Medical Device Link.

Pharmaceutical and Medical Packaging News Magazine
PMPN Article Index

Originally Published PMPN August 2005

INDUSTRY OUTLOOK

Today's healthcare product packagers are taking charge of—or being charged with—more than just package integrity.

Daphne Allen, Editor

Package integrity is no longer enough. Maintaining product integrity and efficacy through packaging is, of course, the primary goal of healthcare packagers. However, packagers of pharmaceuticals and medical devices are now also being asked to enhance patient safety and mitigate counterfeiting and diversion risks, among other things. FDA and purchasers such as hospital groups have been very active in suggesting the use of various packaging and labeling technologies to address challenges in these areas. On top of all this, packagers are constantly being asked to take costs out of packaging, either through downgauging or new packaging formats.

Perhaps prompted by these great expectations, some pretty remarkable advances in healthcare packaging have taken place in the last few years. In this look back at the last year (or so), PMP News examines some of the latest trends in healthcare packaging and how packagers and their material, equipment, and service providers are progressing.

Statistically speaking, the market is a healthy one. According to The Freedonia Group Inc. (Cleveland), U.S. demand for pharmaceutical packaging will rise 4.7% per year to reach $6.8 billion in 2008. Blister packages are expected to show the highest revenue growth, jumping 6.3% per year to reach $1.4 billion in 2008. Freedonia also predicts that the sterile medical packaging market will reach overall sales of $2.1 billion by 2008. Sterile pouches will be the leading packaging product in the device and medical supply market through 2008. Improvements in barrier strength and impact and moisture resistance will aid demand.

Machinery demand is high as well. The Packaging Machinery Manufacturers Institute (PMMI) reports that the U.S. pharmaceutical and medical device industries will spend $715 million on packaging machinery in 2005, 12.1% of the total for all industries.

BAR CODING

With FDA's bar coding rule taking effect in less than a year (April 26, 2006, to be exact), bar code printing continues to occupy pharmaceutical product packagers. It is a significant new responsibility for many packagers, placing them in the role traditionally performed by a package converter or printer. Recent challenges include producing high-quality bar codes on high-speed packaging lines and verifying those codes in-line. Others for the well-advanced set include adding lot and expiration dates using two-dimensional symbology and coupling bar code printing with electronic coding technology such as radio-frequency identification (RFID). Medical device packagers are also being asked to consider the benefits of a similar rule for their products.

Pharmaceutical bar codes have long been printed reliably by flexographic printers, by such units as platen printers from Adolph Gottscho Inc. (Union, NJ) and rotary systems from Griffin-Rutgers (Ronkonkoma, NY), among others. While these technologies continue to be used by drug firms relying on static codes, it is notable that ink-jet, thermal-transfer, and laser printing, for instance, are being looked at because they can be reprogrammed with no tool changeover. Hewlett-Packard (HP) has worked with several printer suppliers in the past couple of years to provide its thermal ink jet printheads in printing systems from Gottscho, Bell-Mark Corp. (Pine Brook, NJ), Nutec Systems (Lawrenceville, NJ), and Greydon Inc. (York, PA), among others. One new system, the HP-100, comes from Greydon, offering HP's thermal ink jet printhead integrated into Greydon's traversing system to produce high-resolution (600 dpi) characters on paper or Tyvek stock.

Verifying the quality of these printed codes in-line in an efficient manner is the next challenge. Joe Costa, director of marketing for Systech International (Cranbury, NJ), says that "new controls placed on the pharmaceutical, medical device, biotech, and healthcare industries for product identification safeguards have resulted in an extraordinary rise in demand for RSS [Reduced Space Symbology] functionality in inspection solutions." The company's product for bar code inspection is TIPS Sentri, which grades codes according to ISO standards. Used in conjunction with Systech's TIPS Advisor Serialized Product Tracking application, it lays the foundation for implementing global supply- chain integrity procedures. Individual item-level product serialization using a combination of bar coding, RFID, and item tracking technology is also a rapidly growing trend in the industries we service. Together, these technologies provide the backbone of serious anticounterfeiting initiatives, says Costa.

