Medical Device Link.

Originally Published PMPN November 2003

Anniversary Special

Daphne Allen

“The coming year will be a challenging one for the healthcare industry and for packaging professionals. More than ever, you need a magazine that helps you sort out the issues and find the information you need to make cost-effective decisions.”
—Melissa Larson, editor, PMP News, November/December 1993

Since PMP News’s debut in 1993, much has happened in healthcare packaging. Professionals have more standards and more regulatory guidance to help them qualify, validate, produce, and test packages. Materials are stronger, thinner, more protective, and more flexible. Machinery is faster and easier to use. 

And yet, some of the challenges facing packagers during PMP News’s first year remain. In our debut issue, Melissa Larson, then editor of PMP News, outlined several key editorial topics for 1994. They were validating packages, developing packaging to meet hospital needs, preventing label problems, designing effective over-the-counter (OTC) packages, and choosing a contract packager. Today we find ourselves continuing to write about these very same issues, especially given two major regulatory efforts: FDA’s OTC labeling rule and pending bar coding rule for institutional drugs.

FDA’s activities have indeed shaped the industry these past 10 years, including the agency’s recognition of consensus standards and participation in harmonization efforts. In fact, the way FDA approaches packaging today is remarkably different from that in 1993. The agency has recently looked to packaging and labeling solutions to protect patients from medical errors and counterfeit products, among other things. It’s a refreshing change from the climate that concerned PMP News’s editors in March 1994, when they produced a feature on FDA’s sluggish review times.

In this article we look back at the last 10 years of medical packaging, as well as our coverage of it. To do so, we’ve enlisted the help of some long-time readers and supporters of PMP News.

TAKING THE MYSTERY OUT OF MEDICAL PACKAGING

Surepak from MeadWestvaco represents the type of senior- friendly, child-resistant unit-dose packaging that’s evolved in the last 10 years.

In 1993, packaging professionals carefully chose their bags and pouches and blisters and bottles, validated their designs and processes, and tested their results, just like today. But back in 1993, professionals were left to themselves to find methods and approaches, with few models to follow. Once they chose a particular method, they then needed to document its reliability and consistency and submit data to FDA to support a drug or medical device application.

Medical packaging professionals, however, weren’t satisfied with the lack of standards and industry consensus. John Spitzley, currently Medtronic’s fellow, packaging, and Curt Larsen, currently with DuPont Medical Packaging, report that in 1993 a group of professionals formed the Sterilization Packaging Working Group of the Health Industry Manufacturers Association (HIMA; now known as AdvaMed). The group “placed a much-needed focus on the science of medical device sterile packaging that had not reached this level in the past,” recount Spitzley and Larsen. “The group then published a guide for sterile packaging, something that, to this point, had not been available: HIMA’s Reference on Sterile Packaging, Report 93-7 1993.” It was authored by Larsen, Spitzley, and Bernie Liebler of AdvaMed. Larsen and Spitzley also indicate that several key articles published in 1993 and beyond helped shape current packaging theory. (See sidebar 1.)

Two of these articles are also cited by Michael Scholla, PhD, currently senior consultant for DuPont. These are “In Quest of Sterile Packaging, Parts 1 and 2.” The articles were based on work done by HIMA’s Sterilization Packaging Working Group, which Larsen and Spitzley say “debunked and put to rest the FDA requirement for whole-package microbial challenge tests.” 


“Ten years ago, FDA was making everyone perform whole-package microbial testing,” Scholla says. “We were able to change FDA’s thinking to accept physical testing to indicate the presence of a packaging breach and to identify its location.” Scholla says that this shift had remarkable implications. “Physical tests are easier to perform and cheaper, and they do not have as many false-positives. And they do not have the validation problems that aerosol-challenge tests have.”

Once FDA began accepting data generated by physical tests, medical packaging professionals began searching for standard approaches to such test methods. ASTM began to fill their needs, evaluating some methods and publishing them after extensive round-robin testing. “I applaud ASTM for its continuing support to our industry,” says Russ Riescher, a packaging engineer with C. R. Bard. “It continuously upgrades and expands its test methods, many of which are considered industry standards.” (See sidebar on page 56 for a list of ASTM methods.) 

