On
April 29, Pat Nolan was invited by Bill Limmer of Avail Medical,
("the worlds largest, most trusted outsource provider of
sterile, single use medical devices") to participate in a
technology conference for Avail's technical staff. Over 100 engineers
from manufacturing, production, quality, material science, regulatory
and other engineering disciplines, gathered in the La Quinta Resort,
California, for a three day conference.
The objectives
of the conference were to bring engineering associates face-to-face,
who may have only interacted by electronic media, to facilitate
communication and cross disciplinary teamwork; and provide technical
information across departments and disciplines that could aid
in understanding the complete process for medical device design,
production and implementation.
Pat was invited
to teach Avail engineers specifically about the package design
and process validation for medical devices. Implementation of
the FDA recognized ANSI/AAMI/ISO 11607 standard for the process
of designing and developing a package for terminally sterilized
medical device packages is essential to the overall endeavor of
marketing a sterile medical device in the international and domestic
community. It is incumbent upon the manufacturer to ensure that
a safe and fully functional product arrives at its end use. This
assurance is complicated by the fact that the package must maintain
its barrier integrity throughout its intended shelf life and through
the rigors of the shipping and handling environments. The ISO
standard specifies the requirements for developing and validating
a total package system including the manufacturing process, and
establishing the protective capability of the package design.
The task lying before the manufacturer of a sterile medical device
is ensuring, beyond a reasonable doubt, that the device remains
in a sterile condition at the point of end use.
Pat's lecture
included how to comply with the ISO 11607 standard including establishing
that the packaged product can withstand the sterilization process,
the rigors of handling and distribution, and long term storage
conditions, without losing its integrity and thus the product's
sterility. This can be done through laboratory testing using ASTM
standards developed by medical device package experts. Standard
test methods include package integrity and strength testing, distribution/transportation
simulation test procedures, as well as guidance for developing
accelerated aging protocols for establishing shelf life of packaged
products. The 2.5 hour session provide an in-depth discussion
of how these methods can provide the necessary data to validate
the package process; from selection of materials, to manufacturing
of packages, to transport of the packaged product to its end user.
Several of the audience indicated the value of knowing how this
process could affect their particular jobs of material selection,
while others saw the importance of this knowledge in developing
the manufacturing process of the device itself; such as reducing
the possibility of 'sharps' in a product which would aid and simplify
the package design.
Pat felt the
goal of his lecture was accomplished and provided valuable cross
disciplinary information to many Avail engineers.