Over the past year, systems have debuted for applying both bar codes and RFID tags that carry electronic product codes (EPC). Markem Corp. (Keene, NH) offers systems for applying RFID tags and labels to cases and cartons. Designed for high-speed lines, they use software to ensure that correct, unique EPCs are encoded in the tags. NJM/CLI Packaging Systems International (Lebanon, NH) offers the Auto-Colt III pressure-sensitive labeler for applying and verifying RFID tags as it applies preprinted labels. Sato America Inc. (Charlotte, NC) has demonstrated RFID Gen 2 interoperability with its CL408e/ CL412e RFID-enabled thermal bar code printers. The next challenge will be to bring RFID encoding to real-time primary package printing, writing to the tag as the label is being printed.

Medical device packagers may soon be weighing these options. FDA held a fact-finding meeting with manufacturers and industry groups in April to determine whether a voluntary bar coding standard would promote proper medical device identification. While there is no industry consensus and FDA has yet to make its plans known, some healthcare product purchasers are interested. The American Hospital Association, the Association of American Medical Colleges, Premier, VHA, and others wrote FDA in May to encourage the agency to consider a bar code rule for medical devices.

To be prepared for any standards, whether mandatory or voluntary, DuPont Medical Packaging is "developing improved printability and bar code readability for its next generation of Tyvek," says John Richard, North America business manager, medical and industrial packaging, for DuPont. Such work is in keeping with the larger industry trend toward printing on demand, he says, such as printing lidstock right on the form-fill-seal packaging line.

SECURITY

Even though industry has always worked to secure pharmaceuticals and medical device packaging, past efforts have largely focused on providing tamper evidence. But FDA's report, Combating Counterfeit Drugs, published in February 2004, has got everyone talking about track-and-trace technologies to combat counterfeiting and diversion. (So much so that PMP News started a new column this year, "Track and Trace.") The goal now is to add packaging and labeling features, either covert or overt, that can authenticate a product and reveal its intended location in the supply chain.

"Packaging professionals are being challenged to think differently to come up with new package designs that make products more difficult to compromise," says Jim Rittenburg, vice president of pharmaceuticals for Authentix (Dallas). "The accepted practice of having standardized packaging across multiple product lines may provide economic advantages to the pharmaceutical manufacturer, but it also represents a weakness that counterfeiters can take advantage of."

RFID is widely suggested as the solution, most likely because of FDA's interest in it. "FDA's recommendation to adopt RFID technology by 2007 has been an everyday conversation with brand owners," says Ralph Mendoza, sales manager, North America, for Stora Enso (Wisconsin Rapids, WI). "In some cases, the term RFID has become the umbrella name to loosely describe initiatives to meet local government requirements in electronic pedigree, track and trace, and brand authentication, all of which may work in tandem with RFID, but equally can be implemented and referred to as a stand-alone application or solution." Two pharmaceutical companies, Pfizer and Purdue Pharma, have been open about their use of RFID for their two high-profile drugs, Viagra and Oxycontin, respectively. Both are aiming for successful read rates at or near 100%.

Some of the challenges to using RFID are being overcome, such as the difficulties encountered when packaging liquids or using metals. Tagsys (Doylestown, PA) and West Pharmaceuticals (Lionville, PA) overcame both these challenges this year when the two companies collaborated to add RFID to parenteral drug vials. Their solution, which embedded the RFID tag into the vial's cap, also eliminated concerns about tag robustness. The 13.56-MHz tag, which uses technology from Philips Electronics, has a failure rate of less than one in 1 million, reports Tagsys' president, John Jordan.