In 1993, however, there weren’t that many medical package testing standards from ASTM. Nor were there ISO or CEN standards guiding the medical packaging industry, Scholla points out. The formation of AAMI/ISO TC 198/WG7 and the resultant AAMI/ANSI/ISO 11607, “Packaging for Terminally Sterilized Medical Devices,” and its companion document AAMI TIR22, both published in 1997, were milestones in medical device packaging, say Larsen, Spitzley, and Scholla. As members of HIMA’s Sterilization Packaging Working Group, the three helped author the standard. So did Donald Barcan, a packaging consultant with Donbar Industries Inc., who calls 11607 “the highlight of the decade.” 

FDA’s Center for Devices and Radiological Health recognized ISO 11607 in 1998 as a consensus standard, which benefited medical device manufacturers in two ways. First, packaging professionals had a clue as to what would satisfy FDA’s packaging requirements. Second, they had a way to satisfy those requirements without giving FDA reams of data—a statement of adherence was all an application needed, backed by in-house documentation should an inspector require it.

Scholla says that ISO 11607 was followed by a proliferation of standardized test methods by ASTM. A second revision to ISO 11607 approved this year by ISO and CEN that harmonizes 11607 with EN 868 includes references to many of those ASTM methods. (ISO 11607 covers materials, design, and processes, while EN 868 just focuses on materials and design.) Another draft is in the works that will split the ISO document into two parts: Part 1 for materials and design and Part 2 for processes. Barcan expects that device manufacturers will find both the second and third revisions “easier to read and user-friendly.”

Ron Pilchik of the Techmark Group sums up the past 10 years in medical device packaging this way: “Everything has changed in the last 10 years. This can be considered the golden age of medical device packaging. FDA has helped drive technology by embracing ISO 11607 and moving toward a risk-based quality system. Medical packaging is always defined as high risk, and FDA’s emphasis will push the science further. ASTM has worked hard to provide test methods and guidance to support ISO. These are embraced by FDA as they are promulgated.”

Larsen and Spitzley are also proud of their 2002 resurrection of IoPP’s Medical Device Packaging Committee, which had fallen dormant in the late 1990s. The committee has formed a number of task groups to discuss and perhaps conquer such challenges as characterizing packaging defects, developing material data sheet specifications, meeting device labeling requirements, and benchmarking industry practices. PMP News will report on the committee’s recent activities in its December 2003 issue. 

DRUG PACKAGING UNWRAPPED

The device industry wasn’t the only niche under wraps in the early 1990s. The guidance at the time from FDA on pharmaceutical packaging, “Guideline for Submitting Documentation for Packaging for Human Drugs and Biologics,” issued in February 1987, “did not go into a lot of detail,” says Dana Guazzo, PhD, a consultant with RxPax LLC, Pharmaceutical Package Development Consultants. “Different reviewers from FDA required different data. The amount of work we did before 1999 varied.”

DuPont’s Tyvek is known for its clean-peel and low-linting features.

For Guazzo, the most significant regulatory development to occur in the past decade was FDA’s release of “Container Closure Systems for Packaging Human Drugs and Biologics” in May 1999. This guidance supersedes the 1987 guideline and the agency’s packaging policy statement issued in a letter to industry dated June 30, 1995, from the Office of Generic Drugs. “The 1999 guidance made a big difference for pharmaceutical packagers. It set a new standard, providing extensive details on the function of a package. It required drug marketers to show that packaging is suitable for its intended use and that it functions properly. And it spelled out in detail what should be included in an FDA application.” 

Rich Hollander, senior director of packaging services for Pfizer, agrees that FDA’s 1999 guidance was a significant milestone in pharmaceutical packaging. 

Hollander also points to the FDA guidance, “Changes to an Approved NDA or ANDA,” released in November 1999, as another milestone. Frank Bieganousky, a consultant with Montesino Associates, agrees. “This guidance introduced the concept of equivalence. FDA offered industry ways to change packaging that were easier and more predictable than ever before.” He adds that FDA’s classification and examples of changes, “while not all-inclusive, are helpful, allowing manufacturers to more easily determine what regulatory steps they must take when making changes. A lot of changes people thought were major changes prior to the guidance weren’t, especially when it came to solid oral doses.” Bieganousky has served as director of healthcare business development for Tekni-Films, and he has held business development and marketing positions at AlliedSignal (now Honeywell) and Rexam Medical Packaging (now Amcor Flexibles Healthcare), as well as technical packaging development positions at Bristol-Myers Squibb and Becton Dickinson. 

