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2010: A packaging odyssey

Pharmaceutical maker Apotex works in concert with systems integrator to assure its packaging operations will meet customer demands at least through the year 2010.

BOTTLE FILLING. Side-by-side tablet fillers on Line 5 at Apotex helped the Canadian pharmaceutical manufacturer double its outpu
BOTTLE FILLING. Side-by-side tablet fillers on Line 5 at Apotex helped the Canadian pharmaceutical manufacturer double its outpu

Released in 1968, the now classic science-fiction movie 2001: A Space Odyssey boldly looked toward the future of space exploration. Although its odyssey is an intellectual quest rather than the adventurous voyage depicted in the film, Canadian pharmaceutical manufacturer Apotex Inc. is using its vision to prepare its packaging operations for the future—based on customer needs, growth trends, and economic factors.

In the year 2001, Weston, Ontario, Canada-based Apotex “embarked on building the largest single expansion within the Apotex Group of companies,” explains Dave Villeneuve, vice president, packaging operations. Villeneuve recalls, “About a year after I started in packaging operations in 1998 (he’s worked at Apotex since 1986), we evaluated our existing plant capability in both bottling and blister-packing areas. We wanted to establish a five-year plan to upgrade equipment and to purchase new equipment to meet our anticipated demand out to the year 2010. The analysis of our existing capacity and how we could better utilize it was important, but setting a strategy for upgrades and new equipment that could carry us through to 2010 and beyond was even more important.”

Villeneuve explains that part of Apotex’s 2010 strategy involved the establishment of specifications and equipment standards that would be consistent across all of the company’s solid-dose product producing plants. “Oftentimes, equipment decisions are based on price at the time of purchase versus adopting a strategy that lends itself to consistency of operation and maintenance across multiple lines and multiple locations,” says Villeneuve.

Evaluate operational costs

“We all agreed we needed to select vendors based on their proven track record of reliability, ease of operation, flexibility, track record of innovative solutions, and the stability of their companies,” he says. “While price is always a consideration, the ongoing operational costs aren’t always considered, so you can end up with a line that’s far too complex to operate with the skill sets [of the personnel] in your organization. For our primary suppliers of solid-dose packaging equipment, we selected companies whose organizations had proven to us that their equipment could withstand the test of time.”

At the top of the list of Apotex’s preferred suppliers is NJM/CLI (www.njmcli.com). “The second part of our strategy was to select a systems integrator that we could build a partnership with—a trusted organization that would not only work for us but work with us in designing, building, installing, and qualifying new lines to support our expanding U.S. business,” explains Villeneuve. “NJM/CLI was selected as our systems integrator. In our opinion, NJM/CLI had proven its ability to work collaboratively with its customers to design effective packaging lines and deliver a quality product on time and on budget. We established what the relationship would be like right from the beginning. NJM/CLI would take on the project management role. If the project timeline was in jeopardy due to something that Apotex wasn’t doing, NJM/CLI was encouraged to point those things out and hold us as accountable as we were holding them.”

But with NJM/CLI serving as systems integrator/project manager, wouldn’t they be partial in advising Apotex on purchasing decisions? “A little,” Villeneuve admits, “but they realize that in some cases we have suppliers that we prefer to do business with versus equipment they supply, and they respect that. [Both companies] respect each others’ opinions, and that is what constitutes a true partnership.”

Project parameters

The $C250 million 2001 Apotex Group expansion was designed to deliver up to five billion dosages for Canadian, U.S., and global markets. “As part of that project, a new packaging area would be built that could deliver up to 2.5 billion dosages in Phase I, with expansion capability to deliver up to five billion dosages by adding additional lines,” says Villeneuve.

He notes, “The biggest challenge for Apotex is the number of stock-keeping-units we produce, and the variability in shape and size of the approximately 260 different molecules.” By molecules, Villeneuve refers to a specific chemical family. For example, Ibuprofen might be a molecule. A molecule has multiple strengths, such as 200 mg and 400 mg. Each strength could be packaged into multiple configurations. So the company has about 260 molecules, in 500 strengths, with 4ꯠ stock-keeping units. To meet those needs, Villeneuve says, packaging lines needed to be designed for:

• Simple, quick changeovers that can be accomplished with minimal tools, in 1.5 hrs or less, while achieving expected line speeds and maintaining those speeds over the entire run.

• Flexibility to handle more than 500 tablet and capsule varieties in fill counts ranging from 10’s to 1000’s.

• Flexibility to handle 13 standard bottle sizes and four potential cap sizes, including both standard and child-resistant varieties.

• Line speeds that could meet or exceed set standards based on extensive analysis by product, size and shape, and fill count.

• Reliability, so that by performing the proper scheduled maintenance, line breakdowns would be almost non-existent.

By 2003, Villeneuve says, Apotex was “ready to start outfitting the packaging expansion. With the involvement of NJM/CLI, we concluded that the needed capability could be achieved with the installation of three new lines, operating five days a week, in a three-shift environment.

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