Still, RFID technology providers have a lot of wooing to do. According to the latest purchasing plans study conducted by the PMMI, more than 40% of respondents say that they are simply "unsure of when their respective plants will be up and running with a fully scaled, long-term RFID system," the report says. Many packaging professionals are taking a wait-and-see approach. Even though this is a broad study of several markets, pharmaceutical firms have expressed similar restraint as they wait for quality to increase and cost to decrease.

Security solutions other than RFID are also emerging. While holography and security printing, for instance, are hardly new in and of themselves, layering their use in pharmaceutical packaging is a relatively new endeavor. Narendra Srivatsa, business development manager, brand authentication, for New Jersey Packaging (Fairfield, NJ), suggests using several technologies in tandem to outsmart counterfeiters, as in the firm's RxTrackNSecure family of solutions. "RFID alone won't solve the problem," he argues. "It provides a big solution to many supply-chain problems, but it must be layered with other covert and overt technologies, like optically variable displays, taggants, and others, for a complete solution." He even suggests the use of technology that consumers can use to authenticate products themselves, and he also says that unit-dose packaging may be needed. "If a consumer doesn't see protection for a product, what will his or her level of confidence be?"

Stamping-foil manufacturer Kurz (Charlotte, NC) has just introduced transparent, holographic cold-stamping foils for web printing. Cold stamping transfers metallized or transparent foils without the combination of heat and pressure. These transparent foils may be overlaid on customer designs, corporate colors, logos or any type of product labeling. According to the firm, the interplay between the holographic pattern and the underlying print raises the barrier to counterfeiters. Transparent cold-stamping foils with continuous designs may also be produced in Trustseal, an optically variable device produced through a proprietary process from Kurz.

Also, Nosco Inc. (Gurnee, IL) combines traditional packaging with consumer-obvious authenticating tech- nologies, such as color-shifting inks or other optically variable structures.

Rittenburg from Authentix says that when he has helped customers add security features to products, he has influenced packaging selection. "Based on our recommendations, a pharmaceutical manufacturer has now decided to change its packaging strategy for a new pipeline product from bottles to blisters. The use of bottles would have greatly increased the chance of illegal distribution and the entry of counterfeits into the supply chain. By changing to unit packaging, this manufacturer will have much greater control over the product distribution and will significantly increase the barrier and cost of entry to counterfeiters who try to attack this product."

An option that builds on some of these solutions is serialization. As mentioned above, manufacturers can assign a unique code to each item, which could be a serialized code or a random one. It could be written to the RFID tag or printed overtly or covertly, says Kevin Erdman, president of Verify Brand. Web-based software, such as that from Verify Brand, could allow supply-chain participants, such as pharmacists, to call in codes for verification.

Adds Rittenburg from Authentix: "Many companies are coming to the conclusion that the near-term solution is likely to be found in hybrid systems that employ serialized bar codes at the unit level and bar coding or RFID at the higher levels of packaging."

Although FDA's report highlighted pharmaceutical counterfeiting threats, medical device manufacturers, too, may need to be concerned. After surgical wound mesh was counterfeited in 2003, the possibility of medical devices facing similar counterfeiting became real. DuPont Medical Packaging is working to raise awareness of that threat by offering workshops and technologies intended to help device manufacturers add authentication features to their packaging. Solutions include color-shifting films and biomolecular markers that provide brand owners the speed and security of on-site, machine-readable product authentication with quick, easy-to-use hand- held readers.

What may be just as important as counterfeiting is product diversion, says DuPont's Richard. "It is important that medical device packaging professionals select and incorporate brand security solutions that aid in both reducing the likelihood of counterfeiting and the potential for diversion of authentic product." He says that diversion risks increase as medical device manufacturers begin serving overseas markets. "Global supply chains with offshore operations present greater risks of product diversion, which can have a detrimental impact on regional pricing strategies."

PATIENT SAFETY AND COMPLIANCE PACKAGING

Making packaging easier and safer for patients to use continues to be a key issue, given the steadily increasing number of patients managing chronic health conditions. "Safety of home medication is a key health issue for governments, consumers, and sustainability-driven companies around the world," says Stora Enso's Mendoza.

