To Protect and Package

May 2, 2009
Hallie Forcinio

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

Pharmaceutical Technology, Pharmaceutical Technology-05-02-2009, Volume 33, Issue 5

Products at INTERPHEX focused on protection, compliance, and deterring counterfeiting. This article contains bonus online-exclusive material.

From a packaging perspective, protection was the unofficial theme of INTERPHEX, held Mar. 17-19, 2009, in New York. Visitors found child-resistant packaging options to prevent children from gaining access to powerful drugs, compliance package designs to help patients take their medication properly, package components to prevent caregiver injuries, authentication technology to address counterfeiting and diversion problems, and systems to ensure product quality. Other innovations centered on boosting the efficiency of the packaging process.

Hallie Forcinio

Protecting caregivers and kids

An augmented syringe label prevents needlestick injuries and can be applied on standard pressure-sensitive labeling equipment with minor modifications. Already in use in Europe, the labels are printed as usual and run through an offline process to attach a small, bend-able plastic "catcher." During use, the caregiver moves the guard away, removes the cap over the needle, administers the injection, lets the guard fall back into place, and presses the needle on a flat surface so it bends into the guard. Caregivers like the design because it doesn't change the feel of the syringe, unlike other needlestick prevention technologies, which tend to result in a bulkier device (Needle Trap, Schreiner MediPharm, Blauvelt, NY).

Two wallet packs achieve an F=1 child-resistant rating with completely different technologies. Both patented designs are senior-friendly and compatible with manual and automated assembly. A large billboard area maximizes space for information such as brand elements and detailed dosing instructions to aid patient compliance.

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One design relies on parallel stripes of adhesive to seal together front and back panels of solid bleached sulfate paperboard. Strategically placed die-cuts and perforations and a carefully registered Tyvek tear strip provide access to the proper dose (CRx Pack child-resistant wallet pack and contract packaging services, Carton Service-Packaging Insights, Norris, TN).

The other child-resistant wallet pack relies on a laminate of solid bleached sulfate paperboard-polyester-heat-seal coating and patented diecutting, which expedites access for adults, but not kids. Frequently used for clinical trials, the design is compatible with virtually any blister-card configuration (3C Pak, 3C Packaging, Clayton, NC).

A new paper-free child-resistant blister card lidding provides easy access for adults. The structure of printed foil-adhesive-polyester-adhesive-foil-heat-seal coating seals at lower temperatures than a conventional paper-polyester laminate, thus enhancing productivity while reducing the amount of heat exposure the product experiences. Eliminating the paper layer also reduces particulate contamination (easy-PIESY Lidding, Constantia Hueck Foils, Blythewood, SC).

We will be seeing more ...

A proprietary top web builds child resistance into various foil laminations used for slender stick packs, a format that is gaining popularity for over-the-counter pharmaceuticals and personal-care products such as unit-dose powders, liquids, and orally dissolving strips. The material can be printed in eight colors and tears easily at the tear initiation point, which can be positioned anywhere on the package and is identified by a printed indicator or text. A layer of 92-gauge polyester imparts high tear strength and puncture resistance. Building the tear feature into the laminate itself reportedly reduces the tooling and material costs associated with traditional notched or slit tear-opening features (Amcor SafeStick, Amcor Flexibles, Mundelein, IL).

Another lamination that builds an easy-opening feature into the stick-pack material relies on laser perforation technology. If necessary, the polyester-adhesive-foil-adhesive-polyethylene lamination can be designed for child-resistance (Stick-Packs with Laser-Perforation, Constantia Hueck Foils).

The guard-equipped Needle-Trap label from Schreiner MediPharm does not add production steps.

Innovative materials

A glassine material with a proprietary barrier coating offers a renewably sourced alternative to foil lidstock for blister cards. It also represents a 20% cost savings versus foil and seals to any blister material, including polyvinyl chloride, polyethylene, polypropylene, and polyethylene terephthalate glycol. It can be printed or tinted to impart brand identity or metallized for added barrier properties and aesthetics (Barrier glassine manufactured by Bilcare, Phoenixville, PA, marketed by CCL Label, Hightstown, NJ).

Anticounterfeiting tools

A new anticounterfeiting technology is an encryption machine that is inserted into the production line and makes nanoscale changes on the surface of a solid dosage form. Pill-level encryption makes it possible to nondestructively authenticate pills anywhere in the supply chain, even if no packaging is present. The process doesn't add anything to the pill or change its dissolution or other characteristics. Three levels of protection include semi-overt, covert, and forensic. For those who know what to look for, semi-overt changes are visible to the eye. Covert changes are at the micrometer scale and can be customized per dose, per drug, or per manufacturer. They are read with a handheld loupe or 20 × power microscope. The forensic level is a nano code that can carry large amounts of information such as batch identification, manufacturing date and location, distribution country, and the serialized information from two-dimensional or traditional barcodes. Decoding requires proprietary equipment and software. The codes are so small that it's possible to fit 350 in the width of a human hair. Commercial products featuring this encryption are expected by the end of 2009 (NanoEncryption technology, NanoGuardian, Skokie, IL).

