New Solutions Address Change
By David Vaczek
FDA requirements for drug product labeling have created demand for larger inserts and expanded labels. Among recent guidance, the Med Guide requirement for prescription antidepressants was extended to include NSAIDs. As of 2007, packagers have added panels to bottle and pouch labels to accommodate warnings required on OTC pain-relief medications.
These mandates followed the agency’s rule for making the package insert easier for practitioners and patients to read and use. Insert sizes grew exponentially when FDA revamped the package insert (PI) in 2006, adding content and design requirements that included minimum font sizes.
|Nosco's label solutions include cartons with preattached inserts.|
Label content is due for further agency evaluation going forward. FDA is reviewing best practices for labeling and packaging in establishing safety practices under the Prescription Drug User Fee Act (PDUFA) IV, Drug Safety Five-Year Plan. The congressionally mandated broader focus on drug safety—funded by additional user fees—will include evaluation of medication safety and reducing the risk of medication errors. A pilot program on good product naming to reduce medication errors will be tested this year, with draft guidance published in 2010 (www.pmpnews.com/article/drug-any-other-name).
While the PDUFA program is likely to generate new labeling guidance in the future, deadlines are pressing for label revisions according to the timetable for implementing the enhanced PI. New drug applications (NDAs) as of June 2006 have required the new format, which includes a Table of Contents, a half-page Highlights section, and a Patient Counseling Information section.
Drugs approved one year before 2006 must meet the rule this month (June 30, 2009). NDAs approved in previous years going back five years face deadlines each year through June 2013.
Cortegra (Fairfield, NJ) met growing demand for wide-format inserts and outserts with the purchase of an MV 2005 insert folder from Vijuk Equipment Inc. (Elmhurst, IL). The unit folds flat sheets of up to 27-in. wide down to 1⅛-×-1⅛- in. inserts, with up to 130 panels.
“More of our customers’ product lines are being impacted by the PI deadlines,” says Narendra Srivatsa, business development manager. “The format is creating more demand for real estate, as well as design assistance for accommodating the information.”
Customers are also investigating alternative solutions as European Union multilingual labeling needs add to the demand for more label space. “Companies don’t want to have different SKUs for different languages,” Srivatsa says. “Drug customers and medical device manufacturers are also considering the use of expanded content labels [ECL], or booklet labels to accomplish this. You can use a label with an insert, or print the PI in the ECL. We offer multiple choices.”
|The P200 (pictured) and P300 case packers from Serpa Packaging Solutions feature balcony design for walk-in access. A walking beam with dual-sided opposing vacuum keeps cases square through to the closing station, without the need for flight lugs.|
In carton converting, vendors face an EU October 2010 deadline for repeating label information with Braille embossing. Cortegra is embossing Braille on select lines for select customers, using spot inspection with micrometers to ensure character heights that conform with the customer’s specification.
“Consensus is developing on the height issue, and quality standards for Braille are emerging.” The key is to check that it is readable. Though the Braille standard apples only to cartons, Srivatsa says the market will drive its use on labels. “People are asking if we can provide product and safety information in Braille on inserts,” he adds.
Nosco Inc. (Gurnee, IL) has developed cartons with preattached inserts, adding to a portfolio of expanded-content offerings that include multipanel labels with removable portions, and its Fix-A-Form booklet-style labels.
One format features a carton with a fifth panel that opens like a book to access the preattached insert. In another, the insert is reached through perfs in a permanently attached cover.
Schneider Packaging Systems offers its HCP-10 horizontal case packer with a stainless-steel frame for pharma applications.
The preattached insert format is user-friendly for doctors and pharmacists, while reducing SKUs, says Kregg Albrecht, director of solutions engineering.
“Some customers want the lean aspect of one SKU,” Albrecht says. “The format also offers the marketing benefit of distinguishing the product, protecting the carton’s contents, and providing added copy space.”
“A pharmacist can read the insert, put it back in, give the box to the patient, and the main portion of the box keeps its integrity,” he adds.
In a third style of carton with preattached insert, the insert is scored to align with the dust flap of a tuck-style carton. The insert presents itself with the dust flap when the carton is opened.
“Our investment in the process for manufacturing the preattached inserts includes inspection systems for ensuring the right insert with the right package,” Albrecht says.
Nosco has developed processes for manufacturing multipart labels for syringes, vials, and ampules. Solutions include three-panel labels with copy on the bottom ply and both sides of the top ply, and labels with stickers or removable perfed sections. Multiple-ply labels can be configured in wraparound style for added copy space.
