Carrying the Ball for Packaging

Packaging service suppliers are working to meet more demands.

By David Vaczek
Senior Editor

 

 

As healthcare products require more from companies, they are asking for more from suppliers. Pharmaceutical companies are looking to packaging suppliers for services that span from initial package design to management of inventory.

Drug companies have sought to introduce formats to improve the patient experience, accommodate antitheft features, and shift to more-sustainable materials. Suppliers are devising services to help clients cost-effectively meet these needs.

Packagers see growing interest in expanded partnerships as pharma firms target their resources on the competencies of drug development, regulatory conformance, and sales and marketing.

“As drug manufacturers focus on drug development and sales, they are outsourcing packaging to open up new capacity levels and increase their speed to market. “Contract packagers are attracting new customers by offering the ability to meet very sensitive timelines, executing strict quality procedures, and providing additional services,” says Eric Allen, director of sales and marketing, PrePak Systems Inc. ( Cookeville, TN).

Just-in-time inventory has taken hold such as in kanban-style scheduling systems where materials and finished product are supplied in response to market demand.

“The market will constantly look for solutions that will save money while ensuring quality,” says Narendra Srivatsa, business development manager, Cortegra ( Fairfield, NJ). “We keep getting inquiries for quick turnaround from customers looking to reduce the size of their orders and inventory to better deploy their working capital. Where two to three weeks lead time has been the norm, some companies are asking for much shorter lead times for some products and sizes.”

Offering package design, package component production, and secondary contract packaging services, Howell Packaging ( Elmira, NY) added to its distribution services last month with the opening of a new facility for trade and sample package distribution. The plant features state-of-the-art facility management, security, and bar code tracking systems.

Joe Lally, sales manager for pharmaceutical packaging at Howell Packaging, notes that clients are relying on the services of contract packagers to react more quickly to market events.

“Our success has been based on providing value across the supply chain by bundling services and integrating our operations more closely with clients’ planning functions,” Lally says. “Our customers can then allocate more of their resources to their core activities.

“We continue to add infrastructure to address outsourcing opportunities,” he adds. “For product launches, patient starter kits, and compliance and relationship marketing programs, we can meet the compressed time frames that clients impose.”

Catalent Pharma Solutions ( Somerset, NJ) expanded its warehousing and cold-chain network for m eeting growth in global clinical trials. Catalent last month opened a new temperature-controlled warehouse in Bolton, UK, that features 2000 controlled ambient storage locations and a 320-pallet refrigerator.

UNIT-DOSE MOMENTUM

Contract packagers are expanding package line capacity to meet current and forecasted demand. Anderson Packaging Inc. ( Rockford , IL) will support bottle packaging and blister and walleting lines with a major expansion of a facility in Rockford.

Compliance packaging is gaining momentum for trade packaging as well as for samples. That trend is fueled by wide-based stakeholder interest in friendly packaging that promises to contain healthcare costs, as well as by the demands of global marketing.

Anderson is manufacturing new starter pack formats designed to help patients start and persist with therapies. Catalent has aligned with One World Design and Manufacturing Group to automate production its NextBottle. Offering an alternative compliance format to blister packaging, the container features a calendarized single-dose dispensing system.

Drug firms nearly across the board have launched or plan to launch compliance package programs. Emerging retailer support for secure unit-dose formats that are efficiently dispensed at the pharmacy adds to the push for compliance designs.

“People are trying to find a way to reduce costs, while at the same time positively impact the patient, and their own sales,” says Tom Grinnan, director of innovation and adjacent markets, MWV Healthcare ( Richmond, VA). “We don’t know of one major pharmaceutical company that doesn’t have an extensive program around blister packaging for the U.S. market. Companies will be putting out at least one package this year, or in 2009, with an initial focus on chronic medications.” Grinnan says that drug firms will be looking to establish wholesale packaging changes.

“The drug industry cannot afford to have two packaging models, as manufacturing is consolidated,” Grinnan says. “As they focus on consumerized packaging, brand teams are looking to standardize on a format that is favored globally.”