Safe medication use relies on a number of packaging and labeling features. FDA has increasingly been asking makers of certain drugs, for instance, to provide more printed information. These include nonsteroidal antiinflammatory drugs (NSAIDs) and antidepressants, which now must be supplied with Patient Medication Guides (MedGuides). To help manufacturers provide such printed materials, label printers like Nosco Inc., Arlington Press (Lake Success, NY), and The Challenge Printing Co. (Clifton, NJ), among others, are marketing multiple-panel or multiple-page labels and inserts and outserts.

Kregg Albrecht, director of solutions engineering for Nosco, says that he sees "tremendous opportunity in servicing our pharmaceutical customers by helping them address some of the industry's most pressing concerns through printed packaging innovations. We often look to the patient's interaction with the package as part of the solution." To support patient compliance and safety, Nosco provides "various forms of child-resistant designs that are combined with options for extending copy space for inclusion of instructions, Drug Facts, or recording charts for regimen drugs. In supporting our multilingual communities, we see growing interest in multipanel labels and cartons for enhancing communications to a broader and more diverse market. The patient–package interaction holds many opportunities for addressing these industrywide concerns and is an area to look to for continued innovations in packaging design."

Unit-of-use packaging may also play a role in promoting safety. Last October, FDA announced that it "intends to work with manufacturers to implement unit-of-use packaging for all antidepressants as a means of ensuring that patients receive a MedGuide with every prescription or refill." FDA defined unit-of-use packaging as "an original container sealed and prelabeled by the manufacturer, containing sufficient medication for one normal course of therapy." Suggesting unit-of-use packaging is a significant move, given the fact that most U.S. prescription pharmaceuticals are supplied to pharmacists in bulk, not in unit-of-use packaging.

Peter Mayberry, executive director of the Healthcare Compliance Packaging Council (HCPC), encourages a broader use of unit-of-use packaging. In the January 2005 issue of Unit Dose Alert, for instance, he writes: "Unit-of-use packaging can be any format— blister, strip, pouch, or bottle—that is shipped by the manufacturer such that pharmacy repackaging is not necessary. It is, in other words, intended to be given directly as it was packaged by the pharmaceutical manufacturer. If the manufacturer adheres a MedGuide to this original packaging, FDA's logic goes, then there is the highest probability that the MedGuide will actually be given to the patient."

He hopes, though, that more U.S. manufacturers will elect to put more drug products in unit-dose packaging in the coming years to protect the drugs themselves. Mayberry notes, "Unit dosing is the only way that each dosage unit can be protected from the time it is manufactured until the time it is ingested."

Also, unit-dose packaging is frequently put forth as a clear means of outlining regimens to promote safe use. The past year has seen creatively designed unit-dose compliance packages, such as the Track Pack from American Health Packaging and Taro Pharmaceuticals for generic warfarin. Rachelle Goto, Taro's vice president of pharmacy services and generic prescription marketing, says that Wal-Mart was looking for better patient packaging that could also streamline pharmacy operations. The Track Pack, which places the tablets in a start-on-any-day design, provides numerous packaging cues to prompt compliance.

Pete Belden, vice president of sales for Anderson Packaging Inc. (Rockford, IL), sees growing demand for compliance packaging. "The recent Ohio State University study on compliance packaging supports what most packaging professionals understand about the benefits to patients when compliance packages prompt people to take their medications properly," he says. "The potential improvement in patient outcomes and positive impact to the total cost of healthcare should continue to drive growth in compliance packaging."

Compliance packaging did suffer a setback this past year, however. HCPC had asked the Consumer Product Safety Commission to change its rules for child-resistant package protocol testing, and the commission declined. HCPC had sought a numerical standard for determining the number of units that could be accessed before declaring a package a testing failure, whereas the commission stuck to its "toxic-level threshold." HCPC had argued that manufacturers have shied away from unit-dose packaging because of the need to determine what amount of drug represents a toxic ingestion. Industry and suppliers alike seem torn on the issue. One solution to this dilemma that has emerged is the design and selection of F=1 packages, or packages that pass protocol testing with children not breaching any of the blister cavities.