Kent Sides, business manager, pharmaceutical films, for Klöckner Pentaplast of America Inc., also calls the guidance on post-approval changes a milestone. He says that it created a formal basis for packagers to change packaging materials when equivalency in performance had been established. “In some cases, this created an opportunity for packagers to improve performance or reduce cost in their packaging by replacing older packaging materials with newer-generation materials without having to invest resources in stability testing,” he says.

Tom Ambrosio is a former packaging professional with Schering-Plough for 28 years and now a packaging consultant. He appreciated the guidance, which he says raised the issue of interchangeability of materials and components for drug packaging. Bieganousky says that interchangeability gives pharmaceutical manufacturers “more flexibility in decisions on materials and suppliers.” 

Issues of equivalence and interchangeability encouraged FDA to pay closer attention to Drug Master Files (DMF), says 
Bieganousky. DMF deficiencies were found, slowing some NDAs. In the end, though, it is encouraging DMF holders and applicants to improve DMF content and maintenance. Hugh Lockhart, professor of Michigan State University’s School of Packaging, Bob Bergeson of Pfizer, Dwain Sparks of Eli Lilly, and others are heading an effort to standardize DMF actions.

PhRMA’s (Pharmaceutical Research and Manufacturers of America) Packaging Working Group continues to play an active role in assisting FDA in establishing policy as it relates to packaging, Hollander says. And, he says, “of recent note is the Product Quality Research Institute’s (PQRI) Packaging Working Group, which is working on developing improved test methods in support of FDA’s pending PACPAC guidance. This is presently chaired by Pfizer’s Dan Malinowski.”

Bieganousky also cites FDA’s adoption of ICH stability guidelines with its June 1998 draft guidance, “Stability Testing of Drug Substances and Drug Products.” “It suggested the use of accelerated-aging studies for stability tests that were much harder on the packages than previous tests,” he says. “It created the need for higher-barrier packages, which encouraged the growth of Aclar films from AlliedSignal (now Honeywell), as well as closure inner liners such as foil induction seals.”

Sides agrees. “Implementation of ICH accelerated-testing standards was probably the single largest influence on functional packaging for solid oral dosage forms in the past 10 years. While this helped ensure the uniformity of pharmaceutical testing in multiple markets, the more-rigorous testing conditions created a need for increased barrier protection as more of a mainstream packaging requirement. Whereas packagers may have relied on low- to mid-range barrier packaging prior to implementation, the need for high and ultrahigh barrier grew quickly. New solutions for high and ultra-high barrier also required that they be more easily processible on high-speed equipment.”

In the 1990s, Sides says that drug delivery systems “focused heavily on rapid-dissolving products for convenience and speed of delivery into the patient. This continued to drive the high-barrier packaging market, due to the inherent moisture-sensitivity of new delivery systems. This also posed challenges for manufacturers and package engineers, alike, as many of these solid dose forms tended to be very delicate structures to feed through packaging lines, as well as dispense from packages. In these cases, peelable child-resistant unit-dose packages answered the call to provide functional barrier protection, physical protection of the product through the distribution channel, and secure packaging where child resistance was a concern.”

Scott Denley, marketing manager for Alcan Packaging Pharma Center (Shelbyville, KY), adds that improvements to high-barrier structures, such as the cold-formable Formpack, have resulted in reduced drug degradation and increased shelf life.” 

CONSOLIDATION

HCPC recognized Lamictal from GlaxoSmithKline this year for its compliance-friendly titration-therapy package.

Many healthcare product packaging professionals saw significant consolidation in the last 10 years, both for their firms and their suppliers. For instance, one pharmaceutical packaging professional who has been through at least four acquisitions says that he has had the same parking space for 15 years, but his firm’s name keeps changing.

“There has been consolidation at every level in the value chain,” says Scholla, “. . . at the hospitals, the group purchasing organizations, the product makers, and the converters.”

In the debut year of PMP News, for instance, we reported that Curwood Inc., a wholly owned subsidiary of The Bemis Co., merged Hargro Healthcare Packaging and Medi-Plus Laboratories into its Cur-Med Group, forming Cur-Med Healthcare Packaging Division. (Cur-Med Healthcare Packaging Division would later be merged with PM Co., a purchase of The Bemis Co., and the entity would later become Perfecseal.) Also, DRG Medical Packaging purchased Modern Packaging and Tower Packaging, then itself be acquired by Bowater, with a name change to Rexam in 1995. 

Consolidations still abound. This year, Rexam’s Healthcare Flexibles business was bought by Amcor. Alcan Packaging has almost wrapped up its acquisition of Pechiney.

