mentation. You then can open the parameters from there to de-
velop a robust and workable set of production parameters to
fully validate, which means quicker time to market.”
An increasing number of OEM clients also are asking pack-
agers for“sustainable” or“green” packaging practices, which is
basically a call for less packaging material to save natural re-
sources and reduce the amount of waste going to landfills (usu-
ally requested by the end user).
“We have certain customers who want to avoid rigid packaging if possible and use flexible barrier systems,”said Bob Lord,
director of sales and marketing for Quality Tech Services in
Bloomington Minn. “Designing a flexible barrier system that
fully protects the device, survives distribution and provides clear
direction to the end user can be a challenge, especially for complex devices. Less waste in packaging can result in less protection for the device, which would then require unique protective
packaging elements—complicating the packaging process.”
As the medical device manufacturing industry continues to innovate with new designs and raw materials (which results in
more creative packaging to control costs and improved product
performance), contract sterilizers must be on top of their game
to meet the ever-changing sterilization needs of their OEMs.
For example, there currently is a demand for lower-cost polymers or co-polymer mixtures in medical devices—but how will
these less-tested polymers stand up to sterilization techniques?
“The challenge is finding a sterilization method that gives
the sterility assurance level required or desired while still maintaining all of the desirable functional and appearance properties
of the device,” said Betty Howard, radiation tech team manager
for STERIS Isomedix Services in Libertyville, Ill.
One of the biggest challenges contract sterilizers face is the
increasing popularity of combination devices, bio-absorbables
and drug-covered stents.
“For these products, it is critical the sterilization technique
does not negatively impact the biologic agent, or create free rad-
icals,” Tillman said. “Traditionally, the higher the temperature,
the higher the kill; if lower temperatures were used, the cycles
had to be much longer. Now we can use lower-temperature and
lower humidity EtO sterilization cycles over shorter cycles, as
well as lower irradiation levels and tighter dose ranges.”
Faster turn times are expected by OEMs, especially for tem-
perature-sensitive products. Some devices have very narrow
ranges of tolerance; others have wider dose ranges that provide
more flexibility in scheduling and allow more product to be added
to each carrier per run, which saves costs. Of course, documenta-
tion of delivered dose or sterilization conditions also is expected
by OEMs and the U.S. Food and Drug Administration (FDA).
“All of this can be accomplished,” added Howard.“The details and limits must be worked out carefully between the customer and the specific processing plant.”
FEATURE: Packaging & Sterilization
E-beam sterilization, a technology that has cycled in popularity over the past few decades, now is recapturing interest because of its speed and effectiveness.
“There is a notable increase in using electron-beam sterilization as medical device and pharmaceutical manufacturers understand and value the flexibility, precision and speed of this
sterilization modality,” said Perlman. “Due to its polymer-friendly processing and ability to sterilize products rapidly, the
12 to 15 percent market share in North America for this technology is anticipated to rise significantly in the next five years.”
About 80 to 90 percent of all disposable medical plastic products currently manufactured are compatible with electron beam
processing. Compared with ethylene oxide, electron-beam processing is faster (hours versus days) and simpler (no need for
pre-humidification, post-sterilization aeration, sterility testing,
or gas concentration, vacuum or pressure monitoring). Electron
beam also does not require the special “breathable” packaging
necessary for EtO aeration. In addition, non-permeable plastic
packaging is less expensive and easily can be penetrated with an
electron beam. Compared with gamma irradiation, sterilization
via electron beam takes a matter of seconds instead of minutes
or hours. Because of the shorter exposure time to the irradiation source, electron beam processing also reduces the oxidation effects on products and reduces material degradation.
“In many cases, manufacturers deliver their products to an e-beam service center and wait for the products to be processed
and released back to the manufacturer as sterile—this takes as
little as an hour from start to finish, depending upon the size of
the shipment,” said Perlman.
Validation and Compliance
Just like medical device manufacturers themselves, contract
packagers and sterilizers also must face the challenge of dealing
with the new and revised standards that govern the industry
(and often are expected by their OEMs to be experts and consultants). The 510(k) process is under stricter scrutiny by the
FDA, resulting in more comprehensive validation testing and
documentation by the device manufacturers and their supply
chains. As a result, MDMs are pushing their outsource suppliers to conduct their own qualifications/vendor management.
Packaging and sterilization play key roles in getting products
approved quickly by the FDA and must be documented through
“Validation is the only thing that changes from package to
package,” said Anderson. “Quality and compliance have to be
constants. However, the validation level to which the product
and corresponding packaging will be held will definitely impact
the package design and direction.”
In the area of drug/device combination products such as
transdermal patches, Tapemark’s Yetter said his firm defers to
the stronger drug regulatory requirements.