Some consider this to be one of the biggest challenges facing the industry. "New package types must be developed that combine effective unit-dose packaging, child resistance, and senior friendliness into one ingenious design," says Mendoza from Stora Enso. "The new solutions must be tested and qualified and applicable to various configurations and large-scale industrial packaging." He explains that the Stora Enso Pharma SHR (small hands resistant) concept has been designed with these requirements in mind. Launched by Stora Enso and Bosch in June 2004 and achieving its F=1 rating in November 2004, the concept consists of a special tear-resistant paperboard, unique carton design, and the ability to be assembled on an automated packaging machine.

Belden from Anderson says that his company is working with numerous pharmaceutical companies to design compliance packages in a variety of formats, many of which require child resistance and senior-friendly access. "We've been able to combine our packaging expertise with our vendor partners' materials and equipment expertise to develop some innovative solutions for compliance packaging."

William Nelson says that "one of the more difficult challenges for makers of blister packaging continues to be the development of foil blister materials that are both functionally child resistant and senior friendly." Nelson serves as director of marketing and business development, Alcoa Flexible Packaging (Richmond, VA). "This has been a formidable challenge over the years. There is new innovative technology appearing on the horizon to successfully bridge this technical gap. Alcoa is working to reengineer the kind of package that will pass the child-resistant protocol test. It will be a combination of new packaging materials and blister design."

Adds Rick Knight, global business manager for Honeywell Specialty Materials, Healthcare Specialty Films, "The change in senior-friendly considerations is driving the need for new innovations from package designers that can prove the balance between safety and efficacy."

CONVENIENCE

Efforts to encourage drug regimen compliance may also help drive trends toward convenience packaging. "Probably the largest trend we see in the medical and pharmaceutical industries is the need for premeasured, easy-to-use-and-dispense packages," says Howard Thau, president of Sonic Packaging Industries Inc. (Westwood, NJ). "On the pharmaceutical side, the greatest demand we are seeing is for a dry applicator and a premeasured dose of a product in a convenient single package. We have recently finalized a package for a particular customer that will contain two different products that would mix at point of use along with one dry applicator. With the continued development of highly concentrated medications in the topical and oral care category, the demand for unique delivery systems is greater than ever before."

Steve Larsen, medical and pharmaceutical business unit manager for Tapemark (West St. Paul, MN), also documents this trend. "We are seeing interest in easy-to-use, single-use products that can be used anywhere, anytime." To meet this demand, the rolled-goods manufacturer has been converting dissolvable film strips that replace solid oral products. "The market progression will move from breath fresheners to vitamins to active drug products, both OTC and prescription." He says that these products will need unit-dose packaging, which Tapemark can provide in the form of a unit-dose pouch. "We are also looking at other single-dose packaging methods that are not pouches," he reports. "You will need child resistance and the ability to maintain product stability, while still being convenient and easy to use."

Thau reports that such convenience packages often require custom filling systems. As a result, "many users are looking to outsource primary packaging to firms that can handle all aspects of the project, from design, testing, and validation to procurement and packaging," he says.

As sophisticated as these packages may get in terms of design and materials, cost is still an issue. "We aim for higher yields and less waste in our in-line manufacturing and packaging, which keeps costs down," says Larsen. The firm operates four shifts at its five facilities on its St. Paul, MN, campus. In April 2005, TUV America completed a successful audit of Tapemark's facilities according to ISO 9001 and ISO 13485 standards. FDA visited that month, too, finding the firm in compliance with GMPs for manufacturing a new drug product.

NEW MATERIALS

New material combinations continue to enter packaging supply chains.

