Originally Published PMPN December
2004
Packaging Machinery
Buying
and Integrating Packaging Equipment
Machinery suppliers offer high-tech options, validation services, and anticounterfeiting features to meet manufacturers’ needs for more-complex, sophisticated packaging.
by
John Conroy
Contributing Editor
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| MGS Machine Corp. offers end-of-the-line options, like the Stealth Cartoner. |
Validation support, service bundling, and product safety remain daily concerns
for the medical and pharmaceutical industry. Now, add the needs of an aging
population, upgraded material-handling machinery, and a search for cheaper production
materials to the list of potential trends affecting both packaging equipment
providers and their customers.
Pharmaceutical companies are adjusting their product packaging to make it easier
to open, and equipment providers are finding they, in turn, need to offer the
proper systems to match their clients’ requirements, says Matt Croson,
director of member services for the Packaging Machinery Manufacturers Institute
(PMMI; Arlington, VA).
“From a pharmaceutical perspective, the biggest thing you’re seeing
is much more marketing toward consumers,” says Croson. “That means
packaging tends to have a little bit more of a direct marketing approach, whereas
in the past you just had a straight bottle with the label on it.”
Croson says that drug manufacturers want packaging for older consumers that’s
“a little easier to open and a little easier to close.” The trend
is having an impact on the trade association’s 508 member companies. “There
are a lot of one-dose units being produced,” he notes. “That’s
a big challenge for operational procedures. Machines have to be very precise
and fast and efficient.”
Tony Miller, marketing and product coordinator for Bosch Packaging Technology
(Minneapolis) has seen this trend firsthand. “Everything is becoming more
consumer oriented, and, yes, you do have to adjust your outlook,” he says.
Cartoners in particular are seeing this rapid shift, where machines are required
to place “two items in the same carton instead of having separate packaging.
They’re adapting existing technology,” he says.
However, tinkering with existing toolsets soon will no longer suffice, Miller
says. “In the next year you’ll start seeing machinery that’s
more adept at doing the more-specialized [work].” He points out that the
cost of producing a machine “to make one specific package is astronomical.”
Over the past year, PMMI’s members have seen an upsurge in sales of inspection
and coding equipment, Croson points out. Between 2003 and 2004, sales of inspection
and checkweighing systems have risen 8.4%. “There is a need right now to
ensure the safety of the product throughout the production line.” Manufacturers
are installing process automation and light readers for this purpose, he says.
Validation
Bill Leib, a senior packaging engineer with B. Braun Medical (Allentown, PA),
says he’s seeing more tool suppliers offering validation services. Multivac
recently installed a horizontal form-fill-seal system for B. Braun Medical’s
line of fluid-transfer sets and epidural kits. “They offered a validation
package that saved us a lot of time,” he notes. The information qualification
process had been “pretty much all set up for us.”
Working on a new project, Leib is collaborating with a supplier to evaluate
different and cheaper materials for blister pack webs, “where, basically,
you’re getting more yield out of a pound of material.” He says B.
Braun Medical is writing protocols in order to launch a pilot program by the
end of 2004. “We’re going through a lot of testing up front to determine
whether it will or won’t work.”
Two and a half years ago, Bosch Packaging Technology opened a division, called
Valicare, dedicated to validation support, says Miller. “That part of the
business has grown faster than any of the other parts of the business. It has
done very well.”
Validation support is a “huge, huge issue” for customers, agrees Tim
Allen, regional sales manager for the cartoning and case packing group of MGS
Machine Corp. (Maple Grove, MN), which recently introduced the new Eclipse
Intermittent Motion Cartoner. “One of the things I do see starting to happen
in the industry is that customers are looking for total integration services.”
Allen says MGS “has a lot of options to offer at the end of the packaging
line.” Integrating services offers clients advantages over competitors
that provide just cartoners or that lack a variety of infeed solutions, for
instance.
Technical expertise alone, however, does not guarantee a competitive edge, Allen
says. In his view, the pressure of meeting FDA regulations may even trump technical
prowess. “It’s an evolving process,” he says. “One of the
hard things to sell and to articulate to customers is that you don’t just
buy a validation package. Customers must partner with a supplier that can provide
you with correct documentation to assist in their validation process.”
IWKA PacSystems (Fairfield, NJ) combines validation services and integration,
says Bernie Conlon, director of sales and marketing. “The ability to integrate
a line at our factory allows the customer to have the factory acceptance test
(FAT) protocol parallel the validation protocol. In this way, when the line
passes the FAT, the customer can be assured that the validation at the customer
facility will go smoothly.” IWKA, which recently introduced new blister
packaging machinery, also offers 21 CFR Part 11 compliance as part of its standard
validation package, Conlon points out.
This validation requirement extends to the code written to control the machines,
says John Wenzler, packaging industry account executive with Bosch Rexroth Corp.,
a technology supplier separate from Bosch Packaging (Hoffman Estates,
IL). “The IEC61131-3 programming standard includes the ability to create
custom function blocks,” he says. “Once a machine is complete, the
builder can have his code validated, and then encapsulate it in a password-protected
function block. This block can then be used elsewhere on the machine, or in
other machines without going through the certification process.”
