sterilization processes and new
validation methods that reduce
the impact of the sterilization
process on product functionality.
3. Share lessons learned: The
sterility assurance community includes individuals with a number
of technical disciplines (nurses,
microbiologists, engineers, pharmacists) and stretches across
many hospitals, medical device
manufacturers, and pharmaceutical companies around the world.
With the different disciplines
needed to effectively deliver
sterile products, there is a need
to ensure that we share lessons
learned across the industry, and
open up the barriers to sharing
information. To that end, John-
son & Johnson Sterility Assur-
ance revived the Kilmer Confer-
ence in 2016, bringing together
leaders from medical device and
pharmaceutical industries from
regulatory agencies and aca-
demia, from contract sterilizers
Attendees of the Kilmer Conference filled out cards affirming their commitments to continue learning new competencies as they moved to
an E2E sterility assurance model.
and contract laboratories, and
from clinical staff and hospital
The Sterility Assurance community is eager to embrace new ap-proaches and change for the needs
of future products. Throughout
change, though, our community will
continue to be focused on one constant: the science of sterility. That
focus, coupled with the enthusiasm
of our community, will be an engine
of sterility assurance innovation in
the years to come.
Joyce M. Hansen joined Johnson & Johnson as Vice President
of J&J Sterility Assurance in 2012.
She is a recognized industry
leader in sterility assurance and
sterilization practices, and she has
over 37 years’ experience in sterility assurance.
There is a need
to ensure that
we share lessons
and open up
to sharing information.