OR WAIT null SECS
Hallie Forcinio is packing editor for Pharmaceutical Technology and Pharmaceutical Technology Europe, firstname.lastname@example.org.
Exhibitors' products prevent counterfeiting, provide child resistance, protect product quality, and improve packaging-line efficiency.
This year's INTERPHEX show, held April 24–26 at the Javits Center in New York, provided an opportunity to see new packaging materials, containers, and machines firsthand. In addition to the usual wide range of anticounterfeiting and quality-control solutions, this year's show emphasized barrier packaging and child resistance. On the machinery side, the theme was line efficiency.
A multitude of overt and covert tools help authenticate products and prevent counterfeits from reaching consumers. New tools include ink technology that allows color to reappear when rubbed or scratched. ("Secur" labels, Ad Tape & Label, Menomonee Falls, WI).
A compact 49 × 23 × 24-in. system based on energy-dispersive X-ray diffraction technology and material-recognition software confirms product authenticity by reading its molecular fingerprint. The material-identification system handles 0.5 × 3-in., 1 × 3-in., and 2 × 3-in. container sizes and stores 5000 sample records. The operator simply places the container in the chamber, presses the start button, and views the results on the display screen about 15 min later. Potential applications include checking finished goods at pharmacies, wholesaler or distributor warehouses, and manufacturing facilities. A manufacturer also could use the system as part of its raw materials and in-process quality-control effort ("XT250" material-identification system, Xstream Systems, Vero Beach, FL).
Another technology with anticounterfeiting potential is radio-frequency identification (RFID). RFID tags can help authenticate products and support data collection for pedigree records. Equipment that encodes and prints tag-equipped labels verifies the tag before and after encoding. If a nonviable tag is detected before encoding, the label is marked with a checkerboard pattern and ejected. Good labels are encoded and rechecked. If tags read properly, labels are printed and their bar codes are verified. If the bar code doesn't scan correctly, the unit pulls the label back in, imprints it with a checkerboard pattern, ejects it, and encodes and prints a new label ("Smartline SL4M RFID" printer, Printronix Inc., Irvine, CA). For automated applications, an encode, print, and apply unit is available. It performs all the checks of the RFID printer and applies the labels at a maximum rate of 100/min ("Smartline SLPA8000" label printer applicator, Printronix).
"Perlalux-Identity" film uses holographic stripes on the tablet side of the blister package to support brand identity and discourage counterfeiting.
At least one label converter can incorporate ultrahigh-frequency (UHF) or high-frequency (HF) RFID inlays in multipanel labels to support product security, inventory control, and track-and-trace functions ("InfoPac label," Tursso Companies, St. Paul, MN).
RFID tags also can be built into injection-molded high-density polyethylene containers, providing visibility to bright or unlabeled stock and eliminating the need to encode and apply fragile smart labels. Embedded tags are tamper-evident and tamper-resistant and rely on a difficult-to-duplicate manufacturing process. Positioning in the base of the container eliminates tag-to-tag contact and ensures consistent orientation. Tag-equipped containers can be supplied encoded or be encoded on-line during the filling process. Pretesting ensures the UHF or HF tag inside the container is viable at a Six Sigma quality level.
Serialized 96-bit electronic product code (EPC) numbers can be encoded at a rate of as many as 550/min. The encoder's antenna looks for the tag identification, communicates only with that tag, writes to it, and verifies it is readable before the bottle leaves the unit's read range. The tag can be removed when the container reaches the consumer. Several drug makers currently are evaluating the tagged containers, and commercial deployments are expected in 2008 (RFID-embedded packages, O-I Healthcare Packaging, Perrysburg, OH).
IMA Libra's "MAC" modular aseptic compact vial filler fits in a shipping container and ships as a single unit to expedite validation.
At least one other vendor aims to incorporate HF RFID tags into bottle closures (injection-moldable tag, Magellan Technology, Annandale, Australia).
RFID can be combined with cryptography to enable on- or off-network authentication. When the tag is encoded with the EPC, it also receives a digital signature using public key infrastructure (PKI) based on IEEE 1363a. Any reader equipped with PKI can authenticate the product. Thus, authentication could theoretically be done by the consumer, but more likely would occur at a "Smart Shelf" or other reader location. Since product information is encrypted in the digital signature, the system not only addresses counterfeiting, but also protects privacy ("Certicom Security" RFID product authentication, Certicom Corp., Mississauga, Canada; RFID chips, Texas Instruments, Plano, TX).
A traditional anticounterfeiting tool, holography, is often applied as a label, but can be incorporated in the forming web of a blister package. The capability, derived from technology used for European Union bank notes, can be customized with logos or other designs and incorporated into various films ("Perlalux-Identity," Perlen Converting AG, Perlen, Switzerland).
