Compass Pharma Services falls into the latter camp. The company has built its business around pharmaceutical customers, and it runs all its bottle, blister, pouch and strip lines in compliance with the FDA's current good manufacturing practices (cGMP). "For us, cGMP is like muscle memory. It's something we've done all day long, every day, for years," says Tony Fenno, Compass chief operating officer and one of its owners. He adds that the company has not had even a single FDA 483 Observation for cGMP violations in the 20 years it has been involved in pharmaceutical packaging.
Practicing good manufacturing
This long cGMP experience and some unique technical capabilities are now helping Compass win new business from some of the biggest names in nutritional supplements.
The FDA's cGMP regulations may be business as usual for pharmaceutical companies, which expect compliance from their contract packagers. Dietary supplement makers have not traditionally had the same exposure to these strict regulations. Yet all that started to change in June 2008, when the FDA began phasing in cGMP regulations for dietary supplements. The smallest of supplement makers, those with less than 20 employees, had until June of this year to bring their manufacturing and packaging operations into compliance.
And compliance isn't easy. Fenno points out that cGMP rules cut across every aspect of manufacturing and packaging operations. Documented quality control systems, batch control, employee training, record retention and cross contamination prevention are just a few areas covered by cGMP rules. "It's not something you can do overnight. It requires a sustained investment of time and money." Fenno says.
Savvy brands adjust easily
Some savvy supplement makers didn't appear to have much trouble adjusting to the FDA regulations. Shaklee Corp., the well-known nutritional supplement company, reports that it already favored packaging houses with cGMP capabilities by the time the FDA rules came down.
"Our major packagers were already up to speed," reports Chris Goodwin, Shaklee's director of planning and contract manufacturing. "We've always appreciated the pharmaceutical industry's quality and lot control standards," Goodwin continues.
Fenno, too, says there are plenty of other nutraceutical makers who adjusted to the cGMP rules without much pain. They tended to have roots in the pharmaceutical industry and were already working with cGMP-compliant contract packagers such as Compass, whose roster of vitamin and probiotics customers includes Shaklee, McNeil Nutritionals, Novartis Consumer, Watson Inc. and Amerifit Brands.
Some supplement makers, however, have had to scramble to more capable packagers as the regulations came into force. And Fenno says the regulations have been a boon to Compass, whose business from dietary supplement makers has grown drastically since the FDA upped the ante on cGMP.
Today, Compass sees about 20 percent of its typical monthly revenue coming from supplement makers, and Fenno expects more growth as supplement makers seek out contract packagers that have a proven track record with the FDA.
Mastering cGMP is just part of Compass' strategy for wooing supplement makers. The company has also been winning jobs on the strength of its specialized technical capabilities.
One such capability is the high-speed handling and packaging of powders (see sidebar). "We've developed a competency with powders that sets us apart," says Fenno.
Another involves blister packaging. Compass does its share of plain-vanilla blister packaging-including cold-foil blisters and thermoformed blister packages from PVC, PVCD and a variety of barrier films. Yet moving beyond the ordinary, the company also runs a singular blister line that packages multiple tablets or capsules into a single, large-format blister.
According to Don Wrocklage, Compass director of project management, the large format line allows a single blister to hold "regimens" of different drugs or nutritional supplements that should be consumed at the same time. "It's adds ease-of-use and compliance elements to the packaging," he says.
One prominent user of the large format blister system has been Shaklee Corp. The company's Vitalizer line of nutritional supplements comes in a six-up blister that holds three tablets, two gels and a small probiotic bead. "We've seen a lot of systems that can pack multiples of the same item in one blister, but packaging multiples of very different items is much more challenging," says Chris Goodwin, Shaklee's director of planning and contract management. "Compass was a good partner in all the intensive engineering that it took to make this innovative package a reality," he says, noting that the product is one of Shaklee's top sellers.