Glued construction and strategically placed diecuts and tear strip impart child resistance to a wallet pack from Carton Service-Packaging Insights.

Another pill-level anticounterfeiting tool relies on high-magnification imaging to capture a picture of each dose as it is blister packed. Each image is stored in a database and linked to the serialized code on the primary package. To authenticate product, a proprietary algorithm compares regions of interest on the tablet with images in the database. When a match is found, users can quickly locate its history by linking to a pedigree database (ISTAR image storage, tracking, and recognition, Phar-morx Security, Framingham, MA).

Similar technology relies on the fact that each punch-die set used in a tablet press imprints its unique fingerprint onto every pill. An ordinary flat-bed scanner or digital camera takes a photo of the punch die surface and stores it in a database on a secure server. To authenticate a pill, an image of its surface is captured by a scanner or camera and compared to the stored punch-die images. A match confirms product authenticity (Fingerprint technology, AlpVision, Vevey, Switzerland).

A handheld reader from Complete Inspection Systems or a cell phone can authenticate product by capturing an image of an otherwise invisible digital watermark.

Digital watermarking provides a covert way to authenticate packaging. It incorporates machine-readable data into graphics or text so that they are invisible to the eye, but detectable by a security-class reader loaded with patented software. The hidden data are virtually impossible to duplicate so if original packaging is copied, the watermark will be missing from the copy (Digimarc Digital Watermarking, Complete Inspection Systems, Indialantic, FL).

Quality assurance

Proofreading systems' ability to help prevent errors in printed packaging and labeling continue to expand. Several systems can not only compare hard copies, but also compare electronic files to hard copies and electronic files to electronic files to accommodate an increasingly digital package and labeling design and production process. Some large, multipage documents (up to 12 × 34 in.) can be proofread in a single scan (AutoProof Pro Proofreading Suite 3.5, Complete Inspection Systems).

For large-scale users, a client-server configuration lowers information-technology costs and makes it possible to update proofreading software from a server rather than installing it on each individual workstation. Set for release before the end of 2009, the format-independent software permits the comparison of unlike files and the simultaneous examination of multiple master documents even if different languages are involved (Docu-Proof R2, Global Vision, Montreal). Other software tools group, number, and classify the differences detected between electronic files or hard copies and flag variations in color (Digital-Page 5.0, Scan-TVS 5.0, Global Vision). Also new is a Braille inspection solution that detects changes as small as 0.1 mm in the height of the embossed or glue dots that form Braille codes (BraillePoint, Global Vision).

The ISTAR system from Pharmorx relies on a highly magnified image to authenticate product at the pill level.

Another proofreading system offers a color-matching function based on the Pantone color system widely used by printers. It also can be configured to work with a corporate color standard (Avia Color Matching Module, Mnemonics, Mount Laurel, NJ). In addition, a color-inspection option has been added to counterfeit-detection software that not only authenticates product, but can export images for use in legal documents (Avia Private Eye Anti-Counterfeiting Module, Mnemonics).

Turnkey line

Preintegrated turnkey lines expedite startup. Shown at INTERPHEX with accumulation tables at both ends, one turnkey line fills, caps, and labels containers ranging from 25 to 85 mm in diameter and from 40 to 115 mm in height. Bottles feed into an electronic solid-dose counter that fills 60 bottles/min. Features include optical beam sensors, toolless changeover, and touch-screen operator interface (FTC 12 Electronic Tablet and Capsule Counter, Marchesini Packaging Machinery, West Caldwell, NJ).

Mega Pumps addresses various pharmaceutical packaging needs with a wide range of pump sizes and styles, including airless.

Screw caps are fed to an intermittent-motion starwheel screw capper, which also features toolless changeover as well as a reject station with reject verification (ML 55 capper with ECO 200/400 cap feeder, Marchesini). After capping, bottles move though an automatic pressure-sensitive labeler. The stepper-driven labeling head handles label sizes from 10 to 120 mm wide and from 13 to 190 mm long. Options include reject with reject verification, thermal-transfer or hot-stamp printing, barcode scanning, and a vision system (SL 200 pressure-sensitive labeler, Marchesini). The line also can be equipped with a bottle unscrambler, desiccant inserter, cottoner, induction sealer, cartoner, bundler, or case packer (ECO-Tablet Line, Marchesini).

Disposable components

Single-use components can eliminate hours of cleaning and validation work while increasing line flexibility. A single-use product path also cuts changeover time and the consumption of utilities and cleaning agents while minimizing wastewater generation, cross-contamination, and capital investment in stainless-steel parts.

An airless pump on NeoPacs barrier tube protects product quality and shelf life.

Bosch's prevalidated, preassembled, and gamma-sterilized single-use system introduced in 2008 was shown in action on a vial filler. An option on all fillers from this company, the disposable system includes a polycarbonate rolling diaphragm pump and disposable filling needles made of stainless steel over-molded with polycarbonate. The latter cost about one-tenth the price of traditional stainless-steel filling needles. The preassembled system also includes all tubing and fittings and can accommodate eight pumps. Already in use for nonsterile products, validation for sterile products is expected to be completed by July 1, 2009.