Insurer reimbursement practices are also an influence. “Health benefit managers are forcing subscribers to cost-effective therapies, so the ability to keep the patient on the medication is critical,” he adds. “Adherence-promoting blisters can provide a competitive advantage over bottles for numerous drugs.”

RETAILER INFLUENCE

W al-Mart has created momentum for compliance packaging with its $4 prescription program. The retailer has adopted MWV’s Shellpak for a large percentage of prescription drugs, sourcing the packaged product from International Labs ( St. Petersburg, FL).

Acquired jointly by MWV and Bilcare, International Labs will serve the needs of multiple customers with its Shellpak program, the companies said.

“As a primary supplier of Shellpak packaging to Wal-Mart, International Labs is providing a consumer-ready product directly to the retailer,” Grinnan says. “This is a very efficient supply chain that takes out multiple distribution and repackaging steps.”

By showing that blister packaging at high volume can be economically viable (even for) low-price-point maintenance drugs, Wal-Mart has fostered interest in compliance formats from brand drug companies and other retailers.

“Retailers are pushing the market to develop more cost-effective compliance solutions to meet a very price-sensitive market in generics,” says Kevin Carter, sales executive, McKesson RxPak. “We have seen a more aggressive market shift toward patient compliance in both packaging and other service programs that can be provided. The key to this push and its ultimate success will hinge on the acceptance of consumers now being exposed to an increasing number of compliance packages in the market.”

McKesson RxPak has established Shellpak filling lines in response to customer interest in the format, expanding a portfolio of compliance designs that includes MWV’s Dosepak and the Key-in package from Nosco.

“Due to the current high demand in the market for this packaging medium, we decided to pursue fully automated packaging lines,” Carter says. “[The Shellpak] lines require significant investment, but long term [they] provide more cost-effective supply to the market.”

McKesson RxPak is also launching the first U.S. production of Burgopak’s compliance blister package, in child-resistant as well as non-child-resistant versions, under a three-year license agreement to develop the pack for U.S. and Canadian markets.

NEW FORMATS

Designed for the U.S. market by Burgopak ( London), the child-resistant version features an injection-molded tray into which the Burgopak is loaded and bonded. Squeeze-and-release locking tabs on the sides are virtually invisible from the outside. Burgopak is performing a final round of child-resistant testing, after the package scored high with children and seniors in initial testing, Carter says.

Burgopak’s format keeps a push-through blister and patient leaflets with the outer carton, when the patient pulls a tab to slide out the contents.

With a fully automated line planned for fall 2009 delivery, Carter says McKesson RxPak will be developing production for samples and 30-day-supply trade packages, with a focus on the branded segment.

“The Burgopak is a unique package with a lot of branding opportunity that we will use conjunctively with the innovative medication adherence solutions being delivered by the McKesson Patient Relation Solutions business” Carter says. “In physician’s office sampling, our TrialScript and LoyaltyScript cards can be incorporated into the package for providing manufacturers’ copay discounts.”

Package expense reductions can be accomplished in package design. In addition, clients are investigating alternate materials, and the prospects for using materials of lighter weight.

Blister package converters are providing more choices in blister materials, affording the opportunity to avoid overpackaging by selecting films and foils that more closely conform to defined barrier requirements and environmental challenges.

PACKAGE REFINEMENT

In package-stability testing following ICH guidelines, drug companies often default to a higher-barrier package that provides more barrier than is needed, and inflates their costs, says Remco van Wereen, senior vice president, marketing and technology, Bilcare Inc. (Phoenixville, PA).

“There are huge barrier differences between most packages put up on stability, [such as] between a PVC and a PVDC, and between a PVDC and Aclar or foil,” van Wereen says. “We are populating our film product lines with more intermediate barrier films to fill in these gaps. [For example], we offer PVDC films in 90- and 120-g weights, so if a put-up of 40-g PVDC fails, you don’t have to go straight to a costly cold-form foil.”

Bilcar e addresses blister costs on another front with the Bilcare Optima program that provides an alternative to industry’s standard methodology of ICH stability testing of multiple packages. In this model, the best barrier solution is selected after quantitative testing of degradation of products’ physical characteristics before packaging.

