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.
In order to understand the Medical Device Packaging
markets , it is essential to have proper perspective
for the industry broken down by product, material and
market segmentation; exclusive value chain analysis by
key areas, and a review of technology developments and
new application opportunities.
The packaging industry is continuously evolving as
medical product companies institute changes in the
design, development, and manufacture of packaging
It is essential to have an awareness of important
packaging issues involving both design and
It is also important to have a basic understanding
of the importance of validating processes and
equipment, and the continuing need to maintain control
of established packaging processes.
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.
This includes allowing for any necessary
sterilization. Packaging contains the product
identification and other information Labeling.
Packaging may also contain integral labeling and
instructions for use. Finally, when the consumer is
ready to use this product, the package should be easy
to open without compromising the quality of the
device. In the end, a well designed package
facilitates use of the device and contributes
substantially to the overall appeal of the product. It
makes sense for the manufacturer to invest in the
development of a safe, user friendly package.
PACKAGING DESIGN CONTROLS
Package design should be an integral part of the
product development program. The total device and
package system should be considered with respect to:
device characteristics, sterilization process if any,
sealing, labeling, secondary packaging, handling,
shipping, environment, storage, federal regulations,
and end use.
Defective packaging and seals have been a major
cause of medical device recalls. This type of recall
can often be avoided by correct package design
including validation of the packaging and sealing
It is important to be aware of the state-of-the-art
in sealing methods and packaging materials, including
their physical, chemical, biological, and
compatibility characteristics and, of course, cost.
"Wet" devices require high-barrier package materials
and sealants with impermeability; resistance to
solvents, grease, chemicals, and heat; and the ability
to contain wetting agents, reagents, oils, or
Design controls require
that a packaging design undergo considerable
validation, review, and documentation. However, the
end result is a smooth transfer into production with
increased package safety and efficacy, resulting in
greater customer satisfaction and cost savings and
In addition to the GMP requirements, manufacturers should always study
current packaging practices for products similar to
theirs to determine current favorable practices and to
prevent user packaging problems. For example,
customary use may dictate the use of double primary
packaging for some sterile devices. Finally, any
packaging used for medical devices should satisfy the
end user or customer requirements, which automatically
satisfies one of the design GMP requirements. This is
a key point to be considered during the design phase.
Fulfilling the design control procedures discussed
above should include using the most appropriate
packaging materials available for the device.
Device packaging and shipping containers should be
designed and constructed to protect the device from
adulteration or damage during the customary conditions
of processing, storage, handling, and distribution.
The package and device should be designed together
so that all factors in the product and package system
can be considered, such as device sharp edges and
severe vacuum stresses. Some other factors to consider
Device size and shape
It is important that sterile devices and their
packaging material meet the requirements of the
sterilization process, package sealing method, and
intended use. For example, radiation sterilization may
discolor packaging and sealing materials, or reduce
their functional capabilities. All plastics are
somewhat affected by radiation sterilization,
occasionally positively, frequently negatively.
Consideration should be given to the effect produced
and the radiation dose needed to produce an effect.
Complete storage and stability data should be compiled
for sterile device packaging subjected to radiation or
should be obtained from the supplier.
Ethylene oxide (EO) sterilization requires
packaging material of sufficient porosity to allow air
to leave the package and the gas to rapidly permeate
the package, sterilize the product, and then leave the
package. Adverse levels of EO residues left on the
device harm the patient. Air washing at the end of the
cycle reduces residues. Evacuation of the
sterilization chamber for air removal, gas fill, and
air washing can induce package stress, particularly
when the cycle calls for high temperature, pressure,
and rapid pressure changes before and after the gas
exposure (dwell) period.