Packaging & Sterilization
“Although all sterilization methods have their strengths and
weaknesses,” said Kahn, “the healthcare concerns regarding EtO
are growing. OEMs are beginning to investigate other sterilization methods that could reduce the use of EtO.”
Packaging and sterilization are absolutely critical for a successful product launch, as well as protecting the final product (and
all the money invested in making it). It does not matter how
well-designed or innovative a product is; if it arrives in a compromised condition, it is a failure and perhaps even a costly liability.
Product design, packaging, and sterilization must be considered
together to achieve an on-time launch; any packaging or sterilization problems resulting from poor planning could delay the
launch, losing valuable market share.
This leaves little room for mistakes. “Recall” can be a terrifying word—not just because of the high expense of undertaking
and fixing a recall, but also compromised patient safety, inconvenience and delay for the end user, and damage done to brand and
This is why sterilization and packaging is critical for protecting
the product lifecycle. However,“packaging is often left as the last
aspect of the design process and given the shortest amount of
time and resources to complete,” said Mach.“This puts significant
pressure on the packaging teams and testing because no one pre-
pares for failures as a result of poor planning. We always suggest
that manufacturers develop prototype packaging and perform
preliminary tests in the beginning to prevent these types of is-
sues when time/money and product become critical.”
Dwyer indicated that delays of up to 12 months can occur if
packaging design and validation are not given enough focus early
in product development initiatives.
“There is a delicate balance between taking time to ensure the
quality and package design of your product and increasing your
time to market,” he said.“Failure to dedicate the appropriate time
and resources during the initial stages of product design can create
significant setbacks during validations. Robust design helps prevent
failures during validation, and while the product is in the field.” v
Mark Crawford is a full-time freelance business and marketing/commu-nications writer based in Madison, Wis. His clients range from startups
to global manufacturing leaders. He also writes a variety of feature articles for regional and national publications and is the author of five books.