Packing in More Labeling Solutions at PACK EXPO
Pharmaceutical and medical device manufacturers alike are gearing up to include more product information in labeling. Many of these products will need to carry item-level serialization or other variable information, and some products must bear detailed warnings to convey product risks. And for manufacturers serving a global market, they must accommodate the 20-plus languages spoken within the European Union (EU), along with new outer packaging requirements under the Falsified Medicines Directive.
Exhibitors at the PACK EXPO International in are showcasing a number of new printing/labeling technologies, along with capabilities to support such processes on automated packaging lines.
In the Pharmaceutical Pavilion, for instance, exhibitors in more than 70,000 net sq ft are showcasing advances in cartoning, labeling and inspection, along with those in filling, blister packaging, flexible pouches, tubes and closures. The Pharmaceutical Pavilion will also feature the Rx Lounge for networking and education. Attendees with questions can visit the lounge’s “Ask the Expert” for additional help. Pharmaceutical and medical device labeling technologies and related support can also be found throughout the show.
New labeling requirements
Under California’s electronic pedigree regulation, at least 50 percent of a manufacturer’s pharmaceutical products will need to bear a serial number at its lowest saleable level by Jan. 1, 2015; the remaining 50 percent will need to do so by Jan. 1, 2016. In July of this year, the California State Board of Pharmacy approved language that states the “unique identification number” to be applied to the smallest package “shall conform to requirements for Standardized Numerical Identifiers (SNIs) set forth” by FDA’s March 2010 guidance.
Also in July, FDA released its proposal for Unique Device Identification (UDI), which would require most medical devices distributed in the United States to bear unique device identifiers. The rule also proposes standardized date formats for medical device labels, as well as direct-part marking for certain medical devices. FDA is seeking comment on the proposal by Nov. 7.
And between March 2008 and January 2011, FDA approved more than 150 Medication Guides for products approved under new drug applications (NDAs) and biologic license applications (BLAs) as part of a Risk Evaluation and Mitigation Strategy, the agency reported in its November 2011 Med Guide Guidance. Many pharmaceutical companies have turned to inserts and outserts and even multiple-panel labels to provide the needed details.
Finally, in July 2011, the EU adopted the Falsified Medicines Directive, which would require the use of outer packaging features that allow users to verify product authenticity, identify individual packs and identify package tampering. Pharma companies serving this market are investigating a range of labeling options.
Given such increasing labeling requirements, it is no surprise that pharmaceutical and medical device packaging professionals are looking for efficient ways to add printing, labeling and verification technologies to their packaging lines. According to a 2012 survey on purchasing trends conducted by Readex Research (www.readexresearch.com) for Pharmaceutical & Medical Packaging News, the most popular purchases are labels, printers, and labelers.
For instance, the No. 1 item on PMP News’s survey respondents’ material/container shopping lists are labels (34 percent), edging out bags and pouches (31 percent) and cartons (27 percent). In terms of packaging equipment, 23 percent are purchasing printers and 22 percent are purchasing labelers, compared with 16 percent purchasing sealers.
“Labeling is a critical component for product identity, as well as instructions for use,” explains Tom Egan, vp, industry services, for PMMI (www.pmmi.org), the organizer of PACK EXPO International. “We are seeing interest in extended labeling to provide more information, as well as digital printing.”
Inline printing can support variable information such as item-level serialization and multiple languages. And there are distinct benefits beyond meeting regulatory requirements. “Not only are you able to print the latest information, but you can also reduce waste and inventory through just-in-time printing,” says Egan.
Vision systems are increasingly being used on packaging lines for labeling operations, Egan observes. “Vision systems can verify that the proper label version is being applied as lines change over from one product to another,” he explains.
Adding sophisticated printing and labeling technologies to high-speed production lines can be challenging, says Egan, but PACK EXPO exhibitors are providing the expertise. “Drug manufacturers, especially those handling generics, are looking for increased speed. They are automating as much as possible. Machinery manufacturers are helping these companies maintain product quality and support frequent changeovers to handle multiple products.”
PACK EXPO exhibitors are also “reacting to industry’s need to be smarter and simpler,” he says. For instance, today’s packaging equipment can draw “information from manufacturing execution systems to ensure that what is intended to happen on the line actually does happen,” he adds. “Human-machine interfaces are also easing operations for those who do not have years of experience. Simpler controls with graphical user interfaces are offering levels of operator access for operation or even quality control. If needed, operators can adjust machine parameters using the HMI. ”
PACK EXPO International exhibitor MGS Machine Corp. (www.mgsmachine.com) is ahead of this trend. “The world’s greatest machine can fail or have a labeling problem, so we have made it easy to identify a fault, clear the fault and get the line up and running again,” says Richard Bahr, president of MGS Machine Corp. “We’ve built diagnostic tools into our HMIs and use pictures and graphics.” MGS will be exhibiting in Booth #2521.
Supporting new requirements
Adding variable information to packaging to support item-level serialization and Unique Device Identification will require a range of printing and labeling technologies and ancillary equipment.