Integration capability continues to run neck and neck with validation support
as a customer requirement, Conlon notes. “As a German manufacturer, we
find that customers want to take advantage of the fact that they can come to
our factory and do one FAT of a complete or partial line.” Because the
majority of pharmaceutical machine suppliers are European, clients can save
both time and money by dealing with just one supplier, he says.
“They do not have to go to six European factories to do individual FATs
before machines are shipped to the United States,” Conlon says. “We
have seen this more and more over the last two years. We will integrate and
take responsibility for the line. This gives the customer more time to focus
on other issues. It also gives the customer confidence that the line will run
when it is set up in the plant.”
Safety Concerns
Proper validation can ensure product approval, but once the product leaves the
plant the risk of tampering remains. An Ohio-based company believes its updated
line of sealing and die-cutting equipment can provide anticounterfeiting product
safety. Peter Zelnick, CEO of Zed Industries (Vandalia, OH), says the
industry has grown increasingly worried over the past two years about the integrity
of wallet packages.
The adhesive can be a problem. “The adhesives that have been developed
over the years are not being used because of environmental issues, or because
of the Wal-Mart syndrome of trying to drive prices down,” Zelnick says.
He asserts that adhesive properly applied “cannot be opened without destroying
the package.” However, now that some companies have been shipping product
with “cheaper alternatives,” rumors abound that black marketeers in
Eurasian countries have been opening packages and replacing the contents with
bogus product, he claims.
Zelnick says it has been difficult to manufacture a child-resistant wallet package
“because you’re just pushing the medication through a foil or die-cut
window, and it’s out.” Multifold wallets with three to four layers
of paper are difficult to process at efficient speeds, he says. In response,
Zed has developed an entire new line of equipment to meet 1-second or 1.25-second
cycle times for speeds exceeding 300 wallets per minute and still offer anticounterfeiting
and child-resistant features.
Called the HH series, the machinery can be fully automated, Zelnick says. He
notes that clients are looking to automate their plants as much as possible
in order to maintain production on shore. Medical customers reason that automation
and workforce reductions can help lower costs when overhead and employee benefits
remain unchangeable. Very little tooling is required to change jobs, Zelnick
says, noting, “If you were changing blister or vial sizes or changing the
literature, all within reason, you could use the system without changing parts.”
As a result, the client can “tool up for less than $10,000.”
Regarding anticounterfeiting measures, Conlon says IWKA’s cartoning machines
“can install labelers that will place a holographic label on the carton.
Also, in our blister packing machine, a holograph can be used on the blister
card lid stock.”
Robotics on the Rise
The semiconductor industry’s pain may be the medical device industry’s
gain, according to Craig Howard, president of Zmation (Portland, OR). As its
electronics industry sales have fallen in the last three years, Zmation has
seen the medical device industry pump fresh blood into its business. Sales of
the company’s robotics equipment to the medical device industry have risen
steadily during the same period, says Howard.
In 2003, sales to medical device companies made up more than 50% of Zmation’s
business. One of the main reasons for the increased sales is that “so much
of our business used to be in the surface mount and computer-related industries,
and most of that manufacturing left here so fast.” Zmation has always had
a small but steady percentage of business from medical device customers, Howard
notes. But, he points out, “In the last three years you really have seen
our classic manufacturing industries just disappear or become extremely slow,
and the reality is that the medical industry [business] hasn’t so much
increased as it has remained steady.”
The industry, he says, has been immune to the downturn that hit the semiconductor
sector. “Device manufacturing is one of the few industries where I can
walk into a factory in the United States and see hundreds of people manually
assembling parts. Almost all of the other industries that do that here are gone.”
Howard has seen “a lot of cross pollination,” as Zmation has picked
up sales leads “from people in electronics and the SMT world.” In
his automation market segment, “the semiconductor industry and the medical
industry have more similarities than differences,” including the use of
stainless steel and the obvious need for cleanliness, Howard says.
Machine efficiency is at the root of at least one new industry trend, according
to Conlon. The development of servo motion control tools “allows each machine
to share precise product position and speed data.” This capability ensures
smoother product transition among machines than previously available.
“This new technology offers unprecedented speeds and efficiencies and overcomes
some of the pitfalls normally associated with material-handling issues,”
he says. “In some cases, it also allows transfer designs that simply were
not possible with the previous generation of machines.” Rexroth’s
Wenzler says the use of OMAC (Open Modular Architecture Controls) tools such
as the PackML State Model and PackTags makes this machine-to-machine communication
easier. “PackTags are naming conventions used for standard information
needed from packaging machinery,” he explains. “If OEMs implement
this convention, machine information flow can be accomplished easier, regardless
of the control architecture.”
Wenzler says that in the same manner, the PackML State model is a controller-independent
machine operation flowchart. “By using this template to develop the machine
code, each machine will have a similar look and feel to the operator, regardless
of the OEM or control architecture,” says Wenzler. “This openness
allows customers to access information within the individual machines and gives
them an increased level of interoperability between the machines on their production
lines.”
Copyright ©2004 Pharmaceutical & Medical Packaging News