A die-cut hole in the key for Chesapeake's "KidKey" carton makes it easy to attach to akeyring for repeated opening and closing.
New child-resistant (CR) blister designs offer improved peelability and printability while maintaining protective qualities that prevent children from accessing their contents.
A CR peel–push lidstock based on 25-μm foil features a layered structure consisting of acrylic print primer, 50-μm white polyester, release adhesive, foil, and vinyl acrylic heat-seal coating. The lidstock can be printed in as many as seven colors to maximize brand identity and eliminate the frustration of hard-to-peel, paper-based lidstock. The absence of a paper layer also eliminates the machinability issues associated with moisture absorption and lengthens the time the material can be stored while awaiting conversion or use on the packaging line ("Safety-Pak Plus PP," Alcoa Packaging, Richmond, VA). A full-panel-peel version accommodates delicate tablets ("Safety-Pak Plus PL," Alcoa Packaging). The adhesive's broad sealing range ensures a reliable peel. For applications requiring maximum security, the peelable adhesive is eliminated, and the resulting blister pack requires a tool to open ("Safety-Pak Plus LT," Alcoa Packaging).
A CR folding carton features die-cut slots on one end flap that align with diecut tabs on the inner wall of the carton to lock the flap in place. Opening requires a die-cut key that is removed from the carton's external panel. The key slides into the slots and pushes down the tabs to free the end flap. Material options include polypropylene (PP) or poly-coated paperboard ("KidKey" carton, Chesapeake Pharmaceutical Packaging, Lake Success, NY).
A desiccant-equipped dispensing device from SÃ¼d-Chemie can be scented to mask unpleasant odors.
Among the barrier films on display, a cyclic olefin copolymer (COC) offers an alternative to coated polyvinyl chloride (PVC). COC is capable of 5-in. draws and can be coextruded to polyethylene terephthalate glycol or PP for enhanced barrier properties. Available in 10–48-mm thicknesses, the material uses the same tooling as PVC. Unlike PVC, it doesn't discolor over time (COC formable web, printed lidstock, printed pouchstock, Tekni-Films, Somerville, NJ).
A two-layer alternative provides an oxygen and moisture barrier equivalent to traditional trilayer PVC–PE–polyvinylidene chloride (PVDC) blister film. Two-layer PVC–PVDC film exhibits excellent lay-flat properties, clarity, and machinability, requires less sealing heat and dwell time, runs on standard PVC tooling, and cuts costs by at least 25%. PVC and PVDC options include 7.5- or 10-mm PVC with a PVDC layer of 40, 60, 80, 90, or 120 g/m2 . The 10-mm/120 g/m2 structure provides barrier properties equivalent to mid-range Aclar structures (pharmaceutical blister films, Ineos Films, Delaware City, DE).
Custom-shaped, compressed desiccant from Multiform Desiccants stays in place to work invisibly as product is consumed.
For ultrahigh barrier requirements, a PVDC with high crystallinity is applied in a 120-g dispersion to create a three-layer symmetrical PVC–PVDC–PVC film that improves the lay-flat property of finished packages and eliminates confusion about the location of the PVDC layer. The multilayer film thermoforms in the same temperature range as monolayer PVC and flows consistently. In addition, the PVC's low coefficient of friction prevents blocking on preheat plates. Available in clear and opaque colors, the film seals to all standard vinyl-compatible lidstocks. The PVDC-coated film now is produced at plants in North America, Germany, and Thailand and will be produced in India and Brazil in 2008 ("Pentapharm alfoil E S03" film, Klöckner Pentaplast, Gordonsville, VA). For less-stringent barrier requirements, two-layer PVC–PVDC and three-layer PVC–PE–PVDC structures are available with enhanced slip properties to improve mold and blister-to-blister de-nest properties and increase filling rates ("Pentapharm alfoil SG" films, Klöckner Pentaplast).
The "Videojet 3320" laser coder's pilot-laser option facilitates and accelerates alignment when switching marking jobs.
For rigid packaging, multilayer barrier structures include COC–ethylene vinyl alcohol (EVOH)–COC, polyethylene terephthalate (PET)–EVOH–PET, and PP–EVOH–PP, as well as other tailored resin combinations. The multilayer, injection blow-molded barrier containers meet US Pharmacopeia requirements for extractables and are compatible with a wide pH range, sterilizable, depyrogenable, and shatter-resistant. Some structures can be specified in place of Type I glass ("MLx" plastic vials, O-I Healthcare Packaging).
