Medical
device maker says goodbye to extra labels and replaces them with
on-line, thermal-transfer printing
A major medical device manufacturer says goodbye to extra labels and replaces
them with on-line, thermal-transfer printing on lidding
material. Print now includes important symbols required
by customers overseas.
Improved legibility and reduced labor costs are just two
of the benefits enjoyed by the company since
thermal-transfer printing became part of its medical-device
packaging line.
The
new equipment also means that the Western US
firm is now able to:
print
symbols required in the international marketplace,
thus eliminating extra labels applied to lidstock
do
custom printing for customers whose products are
contract-manufactured and packaged by the company
rely
on automatic dating, which greatly reduces the
chance for human error in the date-code information
thatÁs necessary on the lidding material
Disposable surgical devices for cardiology and radiology procedures are what the company manufactures. The devices are loaded by hand into cavities formed on a Multivac (Kansas City, MO) M-855 thermoform/seal machine. The Multivac is equipped with five sets of tooling for a variety of package configurations. Maximum depth of draw is 1", and the rated speed of the machine is 10 cycles/min. The Multivac also heat-seals flexible lidding to the filled thermoform.
Before the new on-line printing equipment arrived about a year ago, a dot-matrix printer mounted on the Multivac was used to imprint the lidding material with basic product and manufacturer identification. Other important information, like company address and customer service phone number, wouldnÁt fit, so it had to be added to the corrugated shipper label.
The above scenario was further complicated when product
was destined for overseas markets. As many as six
workers had to give each package pressure-sensitive
labels printed with symbols and/or copy required overseas.
Now
all the information required is printed by the company on the
packageÁs lidding material. Overlabeling is a thing of
the past.
The company prefers not to quantify the reduction in labor costs
since the new on-line printing equipment was installed.
But according to a company packaging engineering manager,
the savings were substantial. As for the workers, theyÁre
redeployed more productively elsewhere in the plant.
Mounted on the thermoformer
The thermal-transfer printing equipment selected by the company was supplied by Bell-Mark (Pine Brook, NJ). Two of Bell-Mark's Easy-Print
programmable traversing machines were mounted
to the framework of the Multivac machines.
We are light years ahead compared to how we used to do
it, says a company spokesperson. Efficiency in overseas shipments, he notes,
is dramatically improved.
The printer we had before only allowed us to print text,
explains the spokesperson. Our logo was preprinted on the lidstock,
and we added part number, lot number and expiration date
in text.
The problem we encountered is that the European Medical
Device Directive issued in June of 1998 identified certain
symbols, accepted by all EU nations, that must be used
on packages destined for EU markets. Until we installed
the on-line printers, we added these symbols by overlabeling
each package, not only at the manufacturing plant,
but sometimes also at our European or Asian distribution
center. That was time-consuming and expensive.
Only some of the symbols are strictly required by the
EU. An example is the CE mark and certification number
indicating that a product has been inspected and is qualified
for sale by European standards. Other symbols are merely
recommended; but if text is used instead, it must be translated
into multiple languages. ThatÁs not easy on a small package.
The Bell-Mark machines are traversing printers, so the printhead moves across the lidding material each time it's advanced by the Multivac machine. As the printhead moves across the film, it transfers the image by pressing a thermal-transfer ribbon onto the lidstock to imprint one lid image for each package in the row.
Maximum print length for each print head is 5". Because
two printers are stacked, the company can print a lidstock image
thatÁs longer than 5", with one printer handling the front
portion and the second printer handling the back. Or,
if the print length on a package is less than 5", printing
can be done two rows at a time.
Product data is stored in the label-creation software,
which an operator can access through a PC. New print designs
are created with the same software. Windows® based,
the software is very user friendly, which is a big help
in minimizing changeover time, says the spokesperson.
We run about 100 different products through this machine,
says the spokesperson. For large orders, we may run the same product
all day, even longer in some cases. But on other days
we wÁll change several times in one day. The line typically
runs 10 hours, four days a week, he said.
The versatility provided by the software also helps the company
in the contract manufacturing/packaging work that it does
for other marketers of medical instruments. Rather than
having to inventory lidding material preprinted with the
customers logos, the company can use the same unprinted lid
stock and print logos on-line.
The company spokesperson says a soon-to-be-implemented upgrade to LabelView
software from Teklynx (Milwaukee, WI) will link multiple
users over a local area network so that print commands
can be sent from a variety of locations.
Suppose the machine operator on a given shift who is responsible
for sending print jobs to the Bell-Marks calls in sick,
says the spokesperson. Someone in engineering or quality control
can send the print job over the LAN.
Symbols
hold info
The stop-cock package shown to the right illustrates how many symbols the company now prints on its lidding material. The hourglass, for instance, is internationally recognized as a symbol meaning use by. The device in this case is not to be used after March of 2003 because its sterility can't be guaranteed past that date. Even the method of sterilization, ethylene oxide, is indicated in a graphic element recognized around the world: STERILE EO. Had the device been sterilized by radiation, it would read STERILE R.
Also
prominent is the CE mark and a circled 2 with a slash
through it: the international symbol for do not reuse.
The notice that the device is nonpyrogenic (ie., contains
no bacterial matter capable of causing fever) is printed
in English, French, Spanish, German and Japanese. Before
on-line printing, this information would have been supplied
on an extra label applied by distribution centers in Europe
or Japan.
Above
the multilingual nonpyrogenic copy is a bar code, useful
in domestic as well as global markets. In that bar code
is a Universal Product Number (UPN) that major customers
around the world require, says the company spokesperson. They want to track
inventory and reorder using bar-code scanners the same
way you see it being done with UPCs in the aisles of retail
stores. The UPN bar code, also imprinted in its human-readable
format, contains three items of information. First is
H656, which the spokesperson calls a labeler identification code,
or LIC. That tells the world that this is our product, says the spokesperson. The number is assigned internationally
to the company.
Next is a catalog number, MS111LG, and finally a packaging
level indicator, in this case a zero, that carries information
on quantities that should be reordered.
Two other pieces of information on the stopcock package
are the company's headquarters address and phone number and
its European contact in Ireland. In the days before on-line
printing, this information wasn't on the primary package.
It was provided only on the shipper.
It's much better to have it on the package itself, says
the spokesperson. If the device becomes separated from its shipper,
everything that needs to be known is there on the package.
The company also appreciates the automatic real-time dating
feature that is part of the Bell-Mark equipment. The printers
automatically pull in things like expiration or manufacturing
dates, says the spokesperson. Not only does it reduce the number
of things an operator must do when beginning a new work
order, it also eliminates the possibility of operator
error in entering dates.
As
Packaging World goes to press, the company was completing the
installation of a new Multivac system in one of its facilities, and mounted to it will be a single Easy
Print C thermal-transfer printer. Print lengths on the
new line won't be as long as they sometimes are on the
other line, so there is no need to stack two printers
this time. Another system has been purchased for use in
the company's facility in Ireland. The objective is plain.
We're looking to expand our markets overseas, and these
machines will help us do that, says the company spokesperson.