Perfect Medical Device Packaging
The medical device packaging
industry involve many disciplines including material
manufactures, material converters, device manufacturers,
educational institutions, package testing facilities and
test equipment and medical packaging equipment
manufacturers.
There is more to medical
device packaging than simply creating a flashy package
that gets consumers’ attention. It is important for
Medical device manufacturers to realize that the
packaging for their devices is as important as the
product. If the integrity of the package and sterility
of the device is violated, the device is useless.
With the continuing growth of
the Medical Device Industry, the need for sterilizable
packaging, barrier packaging and other packaging
requirements for medical/ surgical products is increasing.
With increased performance requirements, medical
packaging converters and material suppliers are faced with
challenges to provide products to satisfy these needs.
National And International
Packaging Standards such as ISO 11607-1; ISO 11607-2; etc,
Regulatory Compliance, Accelerated Aging, Package Failure
Analysis are amongst the issues important for the Medical
Device Industry to understand.
Packaging has to help reduce
hospital acquired infections, which requires packaging
that maintains its integrity, withstands sterilization,
and protects against damage to expensive devices. The main
objective is that the device package should protect the
device during handling and shipping and from the
environment and microorganisms until the package is
opened.
Fulfilling the other
essentials, it should also include using the most
appropriate packaging materials available for the device.
For selecting the right material for packaging, the
following factors must have been considered: Temperature,
Adhesives, Moisture resistance, Package porosity, Thermal
capacity, Cling resistance, Pressure, Device size and
shape, Device composition, etc.
Issues, particularly breakage
of primary containers, have been reported that have
resulted in recalls when either the primary container or
the device constituent interact, or when the patient
interacts with the delivery system.
Not only are the materials
used to pack devices becoming stronger, thinner, more
protective and more flexible almost by the year, but the
medical device regulators around the world are starting
to agree on international standards for the packaging of
medical devices. These standards will not only cover
the actual packaging and labeling, they will also set out
standards for testing the efficacy of the packaging and
the methods used to produce it.
To produce package, the
physical protection is achieved through use of
sufficiently rigid or protective package structure that
can withstand physical and thermal demands while producing
package.
Medical Packaging quality,
standards, how to choose the right materials, Selection
criteria for deciding right material, Emerging global
trends in packaging material combinations, Cost reduction
without compromising the quality, Regulations and
Compliances, Availability of right quality materials,
Regulations and Compliances required for Medical
Packaging, Industry Standards, Physical, thermal &
environmental demands, Equipment qualification required,
Effective test methods, etc. are the very important things
to be kept in mind while manufacturing the medical
package.
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