Cyclo olefin polymer (COP), a relative of COC, is moving from high-precision optics to injection-molded pharmaceutical bottles, vials, and prefilled syringes. Flexible packaging such as IV bags is also a possibility. The material offers a good moisture barrier, extremely low residual-metals content, glass-like transparency, and compatibility with ethylene oxide and gamma sterilization ("Zeonex COP," Zeon Chemicals LP, Louisville, KY).
For sensitive dry powders and solid-dosage forms, desiccant material can be compressed and shaped to fit or drop into inhalers or containers. The compressed format absorbs twice the moisture and is cost-competitive with pouch-packed desiccants ("Coated Solid Form" sorbents, Multisorb Technologies, Buffalo, NY).
Another way to incorporate desiccants into pharmaceutical packaging is to mix the absorber with the resin used to injection-mold a component such as a dispensing device that's designed to release one tablet or capsule at a time. The dispensing control minimizes the exposure of the remaining contents to microbes, pathogens, and other contaminants and can eliminate the need for cotton fill ("Flow-Limiter" equipped with "Advanced Desiccant Polymer," Süd-Chemie Performance Packaging, Belen, NM).
Determining how much moisture- or oxygen-absorbing capacity is needed generally depends on stability testing, a time-consuming, expensive process. Simulation software calculates the water vapor and oxygen transmission rate of any package, predicts the relative humidity of the package's headspace and product hydration level over time, and calculates sorbent requirements. The mathematical model is accurate enough that simulation results reduce the need for physical stability tests. Varying the model according to various barrier structures also helps optimize the packaging ("SimulSorb" service, Multisorb Technologies).
Cold-form foil provides maximum barrier to moisture, gases, and light. A new nylon–foil–PVC lamination can be reverse-printed in as many as eight colors for improved graphics and brand merchandising. Its three-layer structure permits a 15% deeper draw than competing materials, resists delamination, and runs at the highest machine speeds ("Cold Form 3000" laminate, Alcoa Packaging).
X-ray technology can provide 100% inspection of blister packages without any effect on the product. X-ray inspectors can detect problems such as metal contamination, broken or missing tablets, and packaging voids. The units are compatible with foil packaging and can confirm leaflet presence and fill levels. They also can control product–package mass and fat analysis. One family of low-energy X-ray inspection systems relies on linear-array technology to perform multiple checks at line speeds as high as 400 ft/min ("E-Z Tec" X-ray inspection systems, Eriez, Erie, PA).
A checkweigher–laser coder combination relies on magnetic force restoration instead of strain-gage technology to weigh product and code acceptable packages. A magnetic-force restoration system accommodates products spaced closely together moving at speeds as high as 300 units/min ("HC-TQCC Total Quality Check and Coding Centre," OCS Checkweighers, Inc., Snellville, GA).
Packaging execution-system software improves efficiency at the machine, line, and plant levels by communicating in two directions with programmable logic controllers on equipment and with manufacturing-execution systems and enterprise resource-planning systems. Thus, it can deliver information in real time so problems can be pinpointed and corrected ("TIPS Advisor," SYSTECH International, Cranbury, NJ). An overall equipment-efficiency tool added in 2006 pulls data from each machine in a facility and measures its availability, performance, and quality ("TIPS Advisor OEE," SYSTECH International). The software also manages the serialization of RFID tags or bar codes. In addition, a new optical character-verification tool checks rotating text, streamlines font training, and processes data to check more than 5000 characters/s ("Optical Character Verifier 2," SYSTECH International).
Coding equipment at INTERPHEX followed the themes of flexibility, cleanability, and quick changeover. A dual-nozzle inkjet coder combines speeds as high as 916 ft/min with as many as eight lines of information that can include text, logos, and bar codes. An updated electronics package includes a "what you see is what you get" display, logo creation, and memory cards that simplify setup, backup, cloning, and upgrading to multiple units. Compatibility with various inks, including ones that are invisible unless exposed to ultraviolet light, makes it possible to code virtually any substrate ("Excel DN" inkjet printer, Videojet Technologies Inc., Wood Dale, IL).
A laser coder with a 16 × 13-in. print area applies permanent codes and other information, including two-dimensional data-matrix codes, to multiple lanes of product. In a demonstration, the unit generated four lines of information. An air-cooled, high-capacity laser provides maintenance-free operation for approximately 30,000 h and eliminates the cost of conventional consumables such as ink or ribbons ("Videojet 3320" laser coder, Videojet Technologies).
