Interphex Presents a Wide Array of Packaging Innovationsfiles.pharmtech.com/alfresco_images/pharma/2014/08/22/5b459e3f-c760-4c... · Bags used for the delivery of parenteral nu-trition,

30 Pharmaceutical Technology August 2001 www.pharmaporta l .com

rom a packaging perspective, thethemes of the 2001 Interphex showheld in March in Philadelphia wereeasier operation, quicker change-

over, and product security. Nearly all cate-gories of equipment, containers, and ma-terials were well represented among theapproximately 900 exhibitors spread across240,000 ft2 of floor space.

Flexible packagingBags used for the delivery of parenteral nu-trition, antibiotics, and specialty drugs and

for irrigation, peritoneal dialysis, and i.v.applications are being manufactured usinga new chemically inert, coextruded poly-olefin film. This material reportedly of-fers improved leach resistance and a lowrate of extractables, attributable in part tothe absence of chlorine and plasticizers.Durable, yet thin, the multilayer film pro-vides the flexibility of polyvinyl chlorideat half the mass, and its very low water-vapor transmission rate can eliminate theneed for secondary overwrap and accom-panying material and disposal costs. Ste-rilizable at 121 °C, the film also is com-patible with freezing temperatures becauseof its low-temperature flex-crack and frac-ture resistance. Although it is designed toprovide excellent seal strength, the filmalso can be used for multicompartmentpouches that require a frangible seal forproducts in which ingredients are mixedjust before use. During manufacturing, the

film is extruded as a tube in a controlledenvironment so only Class 100 filtered airtouches the inside product-contact sur-face, which then is protected throughoutpackaging, distribution, and use on theform–fill–seal equipment (M312 film, Cry-ovac North America, Duncan, SC).

A hybrid package supplied in two pre-assembled components, a 50- or 100-mLbarrier pouch and airless, patented snap-on pump is designed to dispense oxygen-sensitive creams and gels. The polyethyl-ene (PE)–foil–PE pouch, which can be

positioned inside a rigid container or canstand alone, is designed so it doesn’t col-lapse and close off before all the productis evacuated. The rubber- and metal-freepump primes in three or four strokes andcan dispense a dose of 1340 mL from anyposition. On the production line, afterpouches are filled, the pump–actuator–cap assembly is snapped in place at speeds<80 units/min (SP943 barrier pouch dis-pensing systems, Rexam Sofab USA, Stam-ford, CT).

Interphex Presents a Wide Array of Packaging InnovationsHallie Forcinio

Hallie Forcinio isPharmaceutical Technology’sPackaging Forum editor, 4708Morningside Drive, Cleveland, OH44109, tel. 216.351.5824, fax216.351.5684, e-mail [email protected].

F

Above: The third-generation MAFSbarrier isolator–equipped fillingline from Bosch can be deliveredin 12 months.

Right: An improved stainless-steelreject mechanism on the up-graded MET 30+ metal detectorfrom Lock Inspection Systems iseasier to clean and more durablethan the plastic part previouslyincluded with the system.

Suppliers of

pharmaceutical

packaging materials

and equipment

respond to demands

for easy, clean

operation; quick

changeover; and

deterrence of counter-

feiting, diversion,

tampering, and

accidental ingestion

by children.

August 2001 Pharmaceutical Technology 31

Blister packagingFor low-volume applications such as clini-cal trials, stability studies, and marketingsamples, an in-line automatic blisterpackaging machine is available. The mo-bile, easy-to-operate machine featurestoolless changeover and reportedly han-dles nearly any blister material in formatsizes <275 mm2 at speeds <80 units/min(EZ Blister Automatic, Sepha Ltd., New-townards, UK).

A compact, single-lane, 240-unit/minmachine has been designed to accom-modate higher volumes. Shown for thefirst time in the United States, the thermoform–fill–seal blister packager measures 2.6 m long and features rotarysealing instead of the more common platensealing (UPS 600, Uhlmann Packaging Sys-tems, Towaco, NJ). With compact, self-clamping tools, the unit is designed to beeasy to change, and it integrates with a car-toner, stretchbander, and case packer tocreate a complete line (C130 cartoner,E3040 stretchbander, E4040 case packer,Uhlmann).

Even faster is a 400-blister/min unit thathas been designed to cut changeover timein half with the introduction of toollesschange parts (TLT1400 thermoformer,Bosch Packaging Technology NA, Min-neapolis, MN, formerly Bosch-TL Systems).

