New Systems for Counterfeit Protection and Quality Control

June 2, 2005
Hallie Forcinio

Hallie Forcinio is packing editor for Pharmaceutical Technology and Pharmaceutical Technology Europe, editorhal@sbcglobal.net.

Pharmaceutical Technology, Pharmaceutical Technology-06-02-2005, Volume 29, Issue 6

Most experts recommend layering protective technologies by selecting a combination of overt and covert techniques.

Product security and quality control were major themes of this year's Interphex trade show, held April 26–28 in New York City. A variety of interesting packaging machinery innovations were featured at the event.

Brand protection

Counterfeiting and diversion have become top concerns for pharmaceutical manufacturers as counterfeiting technology becomes more sophisticated, the incidence of fake products increases, and organized crime and terrorists turn to counterfeit goods to generate cash flow. Most experts recommend layering protective technologies by selecting a combination of overt and covert techniques. To provide track-and-trace capability, especially for Class II drugs, some drug manufacturers have begun to include radio frequency identification (RFID) tags at the item level.

Hallie Forcinio

Overt technologies are readily visible and include features such as holograms or color-shifting ink. Covert technologies are not visible to the naked eye and include the use of security markers, or taggants, which can be mixed with inks, coatings, or the packaging material.

One taggant solution consists of using particles half the diameter of a human hair to create a code that is revealed by a special microimaging reader and software. These taggants can be made from food-grade materials such as cellulose or gelatin and can be incorporated into the packaging in various ways, such as:

  • an adhesive;

  • a coating on a label or other packaging substrate;

  • a stripe on the side of the cap;

  • in combination with a desiccant.

The taggant can be customized to create a unique signature for the product. Authentication can occur on three levels, including simple presence detection with an off-the-shelf scope, pattern matching of the cell-like taggant with a camera-based system, and the removal of the taggant to confirm its identity (Invisible Security Marker, Adhesives Research, Inc., Glen Rock, PA, www.adhesivesresearch.com) Invisible Security Marker Micro-Imaging Reader, Complete Inspection Systems, Inc., Indiatlantic, FL, www.completeinspectionsystems.com).

Another taggant supplier can create an almost infinite variety of unique codes by mixing odorless, colorless taggant powder in ink or other media in quantities of less than two parts per million. This low concentration means that it is nearly impossible to find, much less reverse-engineer, the taggant. The randomly dispersed taggants create a unique fingerprint that is readable by a proprietary electromagnetic reader. The fingerprint is identified by reading a specific area on the package or label such as a logo. By using an electronic grid, the reader measures and assigns positions to 12–15 particles in the field of view using an edge detection algorithm. Then, this information is stored in 16–20-bit encrypted code thereby requiring minimal data storage. Plug-and-play software is provided, allowing brand owners to establish and maintain their own databases. The software can be standalone or a bolt-on module for an enterprise resource planning system. Readers can be simple pass–fail devices or decoders and can be disguised as an everyday object such as a cell phone or pen. The process of compounding the taggants with the drug ingredients, or applying a taggant-equipped coating to solid dosage forms, is being studied in conjunction with the US Food and Drug Administration. Such methods would provide product authentication at the pill level (Creo Traceless Security and Authentication System, Creo, Inc., Burnaby, BC, Canada, www.creo.com/traceless).

Label Vision Systems off-line configuration accommodates random sampling typically used to check incoming supplies. An in-line configuration mounts the bar code print verification system on the printing press or at the rewind.

Other covert technologies include inks that are visible only when exposed to infrared or ultraviolet light and sophisticated printing techniques. One printing method conceals a message in tiny type (Microprinting, The Challenge Printing Co., Clifton, NJ, www.challengeprintingco.com). Another special printing technique creates a pattern that is only revealed when a screened key is placed over the printed area. Messages can be printed in two directions so that two different messages can be hidden (Digital Watermark, The Challenge Printing Co.).

Labeling software makes it possible to manage label data and templates while allowing the user to print and encode RFID labels destined for packaging and pallets. Compatible with label printer–applicators, an XML interface allows the program to be linked to any enterprise resource planning system that can handle XML files. Because the program is RFID capable, it can maintain product pedigree and chain-of-custody data that are generated as product moves through the supply chain. A validation protocol cuts script development time by approximately two months (ROBAR Enterprise Label Management System, Innovatum Inc., Sugar Hills, GA, www.innovatum.com).