A family of form–fill–seal blister packaging machines with a maximum speed of 500 blisters/min also exhibit flexibility, cleanability, and quick changeover. Capable of 15-mm draw depths, these machines handle film and foil webs as wide as 270 mm. Options include cold or thermoforming and platen or rotary sealing. Blister machines can be integrated with a servo-driven cartoner ("BMP" blister machines, "CMP-100" cartoner, Heino Ilsemann GmbH, Bremen, Germany and Ilsemann Corp., Sharon Hill, PA).
An extremely compact vial filler for clinical products and other low-volume requirements fits through a 36-in. doorway. The system fills, stoppers, and caps 30 vials/min. It relies on the same motion and dosing systems as higher-volume systems, thus allowing seamless scale-up. The filler accepts 2–100-mL volumes with minimal change parts and can be equipped with an isolator enclosure and overgassing ("FLT1020," Bosch Packaging Technology, Minneapolis, MN).
For high-speed requirements, an 8 × 20-ft system arranges vial washing, depyrogenating, filling, checkweighing, stoppering, and capping in 80% less space than a traditional line. The space savings translates into material savings and cuts the cost of the machine roughly in half. Rated at 100 vials/min, the system actually matches the output of 350-vial/min lines because it changes over quickly. Minimal size and change parts and streamlined cleanup and decontamination shorten changeover time. Fill volumes range from 2 to 100 cm3 . The system's modular design includes separate air handling for accumulator, filling–stoppering, and capping areas, as well as various outfeed and filling options ("MAC" modular aseptic compact vial filler, IMA Libra srl, Bologna, Italy).
A servo-driven, in-line liquid filler that handles flexible and rigid containers relies on easy-to-clean magnetic flow meters to precisely calculate fill volumes from a few cubic centimetres to 1 gal with ± 0.25% accuracy. Capable of top- or bottom-up filling, the system also runs as a time-pressure filler. Its walking-beam design permits speeds as high as 300 containers/min because as many as 12 heads and nozzles are in continuous motion and follow the movement of the containers. Clean-in-place design and one change part (the feed screw) cuts changeover time to a few minutes ("Purefil 1000 Walking Beam Flow Meter Filler," HealthStar Inc., Braintree, MA).
A servo-driven filling system not only delivers precision fills, but also makes different pump styles interchangeable. As a result, drug packagers can switch between positive piston and peristaltic fluid handling. Capable of dispensing 1-nL–500-mL fills, the system integrates into existing filling lines or performs in a standalone mode ("SP&S OnePump," AWS Bio-Pharma Technologies, LLC, Tijeras, NM).
A capper designed to operate without generating particulates eliminates moving belts. Air-conveyor vial transport combined with electromagnetic technology borrowed from the automotive and aerospace industries applies caps without marring, breaking, or scratching. Three models handle 2-mL vials at speeds ranging from 100 vials/min to 305 vials/min. A universal cap-feeder bowl feeds 12- 20- or 37-mm caps with a simple track change. Changeover requires no tools and can occur in less than 30 min ("MajiCap," AWS Bio-Pharma Technologies, LLC).
Hallie Forcinio is Pharmaceutical Technology's Packaging Forum editor, 4708 Morningside Drive, Cleveland, OH 44109, tel. 216.351.5824, fax 216.351.5684, email@example.com
Company Web sites
The following is a list of Web sites for the companies mentioned in this column:
Ad Tape & Label, www.atlco.com~
Alcoa Packaging, www.alcoapack.com~
Aseptic Technologies, www.aseptictech.com~
AWS Bio-Pharma Technologies, LLC, www.AWSBioPharma.com~
Bosch Packaging Technology, www.boschpackaging.com~
Certicom Corp., www.certicom.com~
Chesapeake Pharmaceutical Packaging, www.cskcorp.com~
HealthStar Inc., www.HealthStaronline.com~
Heino Ilsemann GmbH, www.ilsemann.com~
IMA Libra srl, www.ima.it
Ineos Films, www.ineosfilms.com~
Iwata Label, www.iwatalabel.co.jp~
Klöckner Pentaplast, www.kpfilms.com~
Magellan Technology, www.magellan-technology.com~
Multisorb Technologies, www.multisorb.com~
OCS Checkweighers, Inc., www.ocs-cw.com~
O-I Healthcare Packaging, www.o-i.com~
Perlen Converting AG, www.perlen-converting.com~
Printronix Inc., www.printronix.com~
Süd-Chemie Performance Packaging, www.s-cpp.com~
SYSTECH International, www.systech-tips.com~
Texas Instruments, www.ti.com~
Tursso Companies, www.tursso.com~
Videojet Technologies Inc., www.videojet.com~
Xstream Systems, www.xstreamsystems.net~
Zeon Chemicals LP, www.zeonchemicals.com~