Filling, countingTo clean containers before filling, a re-designed washer for vials and ampuls canbe programmed with as many as ninesteps of variable length. Jets deliver veryhot water for injection for washing andrinsing as well as cleaning agents and airfor particulate removal and drying. Thesystem also can steam sterilize. A reposi-tioned programmable logic control andmovable arm–mounted operator inter-face simplify operation (GW24 batchwasher, Cozzoli Machine Co., Plainfield,NJ).

A robotic dispensing system for mediapreparation and small-batch productionfills vessels at a reported rate of 95 testtubes/min. The benchtop unit measures35 3 10 3 12 in. and can be set for single

or repetitive dispensing (Masterflex ro-botic dispenser, Cole-Parmer InstrumentCo., Vernon Hills, IL).

A new model monoblock filling andstoppering machine is designed to ac-commodate vial diameters ranging in sizefrom 18 to 75 mm. A cantilevered bal-cony design positions the mechanicalequipment at the rear of the machine foreasier cleaning and improved laminarflow. PC-controlled brushless servomo-tors drive 180- and 300-vial/min versionsof the continuous-motion, linear machineusing rotary stoppering assembly and per-mit the automatic adjustment of nozzleheight and stroke (ML651 filling andstoppering machine, Marchesini Packag-ing Machinery, Inc., West Caldwell, NJ).

An in-line filling and closing machinefor aseptic environments fills vials four ata time to achieve speeds <320 vials/min.The machine offers a 500-mL dosing rangeand can be used in conventional clean-rooms or equipped with a barrier isolatorenclosure (IMA Sterifill F200 FAST, IMANorth America, Inc., Fairfield, CT).

As barrier isolation technology has be-come more accepted and widely used forthe filling of ampuls, vials, cartridges, anddisposable syringes, a third generation ofequipment has evolved (MAFS mini asep-tic filling system, Bosch Packaging Tech-nology NA). Designed to maintain a Class-100 environment in the filling area, theunit now features servomotor drives forgreater reliability and a reduced numberof mechanical parts, a disk infeed, largermaintenance doors for easier access, andPC control. In addition, the heating, ven-tilating, and air conditioning system andthe isolator enclosure have been redesignedto maximize airflow uniformity. The morestandardized design also means quickerdelivery.

For tablet filling, a counting unit re-portedly fills 15 or 30 bottles simultane-ously with 1–5000 tablets or capsules foran output rate of <400 bottles/min. Bot-tles are indexed under a bank of countingwheels where a smart sensor controlswheel rotation and tablet count. Controlis provided by a touch-screen operator in-terface, and the wheel changeover is tool-less. Bottle-height adjustments are madeusing push-button technology and a lin-ear encoder (B15 filler, B30 filler, AylwardEnterprises, Inc., New Bern, NC).

A standard 60-bottle/min tablet counterhas been reconfigured to simplify the design and reduce the price. In addition,its dust-extraction system has been repo-sitioned to the back of the unit for cleaneroperation and easier cleanup. A three-dimensional product-detecting system en-sures accurate fills of 1–9998 pieces/bottle.Changeover reportedly can be accom-plished in 8 min without the use of tools(Challenger — CVC1220, CVC Tech-nologies, Inc., Rancho Cucamonga, CA).

PAC K AG I N G F O RU M

IMA’s Sterifill F200 Fast in-linefilling and stoppering machine isdesigned for use in cleanrooms orwith isolation technology.

Far left: The IcoreMetal Scout IIe Rxmetal detector fromThermo Ramsey isdesigned to detectvery small contami-nant particles at arate of >10,000tablets/min.

Left: A nondestructiveleak tester is designedto remove productfrom faulty blisterpacks and repackageit.

warranty fraud. Anticounterfeiting de-vices such as holograms; security sub-strates; design, ink, and printing; and elec-tronic identification technologies can beused singly or in combination for addedsecurity, and the results are monitored to ensure continued effectiveness (West-vaco Brand Security, Stamford, CT).

To prevent labels from being removedand replaced, an extended-text film labelwith a liftable back panel printed on bothsides incorporates crescent-shaped face slitsin the primary panel. The slits leave stripsbehind if the label is removed and make it impossible to reapply the label to an-other container. The design is bidirectionalso the label shreds regardless of the di-rection in which it is peeled (Reveal EstateTE, Label Express, Inc., Impaxx Labels andPackaging Network, Schaumburg, IL).