“These small-diameter containers have limited space. With the systems we have developed, the realm of design is now wide open to us [for syringe and vial labeling],” Albrecht says.
“It’s all about customizing to customers’ different requirements,” says Tom Caldwell, Nosco’s marketing manager. “Our solutions engineering group works on a collaborative basis to meet their needs from a design perspective, while ensuring runability on their equipment.”
Schreiner MediPharm LP (Blauvelt, NY) is developing capacity for manufacturing label solutions produced by Schreiner MediPharm in Munich, Germany.
The U.S. facility is installing equipment to produce Pharma-Tac infusion bottle labels with integrated hangers. In addition, it will shortly launch production of Schreiner’s Pharma-Multi-Inform Booklet Labels, says Gene Dul, president. “We are excited about expanding our product offerings to match those of our parent company in Germany. This is a critical step if we are to serve as a backup or redundant site for our global customers,” he adds.
A NEW VIEW ON PRINTING
Catalent Pharma Solutions foresees advantages including shorter lead times and reduced costs with a web-based solution that customers will use for approving and controlling the quality of printed products.
Catalent is upgrading equipment and capabilities at its Moorestown, NJ, facility, as it realigns its printed component operations with the parallel closing of its Pennsauken, NJ, folding-carton printing plant. At Moorestown, retrofits of presses and a new center for design and prepress will support the future e-Magineering solution for on-line printed component management.
Catalent is integrating vision systems on the presses and its enterprise systems with the Web-based solution. Customers will be able to design and manage printing projects, press proof remotely, and monitor quality, with real-time visibility to the production floor.
Upgrades under way at Moorestown include retrofits of two KBA Rapida carton presses, in-line UV coating capacity, and a new wide-format insert press, says Victor Dixon, vice president and general manager, printed components, Catalent.
“We will begin transferring machinery next week, with printing operations fully realigned at Moorestown by the end of July,” Dixon says. “Since we are moving in stages with redundant capacity, we do not expect any production disruption.”
For component management using e-Magineering, customers will have access to the programs and information they need through a Web portal with secure log in. Designers can use a design and graphics module, where the price adjusts as the user configures the carton or label. Moorestown will be the global location for prepress and design of cartons, labels, and inserts, supporting the online design component, Dixon says.
Using e-Magineering, quality management can track the quality of press runs. A supply-chain manager can engage the portal for its visual kanban function, supported by supply bin cameras provided in Catalent’s VMI-In-A-Box solution.
“[While] we have used vision systems to provide an additional quality control measure on the plant floor, we saw an opportunity to bring the production to the user’s desktop,” Dixon adds. “Customers will no longer have to visit the plant for a press proof, and they can verify the print quality and accuracy as their job is in progress.”
Dixon says future upgrades at Moorestown will include next-generation press technology. Catalent has recently purchased a 10-color KBA Rapida press for its Dublin, Ireland, printed components plant. The unit automatically corrects for variations in print color and quality, and enables concurrent production and makeready of alternate jobs on one press.
Press vision systems and enterprise resources are currently being integrated with the management software.
The design and graphics module needs to interface with programs such as CAD, Esko ArtWorks, and PDF graphics. The system ties into ERP “because we are offering the ability to get quotations and take orders. Quality management users will need access to our quality documentation records,” Dixon says.
Dixon says beta testers include the Catalent contract packaging division in Philadelphia. Catalent expects to release e-Magineering commercially in the fall.
In cartoning solutions, vendors are emphasizing servo control and quick changeover functions in units that meet customers’ restricted space requirements. The use of robots has grown at a steady pace, in hand with increasing cost-effectiveness.
Machine footprint is an important factor in pharma production. Packagers for the most part have limited real estate to extend lines that are commonly laid out in linear configuration. Automated machinery often has to fit into the same space dedicated for processes accomplished manually. Cartoners and case packers are not exempt from this requirement.
“If a smaller machine can provide the same level of service as a larger one, many companies will opt for the space-saving smaller machine,” says Bernie Conlon, president, Oystar USA Pharmaceutical Packaging Division (Fairfield, NJ), Oystar IWK.
Oystar IWK’s latest cartoners, the Cartopac SC 5 (continuous motion) and SI 5 (intermittent) machines, feature compact 12-ft-long footprints. The units’ output of up to 200-cartons per minute meet the capacity needs for a large segment of the market, Conlon says.