At PACK EXPO, Hapa & Laetus Inc. (www.hapa.ch) will be exhibiting the 230 hybrid dual printer containing flexo and digital for web printing on blister packs, as well as the RedCube, a drop-on-demand in-line printer for cartons, labels and webs that can be used for track-and-trace applications involving difficult substrates and/or high-resolution requirements, explains Chris Hasson, general manager at Hapa & Laetus Inc. and Gottscho Printing Systems (now owned by Hapa). RedCube can be used as an alternative to thermal inkjet printing (TIJ), Hasson adds. The companies will be exhibiting in Booth #1201.
Laetus offers the MV-50 standalone item level serialization unit containing product handling, vision and digital printing. It features a 360-degree camera that provide a “wrap view” of labels already on bottles and provide full scan/verification, says Hasson.
Manufacturers must print the correct unique identifiers in machine-readable quality, so employing verification technologies is critical. “We are seeing a lot of serialization readiness activities these days,” says Bahr of MGS Machine Corp. To support such capability on the packaging line, “printing and vision go hand in glove,” he says. “We are adding more vision systems these days. They are easier, simpler to use and more inexpensive.”
At PACK EXPO, MGS Machine will be exhibiting its Carton Inspection Module (CIM), a one-meter-long unit for printing and inspecting serialized cartons. Non-compliant cartons are rejected into lockable bins. “The CIM is its own system, discretely validateable, open to any vision system,” says Bahr.
Mettler Toledo (http://us.mt.com) will be exhibiting the DMS XMV Marking and Verification system, which combines inkjet printing of codes with immediate machine vision high-resolution code verification. “All components—which include inkjet printing or laser-marking systems, high-resolution verification cameras, mechanical transfer units and sorting devices—have been finely tuned to work in perfect unison to meet global serialization, E-pedigree and track-and-trace legal requirements and specifications,” says Mark Feher, business development manager, Mettler-Toledo Hi-Speed. The system can employ a wide variety of marking and camera systems. The company will be exhibiting in Booth #706.
The XMV’s mechanical transfer unit takes the collapsible carton directly from the cartoner and transfers it to the printer for serialization marking and verification, explains Feher. “As an option, the XMV can also detect whether the carton has open flaps or is not correctly aligned, to protect the printer head and downstream bundle packaging equipment. All cartons where marking cannot be 100 percent verified as being ‘good’ are reliably rejected into a lockable catch bin. Finally, all ‘good’ cartons are safely transferred to the customer’s conveyor for further processing.” A single touchscreen interface makes product change, download of printing information and camera adjustments simple and fast, reducing downtime, he adds.
Omega Design Corp. (www.omegadesign.com) will be demonstrating a complete line to support unit-level serialization. It will feature manual and semi-automatic end-of-line solutions that are flexible, compact and easy to add to existing processes, explains Glenn Siegele, president of Omega Design Corp. The company will be exhibiting in Booth #2505.
Omega’s line will bottom-code bottles for individually identifiable bottles and secure aggregation. “Secure multi-level aggregation supports reliable inference, a secure downstream supply chain and consumer protection,” Siegele says.
Omega Design will show how integrated equipment can upgrade existing packaging lines into serialized packaging lines overlaid by a live database. Equipment integrated into the demo will be the SRP Unscrambler, for coding, vision and rejection; a checkweigher demonstrating DataSync bottle integrity profile and quality control; 360-degree inspection/LabelSync-Round bottle inspection and complete bottle handling through rejection; the semi-automatic PackSync System with manual CaseSync for simultaneous code inspection ensuring secure parent-child for two levels of aggregation; manual CaseSync demonstration for cartons showing Pack-by-Layer Secure Aggregation with dynamic camera; and the MMX shrink bundler.
“More important than the individual machines is how they all fit together,” says Siegele. “The industry wants end-of-line solutions that are easy to add to existing processes. Omega intends to show PACK EXPO attendees that they offer just that. The company’s secure aggregation process is best-in-class for supporting reliable inference, a secure downstream supply chain and consumer protection.”
To meet increased requirements for Medication Guides, MGS Machine will be exhibiting the ECOM (Extended Capacity Outsert Magazine) machine, which features a new automatic loader. It can be added to existing, fielded outsert machines, such as the MGS TopSerter II or SideWinder. Featuring discrete simple controls, the ECOM typically requires no validation.
“Outserts can be loaded into the equipment right out of trays, and the system is chest high, so it features better ergonomics,” says Bahr. “Operators can load up to 24 trays on the system and essentially walk away from it. No sleeve required, and empty trays are automatically discharged. The system reduces labor, which also helps save costs. We are seeing more projects these days request labor reduction.”
Respondents to the PMP News survey consider several factors when evaluating labeling technologies and other material and equipment purchases. More than half (55 percent) are motivated to invest in technologies that increase manufacturing capacity and increase profitability (53 percent). A sizable number of respondents (46 percent) are interested in reducing waste/resource use (46 percent).
Attendees at PACK EXPO International are likely to find options on display that meet increased demands for info-packed labels and offer heightened capacity and efficiency.