Scholla says that consolidation in both manufacturing and converting was and still is to be expected, given the fact that parties throughout healthcare are trying to take “money out of healthcare and out of devices. The natural progression is for companies to try to take money out of packaging.”

Converters, especially, have been pressed to control or reduce costs. Their customers have been attempting to consolidate business, moving from multiple suppliers to just a handful. Many have asked them to bid during reverse auctions to drive costs down further. As a result, “converters’ volumes have increased significantly, but their profits haven’t,” Scholla says.

Scholla notes that the cost savings that many expected through consolidation haven’t been as significant as expected. “It is a regulated industry, and there are hurdles to switch pouches for existing products. So consolidating business has worked better for new products. And a lot of products have been introduced in the last 10 years.”

NEW TECHNOLOGY

In the April 1994 issue of PMP News, we predicted what materials would be like in the year 2000. “The primary healthcare package of the future is likely to be some type of plastic container,” wrote editor Larson.

That prediction was pretty accurate. “Greatly improved barrier properties of plastics and plastic composites have made inroads in replacing glass and metal,” says a pharmaceutical packaging veteran. 

Since 1994, we have seen plastic compete heavily with glass, foil, and paper. In May 1994, we ran a news item on Klöckner Barrier Films working with AlliedSignal (now Honeywell) to begin producing Aclar-laminated films for pharmaceutical applications, which offered packagers a high-barrier plastic alternative to foil. In February 1997, we wrote about McGaw’s switch from glass IV bottles to plasticizer-free Ecdel elastomer by Eastman Chemical.

Ambrosio calls the development of cyclic olefin copolymer (COC) very “significant.” It offers high moisture barrier, competing with foil and other polymers in blister applications and competing with glass in vial and syringe applications. “They offer the only true alternative in the blister packaging of drug dosage forms,” he says. “They lend themselves to coating with barrier layers and the price structure is competitive.” 

Ambrosio continues to say that converting companies continue to be the movers and shakers in packaging. “They have always gone with the flow and integrated new substrates into the marketplace, whether it be COCs, new Aclars, metallization, cold forming, and many other contributions. I am partial to Rexam [now Amcor] for the good support I have received in designing protective packaging and its openness in sharing its developments.”

Denley also points out that the introduction of the high-barrier Ceramis material, an opaque or transparent SiOx-based coating developed by Alcan Packaging, offers the market an effective high-barrier alternative.

Medical packaging is also increasing its use of plastic. “One thing I thought I’d never see is an all-plastic header bag,” says one medical packaging professional. “We are now using one and it even has a chevron seal. One other thing is our desire to use a clear alternate to foil. We now use an AlOx peel pouch.” 

Pilchik points out another milestone: in 1999, DuPont introduced Tyvek 2FS, a lower-cost Tyvek intended as an alternative to paper. (For more on Tyvek 2FS and other medical packaging materials, see our feature on page 40.) Says Pilchik: “Material evolution has been dynamic, with improved adhesive systems, a new grade of Tyvek, high-performance papers, nonadhesive package systems, and high-barrier products introduced these past 10 years.”

Barcan says that in the last 10 years, PETG has dominated as the preferred material, since it is acceptable for both gamma and EtO sterilization. “Also, the use of polarized light, developed by Eastman, is a major advance in evaluating thermoformed parts for stress that could lead to part failures.”

Further, Barcan notes that “at least 10 years ago, gamma sterilization had already increased its market share to about 50%. To the packaging professional, the increased use of gamma has allowed more opportunities for impermeable packages. Such use has promoted a new packaging concept for medical devices called ‘vacuum packaging.’ Several orthopedic devices are already on the market” in such packaging. 

One medical packaging veteran credits DuPont and converters like Perfecseal, Tolas, and Oliver Products with driving change. Also, “Beacon Converters is a small company, but it has a can-do attitude and has come 
up with some innovative materials,” he says.

This same professional says that his firm “had a push a few years ago to be environmentally conscious. We went away from bleached board to natural for our cartons. The bleached board is easier to print and fold. Now the bleaching process is friendly so we switched back and have seen an improvement in print quality.”

In the early to mid-1990s PMP News covered the growing environmental awareness in healthcare packaging with a number of articles, including its November 1994 cover story, “New Environmental Strategy Includes Common Sense.” This awareness has deepened today. Packagers are now routinely printing with water-based inks, more environmentally friendly than solvent-based inks. When possible, firms are even looking into environmentally friendly packaging designs. For instance, GlaxoSmith-Kline introduced a new packaging design for its Serevent and new Advair inhaled products called Diskus that does not use CFCs. 

