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Article by:
Navas, Deb
Top Technology
Trends in Packaging Verification
Manufacturers
are increasingly relying on packaging systems to reduce risk, improve
quality and productivity, and enhance profitability.
The demands
of global competition and regulatory compliance issues are driving
fundamental changes in packaging line design and implementation.
Packaging lines evolved in the 1990s from strictly mechanical assemblages—positioned
at the end of manufacturing lines to label, wrap, bundle, or carton
finished product for shipment—to bar code-enabled systems capable
of packaging reconciliation. Over the last ten years, in industries
that affect public health, packaging lines have increasingly included
CCD cameras or laser scanners to perform inspection, label verification,
and packaging materials reconciliation by reading both linear and
2-D symbols on all components.
These bar code-based
quality control systems came into use in the pharmaceuticals industry
beginning in the early 1990s, when problems with drug product mislabeling
and recalls led the U.S. Food and Drug Administration to issue a
proposal tightening its packaging and labeling control regulations.
Enactment of Rule 211.122g of the FDA's CGMPs (current good manufacturing
practices) has been annually postponed over the ensuing years, and
many industry analysts now believe enactment is no longer necessary
because all the big drug manufacturers have implemented labeling
and packaging reconciliation systems in anticipation of enactment.
(See the accompanying
sidebar)
Use of these
systems for packaging reconciliation only, however, is old hat;
what's new is the degree to which they are being integrated into
centralized line control systems and also into corporate business
systems, proactively as opposed to reactively.
Tighter Line
Integration
"Companies needing machine vision inspection and packaging verification
are increasingly sharing line resources —that is, using standard
packaging equipment for multiple products on combined lines," said
Paul O'Connell, president and CEO of Operations Concepts Inc. (Cherry
Hill, NJ), an independent project management and systems integration
firm whose clients—Sterling Pharmaceuticals, FMC International,
and Searle Ltd. among them —are leaders in the pharmaceuticals and
food industries.
In a combined
line, for example, vial and bottle products that have been filled
on separate lines might then share the same labeling and inspection/verification
systems (in separate runs). After labeling, the products would be
diverted into two separate lines for unique unit cartoning or bundling.
The lines might then converge again at palletizing. With resource
sharing, relatively expensive machine vision inspection and bar
code label verification systems can support several products; separate
implementations on each dedicated product line are no longer necessary.
Another recent
trend, according to Mr. O'Connell, pertains to broader corporate-wide
centralized management initiatives. "Today there is a strong desire
for automation using centralized management and monitoring software
on both stand-alone and combined packaging lines," he said. In such
scenarios, each machine on the line has its own PLC connected on
a data highway to a centralized logic controller, which can communicate
with a line control and monitoring software package resident on
a local PC or LAN terminal. The centralized management package monitors
and adjusts all line machinery while it's operating. The program
also tracks all packaging components used and rejected for every
lot, batch, or shift. It provides downtime documentation as well
as component reliability reports.
The most prominent
use of packaging line management systems can be observed within
the pharmaceuticals industry, according to Mr. O'Connell. Line management
software provides the operating system within which packaging and
label verification takes place. It integrates inspection, identification,
and data collection within a complete line management system. "These
systems are understandably very complex and have taken years to
develop in order to be compatible with all the different PLCs out
there," he said. "But now you can literally buy the software off
the shelf and have a packaging integrator fit it to all the equipment
pieces on your line. It can also be directly integrated into the
corporate LAN, thus making investigation and reconciliation reports
directly available to QA departments companywide."
The line management
system currently seeing most widespread use in pharmaceutical packaging
is TIPS Advisor, from SYSTECH (Sys-Tech Solutions Inc., Cranbury,
NJ), a company that produces intelligent machine vision systems
integrated with packaging line technologies. TIPS Advisor can be
integrated into packaging lines to perform line setup and process
control. By acquiring real-time data, TIPS Advisor enables process
monitoring at any stage in production to ensure optimal productivity
and efficiency.
"The increasing
complexity of global markets, increasing manufacturing costs, and
shortened life cycles are challenging manufacturers to produce more
product with quicker response times, while using fewer resources
in terms of both capital assets and employees," said SYSTECH's president,
Robert DeJean. "With supply chain initiatives under way, every sensor
and scanner on the line must become a knowledge source for production
status, making data available at all times to increase product quality
and drive process improvement."
Packaging lines
use bar coding, machine vision, and sensors, among other technologies.
The ideal situation for making critical process and product decisions
is an integrated system that optimizes all these line technologies.
The packaging line is the most advantageous point for quality inspections—it
is where manufacturers can take the last long qualitative look at
the product and its wrapping before delivering it into the customer's
hands, Mr. DeJean noted. For industries such as pharmaceuticals
and food, where public health is a critical issue, machine vision
provides the most reliable final inspection, and the data can be
analyzed to pinpoint the source of any problems or errors.
"The FDA initiated
CGMP compliance regulations to first push automated inspection/verification
technologies back in 1993," Mr. DeJean explained. "But the industry
is now pulling for purely business reasons: risk management, quality
improvement, and increasing traceability, productivity, and profitability."
