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Testing, standards drive medical device
packaging session
Insights into cold chain shipments, aging,
test method validation, and the distribution environment highlight
MD&M West's medical device packaging session.
By Jim Butschli, Editor
Medical device manufacturers (MDMs) have their hands full, not
just in coping with the complexities of designing, manufacturing,
and distributing effective medical devices, but also in facing rising
economic and environmental pressures. An ever-developing number
of tests and standards can help MDMs navigate these challenges.
"Keeping the sterile barrier intact and the product usable
is a main responsibility we have in medical device packaging,"
said Jan Gates, principal packaging engineer for Abbott Vascular.
Gates made a presentation entitled "ASTM Distribution Testing
for Sterile Medical Devices," at the Feb. 9 Medical Device
Packaging session during the Medical Design & Manufacturing
West 2009 Conference in Anaheim, CA.
Gates provided attendees with a series of new terms, regulatory
requirements, and package testing-versus-conditioning test details.
She noted that under ANSI/AAMI/ISO/EN 11607 – 1 and 2, the
term "sterile barrier" now includes primary packaging.
She said that conditioning tests equate to tests conducted on packages
with product, or with simulated product, to condition or simulate
environmental stress on a packaging system to the use point before
conducting package or product integrity/design tests.
Collecting your own data from multiple shipments is considered
to be the best option for transit conditioning tests, Gates said.
"However, this is expensive, and time-consuming, and it takes
some specialized expertise to complete," she added. Testing
by a standard is the next best option, Gates noted, saying that
the U.S. Food & Drug Administration prefers the use of consensus
test standards. She then referred attendees to two specific Web
sites: www.fda.gov/cdrh/osel/guidance/321.html
and www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/search.cfm.
Through a series of photos, Gates showed how the distribution environment
can be brutal for medical devices. Gates noted that single-parcel
carriers tend to fit the most packages into a truck or container
as they can, as shown in the accommodating photo. She said, "Arrows
mean nothing and fragile [labels] do not have much meaning,"
on such packages. "It's amazing what can happen to a long,
skinny catheter box out in the field," she said. Another difficulty,
she noted, is that "more recycled material is being used in
corrugated, making it weaker."
Still, it's an MDM's responsibility to safely get its
product through the rigors of distribution. Gates cited the FDA's
Code of Federal Regulations, Subpart K, Section 820.130: "Each
manufacturer shall ensure that device packaging and shipping containers
are designed and constructed to protect the device from alteration
or damage during the customary conditions of processing, storage,
handling, and distribution."
She advised MD&M West attendees, "Understand your distribution
system. Distribution conditioning is not package integrity testing.
Distribution testing labs require your interpretation of the conditioning
tests to be conducted." Gates recommended joining and becoming
involved in the ASTM D10 committee and suggested that MDMs send
questions and comments regarding performing distribution conditioning
tests to www.astm.org/COMMIT/COMMITTEE/D10.htm, then click on Kevin
Shanahan's underlined name for his direct e-mail link, and his phone
number.
Standards help serve MDMs
With so many test standards, "there becomes some confusion
in the industry," said Curt Larsen, CPP and principal of Spartan
Design Group. "The standards and glossary of ISO 11607
are important and helpful." He recommended that attendees
refer to a compendium of terms used in the standards of Flexible
Barrier Packaging Committee F02 (F17).
He said that in considering testing versus aging, "it's
all about what you do with the samples. The preparation of samples
is the conditioning when evaluating them as good enough to get to
the end user," he said. "When you're done preparing,
then you go to a post-stress evaluation." Addressing conditioning
and aging, he referred to F1980-07, saying, "The objective
is to see what happens to the seals and materials that make up that
sample due to the passage of time. "
Larsen also offered the following insights:
- Don't use the same samples for both aging or shelf-life
studies and for distribution or design qualification testing.
- Humidity has detrimental effects on materials in that it can
act as a reactant in a chemical reaction, and can modify the characteristics
of a material.
- To save time and money, don't repeat test work that has
already been performed. Once you have established aging characteristics
of a "sterile barrier system," sterilized in a particular
methodology, you do not need to repeat it for new or additional
products. Aging won't change from a 3 x 5-in. pouch to a
12 x 14-in. pouch if the two materials and sterilization processing
remains the same.
- Distribution environments are normally less severe than canned
tests.
- Ten boxes with a dozen packages in each box does not equal 120
samples—it's 10 samples. Use 30 as a typical sample size
for attribute data.
Evaluating medical device distribution
Russell Darley, project manager, Global Packaging Development for
Smith & Nephew, made a presentation called "Investigation
and Evaluation of the Distribution Environment for a Medical Device."
In it, he discussed how to design packaging that protects its products
in a cost-effective manner that efficiently employs material configuration.
The Smith & Nephew project ran from August 2007 to December
2008 and included data collected from 10 states, 11 cities, and
seven countries. The distribution channel was segmented into four
parts: sterilization, warehouse (Global Distribution Center), the
FedEx distribution system, and sales rep cycle.
Smith & Nephew measured its distribution environment by employing
Lansmont Saver® 3X90 equipment
that measures internal temperature and senses relative humidity.
It can record shock, vibration, and drops using a tri-axial accelerometer.
Darley said a data recorder was used within a shipping case for
the testing.
Among the lessons learned from the study:
- Domestic and international shipping are similar, so there's
no need for separate test protocols.
- Standard Overnight® delivery has the least variation in
temperature and relative humidity.
- Sales representatives can have an impact on product exposure
to different temperature ranges.
Darley said the tests helped Smith & Nephew develop three key
"next steps":
- Conduct further internal evaluation of sterilization and warehouse
procedures.
- Select one location and ship product multiple times to better
track temperatures over seasons and increase statistical confidence.
- Share data and information between Smith & Nephew locations,
and use the data as an educational tool within the company.
The Medical Device Packaging session concluded with a brief update
on the Institute of Packaging Professionals'
(IoPP) Medical Device Packaging Technical Committee. MDPTC officers
Darley and Karen Greene of DDL
spoke of MDPTC as a source for education, networking, "and
tackling industry problems." Greene said the committee "is
trying to be an educational voice regarding regulatory issues, packaging
systems, barrier materials, sterilization, labeling, and equipment.
We're involved in liaison activity and standards interpretation,"
she added.
MDPTC has developed five task groups: Materials Specifications,
Industry Benchmarking, Labeling, Electrostatic Discharge, and Materials
Data Base. Abbott's Gates said, "Learning how people
apply and interpret standards is important. The FDA allows you to
benchmark with other companies, helping you to see where you are
at next to others."
MDPTC co-chairs are Harold Reisman, C.R.
Bard and Alison Tyler, Beacon
Converters. Greene and Darley welcomed packaging session attendees
to join and become involved in the IoPP committee by visiting the
association's Web site and going to the MDPTC portion.
Wallet pack honored
in Europe
A three-part "Triguilar" wallet pack was among the finalists
for the European Healthcare
Compliance Packaging Council Packaging Awards. Developed by
August Faller KG in Germany, it is used for a contraceptive sold
by Bayer Schering Pharma AG in Berlin and produced by Schering GmbH
and Co. Produktions KG in Weimar, Germany. The package combines
compliance and convenience. The wallet is flat and easy to carry.
It has the form of a miniature folder, consisting of three sections:
a blister card holding the pills, patient information, and dry-peel
calendar labels. These are preprinted and can be flexibly applied
to the blister card to help the user remember when to take the pills.
The labels are easy to remove, and the resulting free space can
be used for personal notes.
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