Fortune Favors the BoldThis contract pharmaceutical packageris primed for growth.

By Melissa Larson

2012Packaging Line of the Year

There are packaging com-panies that fly under the radar by sticking with

tried-and-true processes and customers, thinking twice or even three times before build-ing new facilities or purchas-ing state-of-the-art machinery, and keeping their expansion plans a secret.

Quality, flexibility and responsiveness are theattributes a successful contract packager must have.

Then there’s contract packager Legacy Pharmaceutical Packaging, Earth City, Mo., whose corporate mot-to might be “Fortune favors the bold.” A new unit-of-use bottle filling line at Legacy’s second facility outside St. Louis has been awarded the 2012 PMT Packaging Line of the Year Award. That’s noteworthy enough in itself. But privately-held Legacy’s innovative spirit, deep operations knowledge and meticulous pharmaceutical market re-search suggest that they intend to pile up many more honors and awards on the way to becoming indispensable to their customers.

Visitors who come to see the award-winning bottle line soon notice that four other packaging lines are in various stages of being built—each one within freestanding side-by-side “suites” within the 189,000 sq. ft. warehouse. It’s all part of the compa-ny’s forward-looking operations plan

and the willingness to invest in that plan. It is the result of seeing a niche in the pharmaceutical industry and com-mitting the capital—both human and financial—to execute that niche.

The MarkeT“The market for generic drugs has

never been better, and with an historic number of patents set to expire—we call it the patent cliff—it will only get bigger,” says Legacy Founder and COO Wayne Welborn, who started the company in 2004 after a long pharma-ceutical career.

“Contract packaging is also grow-ing quickly in the pharmaceutical industry,” he says. “Drug companies would rather spend their money on R&D and marketing. We have the vi-sion and the capital commitment to build state-of-the-art lines for unit-of-use bottle and blister packaging, so that we can offer a good value proposition

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Generic Drug Market: Stats Tell the Story• For the decade ending in 2010, use of generic prescrip-

tion drugs in place of their brand-name counterparts saved the U.S. health care system more than $931 billion.

• In 2010, the average co-payment for a generic drug was $6.06 per prescription, versus $23.65 for preferred brand drugs.

• Generic drugs as a percentage of total prescriptions dispensed in the U.S. have increased from 60 percent to 80 percent over the last five years, and that trend is expected to continue.

• Between now and 2016, a number of blockbuster drugs, with about $255 billion in global annual sales, are set to go off patent. The magnitude of expiring drug patents is unprecedented.

• Wal-Mart dramatically changed the pharmaceuti-cal landscape with the introduction of its $4 Prescrip-tion Program in September 2006. This program provides an affordable solution for those without health insur-ance. It is especially important to Medicare beneficiaries as it provides a lower cost option when they reach the “doughnut hole” in their Medicare Part D coverage. That is the point when beneficiaries have to pay 100 percent of their costs.

• A study conducted by University of Pittsburgh Gradu-ate School of Public Health estimated $4 generic programs could help save society close to $6 billion.

for our potential customers.”Who are those prospects? They

are large retail drug operations, wholesalers and generic drug companies themselves. The big re-tailers are dispensing millions of pills per day of the “maintenance” drugs baby-boomer consumers will need to manage chronic con-ditions: prescriptions for high blood pressure, diabetes, arthritis, heart disease, depression, etc.

Welborn and Legacy managers rea-soned that big retailers would be at-tracted to the price/value proposition of offering unit-of-use packaging for these maintenance drugs. Instead of “count, pour, lick and stick” using an amber vial, pharmacists can pluck a prelabeled bot-tle that contains a 30-day supply right out of a Legacy paperboard dispensing carton. With a quick check to see that it’s the right medication and the application of a label with doctor’s instructions, the prescription is filled.

The Line“Quality, flexibility and responsive-

ness are the attributes a successful con-tract packager must have,” says Legacy Engineering Manager David Burgos. Those attributes were kept in mind as Legacy management drew up plans for a bottle-filling line that would have both

quick-change flexibility and the speed to accommodate up to 200 bottles per minute. Legacy’s aim is to possess equip-ment, facilities and quality systems that are as good as, or better than, pharma-ceutical customers maintain in their own plants. “If you don’t have robust quality, it doesn’t matter what else you have,” says Welborn.