Medical device packaging converters report that they are fulfilling a lot of orders for foil-based flexible packages. "We continue to see increased demand for our high-barrier materials," reports Leslie Love, vice president, sales and marketing, for Tolas Health Care Packaging (Feasterville, PA). "This includes our Dispos-A-Vent pouches, which can be made of foil or double aluminum oxide–coated PET. They are designed for EtO-sterilizable products that need high-barrier packaging for shelf life." She adds that Tolas has just validated a peelable version of the double aluminum oxide– coated film with barrier properties "approaching foil." Absorbable and reabsorbable medical devices, and biologicals in particular, are in need of such barrier, she says.

Amcor Flexibles Healthcare (Mundelein, IL) has also introduced its foil header pouch, which is made on new pouch-manufacturing machines installed in a controlled environment to reduce the risk of contamination.

Some materials are crossing over from the pharmaceutical niche to the medical. Aclar Flex film from Honeywell International, for instance, is designed for medical bags, pouches, and overwraps. Offering the high barrier that Aclar is known for in the pharmaceutical industry, Aclar Flex film can offer up to 10 times the barrier of PVC or polypropylene, Honeywell claims.

Jerry Bennish of Amcor says that some manufacturers of products that are currently packaged in foil barrier materials are looking for clear high-barrier materials. "There is a market need for transparent high-barrier packaging to determine if the product is situated in the package properly and not sealed in the seal area and to view the product before opening to confirm that it is the appropriate size."

A new top web or lidding material introduced to medical device manufacturers this year is Ovantex from Oliver Medical (Grand Rapids, MI). Made of synthetic fibers, the breathable substrate is coated with a nontoxic hot-melt heat-sealable adhesive to prevent fiber tear of peelable seals. Oliver's Jeff Murak reports that "there are multiple large medical device manufacturers in the process of testing and validating Ovantex." Since its introduction in January 2005, Oliver Medical has made the material whiter at the request of several potential users, without affecting performance or requiring these firms to start their validations over again, says Murak.

Medical device packager interest in peelable or sealable films continues to be strong. Market offerings include Core-Peel extrusion-coated films and laminates from Amcor Flexibles Healthcare and Clean Peel Transfer (CPT) films from Perfecseal. These films feature separate seal and peel layers in polyethylene, nylon, paper, and foil materials, eliminating the need for coated top-web material. While these materials are typically more expensive than traditional films, in some cases they have helped drive down total package costs.

For instance, Bill Leib, senior packaging engineer for B. Braun Medical Inc.'s Hospital Care Division (Allentown, PA), says that he is currently validating PerfecFlex Ice, a blown nylon/polyethylene film using the firm's CPT technology, with an uncoated top web. "The material may possibly allow us to downgauge from a 10-mil bottom web to 6 mil."

Leib adds that converters like Perfecseal and Oliver have been particularly helpful in his search for more- cost-effective materials. "In an operation as big as our Allentown facility, we need to keep costs down. We can't compromise our sterility barrier, but we need cheaper materials. They give us samples for testing, and they have more materials than we have time to test."

For pharmaceuticals, high-barrier materials are available for moisture-and oxygen-sensitive materials. Recent offerings include films from Klöckner Pentaplast of America Inc. (Gordonsville, VA) and Tekni-Film, a division of Tekni-Plex Inc. (Somerville, NJ). Klöckner Pentaplast's Pentapharm Aclar 400/02 is a two-layer laminated film that uses 4-mil Aclar along with PVC. Tekni-Film's high-barrier film uses 4-mil PCTFE in either Aclar or Vaposhield types along with a standard thermoformable film, such as PVC, PP, Barex, or PETG. Both claim the films offer the highest moisture barrier available in a thermoformable film.

Klöckner Pentaplast also supplies Pentapharm Aclar G03 film, a three-layer laminated film that incorporates EVOH as a moisture and oxygen barrier; and Pentapharm Aclar S03 barrier film, a high-barrier Aclar-laminated film for higher performance on packaging lines and improved lay-flat of finished packages. It can be ultrasonically sealed to vinyl face-seal cards without a coating.

