What keeps you up at night? For Steve Meeker, it’s answering questions such as: If our company considers itself a “solutions” provider, are we doing enough for our customers, for our shareholders, and for our employees?
Customers long for their packaging supplier partners to provide the agility they need in an ever-changing marketplace says Meeker, a 40-year pharmaceutical industry veteran who was recently appointed President of contract packager Legacy Pharmaceutical Packaging.
“We operate in a pharmaceutical industry in which you have to reinvent yourself to exemplify and differentiate your company. You have to create value at all times and focus on what you need from a personnel, technical and facility standpoint to provide the solutions customers need today and in the future,” he states.
To meet those customer needs, St. Louis-based Legacy modernized its 190,000 sq-ft production facility, adding packaging equipment to increase production. Among the most recently added machinery are the following:
• A NJM Packaging Cremer CFI-622 tablet counting and bottle filling system.
• A Serpa P100 cartoner.
• A new cage to its Drug Enforcement Administration-approved Schedule III-V vault that holds up to 300 pallets of product and meets federal regulation code 21CFR 1301.72 for pharmaceutical applications.
Meeker’s experience with pharmaceutical manufacturing firms including Bayer Healthcare (which he says also included a contract manufacturing arm to better utilize investments), Sanofi, and Marion Merrell Dow gives him first-hand understanding of Legacy’s customers.
Legacy packs finished solid-dose forms, with bulk capsules, tablets and softgels sourced globally.
Approach to facility management
Managing a facility to meet customer needs involves more than adding efficient packaging machinery. Meeker explains, “When the company created the floor plan for the modernized facility, it took a very open floor plan and modular concepts to develop packaging suites with great material flow in mind. There are no hard walls within the interior of the building, so it operates like a greenfield facility whose open layout optimizes operations.”
That means separation of bottle unscrambling and bottle filling functions, for example, with positive pressurized air used to prevent corrugated fibers from entering filling suites. HEPA air filtration is used within each filling suite.
In all, Legacy runs 13 packaging lines, with plans for two more lines producing commercially next year, one in the first quarter, another in quarter three.
Additionally, to make room for even more packaging suites in their primary facility, Legacy has expanded and assumed another 107,000 sq ft of GMP offsite warehouse/distribution space. Utilization of this space will include offsite storage of materials and, in an effort to provide even more service to customers, will establish a 3PL distribution service out of this facility.
Meeker adds, “We continually strive to provide even greater levels of value-added services to our customers. Annexing this new space, which is literally located directly across the street from our primary facility, allows us to provide one more level of vertical integration for our customers.”
All of these lines are built with agility and high-speed changeover in mind—addressing the technological effort to increase customer value. Legacy’s technical offerings are diverse, with a blend of high-speed, serialized bottle filling lines including inline cartoning, to mid-speed lines, offering higher levels of flexibility. The same thing holds true with blister packaging lines, which include equipment from Pharmaworks.
“One of our differentiators as a contract packager is our service,” he says. “About 80 percent of our products can run on multiple packaging lines, so even if one or two lines are already running a product, we can run a job on another line. We need to maintain quick turnaround times for our customers, working closely with them on their demand planning.”
Legacy typically receives solid-dose forms in bulk quantities, within fiber drums, plastic barrels, and other large-quantity containers. “We’re flexible on packaging suppliers, but we run a turnkey model where we specify, with the customer’s endorsement, bottles, caps, labels and cartons,” Meeker says. “That’s what we’ve built our infrastructure around.”
What’s Legacy’s position on vendor standardization? “I think there is financial benefit in the standardization of spare parts and change parts,” says Meeker. “I also think it's important to build and rely on those relationships with a particular vendor. If you're an organization that buys filler “x” today and filler “y” tomorrow, that makes it tougher to build and foster a relationship with equipment providers.”
Training is another factor that can be overlooked. Says Meeker, “I think one of the things that we've focused on here is training, including comprehensive operator, maintenance, quality and even material handler certification programs. Building those programs for a variety of different equipment providers is tougher.”
He believes using multiple vendors for a specific type of machinery also makes it more challenging for operators to develop technical familiarity with that equipment. So using the same machine supplier for labeling, for example, allows Legacy personnel “to become subject-matter experts more quickly,” he says. And that further benefits customers, as it allows Legacy to maximize productivity/output, while reducing labor and waste.
As a pharmaceutical contract packager, Legacy sees itself as being on the front lines of serialization, with customers looking to them for serialization expertise. Meeker says it’s the topic represents the single-biggest customer concern today. “I think everybody is scrambling a little bit to understand what they need to do, how it’s going to work and to understand the technical solutions that exist and their costs.”
Legacy continues to add technical capabilities and the IT infrastructure to support serialization efforts. That includes building relationships with providers “on the data side and on the software side,” says Meeker.
Meeker believes the ability to provide serialization will separate the contenders from the pretenders in the contract packaging arena. “There will be contract packagers that just won't be able to manage the barriers of entry, whether it's complexity, intellectual resources, or finances.”
For those who think serialization is primarily a regulatory or automation issue, Meeker notes, “It changes the dynamics on the packaging line. With serialization, the case packer associate who was manually loading cases for years all of the sudden has to be as knowledgeable as the filler operator in order to address serialization issues.”
About two years ago, Legacy initiated a serialization master plan in which each of its lines would ultimately be equipped to meet 2017 DSCSA requirements.
From a packaging perspective, Meeker says Legacy has standardized on Optel Vision camera and scanning systems on all of its labeling equipment. “We’ll build on those platforms on a unit basis on the labels, then integrate that for bottles, cartons, bundles and shipping cases.”
How will Legacy justify the economic investment in serialization, which will run in the millions of dollars? “We look at it as a changing baseline requirement that allows us to stay in business,” says Meeker.
Circling back to the customer
“We consider our customers as our sponsors,” he notes. “Somebody on the other end of the phone can call us and say, ‘Hey, I’m in trouble. We’ve got to get this product to the market in six weeks. Can you help us?’ We look at this as not just a business opportunity, but as a partnership.
“We’ve experienced tremendous growth in recent years and we anticipate that to continue over the next five years,” Meeker says. “That’s a wonderful place to be. But I always go back to the ‘solutions provider’ thing. Are we differentiating ourselves and ensuring that we’re keeping up with market changes, be it compliance with DSCSA and serialization, the quick responses needed in the generic pharmaceuticals area, or a full-blown market launch of new products, we take pride in providing quick alternatives and ‘solutions’ for our customer partners as they need them?”