It's Showtime!

SPECIAL NOTE: Check out PharmTech's preliminary program for its live video interviews at Interphex 2010.

This year's Interphex will deliver one of the best opportunities of 2010 to learn about the latest pharmaceutical packaging materials, containers, machines, and services. Interphex 2010 will take place on April 20–22 at the Javits Center in New York and will reveal new packaging designs as well as technology for filling, brand protection and traceability, coding and labeling, and quality control. The conference program also will feature several packaging-related sessions.

Hallie Forcinio

Filling

A semiautomatic benchtop filler incorporates features normally found only on automated systems, including networking capability and a user-friendly operator interface. Four easy-to-change metering systems broaden the number of products that the unit can handle (AdaptaFil benchtop filler, Filamatic, Baltimore, MD).

Brand protection and traceability

A new patented process invisibly marks packaging surfaces with a pseudorandom pattern of thousands of microdots (10–15 μm in diameter) to provide anticounterfeiting protection without changing the printing process or ink. The process also does not change the appearance of the finished package, raise production costs, or increase energy consumption. Microscopic variations in the thickness of the varnish layer also can be used to invisibly mark the packaging in a way that's impossible to replicate. Compatible with offset, rotogravure, flexographic, laser, or inkjet printing, the micropatterns rely on a digital key of 128 bits and easily integrate into any packaging production line. Product authentication is accomplished in seconds by capturing an image of part of the packaging on an office scanner or camera phone and emailing it to a secure server for automatic verification (Cryptoglyph process, AlpVision, Vevey, Switzerland).

TETRA IMAGES/GETTY IMAGES

A serialization system provides a standard, yet customizable, way to add product traceability to packaging lines with a minimum of reengineering. Designed to work with various printers and cameras, the system links to information technology networks through tried-and-tested data-communication protocols. A high-precision mechanical transfer unit capable of operating at a speed of 90 m/min takes each folding carton from the cartoner and transfers it to the printer in the optimal position for serialized marking. A camera verifies print legibility and correctness. The system is available with a feature that detects whether the carton has open flaps and whether it is correctly aligned. Any carton on which the marking cannot be verified as "good" is reliably rejected into a lockable catch bin (XMV Mark and Vision System, Mettler-Toledo Hi-Speed, Ithaca, NY).

A new name in anticounterfeiting technologies specializes in multilayered brand-protection solutions. Printed covert and overt security features and software help pharmaceutical packagers achieve serialization, authentication, and track-and-trace objectives (AuthentiTrack software, Covectra, formerly known as Pharmorx Security, Southborough, MA).

Digital-watermarking technology embeds an encrypted code into existing package graphics. This covert authentication feature cannot be seen by the unaided eye but can be identified digitally by a web-enabled mobile phone or handheld reader using patented security-class software. The code not only authenticates the product, but also provides background data and refers consumers to interactive websites where they can obtain additional information or place orders (DigiTrack digital security feature, Catalent Pharma Solutions, Somerset, NJ, based on hardware and software from Complete Inspection Services, Indialantic, FL, and its technology partner Digimarc, Beaverton, OR).

Coding and labeling

A small-character continuous inkjet printer combines maximum uptime, ease of use, and a simplified fluid-replacement system. The microchip-equipped fluid cartridge identifies contents to prevent errors in ink selection and confusion between makeup and ink bottles. The cartridge shape ensures that it drains completely, thus minimizing residual fluid and waste and further reducing costs. A needle-and-septum design eliminates the need for operators to pour ink and prevents spills and waste. A calibration feature automatically adjusts the printhead based on changes in the environment to ensure consistently sharp print reproduction quality, regardless of ambient temperatures, which can alter ink viscosity.

The easy-peel Pharma-Comb label from Schreiner MediPharm integrates with pharmaceutical manufacturing processes. (PHOTO COURTESY OF SCHREINER MEDIPHARM)

A modular design consolidates key components and reduces the frequency of preventive maintenance to every 9000 h, or 18 months, for medium-duty applications. A countdown meter on the user interface shows how much time remains until module changeover, which takes about 30 min and doesn't require a service call. A USB port lets users hot swap print jobs and back up printed messages. Ethernet capability enables off-site control and diagnostics as well as real-time message changes (Videojet 1510 inkjet printer, Videojet Technologies, Wood Dale, IL).

A servo-driven feedscrew and trunnion roll system on a servo-driven, pressure-sensitive label applicator keep vials under positive control to achieve label placement accuracy of ±0.5 mm. Fixed-position product sensors eliminate the need to make mechanical adjustments when setting the label location on the container. An integrated air reject on the servo-driven feedscrew removes fallen containers, thereby reducing jams and minimizing unplanned downtime. Fail-safe logic keeps the system running even when the web is missing a label.

The Videojet 1510 is designed for medium-duty applications that involve printing codes roughly 16–20 h/day for six days each week. (PHOTO COURTESY OF VIDEOJET)

The servo technology also minimizes maintenance requirements and quickens changeover, which takes less than 10 min and requires no tools. To ease maintenance, the full barrier guard features front- and back-access doors, and the main control panel is mounted on a pullout drawer for easy access. Quick disconnect sensors allow failed sensors to be replaced without rewiring.

