucent polypropyleneovershell returns to the market followingthe acquisition of the patent holder. The steel undercap can be lithographed in various colors and embossed. Availablefinishes include 24–, 28–, 33–, 38–, and45–400. Caps can be supplied with induc-tion seal or pressure-sensitive liners toprovide tamper evidence and child resis-tance (Saf-Lok CRC, Penn-Wheeling Closure, Glen Dale, WV).

Container innovationsAn alternative to prefilled aluminumunit-dose cups for liquids is injection-molded amber polyethylene terephtha-late. The current size accommodates fillsof �1 oz, but a smaller cup for fills of5–10 cc may be produced in the future(PET Unit-Dose Cup, Lyne Laboratories,Brockton, MA).

The impressive display of pharmaceu-tical processing and packaging equipmentat the 2002 Interphex show isn’t the onlyopportunity to see pharmaceutical pack-aging equipment in action this year. Aconsiderable range of pharmaceuticalpackaging equipment, including newproduct introductions, will be shown 3–7 November 2002 at Pack Expo Inter-national at McCormick Place (Chicago,IL). Meanwhile, it’s not too early to startplanning budgets and goals for next yearwhen Interphex returns to New York’sJavits Center, 31 March–2 April 2003. PT

40%. Upgrades can be performed in �30 sfrom a Web site that enables a Flashdownload into onboard chips (Model3038 Printer Applicator, Label-Aire).

A PLC-based 12-pocket carousel out-sert literature feeder integrates with pressure-sensitive labelers as part of a newline or as a retrofit. Changeover requiresapproximately one minute because notools are needed and the hopper’s quick-change design allows 1219-mm trays ofoutserts to be slid into place even whilethe machine is running. During opera-tion, the carousel indexes to empty eachtray before moving to the next one, dis-pensing outserts at a rate of �250/min.Outserts range in size from 22 � 28 to 38 � 101 mm and may be applied to con-tainers, caps, or under labels (Model 276Carousel Outsert Literature Feeder, NJM/CLI, Pointe-Claire, QC).

Extended-text labels have been availablefor rigid containers for several years andnow are offered for blister packages. Ap-plying a multipage booklet or concertina-folded leaflet label to a blister’s foil lid-stock reduces the packaging needed forclinical trials and samples and could elim-inate the need for cartons. Because insertinformation is integral to the blister, blis-ters could simply be banded together fordistribution. The leaflet label covers thefoil, making the yet-untested design po-tentially child resistant. The label may beproduced in a two-part design, which in-cludes a removable doctor’s leaflet in addition to the patient leaflet (Inseal Blis-ter Pack Leaflet, Inprint USA, St. Charles,MO).

Interest in extended-text labels hassurged as pharmaceutical manufacturersseek ways to meet requirements to includea “drug facts” box on over-the-counterproducts. One design boosts label real estate by approximately 70%. It featuresa single-ply label with print on both sides.Nearly two-thirds of the back is printedwith ink and a pressure-sensitive, adhesive-deadening material so that section of thelabel can be lifted, read, and replaced re-peatedly (Pharmalabel Text-A-Peel, Rx-Perts Printing Alliance, Greensboro, NC).

Yet another extended-text design con-sists of a 40-page booklet with a gluedspine. It can be applied with glue or com-bined with a pressure-sensitive label (40-Page Booklet Label, Pharmaceutic Litho& Label Co., Chatsworth, CA). A varia-tion of the booklet label with as many as12 pages can be applied with a sling-stylelabel made of heavy-duty 5-mL plastic.The integral hanger eliminates the needto add hanging hardware to containersintended to be suspended from i.v. polesor other devices (BPS 2000 combinationbooklet/sling label, Pharmaceutic Litho &Label).

Multilayer labels for the smallest ampulsand vials are available in several configu-rations. Options include labels with peel-able sections for transfer to medical files

shipping container and activated as itleaves the manufacturing facility, the unitrecords as many as 64 temperature devia-tions beyond a preprogrammed range.These data are downloaded into a hand-held RFID scanner when the shipmentreaches its destination. The system is ex-pected to be validated by the end of 2002(TempLog Label, Schreiner Pharmaceuti-cal Labels, Oberschleissheim, Germany).

Coding and markingA hybrid printer combines a standardplaten printer with a variable coder usinginkjet, programmable hot stamp, or lasertechnology. The combination allowsgraphics and fixed text to be flexographi-cally printed with conventional or UVlight–cured ink and information such aslot codes, expiration dates, and bar codesto be variably printed. Variable printingsimplifies tracking and tracing of indi-vidual packages and is a valuable tool inrecall, diversion, or counterfeiting events(Platen Printer/Programmable Printer Hy-brid, Adolph Gottscho, Inc., Union, NJ).

An enhanced continuous-motion thermal-transfer coder applies high-quality, 300-dot-per-inch lot and datecodes at a rate of 1.5 m/s to moving webssuch as those found on wrapping or bag-ging machines. Printing directly on bagor pouch surfaces can eliminate the costand handling involved with preparing andinserting a separate instruction sheet. A900-m ribbon minimizes downtime forroll changes (SmartDate 3, MarkemCorp., Keene, NH).

Laser coders eliminate the need for inkand produce a permanent code on a vari-ety of substrates. Compact electronic parts

The Label-Aire model 3125 wipe-on labeler adjusts its speed automatically to container inputspeeds, ensuring label placement accuracy within �0.4 mm.

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