Retrofittable on existing lines, the prevalidated disposable system also allows users to switch back and forth between disposable and multiuse components with a process that's no more complex than a standard product changeover. The flexibility to use single- or multiuse components simplifies the handling of toxic products and accelerates time to market because it eliminates validation related to cleaning and sterility (PreVAS Single-use Dosing System on FLC 3080 vial filling machine, Bosch Packaging Technology, Minneapolis, MN).

Each punch die set carries a unique fingerprint and imprints on each pill it makes.

Benchtop filler

Maximum flexibility is provided by a semiautomatic benchtop filler that can be ordered with four interchangeable metering systems. Options include peristaltic, gear, lobe, or piston pumps that simply slide in and out during a tool-free changeover. Fill rates include 4.37 L/min for the peristaltic pump, 13.25 L/min for the gear pump, 15.14 L/ min for the lobe pump, and 50 strokes/ min, dispensing 0.1-260 mL per stroke for the piston pump. The servo-motor-controlled, stainless-steel unit handles fill volumes from milliliters to gallons with accuracy of ±0.5% and can connect with equipment such as printers. Although targeted to pilot plants, laboratories, and universities, linking two or more microwave-size fillers addresses high volume requirements. A touch screen provides a user-friendly operator interface and access to stored recipes (AdaptaFil Benchtop Filler, Filamatic, Baltimore, MD).

Blow-fill-seal technology

Patent-pending technology combines aseptic blow-fill-seal production with polypropylene construction to produce a delivery system for injectable products that ensures quality, cuts costs, and differentiates product. Other features include a specially designed rubber stopper, a color-coded cap that stays with the vial after opening, and a pop-off opening device that provides one-handed access to the stopper surface. The blow-fill-seal process eliminates problems with aluminum or glass particulates and glass breakage. It also minimizes chances of microbial contamination and protects operators from exposure to the drugs being filled. Furthermore, it eliminates the need to siliconize stoppers and inventory glass vials. Preliminary stability-test results for the system have been positive for several biologic products. (Contract packaging in Secure-Vial blow-fill-seal container, Catalent Pharma Solutions, Somerset, NJ, on equipment from Wei-ler Engineering, Elgin, IL).

Comparing fingerprints of tablets and punch dies authenticates product at the pill level.

Advanced printer

A combination of ink formulation, easy-to-change ink cartridges, solid-state printhead, and advanced print-quality algorithms combine to deliver as many as five lines of high-quality printing and minimal downtime. With a printhead that needs no field service or adjustment and features automatic cleaning and purging, the printer is designed to run for 9000 h (i.e., 18 months of two-shift days) before the user must swap out the core. A smart chip on the ink cartridge allows the printer to select the appropriate print-quality algorithm and track ink consumption. The machine also features one-button startup and shutdown (Videojet 1510 inkjet printer, Videojet Technologies, Wood Dale, IL).

Embossed cartons and labels from Cortegra meet the EU mandate (effective in October 2010) that requires packaging to incorporate product name, formulation, and strength in Braille.

Guide to packaging materials

Misinformation about sustainability is widespread, and some packagers tend to favor one packaging material over another without considering all ramifications. In this light, one exhibitor stressed the need to look at the big picture and consider brand recognition, product integrity, smart service, compliance, and product security and logistics along with sustainability (iWheel Solutions, Alcan Packaging, Kirkland, Québec, Canada). It gave booth visitors at INTERPHEX a chance to play a game developed to educate its personnel about sustainability. The game tests knowledge of issues and points out common pitfalls (Eco-Challenge, Alcan Packaging). "The industry needs to elevate the conversation," says Nina Goodrich, director of sustainnovation [sic] at Alcan Packaging. "We don't want to reinforce the idea that packaging is garbage because it's not."

Equipped with one of four interchangeable pump styles, Filamatics AdaptaFil benchtop filler can vary filling speed and incorporate drawback at the end of the fill.

Dispensing tubes

A self-sealing actuator protects oxygen-sensitive lotions and creams in barrier tubes ranging in size from 15 to 150 mL and delivers a metered dose of 500 or 800 μL. The polyethylene-foil-polyethylene tube blocks oxygen and light transmission, while special seaming technology results in an almost invisible seam. The self-sealing design reduces the chance of product contamination and discoloration and prevents the contents from drying out. Although no products are commercially packaged in this tube yet, several formulas are undergoing stability testing (Airless pump, MegaPumps, Eaton-town, NJ, on polyfoil tube, Hoffmann Neopac, Oberdiessbach, Switzerland).

Another style of dispensing tube has just completed tooling validation. A conical silicone valve inside the dispensing closure makes it possible for this barrier tube to dispense a precise flow of product (Pinpoint closure from Seaquist Closures, Mukwonago, WI, on polyfoil tube, Hoffmann Neopac).