In the early days of PMP News, we focused a lot on the potential of blister packaging to reduce problems associated with drug regimen noncompliance. These articles included November/December 1993’s “Blister Packs Are Poised for Growth” and June 1994’s “Breakthrough Blister Technology.” The Healthcare Compliance Packaging Council (HCPC) played a big part in such coverage, sharing results of a blister study with Michigan State University’s School of Packaging. The study demonstrated that “blisters can often be cost-competitive with vials and caps,” wrote editor Larson in 1993.
Peter Mayberry, HCPC’s executive director, says that the study was helpful, and that “its conclusions have never been challenged.” In 1996, HCPC began offering its Certified Compliance Packaging Seal to identify “pharmaceutical packaging formats that improve adherence to medication regimens.”

“Blister use has grown over the last 10 years,” he continues. “The most dramatic changes have been use of unit-dose formats as manufacturers’ original packaging and the role repackagers have taken as the primary supplier of hospital unit-dose (HUD) formats. In the 1990s, we thought a shift from bulk distribution in the United States would not likely be seen in our lifetime and that pharmaceutical manufacturers would always be the primary source for HUD formats. We now feel that in the future it will be far more common for drugs to be supplied in blister packaging directly from the manufacturer. In addition, we feel that healthcare facilities will increase their reliance on reputable repackaging operations.” 

With regard to the shift away from bulk distribution, Mayberry points to Pfizer’s growing use of unit-dose formats as a potential harbinger of things to come, as well as to the fact that blister technology has improved over the past 10 years. Both trends, he points out, can be demonstrated by the winners of HCPC’s Compliance Package of the Year programs. He points to this past year in particular, when GlaxoSmithKline, Merck, and AstraZeneca, all leading brand-name drug manufacturers, took top honors for their retail packages for Lamictal, Fosamax, and Nexium. “And more are on their way,” he says. 

Medical packaging machinery has also advanced. Pilchik says that “sophisticated processing equipment with state-of-the-art controls, data acquisition systems, and in-line printing capabilities are common now.”

Rick Sury also sees such machinery sophistication on the pharmaceutical side. Sury is vice president, strategic partnerships, for Alcan Packaging— Contract Packaging and Specialty Cartons. “Blister packaging equipment from manufacturers Uhlmann and Klöckner Medipak, for instance, have better forming capabilities than they did 10 years ago, and they are easier and faster to set up. This, plus faster running times, keeps output up and costs down.” 

Easy validation has always been the goal, even back in 1994. One heat sealing equipment provider was quoted in our October 1994 feature, “Science of Heat Sealing Advances with PC Control,” as saying, “We’re trying to design our machines so as to make it as easy as possible for our customers to validate them.” In 1994, close monitoring and careful control of sealing parameters were cited as key to validation, just as they are today. “Nearly every sealer out there is now validatable,” one packager says now. Larsen and Spitzley find “new easily validated heat sealing equipment” to be significant.

But back then, the solution was PC control of sealing parameters. Today, however, PCs have been replaced by PLCs, which are now in some cases being replacing by digital controllers. In addition, servomotors are replacing mechanical drives. There is also some interest in a move from proprietary to open machine controls and off-the-shelf software.

NEW FDA, NEW WAY

As stated earlier, dealing with FDA in the early 1990s was often frustrating. Drug and device packagers didn’t always know what was expected of them. Applications took time. And following FDA actions took diligence, since the agency didn’t widely publicize them. Today, however, FDA shares details on its decisions and routinely solicits industry input. It promotes its actions regularly and runs public service announcements to educate consumers.

While the agency has always focused on serving public health, it has changed its means to that end. Ten years ago, FDA’s solution to ensuring that consumers had access to safe and efficacious drugs and devices was to take its time reviewing applications and questioning submitters with seemingly little care about delays. Today, however, FDA has made it a mission to help bring about safe and effective products to consumers efficiently.

For instance, through its modernization of pharmaceutical GMPs, discussed on page 18, the agency “aims at ensuring that regulatory review, compliance, and inspection policies are based on state-of-the-art pharmaceutical science and do not impede rapid adoption of new technological advances by the pharmaceutical industry. It also promises to enhance safety and quality in drug manufacturing while increasing efficiencies.”