“The blister is modeled around the tablet based on the moisture levels we know will degrade the product. When you know it will pass in a particular material, you only have to put one package up on stability,” van Wereen says.

The testing discovers how the interplay of multiple variables (moisture, relative humidity, light) affect characteristics such as moisture absorption. “It is our experience that 95% of the time, products’ physical characteristics degrade long before any breakdown in the products’ chemistry. In 35–40 days time, we can identify the exact moisture levels at which product incurs dissolution, loses hardness, or discolors, and recommend a material that will meet the client’s shelf-stability requirements.”

In b ottles, customers are trending toward one-piece closure and bottle systems that support simpler manufacturing, as well as sustainability concerns, says Paul Zurawick, global new product innovation manager, healthcare closures and prescription, Rexam ( Perrysburg, OH).

“Customers are asking how materials can be taken out of packaging and for package light-weighing,” Zurawick says. “We are looking at innovation moving forward where component parts can be simplified from a cost and sustainability standpoint. One-piece systems can be more economical by eliminating the two-piece cap component.”

For less muddying of t he waste stream, one-piece systems of one material can replace two-piece closures with multiple materials. For one product that uses silicon in a valve-dispensing system, Rexam is developing an all-polypropylene system with a PP component that simulates the valve’s functionality.

“We have technology that supports removing the PVC tamper-evident shrink band, and the closure’s foil liner,” Zurawick says. “In some applications, you can go to a closure with an integrated tamper-evident band, and a compression-molded barrier liner.”

Rexam Prescription has launched prescription ovals for liquid prescriptions in seven sizes made with 100% postconsumer recycled PET resins.

OTC bottles can be designed to increase billboard space that potentially allows for eliminating secondary boxing. Zurawick says downsizing the container’s finish is a coming trend. “For many products, you can save in the size and weight of the bottle and the closure, without losing any functionality.”

Customers are also exploring reducing the number of SKUs, which opens the door for material reduction and fewer molds to service and maintain.

GOING LEAN

Packagers are engaging in more vertically integrated supply chains, where materials procurement and supply management are outsourced.

“Our business model continues to reflect our customers’ needs,” says Jason Aymerich, vice president, sales, Diamond Packaging ( Rochester, NY). “More customers are asking for ‘pure buy’ scenarios where we are responsible for the purchasing and relations with the customers’ vendors.”

“By flexibly responding to changes in demand, we can better manage our variable costs,” Aymerich adds. “We have brought in resources from the Rochester Institute of Technology for implementing lean principles in our contract packaging and printing operations.”

MWV’s Grinnan sees an increasing focus by customers on total delivered cost. “As companies more closely align manufacturing and purchasing objectives, they are allowing the supplier to work all the way into the manufacturing suite,” he says.

“We are being asked by some customers to set up teams where we help them to reduce the internal costs associated with our packaging on their lines, using the Six Sigma and process engineering perspectives we apply on our own production lines,” Grinnan adds.

PrePak Systems provides value-added
services to clients in the market for contract packaging and repackaging services. The company handles smaller-volume packaging requirements, with the flexibility and capacity to handle multimillion-unit runs, says Allen.

PrePak will support product launches with complete package design, working directly with customers’ sales and marketing teams if requested.

“A customer will say, ‘Here is our concept, go with it,’ ” Allen says. A complete project can include logo design, Web site creation, point-of-sale materials, product labels, packaging, and fulfillment services to regional distribution points.

“With the addition of our fulfillment services, we can provide clients an alternative distribution process that will help streamline the customer’s supply chain,” he says.

Primarily a bottle packager for generic drugs and government contracts, PrePak has seen industry growth in bottle unit-of-use packaging and unit-dose pouches for hospitals.

Allen notes that both packaging types help increase patient safety and reduce dispensing costs at retail and hospital pharmacies.

“By having drug product available in dispensing counts, patient safety is increased by minimizing the potential for cross-contamination and dispensing errors, and pharmacists’ valuable time isn’t wasted in pill counting,” says Allen.