Labels, inserts, and cartonsPC-controlled labelers that have a canti-levered design and are intended for phar-maceutical applications eliminate the needto change parts, thereby shorteningchangeover time. Instead of a standardbacking rewind, this pressure-sensitive (P-S) labeler features a web cutting systemand a vacuum waste-suction device thatare designed to deliver a clean operationand a simple label path (Key PackagingRB300, OC400 and ROC200 container labelers and ET600 carton labelers, ACCompacting LLC, North Brunswick, NJ).

A P-S labeler that is capable of handlingtrays of vials at a speed of <300 vials/minkeeps up with most filling and capping ma-chines. The system incorporates a coderand vision system to apply and verify dateand lot codes and simplifies operation with a touch-screen operator interface (viallabeler, Capmatic Ltd., Montreal, QE).

Another P-S labeler that is available withan integrated vision system stops if a pass-ing bar code, label length, or container sizedoes not match the information stored inthe system’s memory. It also stops if it detects a missing hot-stamp code. Change-over time is minimal because setup is ac-complished simply by setting a containeron the conveyor and pressing a button to electronically activate all adjustmentsnecessary for the run. The machine is de-signed to deliver instructions via the moni-tor or by audio recordings in English,Spanish, or Chinese (CVC 302 The HawkSelfSet, CVC Technologies, Inc.).

For carton loading, a servo-driven,continuous-motion model that wasshown for the first time in the UnitedStates combines cantilever structure anda belt transport and is designed to load<170 cartons/min. Electronic control andtouch-screen operator interface provideflexibility, quick changeover, and user-friendly operation. The unit also is avail-able in an intermittent-motion model(Flexa cartoner, IMA North America,Fairfield, CT).

Next year, when over-the-counter la-beling requirements take effect, fitting

32 Pharmaceutical Technology August 2001 www.pharmaporta l .com

Package securityVendors continue to work on ways tostymie tamperers and counterfeiters andprotect children from accidentally ingest-ing harmful substances. One injection-molded polypropylene container that isshaped like a cigarette pack incorporates apress-to-release hinged lid to access contents. On the back, a bottom-hingeddoor flips down to reveal a narrow com-partment for product literature. Final de-signs are expected to be both tamper evident (TE) and child resistant (DumaCombi, Superfos Pharma Pack, Cumber-land, MD).

More standard are ranges of round,high-density polyethylene containers witheasy-open, TE, low-density polyethylene

caps featuring easy-to-grip pull strips (DumaSpecial and Dudek con-tainers, Superfos). Nine-teen sizes accommodatevolumes from 15 to1500 mL.

To authenticate prod-ucts, foil counterfeiters,and communicate prod-uct information, vendorsare combining overttechniques such as holo-graphics with coverttechniques such as machine-readable digitalwatermarks. Digital wa-termarks can be added tonew, existing, or holo-gram designs and can beprocessed by means ofcommercially availableimage-capture devicesand special software. Thelayered technology re-sults in a difficult-to-

duplicate, highly secure product (Holo-graphic Digital Watermark, American BankNote Holographics, Inc., Elmsford, NY;Digimark, Tualatin, OR).

Another layered technology combinesa high-security hologram, TE break pat-tern, black-light verification system, anda machine-readable code in a pressure-sensitive carton seal (HoloSeal, AmericanBank Note Holographics, Inc.). Alreadycommercially used in South America byEli Lilly and Co. (Indianapolis, IN), theseal is easy to verify in the field and leavesbehind a holographic pattern when re-moved. Once peeled, the label will not re-adhere. Labels can be numbered or per-sonalized to provide accountability byregion, plant, or individual product andcan be applied manually or by using stan-dard labeling equipment. A clear designallows packag-ing graphics and printedinformation to show through.

Brand security is the sole concern of a new business group that offers technology-independent customized solutions to identify weaknesses in thesupply chain and prevent counterfeit-ing, diversion, tampering, and returns–

Top: A dual laser head on the DDC 3 laser coder fromDomino Amjet adjusts to code different surfaces.

Center: Touch screen–controlled servomotor drives andtoolless change parts reportedly cut changeover time in halfon the TLT 1400 thermoform–fill–seal blister packager fromBosch.

Above: Ink-jet coders with ultraviolet ink from Domino Amjetapply an invisible tracking code to containers to ensureproper product identification for subsequent labelingoperations.