Mayberry says that FDA has become more of an activist. “FDA’s regulation requiring iron supplements to be placed in blisters, albeit now repealed, is a good example of this activism. Other examples include its proposed rule on bar coding prescription and OTC drugs used in hospital facilities and its attention to the Institute of Medicine’s report on medical errors. These are all good indications that FDA is trying to help patients,” he says.
 
“Looking ahead,” he continues, “we are hopeful this activism will carry over to assurances that useful printed information intended for patients will be included by pharmaceutical manufacturers with all prescription drugs. This is long overdue.” The creation in 2000 of the Pharmaceutical Printed Literature Association (PPLA), for which Mayberry also serves as executive director, is another milestone in the past decade. “Printed literature has historically served as the cornerstone of FDA’s efforts to ensure that prescription drugs are dispensed and consumed properly. PPLA’s mission is to ensure that printed literature doesn’t get abandoned in the Internet age.” 

Another example of FDA’s activism is its commitment to its Five-Part Plan announced in August 2003 intended “to protect and advance public health for America.” In addition to its proposed bar coding rule, the agency is also helping industry look for tools to deter and prevent counterfeiting.

It has also begun investigating repackagers providing “potentially dangerous products” as well as entities selling drugs over the Internet from other countries.

Still, some are cautious about FDA involvement. One drug packaging professional fears that FDA may mandate certain packaging or labeling formats to address counterfeiting, which he feels would release too much information to the counterfeiters. Another says that mandating unit-dose formats for bar coding could hinder the current trend of manufacturers moving toward blisters. “The pharmaceutical industry, with its strong ties to Capitol Hill, is naturally defensive when the agency proposes any sweeping requirements that apply to packaging,” he says.

And some feel that FDA still has a lot to learn about packaging. “FDA still has no trained and experienced medical device package engineering professionals on its staff to this day,” says one medical packaging veteran.

TEN MORE YEARS

One packaging professional predicts the following developments in the next 10 years: 

• Visible bar codes on all products.
• Invisible bar codes on components and semifinished goods to facilitate supply-chain tracking.
• RFID on all pallets.
• Quality inspections of single units versus lots. 
• Increased level of in-line printing: not just variable-information printing, but also package inserts and label copy printing.
• Increased supply-chain security against economic and sociopolitical terrorists

Hal Miller, director of packaging technology for Johnson & Johnson, says the development of medical devices and drugs that cross over into both disciplines will challenge the two industries to begin thinking alike. “The lines are becoming grayer, so packagers will need to address the issues facing both industries,” he said earlier this year at HealthPack 2003, in Scottsdale, AZ. Issues to consider include container/closure product integrity, product and package compatibility, sterile package integrity, stability studies, label control, material qualification, and process validation.

In addition, he said, demands for more labeling information to meet FDA requirements and multiple languages will test packagers. “With limited real estate and demands for 25-plus languages, you’ve got to consider bar coding, labeling on demand, and country-specific labeling.”

Miller also predicts that packagers will need to deal with threats from theft, pilfering, counterfeiting, and bioterrorism. “If you can see it, it can be duplicated. You’ve got to safeguard your products, even from irradiation and other processes designed to reduce the risk of bioterrorism.”

Miller pointed out that predictive engineering tools will also help packaging designers, like the use of design simulation software. Examples include Black Box technology from Rexam (now Amcor Flexibles) and work by Stress Engineering. “Predicting performance outcomes needs to be part of the future. You can predict where the shock and stress points are.”

Ambrosio agrees. He witnessed a demonstration by Rexam (now Amcor Flexibles) of optimizing thermoforming conditions for various substrates. “You saw the wall gradients in living color,” he says. “These simulations have to be very useful for packaging machine criteria for different rheological situations.”

At the very least, some professionals hope that packaging continues to grow in importance. In February 1994, columnist William LeMaire predicted that drugs about to switch from prescription to OTC status would not be using packaging to its full advantage. “Don’t look for manufacturers to unveil their new OTC entrants on bold new packaging. . . . Cost containment pressures dictated that [some companies] not spend funds developing special, innovative packaging.” 

LeMaire then predicted that 2000 would be the year to watch, since eight drug best-sellers were set to come off patent. “Perhaps by then the pharmaceutical business will turn to its underutilized packaging weapon for a competitive edge.” In 2003, some are still waiting for manufacturers to use that weapon. 

Copyright ©2003 Pharmaceutical & Medical Packaging News