|
 Packaging Performance Standards May Not
be Necessary
If you package medical
devices, you've got to remain up to date on ASTM
standards. If you just came back from HealthPack 2007 in New Orleans, you've got a good
head start.
Most of the speakers at the
two-day annual event cited some ASTM standard, whether
it was an emerging one, a recently revised one, or a
tried-and-true method. These mentions are for good
reason. ASTM methods are included in the appendices of
the newly revised ISO 11607, which outlines packaging
responsibilities for medical device manufacturers. "ASTM
methods are tools you can use to comply with ISO 11607,"
explains Mike Scholla, senior consultant for DuPont
Medical Packaging. (Scholla, a member of the PMP
News editorial advisory board, spoke at HealthPack
about sterilization, unrelated to this article.) "If
companies comply with 11607, they will have a safe and
effective package," he says.
Given the lack of minimum
package performance standards for medical device
packaging from FDA, ISO 11607 and ASTM standards have
become the de facto means of determining whether you
have a good package. Don Marlowe, standards
administrator for FDA, told HealthPack attendees that
performance standards should be developed. "ISO 11607 is
parametric, [whereas we] would like to move toward
performance standards," he said.
Scholla appreciates
Marlowe's hope. However, he says that developing
performance standards isn't as easy-or may not be as
useful-as first thought. "Minimum specifications for a
package are dependent upon the device inside," says
Scholla. He points to the hotly debated "minimum seal
strength" as a potential performance requirement.
Picking one particular number that would meet every
product's needs would be next to impossible. Half a
pound per square inch may be too much for a Band-Aid,
but not enough for an implant. "Minimum performance
standards are hard to do, given the variety of medical
devices on the market," he concludes.
Without specific oversight
from FDA, the medical device industry has historically
turned to AAMI and ISO for packaging guidance. Hence,
ANSI/AAMI/ISO 11607-1997, with AAMI's technical
information report published in 1998. But AAMI hasn't
been a "test method organization," says Scholla, "so
over the years the test methods that enabled companies
to comply with ISO 11607 grew out of ASTM, with its
round-robin test method procedures for generating
data."
"ASTM has done an awful lot
for the industry," continues Scholla. "People are aware
ASTM, but there's always room for more
awareness."
HealthPack speakers
encouraged such awareness. Randall Troutman, senior
engineering manager for Oliver Medical, spoke about
developing an overall strategy to validation planning for the
internal use of package test methods. "There are many
helpful E-series ASTM standards that should be reviewed
to develop a program to evaluate both quantitative (e.g.,
peel-strength testing, which produces variable data) and
qualitative (e.g., dye-penetration testing, which
produces attribute data). Because of the numerous types
of test methods, there is not a one-size-fits-all method
for evaluating test methods. By reading the
E-series ASTM standard, companies will be able to
determine what program will work best for a particular
application."
We often hear readers ask
for a checklist of all the steps they need to take to
create a good package. Perhaps that was what Marlowe was
getting at when he mentioned performance standards. But
industry does have a checklist of some sort-ISO 11607.
It lists several test methods that can be put into play,
including-but not limited to-ASTM methods. However, the
document doesn't put forth a one-size-fits-all approach,
either. Instead, companies can pick from a pool of test
methods to build their own approach to package and
process validation.
The key is to choose
wisely. Stay informed of your options, and-above all-be
able to document and defend your packaging
decisions.
Daphne
Allen
Editor
P.S. ASTM
International's Kevin Shanahan spoke briefly at
HealthPack to encourage packaging professionals to
become individual members. For more details, visit
www.astm.org. |
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