|
 Validate Your Test
Methods
There seems to be some confusion among medical device packagers
regarding test method validation. ISO 11607 was revised last year to
clear up some of that confusion. Unfortunately, some misconceptions
still persist.
Mike Scholla, senior consultant for DuPont Medical Packaging and
a PMP News editorial advisory board member, shared his
perspective as he chaired the ISO 11607 Implementation panel
discussion during Medical Design & Manufacturing West 2007. The
conference took place in Anaheim, CA, February 15.
 ISO 11607, Packaging
for Terminally Sterilized Medical Devices, was revised and published
in April 2006 in order to harmonize the document with Europe's EN
868, Part 1. The global standard is now known as ISO EN 11607 and is
published in two parts, ISO EN 11607-1:2006 and ISO EN 11607-2:2006.
Part I covers requirements for materials, sterile barrier systems,
and packaging systems. Part 2 addresses validation requirements for
forming, sealing, and assembly processes. "If you market products in
Europe, 11607 is no longer a [voluntary] guidance," said Scholla.
"It is a requirement."
The standard has also been adopted as a voluntary American
national standard titled AAMI/ANSI/ISO 11607-1 and AAMI/ANSI/ISO
11607-2. An AAMI technical information report is close to
completion. (And FDA is expected to recognize it as a consensus
standard.)
One of the most confused aspects of ISO 11607 is its discussion
of validated test methods, Scholla told MD&M attendees. The
document's Annex B lists test methods for qualities such as strength
and integrity that packagers can use. Some packagers, however, have
mistakenly believed that using any method from the list means that
they are using a validated test.
"A test method is only validated if you have validated it
yourself in your own lab," Scholla emphasized. "A misconception is
that a test method that has been subjected to a round-robin study is
already validated. This is a hot button for FDA. You have to
validate ANY test you use yourself."
Scholla admits that some of the test methods listed in Annex B
are "unvalidatable." In order to harmonize 11607, however, the
revision's authors had to include many methods used around the
world, even if in only one country. But because the document has to
be revised every five years, the authors chose not to hold the 2006
revision up and decided to address the issue in the next revision.
"For a test method to be included in the future revision's Annex, it
will have had to have been subjected to a intralaboratory study,"
said Scholla. "If in five years we cannot find anyone willing to
study a particular test method, why bother to include it?"
And companies are not just limited to methods included on the
list. "Any test method can be used to evaluate packaging as long as
it is validated," Scholla said.
Another panelist, Randall Troutman, senior engineering manager
for Oliver Medical (Grand Rapids, MI), said that he, too, encounters
confusion over validation. "Your [tests] must be verified in your
lab to ensure that the methods produce data comparable to the
results in the intralab study," he said.
"Some people only test a packaging system and consider that
validation," Troutman lamented. "They don't realize that they have
to validate the process used to seal the package as well as validate
the method used to test the package."
Troutman's advice? "Understand your processes. You are the
resident packaging expert within your company, and you will need to
make decisions based on your environment and situation," he said.
"Read both parts of ISO 11607 a number of times and develop your
action plan."
Sounds like good advice to us!
Daphne
Allen
Editor
PMP News will be covering ISO 11607 implementation in detail
in upcoming print editions. | 
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