34 Pharmaceutical Technology August 2001 www.pharmaporta l .com

required product information on the rela-tively small packages used for pharma-ceuticals will become an even bigger thanusual challenge. One solution applies theconcept of extended-content labels to secondary cartons. A variety of designswith fold-out flaps accommodates bottles,blister cards, and other types of primarypackaging (ECC extended-content car-ton, Mebane Packaging, A Westvaco Pack-aging Resource, Mebane, NC).

Another solution to the problem of fit-ting a lot of information in a confined spaceis a 28-page booklet that has the same fin-ished size as a folded insert. The booklet isproduced from one piece of paper with barcodes on both sides to ensure accuracy(ClinBook, Arlington Press Inc., part ofImpaxx Pharmaceutical Packaging Group,Brooklyn, NY).

Quality controlA metal detectordesigned especiallyfor the pharmaceu-tical industry hasbeen upgraded toinclude a stainlesssteel reject mecha-nism. The mecha-nism enables thedetector to with-stand the aggressivecleaning conditionsexperienced whenchanging from oneproduct to another.The sensitive unitcan detect micro-scopic fragments ofsieve mesh or presstooling at reportedspeeds of <30,000tablets/min. Ad-vanced electronicsare designed to en-sure precise and

consistent operation and handle de-manding applications such as productswith a high iron content (MET30+ phar-maceutical metal detector, Lock Inspec-tion Systems, Fitchburg, MA).

Added features on another metal de-tector for pharmaceutical applications in-clude a patented AuditCheck automaticperformance verification system, rejectverification, and a MetalNet data com-munications package (Icore MetalScoutIIe Rx pharmaceutical metal detector,Thermo Ramsey, Minneapolis, MN, for-merly Ramsey Technology).

A checkweigher designed especially forsmall, light items such as tiny aerosol cansor vials checks weights of 620–50 mg at3 s for a reported throughput of <600products/min. The unit can be used withcontainer diameters <15 mm and incor-porates a miniconveyor offered in widthsof 50 and 100 mm and lengths of 100, 150,and 200 mm (Garvens S1 checkweigher,Garvens USA, Pine Brook, NJ).

To ensure that the correct product is

put into the correct package, near-infrared(NIR) analyzers are being mounted onthermoform–fill–seal blister packagers todetect errant tablets. One system being de-veloped in conjunction with Sanofi Inc.(New York, NY) ultimately will be com-patible with high-speed blister packagers(QualitySpec TI, Analytical Spectral De-vices, Inc., Boulder, CO). The NIR unitwas demonstrated on a low-speed ma-chine (EAS blister packager, KlöcknerMedipak, Inc., Clearwater, FL) and isbeing validated to show it can flawlesslydetect errant tablets at production speedsas well as identify product variations suchas those sometimes present in clinical trials. The advantage of NIR technologyis that it relies on the chemical signatureof the product and not on a visual differ-ence in size, shape, or color.

Machine vision is another popularmethod to check blister packs. One systemthat uses color to inspect for missing orpartial tablets and foreign objects relies ona high-resolution digital color camera arrayand spectral analysis. Setup is accom-plished by presenting an empty blister anda properly filled blister to the system (TIPSHD-CBP inspection system, Systech, Cran-bury, NJ).

Geared to operate similarly is a color-vision system that can incorporate a unitto detect cracks >15 mm in cold-formedfoils or foil lid–wrapper materials (Scan-ware Lynx-Ultra blister inspection systemand Scanware Lynx-Focon PD2Z foil frac-ture detector, Micron Automation, Inc.,Tampa, FL).

Another nondestructive blister inspec-tion device checks for leaks in a 30-s testcycle. Vacuum application and light scansnot only indicate whether a pack passesor fails but also show the location of anyflaws so the blister machine can be ad-justed if necessary. The unit is designedto detect leaks and weak seals >5 mm(BlisterScan inspection device, Sepha Scan,a part of Sepha Group, Newtownards,UK). Should the package fail, the productcan be deblistered and returned to thehopper for repackaging. In traditional dyetests, the product in faulty blisters is lost.

Pinholes, cracks, fractures, and pores>10 mm reportedly can be detected inboth deep-drawn and flat films and foilsby means of an infrared scanner. The sys-tem operates at speeds of >100 in./s (In-telliScan MT-160 material inspection sys-tem, IC Technologies, Inc., Tampa, FL).