PrePak is in an acquisition mode to expand from current services in pharmaceutical solid- and semisolid-dose packaging. PrePak is exploring companies for adding packaging services that might include liquids, powders, gels, and creams, Allen says.

GOING GREEN

Sustainable packaging is influencing packa ge design and material choices. Diamond Packaging has completed production of a new green promo kit, designed as a tool for brand managers and designers. The kit includes printed samples of virgin, recycled, and mixed-source paperboard options, all produced using 100% wind energy. Samples are included in the kit with descriptions of their environmental attributes, says Dennis Bacchetta, director of marketing.

“One sample is printed with an optional MiraFoil coating which adds environment-friendly meta llic effects in-line,” Bacchetta says.

Diamond’s greenbox initiative addresses sustainability through all package life cycle phases. In design d evelopment, customers’ existing formats are reviewed with tools including Wal-Mart’s Package Modeling software and ArtiosCAD for structural design.

“T here is a push by our pharmaceutical customers to reduce packaging weight and eliminate unnecessary materials, since package weight reduction offers the most significant opportunity to conserve raw materials and energy, reduce greenhouse gases, and minimize discards,” Bacchetta says.

For addressing waste-stream complexity, Bilcare offers the Nova PVDC-coated paper lid stock. “In the past two to three months, Nova has generated huge interest from brand and generic companies and retailers looking for fully recyclable packaging,” says van Wereen.

When used with PVC blisters, Nova provides barrier and stability comparable to PVC with foil-based lid stock. “Nova has the same or better push-through properties as non-CR foil. We are developing higher-barrier Nova lid stocks for use with higher-barrier webs,” he adds.

PACKAGE ID

Contract packagers and suppliers have mounted support for serializing products with bar codes and offer portfolios of authentication solutions. Catalent’s partnership with Secure Symbology features in-line bar code serialization with data storage for pedigree management. Keller Crescent has launched a preprinted solution for item-level bar coding, teamed with Secure Symbology, FujiFilm Hunt Chemicals, and Label Vision Systems.

Although some firms such as Biogen Idec, for whom Calalent is serializing product, have committed to item-level 2-D coding, industry at large is taking a second look at available options and waiting for FDA guidance.

“Pilot evaluations are going on, but the pace has dropped off [since the delay to 2015 of California’s e-pedigree requirement],” says Cortegra’s Srivatsa. “FDA could establish a tighter deadline of 2011. I do not think they will spec the technology entirely, but they will require unique product identification with item-level serialization.”

“People are taking the opportunity to look at track-and-trace and authentication from a larger perspective. They are asking, ‘Do we have the right resources, and the right people? Are we testing the right technology?’ Additionally, companies are looking at RFID technologies for supply chain value, which is what RFID can deliver more easily,” Srivatsa adds.

Cortegra is commercializing its Biometric authentication solution in partnership with Signoptic in which an alphanumeric code is tied to signatures derived from the unique and random characteristics of the package substrate. The ID number can serve as the serialized portion of the GTIN format coded to an RF tag or bar code

“2-D bar codes can be copied,” says Srivatsa. “[And] e-pedigree scanning will not pick up the counterfeits. When Biometric fingerprints are used, field inspectors can confirm packages’ authenticity as these cannot be duplicated.”

“What we are telling customers and prospects is that if you are going to invest, then here is another technology that would complement serialization requirements, but also provide additional significant value through authentication,” he adds. “We need to look at getting more value out of our multimillion dollar investments and make sure the technology is doing what it is supposed to do— adding value for patient safety.”

Bilcare has launched a fingerprinting technology based on random patterns created by nano sized magnets. The fingerprint is supplied on a 7 × 7-mm label that can be applied on a bar code. The system includes bar code and security mark readers. Unique identifiers tied to each pattern are activated in a database when the tags are used by the customer.

Scanners may be used by drug company sales reps or investigators, and wholesalers for spot checking. “We have received feedback from some retailers who would favor in-store kiosks where the patient could swipe the package to confirm the product’s authenticity,” says van Wereen.

Data can be managed to support patient-persistence programs, where, for example, patients that scan activated tags could be asked if they would like to receive refill reminders, van Wereen adds.

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