The prototype Integra 9500 Package Insert Counter can confirm that bar codes match and validate color coding.

Quality control

Vision systems continue to evolve. A compact system can support more than one smart camera for infrared or traditional imaging. A high-speed frame grabber processes images at speeds as fast as 1000 frames/s, which is quick enough to freeze an image of a moving bullet or glass breaking. The card-based system plugs into any personal computer. Applications include advanced motion tracking and synchronized data and image acquisition (PCI Express NI PCIe-1429 Frame Grabber, National Instruments, Austin, TX, www.ni.com).

Software that compares electronic files on packaging, labels, inserts, and other printed material identifies differences among files and creates a record of changes in text, fonts, style, and location. The resulting inspection report highlights and numbers differences between two files, notes document differences to the report, and can incorporate proofing comments. The software supports numerous file types including Microsoft Word, PDF, XML, SPL, text, and RTF files in any language. This feature permits drug makers to check and compare text and artwork revisions. The software is 21 CFR Part 11 compliant and includes filters to handle various fonts. (Docu-Proof C3 Copy+Content Comparator, Global Vision, Montreal, QC, Canada, www.globalvisioninc.com).

Uhlmann VisioTec's modular unit checks blister packs at line speeds.

A bar code print verification tool introduced this past year now can be equipped with auxiliary heads that compensate for curved or raised surfaces by using a template that ensures the container or blister pack is positioned properly. Capable of grading multiple codes on a single label simultaneously, the system is certified to Uniform Code Council–European Article Numbering standards. A color-coded analysis pinpoints any problems. In addition to bar code verification, the system can perform optical character recognition and check for print blemishes and color registration (Integra 9500 Bar Code Quality Station with LVS Auxiliary Reader, Label Vision Systems, Inc., Peachtree City, GA, www.lvsinc.com).

For inserts, a stand-alone, vision-based reading station counts and identifies an entire box of 500 parts in a few seconds. The prototype system also can validate color coding and check whether all bar codes match (Integra 9800 Package Insert Counter, Label Vision Systems).

A low-cost, low-resolution camera-based sensor can check 3000 ppm. The camera-based system is primarily used to replace photo eyes and programmable logic control for presence– absence inspections. The system is self-triggering and records any faulty packs (Checker, Cognex Corp., Natick, MA, www.cognex.com).

DuPont's Bio-Molecular Fingerprint mixes DNA markers into ink. The markers are revealed by running a special pen across the printing to create a luminescent signal that can be read by a handheld reader.

A camera-based inspection cell for blow–fill–seal containers with a vertical feed and integrated strobe light provides a single-pass alternative to manual inspection. Dropping the containers from above exposes them to a full field of view, enabling an inspection that is faster and more accurate. The turnkey system changes over in less than an hour and can inspect for molding deformities such as voids, pits and holes, broken tabs and twist tops, separated cards (including split cards), wall discoloration, foreign particle inclusions, liquid fill level, and particulates in the liquid. It also can be set up for optical character verification or bar code traceability applications. Rated at 60 items/min, the cell was designed for a company that makes generic ophthalmic products (Ampuscan High-Speed Inspection System for Blow–Fill–Seal Containers, ATS Automation Tooling Systems Inc., Cambridge, ON, Canada, www.atsautomation.com).

Desiccants in sachet or canister form have been joined by a third format: coated desiccants. The pharmaceutical-grade coating eliminates dusting and provides a good surface for printing. A condensed formulation of silica gel, activated carbon, or a combination of the two materials doubles the absorption power of the coated desiccant. The more-powerful desiccant can eliminate the need for double drops and reduce desiccant costs by as much as 30%. Coated desiccant can be produced in various shapes. One style mirrors the size and shape of 1- and 2-g canisters to serve as a drop-in replacement using existing insertion equipment. Rounded edges expedite flow through the insertion machine. Another possibility, a large flat disk, is designed to sit at the bottom of a container, essentially hidden from view (Multiform Coated Solid Form desiccants, Multisorb Technologies, Inc., Buffalo, NY, www.multisorb.com).

