Feature
packagers will not be able to meet
rapidly emerging serialization regulatory requirements or be able to realize
additional value.
6. Existing processes and
equipment will change. A typical
packaging line, whether automated or
semiautomated, is made up of specialized machines integrated into a single
line. These machines (fillers, blister
machines, cartoners, bundlers, case
packers, palletizers, etc.) are set up to
efficiently package identical products
to exacting requirements. Serialization
places the added dimension on the
packaging process. This often means
replacing or retrofitting existing packaging equipment. Use cases for the
serialization system must consider the
unique requirements of each packaging process. It is important to understand how serialization will work on
the line before new equipment is purchased or modifications are made to
existing equipment. Detailed requirements need to be communicated to
machine builders and/or line integrators to minimize costly rework. When
planning a serialization project, the
amount of time to build new equipment and integrate it into a line or
to modify existing equipment often
becomes the critical path on the
project. Long lead times should be
taken into consideration when determining when a serialization project
must begin to meet future regulatory
requirements.
Packagers should also consider
future serialization requirements when
purchasing new equipment or building
new lines. Let’s take, for example, the
new coding requirements in France
referred to as CIP13. While CIP13 is
not a serialization requirement, it is a
requirement to put a two-dimensional
bar code on each item. This requires
most packagers to add new print-and-verify capabilities to their lines.
Installing solutions that can meet current requirements and are proven to
address potential future serialization
requirements is a wise move for most
packagers. In other words, it is likely
to be far less expensive to plan for serialization now than to retrofit existing
equipment or lines in the future.
7. Leverage a productized
solution. As depicted in the image
on page 8, a solution for enabling serialization, in this case, Systech’s Serialized Product Tracking application
or (SPT), includes many different
components. The solution maintains
control over serialization at the item,
Best Practices
in Serialization
1. Serialization is a business
strategy.
2. Serialization must be a
cross-functional endeavor.
3. Serial number control in
packaging is fundamental.
4. There will be multiple
requirements for each
packaging operation.
5. Bidirectional communication
between packaging and IT
is a must.
6. Existing processes and
equipment will change.
7. Leverage a productized
solution.
bundle, case, and pallet levels. The
solution must support differing types
of packages (blister, bottle, vial, etc.)
and equipment on the packaging line.
Serialization solutions need to support
automated, semiautomated, and manual processes. Finally, they must manage serialization over multiple lines
and as mentioned earlier, provide a
gateway for bidirectional communications between the packaging environment and the IT environment.
While companies can try to build
custom solutions, there are a number
of downsides to this approach. Customized solutions tend to be limited
in their scalability and adaptability.
Custom solutions or a custom solution based on limited product software that only addresses some of the
requirements are often not suitable
for use across multiple lines with different packaging processes. When
custom solutions are changed or
modified, they typically require significantly more validation than solutions based on a productized offering.
According to GAMP5 guidelines for
a risk-based approach to compliant
computerized systems, productized
solutions based on configurable software typically represent less risk than
customized solutions. As a result, configurable software requires less validation time and effort. Furthermore,
a configurable productized solution
can be deployed across many different packaging lines, with different
machines and processes to meet multiple regulatory drivers and still provide a consistent interface to the IT
environment. Along with a common
user experience, using a productized
solution minimizes the cost and effort
to support the system and to train
staff, thereby reducing the total cost
of ownership.
CONCLUSION
“Making the right investments
immediately in packaging operations
can satisfy regulatory requirements
and provide a platform for serialization
that protects patients, brands, and supply chains from counterfeit threats,”
concludes Ringwood of Systech.
Progressive manufacturers are
moving beyond pilots and are deploying technology on multiple lines in
many regions of the world. At the
same time, these leaders are working
with standards organizations, industry associations, and regulators to
discuss, clarify, and refine standards
and best practices based on their
experiences.
Packagers recognize that additional learnings are required to execute
strategies and to make serialization a
useful tool in their supply chains. But
they are not standing still. ■