Nelson reports that Alcoa is developing new sealing lidstock materials with high-barrier properties that will decrease moisture transmission in the package 10–30%, depending on the material choice. The design of these materials is to seal to current thermoform film blister materials including PVC, PVdC, PETG, PET, and Aclar films. "Higher-barrier sealants provide increased shelf life for our customers' products, and this translates into cost savings to the customer. These sealants are being designed to function with all the opening features currently being used in blisters, including push-through, peelable, and peel-push specifications."

Nelson reports that Alcoa is developing new sealing lidstock materials with high-barrier properties that will decrease moisture transmission in the package 10–30%, depending on the material choice. The design of these materials is to seal to thermoform film blister materials including PVC, PVdC, PETG, PET, and Aclar films. "Higher-barrier sealants provide increased shelf life for our customers' products, and this translates into cost savings to the customer. These sealants are being designed to function with all the opening features currently being used in blisters, including push-through, peelable, and peel-push specifications."

Hueck Foils LLC (Wall, NJ) is promoting its blister foil that has been engineered to seal to Alcar. The foil allows users to invert the Aclar lamination so that the Aclar layer is on the inside, improving the package's barrier.

Some professionals report some material challenges to the increasingly global healthcare supply chain. "When moving into other markets, such as China, medical device manufacturers are having to manage long supply chains," DuPont's Richard says. Packaging professionals therefore may now be responsible for operations around the world and for obtaining material for those operations. To support such global operations, DuPont is working "to develop a product that is compatible across all its manufacturing sites so that it can distribute that product globally," he explains. Packagers may still face the challenge of managing the proprietary coatings and processes of local converters in the different regions, however, he says.

MACHINERY ADVANCES

Packaging machinery continues to advance, with new units offering validation and changeover ease. For instance, Multivac Inc. (Kansas City, MO) has just launched its T 450 tray sealer for generating various tray sizes with quick, toolless changeovers.  

At the Medical Design & Manufacturing East exposition in New York City this past June, Alkar-RapidPak (Lodi, WI) introduced a form-fill-seal machine with such advanced features as servo lifting systems, servo-driven plug-assisted forming, and side-extractable tooling, all aimed to ease changeover and operation. John P. Merritt, a veteran of the medical device industry, has joined the company as director, medical development. Machine and tooling validation continues to be a significant endeavor. Don Barcan, president and CEO of Donbar Industries Inc. (Long Valley, NJ), a medical device packaging consultancy, says that "ensuring that the combination of equipment and tooling can demonstrate adequate process control and meet design specifications and controls is the primary concern." Part of his recent machinery specifications for his medical device customers have included proper validation ports and precise instrumentation, he adds.

In keeping with that need, SCA Packaging, maker of Alloyd Sealing Machines (DeKalb, IL), now offers an external validation port for exporting sealing parameter data for process validation. It is an option on all models of the firm's Aergo 2 tray-sealing system. One user in particular was able to cut validation time down to two weeks.

Other efforts such as Multivac's to do some upfront validation work are helping, too. Leib of B. Braun Medical just purchased an R530 from Multivac for its Dominican Republic facility, and he opted for a validation package that included validation of all the controls and gauges. While he still has to conduct an IQ, OQ, and PQ of the Multivac, his tooling, and his packaging materials, Leib says that the option from Multivac allowed him to speed the whole validation process once the machine was placed on the production floor. "We didn't have to do a lot of the protocols because Multivac's validation package covered it ahead of time," he explains. SCA Packaging offers a similar validation package with its Alloyd tray sealer.

Leib is pleased with the new machine's other features. "It has quiet, independent lift systems for forming and sealing and plug assist. The latter will help distribute the material uniformly, with less cold spots or spinning in the material, which lead to material stress," he says.