That engineering work included refurbishing a Bosch Packaging Technology blister line with multiple filling stations and a color vision system to make certain the right mix of product ends up in each and every blister. Mactec Packaging Technologies helped Compass with the system integration, which included new controls to get all the fillers and blister forming operations running in lock-step. Wrocklage notes that the Bosch equipment works well in this system in part because it has a relatively long bed that can accommodate as many as six feeders. "Finding enough real estate for all those feeders would have been a big challenge on smaller machines," he says.
Shaklee's six-up blister so far represents upper limit for these regimen packs. And while Compass could conceivably squeeze more pills or capsules in a single blister, Fenno says the demand from pharmaceutical and supplement makers has so far focused on fewer pills per blister. "The goal is to create packages that make life easier for patients and supplement consumers," he says.
Short runs on the rise
Lots of contract packagers live or die by their ability to bring in high-volume jobs. Compass is no exception, with plenty of big jobs that run for months on end. "Everyone in our business wants the long run," says Kevin Flanagan, Compass' president and one of its owners.
Compass increasingly puts a lot of effort into short runs, too. Flanagan reports that the company has been doing a growing number of line trials, some as small as just a few kilograms of product. "Line trials are up about 30 percent this year," he says.
Turning trials into business
Trials obviously make good business sense if they turn into production runs. And Compass has set up a defined path-in terms of its equipment purchases and utilization strategy-to scale up any job it runs as a trial. In its thermoformed blister packs, for example, the company can prototype and perform trials on its smaller Mactec machines and quickly move full production runs over to its larger Uhlmann USP4 thermoformer, which can handle up to 50 cycles/min. Compass takes a similar scaleable approach with its bottle and pouch lines.
The upswing in trials reflects more concern about packaging earlier in the drug or supplement development process. "More and more formulators are working with us up front," says Flanagan, who contrasts the early involvement with the past practice of handing off finished products that may not be optimized for ease-of-packaging.
Armed with information about the bulk properties of developmental products, Compass engineers can get a head start on filling systems, tooling design and process control parameters. "If we can have some input into the product's bulk characteristics early in the game, we can help customers end up with something that's more easily machinable," says Wrocklage.
The growing diversity of drug and supplement forms has also made trials more important, particularly for supplement makers that have traditionally outsourced more development work than pharmaceutical companies. Flanagan points out that Compass contends with an ever-expanding lineup of powders, liquids and pills. Each one has its own handling and filling challenges. "We're not just putting pills in a bottle anymore," he says.
The power of powders
Compass Pharma is increasingly setting itself apart from other contract packagers based on its ability to handle powdered pharmaceuticals and nutritional supplements. While some of these powder jobs are relatively simple, e.g., dropping powders in bottles, others are far more difficult.
One of Compass' emerging specialties, for example, is micro-powder packaging in pouches. The company has a dedicated pouch line capable of packaging sub-gram quantities of powder at high speeds. Built around an HMC pouch machine, the system includes an OCS check weigher with a 0.001-gram resolution and a 250 pouch/minute capacity. Closed-loop control based on real-time weight readings regulates the system's All-Fill filling station.
Currently, Compass has one pharmaceutical job that requires it to package just 475 mg of powder with a +/-5 percent tolerance. "That's really pushing the envelope," says Tony Fenno, the company's chief operating officer. With such small quantities of powder, variations in weight of the laminated pouches can easily eat up the entire 5 percent filling tolerance. "Control of the filling station has to be perfect for this to work," Fenno says.
Hard-to-handle powders have become so important to Compass that the company typically customizes filling equipment tooling, mostly augurs, for each job. Don Wrocklage, the company's director of project management, says the company typically works with its filling equipment vendors to characterize each powder's flowability attributes, such as particle-size distribution, shape and moisture sensitivity. "We then design optimized tooling around what we know about the powder, rather than taking existing tooling and hoping we can make it work."
More information is available
All-Fill, 866/255-3455, www.all-fill.com
Bosch Packaging, 715/246-6511. www.boschpackaging.com
HMC Products Inc., 815/397-9145. www.hmcproducts.com
OCS Checkweighers Inc., 678/344-8300. www.ocs-cw.com
Uhlmann, 973/402-8855. www.uhlmann.de