Banner Engineering's compact, low-cost vision sensors can be installed on equipment to perform various inspection tasks.

Aseptic advances

Aseptic fillers, long used in the food industry for bulk bags, fill product through a proprietary filling port with a dual membrane. In operation, the port is positioned in the machine where steam sterilizes the top membrane. The membrane is then pierced and liquid is dispensed into the bag past the partially sealed internal membrane on the bottom of the port. After filling is complete, the lower membrane is heat-sealed in place and the port is flushed with steam or sterile condensate (Intasept Port and Intasept 2416M Aseptic Filler for Bio Process Containers, Rapak, Romeoville, IL, www.rapak.com).

A filling machine suitable for cleanroom installation or barrier–isolator configuration, targets small-scale production lines. Capable of handling 2–100 mL-glass vials at 50 containers/min, the machine features an integral checkweigh system, simple setup and pump calibration, and streamlined statistical data collection for fill weights. All stainless steel construction above the tabletop facilitates vapor-phase hydrogen peroxide sterilization (Model P-1510 Filler, M&O Perry Industries, Inc., Corona, CA, www.moperry.com).

Fixed cameras and an oscillating mirror minimize moving parts on Seidenader Maschinenbau's vial inspector.

Packaging line innovations

A new unscrambler handles square or round containers and eliminates belts that can mar bottles or wear out and cause downtime for replacement. An integrated rotary cleaner turns over bottles and injects a blast of air before returning them to an upright position (NERBU Unscrambler, New England Machinery, Inc., Bradenton, FL, www.neminc.com).

A tablet counter that can achieve speeds of 200 bottles/min in a dual-lane configuration relies on an infrared counting system. The self-tuning system detects space between tablets and adjusts vibrator motion to increase or decrease delivery speed (Swiftpack SP 200, IMA Nova Packaging Systems, Leominster, MA, www.novapackagingsystems.com)

A continuous-motion, high-speed, horizontal cartoner making its US debut combines positive carton opening with a personal computer-based control, a compact footprint, and an easily cleaned balcony design. Extremely quiet operation means the servo-driven machine is barely audible even when running at 200 cartons/min. This machine is highly flexible and is compatible with most automatic feeders to handle tubes, blisters, jars, pouches or bottles. Changeover requires no tools and can be accomplished in 15 min because digital scales expedite manual adjustments (Promatic PC 4000 cartoner, Romaco, Inc., Pompton Plains, NJ, www.romaco.com).

A side-load case packer features a canti-levered design for easy cleaning. Servo systems for all main machine movements eliminate the need for change parts for various case sizes. The small footprint machine fits into a space measuring 3700 × 1750 × 1700 mm and operates at 20 cases/min. The unit can be set up for tape sealing, glue sealing, or a combination of tape and glue. Case sizes range from a minimum of 150 × 100 × 120 mm to a maximum of 500 × 350 × 350 mm (GSL20 Side Load Case Packer, MG America, Inc., Fairfield, NJ, www.mgamerica.com).

A new syringe labeling system labels plastic or glass prefilled syringes offline. An integrated denesting unit increases loading speed to 120 syringes/min and reduces manual handling (NVS2, Newman Labeling Systems, Inc., San Diego, CA, www.newmanlabeling.com)

Materials and supplies

As the September 2005 deadline nears that will require wood pallets shipped outside the United States to be heat treated and certified, interest in nonwood alternatives is growing. A 40 × 48-in. polypropylene pallet is competitively priced and can go straight into work-in-process or cleanroom environments. Thermoformed from a single sheet, the pallet weighs only 10 lb and is designed for one-way trips and forklift handling. It also can be used to store raw materials or finished products if the warehouse racking system will support it. Plastic pallets reportedly clear customs faster because officials don't have to check for certification or infestation (40 × 48 CISS PP Export Pallet, Orbis, Oconomowoc, WI, www.orbiscorporation.com)

A two-layer laminate with a 4-mil layer of Aclar (polychlorotrifluoroethylene, PCTFE) delivers the highest moisture barrier available from a clear film. The PCTFE-polyvinyl chloride laminate is roughly 25% less permeable after thermoforming than other clear films and can serve as an alternative to cold-formed foil for blister packaging. Other attributes include good optical clarity and excellent machinability (Pentapharm Aclar 400/02 film, KlÖer Pentaplast of America, Inc., Gordonsville, VA, www.kpfilms.com).

