Page 143 - Assurance of Sterility for Sensitive Combination Products and Materials

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tect sensitive products has been consistently accomplished by building
on existing packaging material technologies and the core platforms of
structural design. Current global business drivers are still emphasizing cost
reductions and efficiency improvements. In addition to these drivers, the
increased complexity of pharmaceuticals and biologics, medical devices
and combination products, and their accompanying packaging challenges
is now creating the need for better solutions, such as a new generation
of materials and design platforms. Technology advances for finished
product packaging is driving a focused effort to improve manufacturing
equipment and operational efficiencies. Historically, new processes and
materials in the health-care packaging industry are very slowly adopted.
This is largely due to the cost of conversion and a risk adverse mindset
which results in a very conservative ‘wait and see’ approach to adoption
of new technologies. This conservative approach may not be acceptable
in the future as suppliers increase focus on new technologies to support a
rapidly changing health-care market. In some cases, new packaging tech-
nologies could be the only way to deliver an important new therapy to a
patient. Therefore, it is becoming increasingly important for health-care
product manufacturers to revisit the mindset and process of packaging
technology conversion to keep pace.
The most critical material performance attribute for packaging complex
products is that of barrier performance. While material technology contin-
ues to improve properties, such as barrier performance, the need for robust
packaging systems and operations continues to grow. Packaging equipment
improvements focus on efficiency increases. Some improvements include
the reduction of change overtimes and difficulty (from machine to ma-
chine, as well as product or format changes on one machine) technology to
improve safety, improved line clearance efficiencies, smaller footprints, and
self-diagnosing machine problems vs time-consuming troubleshooting. The
increase in combination products is driving manufacturing product handling
changes such as reduced component exposure to minimize bio-burden and
the addition of controlled atmosphere areas. There have been significant
advances in package filling technologies which have enabled manufacturers
to handle micro dosages and sensitive products (such as biologics) as well as
accommodating complex combination products like inhalers.
The area of ‘connected health care’ is rapidly advancing. An exam-
ple is an electronic closed system where consistent, direct patient mon-
itoring occurs and based on the monitoring, medication is dispensed to
a specific area of the body for maximum effectiveness. Electronic and