Image Area

V
i
e
w

P
o
i
n
t
www.infosys.com
Best practices in SAP for packing and
labeling of diagnostics kits
Abstract
Packing and labeling of diagnostics test kits is an intricate part of kit manufacturing. Many system integrators are involved
in developing packages and labels to ensure that integrity of components of a kit is maintained and packing & labeling
are easy for patients and clinicians to use and understand. In this PoV, I am sharing packing and labeling requirements of
diagnostics kits; challenges in packing and labeling; best practices and design in SAP to counter these challenges.
-Arun Jatwani
02 | Infosys
Packing and labeling requirements for Diagnostic test kits
Diagnostics test kits (hereafter referred to as kits) are an important part of life sciences industry. Kits include a set of test reagents, an assay,
specimen collection and measurement devices. Reagents react with the collected sample in kits to produce an entity that can be measured.
The tests are generally done in pathology laboratories and sometimes by patients themselves. The measurement results provide information
to clinicians in diagnosis and treatment of a disease.
Accuracy and usability of a test result from a kit essentially depends on its packing and labeling. A change in chemical, physical and biological
characteristic of a kit leads to deteriorated end results. Quality, protection, appropriate identifcation form the basis for packing and labeling.
Identifcation via packing and labeling is how kit manufacturers communicate with consumers. The requirements below are aligned to
marketing and manufacturing strategies that are consistent with the diagnostics business:-
P
a
c
k
i
n
g
Protective cushioning.
Handling instructions.
Sterilization suggestions.
Protection
Light transmission
Moisture and
oxygen sensitivity
Documentation
Environmental
requirements
Legislation
requirements
Cap inserts and desiccant stoppers to prevent moisture.
Scavengers to prevent oxygen exposure.
Documented instruction and quality manual.
Product specifcations.
Multilanguage guidelines
Functional and environmental performance.
Recycling and fnal disposal.
Usage of polymer grades and flms to prevent any possible
chemical reaction because of exposure to light.
Country specifc regulations.
L
a
b
e
l
i
n
g
Fragility.
Mechanical strength.
Damage sensitivity
Dimensions
Intended uses
Warning statements for
devices
Directions for use
Integrity of information on labels, objective intent of the kit.
Legibility of labels, labeling claims
Word of cautions.
Side efects.
Chemicals used in kit manufacturing.
Directions under which a layman can use a kit.
Method and duration of administration.
Shape and Size.
Challenges in packing and labeling
The packing and labeling function involves a lot of guesswork and assumptions.
The expected package and label design is rarely precise and the design consistently
evolves. The lack of defined design requires the team to be flexible. Second, the
package and label is built by people for people, requiring that the team have the
ability to build a package which meets the needs of users. For example: the location
of a label on the kit packing can make a crucial difference to its usability.
Based on the above, there are three fundamental challenges for outlining packing
and labeling of a kit. These interrelated challenges call for a robust investment in the
right mix of capabilities.
Infosys | 03
Figure 1: Challenges in packing and labeling
1. Defning active elements in the kits, sterilization needs and setting up product
and packing compatibility.
2. Distribution and shipment needs, potential market for the kit and environmental
conditions for end user.
3. Making the kit packing and label design consistent with the advertisements.
Distribution and
shipment needs,
Potential market,
Environmnetal
conditions
Consistent
design
Active
elements,
sterlization and
compatibility
Best practices in SAP to counter these challenges
It is critical to address the challenges to maintain the end users impression of the kit, communicating desirability, acceptability, ease of opening
and disposal.
Defining active
elements in the
kits, sterilization
needs and setting
up product
& packing
compatibility.
Design includes defining:-
Number ranges of the handling units (physical unit consisting of packaging materials).
Packing control for item category (gives an option to specify that kit requires packing).
Requirements for packing- This is one of the most significant configurations in SAP for including active elements
in packing the kits. These requirements constitute routines with subprograms in which several criteria for packing
are written.
Packing material type- It is linked to material group for packing materials, which is assigned to the components
used in packing kits. The packaging material type controls the output/paper work generated during packing.
Distribution and
shipment needs,
potential market
for the kit and
environmental
conditions for
end user.
Determine criteria that should be used to pack a kit for a certain customer or market- includes packing instructions
determination.
Design includes defining:-
Key for packing instructions determination- Instructions are determined based on the kit to be packed, usage,
route by which it will be shipped, storage type and the respective customer. SAP will determine the specific
packing instruction depending on the criterion.
Access Sequence for packing instruction determination- Search strategy that SAP uses to search for valid
determination records for a packing instruction determination type.
Making the kit
package and label
design consistent
with the
advertisements.
Use available SAP enhancements to make the package and label design aligned to the way kit will be perceived in the
market.
SAP has an enhancement named PACKMODI. In this enhancement, we can write our own logic and create the
necessary customer-includes to:
Print custom labels with item wise description of the kit components.
Barcodes that match and confirm with kits serial number requirements.
Align the package and label design with the end users perception of kit usability.
Determine how the kit will be packed - includes determination of combination of constituents in which kit is packed.
Challenges Best practices in SAP and their design
2012 Infosys Limited, Bangalore, India. Infosys believes the information in this publication is accurate as of its publication date; suchinformation is subject to change without notice. Infosys acknowledges
the proprietary rights of the trademarks and product names of other companies mentioned in this document.
About Infosys
Many of the world's most successful organizations rely on Infosys to
deliver measurable business value. Infosys provides business consulting,
technology, engineering and outsourcing services to help clients in over
30 countries build tomorrow's enterprise.
For more information, contact askus@infosys.com www.infosys.com
Conclusion
The packing and labeling function for kits is exceptionally vigorous and is changing with new kits being developed all the time. The key to an
efcacious packing and labeling will be how well a system integrator understands the requirements of packing and labeling kits. I believe that
the fnal design will be far better served if the integration skills are applied by considering the best practices of SAP.
About the Author
Arun Jatwani
Principal Consultant with Consulting and Systems Integration unit at Infosys Limited.
He has rich experience in deploying multiple IT applications including SAS for business intelligence and SAP ERP in
manufacturing and life sciences domains. He specializes in supply chain areas like logistics, sales and 3PL warehouse
management.
He can be contacted at arun_jatwani@infosys.com