Interpack highlights

Interpack, the triennial packaging show held in Düorf, Germany, showcased many new machines for pharmaceutical packaging during its April 21–27 run.

Counterfeiting prevention also was a theme at this international show. One supplier launched an overt color-shifting film for labels or seals. A series of vacuum-coated layers, some as thin as 5 nm, creates the machine-readable color shift (Color Spectra Film, DuPont Packaging and Industrial Polymers, Security andSolutions business, Wilmington, DE, www.dupont.com).

On the covert side, DNA-marker technology is supplied as a customer-specific ink. Marking the printing with a special pen activates a chemical reaction and generates a luminescent signal that can be measured with a handheld reader. A German pharmaceutical company can trace its HIV and cancer drugs by using marker-impregnated ink to print bar codes on 18 different packages the company uses (Bio-Molecular Fingerprint, DuPont Packaging and Industrial Polymers, Security and Solutions business).

Although it is not yet used in this way, an inkjet coder using food-grade colorant can mark solid dosage forms with bar codes or other images to make counterfeiting more difficult and simplify tracking. Logos, graphics, bar codes, or alpha-numeric characters can be reproduced in four-color process, with monochrome or spot color. The single-lane unit prints images as large as 2.8 in. wide at 500 ft/min, but multiple lanes or wider print widths may be accommodated (Spectra–Merlin FG inkjet coder, Spectra, Inc., Lebanon, NH, www.spectra-inc.com).

Quality control

To reduce manufacturing expenditures, quality costs, and the chance of recalls, a quality control system provides 100% inspection of blisters at line speeds. The modular prototype unit can inspect blister pack seal integrity by using vacuum pressure and camera inspection. Subsequent modules print lidstock and verify printing. Reject mechanisms remove faulty packages from the line before they move to the next step, and feedback control ensures prompt alerts if the process starts drifting out of spec (Visio4U, Uhlmann VisioTec GmbH, Laupheim, Germany, www.uhlmann-visiotec.com)

Vision sensors continue to shrink in size and cost and are frequently installed on existing equipment for new inspection tasks. Possible jobs include verification of labels, date/lot codes, syringe assemblies, vial stopper alignments, and blister packs, as well as fill level detection and case inspection (PresencePLUS P4 vision sensors, Banner Engineering Corp., Minneapolis, MN, www.bannerengineering.com)

A new generation of vial-inspection machines can check liquid or freeze-dried products and compensate for downstream problems by closing the pockets of the infeed starwheel and then reopening them as soon as the jam or error condition is resolved, thus maximizing operation at full production speed (typically 600 vials, ampules, or cartridges/min). Fixed cameras and an oscillating mirror minimize moving parts and deliver smoother machine movement, while a pitch transformer simplifies changeover for various containers (Seidenader VI 60, Seidenader Maschinenbau GmbH, Markt Schwaben, Germany, www.seidenader.de).

Equipment innovations

Blow–fill–seal machine improvements include larger motors and eliminating hydraulics. Compatible with polypropylene as well as high-density polyethylene, the latest models are designed for maximum uptime with in-line filter testing and reduced changeover time (bottlepack blow–fill–seal machines, rommelag USA Inc., Edison, NJ, www.rommelag.com).

A mobile pallet turner powered by rechargeable batteries makes it easy to replace incoming wooden pallets with aluminum or plastic (or vice versa) for outgoing shipments. Capable of turning loads weighing as much as 1000 kg on pallets measuring up to 1000 × 1200 mm, the standard unit handles load heights as large as 1300 mm (Toppy Pharma, Toppy srl, Bazzano, Italy, www.toppy.it).

Hallie Forcinio is Pharmaceutical Technology’s Packaging Forum editor, 4708 Morningside Drive, Cleveland, OH 44109, tel. 216.351.5824,fax 216.351.5684, editorhal@cs.com