The Cartopac line features modular design supporting flexible machine reconfiguration.
“We have added the modular concept with the Cartopac to support cost-effective and faster conversions,” Conlon says.
Modular design also supports shorter lead times. “We can build the machines to a high level of completion, before adding customer-specific requirements,” he adds. “So we can offer a quicker delivery.”
For positive mechanical opening of the carton, Cartopac cartoners feature a preopening system that uses mechanically driven fingers. A linear picking feature for picking the flat sheet stock provides flexibility for handling flat stock with different tolerances.
“The rotary motion of the cycloid is supplemented by carton picker heads that move linearly in and out to pull sheets from the magazine,” says Conlon. “This helps with sheets of different sizes, or where companies are buying from different suppliers.”
“Our customers are using robotic infeeding for flexibility, where you just need to change the end effector of the robot,” Conlon says. “If you are moving from packaging tubes to bottles, you don’t need a whole new transfer system.”
MGS Machine Corp. (Maple Grove, MN) features a carton loader module to autoload components on higher speed lines. The expanded capacity prefeeder (ECP) autoloads pretrayed cartons into the magazine. “The ECP can handle all sorts of commodities including literature,” says Richard Bahr, president and CEO. “Customers have used these to reduce the numbers of operators required for manual loading.”
ESS Technologies has launched the Model K 15 Automatic Horizontal Case Packer, occupying a compact 8.8-×-6-ft footprint. Aimed for markets including pharma and medical devices, the Bergami-made machine maximizes use of servos for case-loading product in primary packaging or in cartons at speeds of up to 15 cases per minute. Servos control functions including the infeed, down stacker, pusher, and case transport, says Walter Langosch, director of sales and marketing, ESS.
The Model V 30 Vertical Robotic Case Packer, manufactured by ESS Technologies, similarly provides complete servo control for high-speed packaging of cartons, bottles, tubes, and bags. Featuring an integrated Fanuc M-20iC robot and Allen Bradley (AB) operator interface, the unit handles product at a rate of 400 per minute, Langosch says.
The units include an adjustable case magazine and servo-driven infeed system that support virtually all pharma packaging applications. “This is a very flexible and versatile machine. We have applications in which the customer is case-packing sachets and tubes on the same machine, and another system running nine different bundled carton configurations. One pharma customer is using the Model V 30 for case-packing loose bottles in a chipboard grid, which uses one robot to load into the grid and another to load the grid into the case,” he says.
Bergami and ESS have added a seventh model to the line of AS series cartoners, the AS 350. “We have quoted this up to 400 cartons per minute so far,” Langosch says.
According to Langosch, Bergami is converting the majority of its machines to an Elau control platform for sales in Europe and other world markets. “[About] 70% of our annual sales are to existing customers using AB controls. We will support both systems, as will Bergami, which will continue to make AB-controlled units for customers who request it,” he says.
The cartoner line from Uhlmann Packaging Systems (Towaco, NJ) supports a range of cartoning speeds, starting at 130 cartons. The highest-output machine, the C 2504, produces cartons with a 4-in. pitch at 500 per minute. Modular design supports flexible machine configuration to meet customers’ current or projected needs.
The latest-generation cartoners feature added servo controls, and automatic adjustment for changeovers. Changeovers take no longer than 15 minutes, as stepper and servo motors support recipe-driven changes at the push of a button, says Dirk Corsten, managing director, sales and marketing.
Uhlmann offers a rotary carton feeding system, with a patented prebreak function. The system over-breaks cartons at a standard setting of 140 degrees.
“The material’s memory moves the carton panels to 90 degrees after feeding into the carton chain. With servo control of the over-break, the owner can set the break to any angle, so you can run any quality of carton on the machine,” Corsten says.
Schneider Packaging Systems (Brewerton, NY) has launched a version of its HCP-10 horizontal case packer with a stainless-steel frame for pharma applications.
“The HCP-10 is an excellent option for spacesaving, that efficiently combines case erection, collation, loading, and sealing in one solution,” says Terry Zarnowski, sales and marketing director.
Schneider integrates Fanuc robots into modified case-packers in custom-configuring end-of-line solutions, for robotic picking of product, cartons, or literature. In one application, robotically picked folded leaflets are placed between bottles packed in a tray, Zarnowski says.
The PLC-controlled, intermittent-motion HCP-10 packs bundles of cartons at speeds up to 10 cases per minute. ■