Regarding 2-D
symbologies in label/ packaging verification, Mr. DeJean commented
that the industry hasn't seen the rapid growth expected: "We are
seeing an increasing rate of [2-D] usage in packaging, partly because
of improving printing techniques and the fact that packaging primarily
uses fixed readers. The real growth won't occur for these applications
until 2-D scanners become competitive with laser scanners in cost
and ease of use."
2-D Packaging
Verification
The price gap between fixed-mount and handheld imagers that read
2-D symbologies and their laser counterparts, however, is fast closing.
According to Jim Hahn, president of Auto Image ID (Cherry Hill,
NJ), a 2-D scanner and verifier systems supplier, the current street
price of a fixed-mount imager is in the $900 to $1000 range, as
opposed to $500 to $600 for an equivalent laser. "Right now, customers
who want 2-D are willing to pay more for the scanners, but prices
will probably be at parity within the next two years," he said.
"What inhibits 2-D growth more is the up-front bill in replacing
an entire existing system. Currently users don't convert to 2-D
until they see a payback or are constrained by the need for more
marking space or data capacity."
The ease of
use issue may be more a matter of perception than substance in that
current imaging scanners—either fixed-mount or handheld—are no more
difficult to operate than laser scanners. The one caveat Mr. Hahn
suggested was the possibility that the laser beam itself is a more
obvious targeting mechanism: It is easier to see than the 2-D imager's
targeting LEDs, which aren't quite as bright. Such perceptions disappear
as the technology becomes more familiar.
Many drug companies
and packaging printers are introducing the most space-efficient
2-D symbology, Data Matrix ECC200, to their packaging lines. AxiCode
Technologies, a systems integrator located in Monrovia, CA (with
headquarters in York, PA), recently installed an Auto Image ID verifier
for one of its clients, Royal Paper Box in nearby Montebello.
Jeff Russell,
vice president of AxiCode, noted that Royal Paper Box's client,
a large pharmaceuticals firm, was already using a Data Matrix encoded
product number on its cartons for its own in-house packaging verification
but requested that the symbol be verified at printing as well. Royal
Paper Box is now using the Auto Image ID verifier to validate the
prepress master, verifying against the ANSI Data Matrix standard.
Cartons are printed on the flat, and a fixed-mount imaging scanner
on the gluing line scans and counts boxes as they are folded and
glued. "This system wasn't FDA motivated but selected absolutely
on the merits of Data Matrix alone, for in-house quality control,"
said Mike Cizek, who handles Auto Image ID's Western sales.
"Requests for 2-D
are beginning to come in from pharmaceuticals manufacturers to our
clients," Mr. Russell said. "The primary reasons they're moving to
2-D are code integrity and the smaller code footprint."
According to
Mr. Cizek, "Verification is becoming very important for 2-D in packaging,
because the data encoded often isn't a license plate look-up, but
product-critical information such as lot and date data.
"Data Matrix
has built-in error detection and correction that makes it far more
accurate than 1-D symbologies. Code 39 with a check digit registers
one error in 3 million characters; Data Matrix ECC200 registers
one error in 1020. Probably not in your lifetime will
you see an error." (For more on verification processes at Royal
Paper Box, see "No Margin for
Error," April 1998, p. 54.)
Tim Lydell,
director of sales and marketing for Label Vision Systems (Peachtree
City, GA), has seen dramatic growth in both interest in and sales
of 2-D systems. "We've been experiencing ever-increasing, almost
explosive, growth in 2-D," he reported. "In the last four months,
especially, there has been an upsurge in its use in electronics,
where we're reading Data Matrix on chips and wafers. We're also
seeing significant interest from packagers. One of our packaging
clients is using a Data Matrix encoded number as an 'intelligent
registration mark' to identify packaging material on press runs
more accurately."
Data Matrix
is replacing a cruder registration method long used by the printing
industry, whereby a simple black box was positioned in a unique
location on the waste area of uncut sheets; the location of the
box on a sheet signified the product ID. Positioning a photo eye
to locate this mark for proper registration might take anywhere
from five to fifteen minutes of set-up time. The benefits of using
the 2-D code and scanner system instead include significantly reduced
set-up time and enhanced accuracy, ensuring that the correct materials
are used for the job.
"We're seeing
this technology finally taking off," Mr. Lydell said. "Two-D has
been around for a while, but now because of its compact size and
accuracy benefits, people who are upgrading their lines are asking
for it."
Product
Information:
LVS
6000 Data Sheet (requires Adobe
Acrobat Reader)
LVS
3200 Data Sheet (requires Adobe
Acrobat Reader)
More information:
Label
Vision Systems, Inc.
101 Auburn
Court
Peachtree City, GA 30269
1-800-432-9430
+1 770-487-6414
www.lvs-inc.com
Helmers Publishing,
Inc .
174
Concord St.
Peterborough, NH 03458
Telephone: (603) 924-9631
Fax: (603) 924-7408
E-mail: mailto:editors@idsystems.com
Copyright © 1998 Helmers Publishing, Inc.
All rights reserved.
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