Suitable for containers with diameters of 0.563 to 2 in. (14.3–50.8 mm) and shoulder heights of 0.813 to 3 in. (20.6 to 76.2 mm), the labeler applies wraparound labels to as many as 300 containers/min. Four servo motors compensate for speed variations and synchronize with the conveyor, and the control system provides label tracking capability. Options include an optical character-verification or optical character-recognition camera; radiofrequency identification labeling; hot-stamp, laser, or thermal-transfer coders; label-placement inspection; barcode readers; soft reject stations; and an automatic label-removal station to remove faulty labels from the web (Model 326 Auto-Colt III Trunnion vial labeler, from NJM/CLI, Lebanon, NH).

NJM/CLI's Auto-Colt III Trunnion labeler meets good manufacturing practice standards and offers exceptional durability. (PHOTO COURTESY OF NJM/CLI)

A new label design for multidose medications features a multilayer construction that peels easily to free labels for attachment to filled, disposable syringes. Because all critical information is provided on the detachable label parts, it's available at any time and provides clear identification and traceability of the drug until the time of administration (Pharma-Comb label, Schreiner MediPharm, Blauvelt, NY).

Quality control

A document-comparison system ensures the accuracy of printed materials including labels, inserts, packaging, and manuals. To ensure error-free performance, the system reads PDF files and compares the underlying data of each character rather than its shape or appearance. Discrepancies are highlighted and listed in the same order that errors would be spotted by a human reader (Quantum Compare document comparison system, Complete Inspection Systems, Indialantic, FL).

A metal-detection system seamlessly transfers open and closed bottles into the unit to provide 100% inspection for metal contamination. If any contaminants are found, an automatic diverter performs a soft reject (Insight PH metal detector, Lock Inspection Systems, Fitchburg, MA).

Another high-speed metal detector checks tablets and capsules as they are discharged from the molding press. An operator interface with a Windows-style, color touch-screen makes the system easy to run, while sophisticated software delivers the sensitivity necessary to locate the tiniest fragments of difficult-to-detect nonmagnetic stainless steel. Advanced condition-monitoring technology in the controller provides early warning of maintenance needs and prevents unscheduled downtime. Other features include robust, low-profile casters and three-axis head adjustment (Tablex 2 metal detector with a PowerPhasePRO operator interface, Mettler-Toledo Safeline, Tampa, FL).

Research shows that vacuum-decay leak testing detects the slightest amount of vapor and gas release and is a suitable way to confirm the integrity of syringes, vials, and ampuls. According to two studies, the vacuum-decay unit identified all defects ≥ 5.0 μm with no false positives or negatives (1, 2). The researchers concluded that the vacuum-decay device not only provides quantitative results that are not subject to human interpretation, but also can be incorporated into protocols at any point in the handling process because it is nondestructive, noninvasive, and requires no sample preparation (VeriPac 325/LV, PTI-Packaging Technologies and Inspection, Tuckahoe, NY).

A four-camera system inspects various colors of full or empty plastic or glass bottles. Compatible with container sizes as large as 1.5 L, the system operates at line speeds as high as 400 bottles/min. The four cameras eliminate the need to orient the container for label inspection. Eliminating container orientation reduces space requirements and cost while increasing throughput (360° Full View bottle inspection system, Mettler-Toledo CI-Vision, Aurora, IL).

Conference sessions

Interphex is accompanied by a full conference schedule. Packaging-related sessions include the following:

• Integrity Testing of Single-Use Bags by Helium Method. Speaker: Alex Terentiev, US director of research and development, ATMI Life Sciences (Lexington, KY)

• Reduce Waste and Improve Sustainability through Prevention, Early Detection, and Reprocessing. Speaker: Alan Shuhaibar, president, BellatRx (Pointe-Claire, Canada)

• Green Solutions for Temperature-Controlled Shipping. Speakers: Elizabeth M. Steiner, executive director, Alliance of Foam Packaging Recyclers (Crofton, MD), and Al Valkema, national industrial accounts director, Sebright Products (Hopkins, MI).

• What, Where, When, and How to Use Radio-Frequency Identification (RFID) Technology in the Pharma Supply Chain: Identifying the Real Business Value. Speaker: Anthony Palermo, director of business development, Academia RFID (Montreal)

• Worldwide Pharmaceutical Package Traceability. Speaker: Ron Lawson, president, Seidenader Vision (Florham Park, NJ);

• Attacking the Cold-Chain Challenge. Speaker: Chad Wachter, business-operations manager, GlaxoSmithKline (Research Triangle Park, NC)

• Securely Implementing RFID in the Pharmaceutical Supply Chain. Speakers: members of the RFID Security Alliance (Sausalito, CA).

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.

References

1. H. Wolf et al., J. Pharm. Sci. Technol. 63 (5), 472–488 (2009).

2. H. Wolf et al., J. Pharm. Sci. Technol. 63 (5), 489–498 (2009).