Kevin Carter, regional sales manager for Uhlmann (Towaco, NJ), says that he is seeing increased demand for complete packaging systems supplied by one manufacturer or integrator. "About 30–40% of our demand is for turnkey lines, where a customer goes to one company for everything." The benefits of such one-stop sourcing include one contact for warranties and one source for all parts and maintenance. Complete systems that Uhlmann has been providing include the blister-forming machine plus architecture for controls, checkweighers, labelers and printers, and product feeders such as toploaders. He also reports increased inquiries in walleting systems, for producing packages similar to the award-winning Actonel Dosepak provided by MeadWestvaco for Procter & Gamble.

Merritt of Alkar-RapidPak says that in-line printing has been common in the medical industry, for some time. But he sees a need for better integration with horizontal form-fill-seal (HFFS) machines. "Too often it seems that the printer is simply bolted on the HFFS with minimal interface and a separate control panel when there is more than enough firepower in a machine's PLC to handle the printer. You would then have a single control station, which provides convenience and cost advantages."

As a another trend in packaging machinery, Carter points to servomotor control. Uhlmann provides such control on its machines, including its latest B1880, which Carter calls the next-generation 1070. It can output 1300 blisters per minute. But he says that Uhlmann wants to dispel a myth that he hears regularly. "You don't have to be an electrical engineer to run the machine. We are implementing refined touch control so that machine operators can run and change over the machine."

STANDARDS AND RULES

After taking on these new responsibilities and studying these new options, packaging professionals still need to manage the basics. That means following ISO 11607: "Packaging for Terminally Sterilized Medical Devices" if you package medical devices and FDA's "Container Closure Systems for Packaging Human Drugs and Biologics" if you package drugs.

Could compliance still be an issue? Barcan says that "the biggest challenge is making sure that all package designs and processes conform to ISO 11607 and are properly validated. I still find that there are far too many medical device companies that do not have a clue about this important document."

Leib, however, says that ISO 11607 is his bible. "We are able to show customers the guidelines that we follow, and they have a certain level of confidence in us," he says.

The document's revision, which harmonizes it with Europe's EN 868, "Packaging Materials and Systems for Medical Devices Which Are to Be Sterilized, Part 1, General Requirements and Test Methods," is moving along, says John Spitzley, cochair of the Medical Device Packaging Committee of the Institute of Packaging Professionals. The revision is now at ISO headquarters as a final draft international standard about to enter a two-month ballot. There will be no more technical changes, only editorial revisions, reports Michael H. Scholla, senior consultant for DuPont Medical Packaging. He is also chair of a task group of the Association for the Advancement of Medical Instrumentation (AAMI) that is now working on revision to AAMI TIR22. It provides guidance in applying ISO 11607.

As far as regulatory updates for pharmaceutical packaging go, industry is still awaiting PACPAC, FDA's long-discussed guidance for packaging changes post drug approval. According to a spokesperson for FDA's Office of Pharmaceutical Science, the agency "recognizes the role a PACPAC guidance could play in streamlining the review process. Currently, FDA is considering the best approaches to address the issue of postapproval packaging changes in light of the various initiatives, such as risk-based and science-based review and inspection. CDER is currently reevaluating the best format for future guidances."

FDA's overall approach to drug packaging oversight has evolved, but not changed, says the agency spokesperson. "A change in the FDA perception of risk associated with a particular packaging change has evolved over the last few years so that a packaging change involving a solid-oral-dosage formulation, for example, is considered less risky than a packaging change to an oral solution or an ophthalmic drug or a sterile dosage form. FDA guidances and internal thinking reflect this change in risk assessment as to [how] the industry reports certain packaging changes, [such as a] shift to reporting a packaging change in annual reports."

How should healthcare product packagers proceed? Knight from Honeywell advises package designers to continue to maximize the efficacy of their products, [while] looking for ways to differentiate their products in today's competitive marketplace.

Copyright ©2005 Pharmaceutical & Medical Packaging News