A high-speed X-ray inspection devicesometimes can substitute for both metaldetectors and checkweighers. One PC-based system detects variations in densityto locate packages with missing, broken,or damaged product or missing packag-ing components such as inserts. It also canidentify package voids, confirm fill levels,and detect contamination such as metal,stone, glass, bone, high-density plastics,and rubber. According to the company,the unit can perform more than one in-spection simultaneously on products pass-

Top: A near-infrared analyzer from Analytical Spectral Devicesverifies the chemical composition of solid-dosage forms toverify that the correct product is put into the correct blisterpocket.

Center: The Automatic Masterflex benchtop dispensing systemfrom Cole-Parmer simultaneously fills multiple containers.

Above: Coextruded M312 medical film from Cryovac isdesigned to offer superior leach resistance and barrierproperties.

August 2001 Pharmaceutical Technology 35

ing at typical line speeds (Clearview Type21 inspection system, Safeline AVS Inc.,Tampa, FL).

Coding and markingInterest in eliminating ink from packag-ing lines has compelled pharmaceuticalmanufacturers to adopt laser coding. Onelow-cost unit marks primary cartons, la-bels, or polyethylene terephthalate bot-tles. The compact laser coder mounts eas-ily in tight spaces. Because the coder isnetworked to other control units on theline, it does not need its own PC (Smart-Lase coder, Markem Corp., Keene, NH).

A dual-laser head enables another lasercoder to simultaneously mark radically dif-ferent substrates such as bottles being loadedinto cartons. Matrix-arrayed laser tubes take turns operating, thereby reducing theneed for maintenance-intensive, cumber-some cooling systems; energy-wasting beam guides; and deflection schemes. Thesystem offers a choice of standard or near-graphic-quality fonts in single- or twin-lineformats (DDC 3, Domino Amjet, Inc.,Gurnee, IL).

A steered-beam, or vector, system of-fers crisp print at a lower cost than thatoffered by other styles of laser coders. Theunit is designed to generate tri-line, re-verse, and inverted print; serialize codes;mark date and time; and store as many as20 messages with 100 characters per line.Scalable fonts from 0.1 to 2.5 in.2 allowcharacter height and width to be adjustedduring operation, reducing changeovertime and increasing throughput. Adjust-ments are made by means of a handheldterminal, which can be removed from theunit after setup so codes cannot be acci-dentally or intentionally changed withoutproper authority (MDS Focus 1000 lasercoding system, Marconi Data Systems Inc.,Wood Dale, IL, formerly Videojet/MarshCo.).

New inks are helping ensure productquality. A thermochromic ink changescolor from black to blue after the ink un-dergoes temperatures of 120–125 °C for20 min to confirm the efficacy of heat sterilization (767BK ink, Domino Am-jet). An ultraviolet ink, visible only underultraviolet light, permits “bright” con-tainers to be coded for future identifi-cation and tracking. Pharmacia R&D(Skokie, IL) applies two-dimensional (2D)Data Matrix codes to vials of productmanufactured in the United States but la-beled in Europe with country-specific la-beling. “This is a proven, reliable, and eas-ily validated technology in that ink jetcoders and vision systems are alreadycommon in most plants,” says Ralph Dil-lon of Pharmacia.

Because 2D codes can condense moredata into a smaller space than can linearbar codes, readers capable of decodingthese symbols have attracted increasinginterest. One 30-code/s unit features anintegrated camera and processor and Eth-ernet communications link (AV610 com-

pact industrial CCD bar code reader,Accu-Sort Systems, Telford, PA). Anothersmart camera integrates lens, lighting, and a microprocessor in the same hous-ing and sets up quickly by means of a laser beam aiming aid (HawkEye 15, RVSICiMatrix, Canton, MA). A third unit iscapable of optical character recognitionas well as linear bar code and Data Matrixinterpretation and also measures code in-tegrity and print quality (SmartReader,DVT Corp., Norcross, GA).

Interphex 2001 is past, but plans alreadyare well under way for next year. As partof the new International PharmaceuticalIndustry Week, Interphex will be co-located with the new ePharmaceutical So-lutions Exposition and PharmaceuticalContract Services and Outsourcing Expo-sition, 15–17 April 2002 at the Jacob K.Javits Convention Center in New YorkCity. PT

Top: Networking software on Markem’s compactSmartLase coder allows it to be controlled from anymachine or production-line controller.

Center: The Flexa cartoner from IMA may beordered in either an intermittent- or continuous-motion version.

Above: The primary portion of the Reveal Estate TEextended-text label cannot be removed withoutshredding.