As for which supplier would provide the needed machinery, Legacy already had a pretty good idea who it would be. As a matter of fact, its leaders knew just what model filler they wanted. The first call placed was to NJM Packaging, Mon-treal, Que.

“Since we’ve worked closely with NJM for years, we were told in advance about the new Cremer CF-622, and waited for it to become available,” says Matt Rayner, Legacy’s director of operations. “We wanted to be the first to operate it in the U.S.”

The Cremer CF-622 tablet machine is modular, completely servo driven and built for very accurate and repeatable product feeding, counting and filling. Its vibratory design is ideal for contract packagers. Because they are not specifi-cally tailored to each tablet shape and size, vibratory systems can handle a vari-ety of tablets with little to no changeover. Assuming the bottle neck diameter re-mains the same, vibratory counters

Congratulations to Legacy Pharmaceutical Packaging, St. Louis, MO on winning the eighth annual PMT Packaging Line of the Year.

NJM Packaging is proud to have been a key supplier in delivering a new Bottle Filling Line to meet the higher outputs and reduced change-over times.

PMT 2012 Packaging Line of the Year

Cremer CFS-622*3 Tablet Counter Tablet Counter

ALLNEW

USA 1-800-432-2990 • CANADA 1-800-811-6990 • www.njmpackaging.com

A Century of Packaging Expertise

Want to Know What Customers Need? Ask Them.Tom Harmon, president of

Legacy Pharmaceutical Packag-ing, Earth City, Mo., has an easy manner, but that does not conceal his laser focus on his company’s market niche. He and Founder/COO Wayne Welborn, as well as other members of the Legacy team, have spent significant time sitting across from pharmacy managers and asking questions.

“When you ask customers about what they like and don’t like, and really listen,” Harmon says, “they will tell you even more than they think they’re saying about how you can help them.” Through these conversations, Harmon and Wel-born learned that retail pharmacists want prefilled and pre-prepared packaging. “That way they can spend more time counseling patients,” says Welborn.

Consumers also had a wish-list when it came to drug packaging. With input from both pharmacists and con-sumers, Legacy managers focused on providing a packag-ing design that would address one of the biggest issues fac-ing the prescription drug industry: non-adherence (see the sidebar “Generic Drug Market: Stats Tell the Story”). The new packaging needed to provide the following:

• Give consumers an easy way to determine whether or not a dose has been taken or when they need to refill their prescriptions—without physically counting the medica-tions remaining inside.

• Provide protection from moisture, spilling and contamination.

• Make it easy for patients to read important label information.

• Move away from the standard look and feel of the am-

ber vial, which can make it difficult for patients to distinguish among their different medications.

Legacy managers decided to go beyond the bottle with their unit-of-use offerings. In collaboration with Keystone Folding Box Co., Newark, N.J., Legacy is launch-ing the Ecoslide-RX, a unit-of-use blister compliance package. The Ecoslide-RX carton is made from unbleached paperboard with a clay-coated surface and was developed to support blister packages em-ploying a minimal amount of film

and foil. It has several advantages over existing compliance packs including recyclability, cost reduction, senior-friend-ly design and a better substrate for graphics.

“Our customers that have sustainability initiatives really like that that the Ecoslide-RX carton is made from paper-board, a renewable resource. Since there is no plastic in the outer carton, it is not only 100 percent recyclable but if it ends up in a landfill it is completely biodegradable. It is a true eco-friendly packaging solution,” says Harmon.

Ecoslide-RX packs have calendars printed on the blis-ters, which are designed to help patients follow their drug regimen. Patients or caregivers can quickly determine when medications need to be taken next, if medications have al-ready been taken and when refills will be needed.

Ecoslide-RX is particularly suited for prescription products, physician’s samples and clinical trial materi-als. According to Legacy, it is smaller than some existing compliance packs, which may better suit retail pharmacies employing tube chutes. Legacy is currently installing auto-mated blister lines in order to launch the package in the next few months.

usually require no change parts. That saves not only money but also time, improving changeover efficiency and allowing a manufacturer to be more responsive to the market.

According to information from NJM, a contract packer like Legacy can theoretically begin packing the

same day it strikes a deal because it is not necessary to order different slats or bottle change parts to accommodate a new tablet or container size. This is espe-cially valuable for a contract packager of generics that deals with a wide range of products with shorter times-to-market than branded drugs.

Legacy rounded out the bottle line with the following equipment:

• IMA A300 Unscrambler• NJM Beltorque Capper• Enercon Induction Sealer• NJM Beltorque Retorquer• NJM Bronco 130 Labeler, equipped

with Optel Vision System• Econocorp Twinsealer, custom-

ized for unit-of-use cartoning at line speeds

accoMModaTing The Line

The Cremer tablet unit was ordered in May 2011. Meanwhile, Legacy had a big, new empty production facility and a lot of equipment to be delivered, but no ap-propriate built-out space to accommodate it. That’s where Michael Vaughn of MRV Services came in. He acted as general con-tractor and managed the installation of the “suites” that Legacy used for the new line and subsequent lines.

“The walls are modular and made of fiberglass-reinforced plastic, which comes in panels, and are cleanroom caulked,” Vaughn says. “If a piece of equipment needs to come in, you only have to remove a panel or two, not tear down a wall. The panels make quick modular rooms with a lot less dust and dirt than stick construction.” HVAC, wiring and plumbing were also quickly managed to Legacy specifications, with an independent air handling unit to maintain product con-tainment. The suite was finished by Novem-ber 2011, and the equipment was started up, validated and in commercial production in early December 2011.

Within the 145 ft. long by 30 ft. wide suite, the bottle line separates the primary and secondary packaging. The primary packaging space (unscrambler, tablet filler, capper and induction sealer) is enclosed, and features HEPA-filtered, conditioned air and differential pressure to ensure product isolation from surrounding rooms.

After bottles exit the Enercon induction

sealer, they pass through a wall and into the secondary packaging area, where they are labeled by an NJM Bronco 130 labeler and cartoned. The secondary packaging area is also temperature and humidity controlled, but does not require filtered air and has an open ceiling.

Differential pressures are maintained and monitored daily to ensure that the air flow direction is correct, assuring product integrity right up to induction sealing of the bottles.

The entire facility is temperature and humidity controlled. Complete label con-trol and accountability are maintained, ac-cording to Legacy, through the use of segre-gated storage cages and carefully developed control systems and procedures.

“Changeovers are quite easy with all of the equipment on this line,” says Rayner. “NJM Packaging supplied set-up sheets which include every adjustment and HMI setting change that is required to perform a bottle size change. Also, the Cremer filler bottle-size change is simplified with prod-uct-specific change parts that can be re-placed in minutes.”

The FuTureAs Legacy gears up to add what may be

several new blister lines to its bottle line (see the sidebar “Want to Know What Custom-ers Need? Ask Them.”), managers have lit-tle time to reflect on recent installations—

they’re focused on the next one. “Our vision is packaging line suites stretching all the way to the back wall of the facility,” says Legacy President Tom Harmon.

“We want to be the leading solutions pro-vider for unit-of-use packaging—whether blister or bottle.”

The awardPMT magazine congratulates contract

packager Legacy Pharmaceutical Packag-ing for receiving the eighth annual PMT Packaging Line of the Year Award for the unit of use bottle line at its Earth City, Mo., location.

PMT’s Packaging Line of the Year Award, presented since 2005, is the packag-ing industry’s most prestigious recognition of packaging line innovation and engineer-ing excellence.

The competition is open to lines that have been installed or renovated within the previous 12 months. PMT editors and Edi-torial Advisory Board members evaluate entries on criteria including the packaging line’s contribution to the company’s busi-ness plan, the level of innovation in pack-aging line design, the layout/use of floor space and the integration of machinery to optimize productivity.

Past winners of the PMT Packaging Line of the Year Award are Florida Special-ties LLC (2011), Progressive Processing at Hormel Foods (2010), Barry Callebaut LLC (2009), Ste. Michelle Wine Estates (2008), Swisher International (2007), Green Mountain Coffee Roasters (2006) and Kraft Foods (2005).

Reprinted from PMT November/December 2012 issue

Congratulations toPMT Magazine’s 2012

2012 PACKAGING LINE OF THE YEAR

The following suppliers are proud to be part of Legacy Pharmaceutical Packaging, for their innovative

spirit, deep operations knowledge, and meticulous pharmaceutical market research sugg est that they

intend to pile up many more honors and awards

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