There is no tolerance for microbial contamination within an
aseptic manufacturing system.
Isolators have helped to make that a reality, but proving
the negative can be a daunting challenge. The last
few years have seen the increased sensitivity and rapid
methods evolve in microbial detection methods, but
also mechanical systems such as automated glove leak
testing systems have been important quality assurance
components in a monitoring and contamination
SKAN’s sterility testing isolator systems also have evolved
with increased requirements for batch reporting and data
Q:SKAN’s service operations in Raleigh include a distribution center. Is that strictly to move
services parts, or does the center take on a wider role
for the company?
Edwards: As noted above, we continue to emphasize our
commitment to North America by expanding our SKAN US
headquarters in Raleigh, NC. SKAN’s US headquarters is
available for many other customer support roles as well.
We have a microbiology lab where you can come and see
our isolator equipment, test out your process or sterilization load patterns, and schedule our cycle development or
annual cycle requalification work.
We have a RABS retrofit business that is headquartered
in Raleigh as well, where we can help build an engineered
solution to extend the life of older filling lines, which is in
very high demand recently.
Q:SKAN says it offers educational seminars and training programs. What kinds of subjects are
addressed in the seminars, are they regularly scheduled,
and how extensive are the training programs?
Edwards: SKAN offers a number of
training courses on a variety of topics for
a wide range of participants. We have
SKAN Academy training for customers to
get trained on testing or servicing SKAN
isolator equipment, which can be offered at
our SKAN AG Swiss headquarters, at SKAN
US in Raleigh, or customized at any SKAN
customer site as well.
We also offer training on cycle development
and microbiological qualification methods,
all available from SKAN US. From May 9-11,
2018, SKAN is offering our first SKAN US
Service Conference as well where you can
receive certificate training on various topics
and learn more about SKAN isolators and
Edwards: SKAN’s 2018 emphasis is not only on “product”
technologies, but also services. A huge need has evolved for
the handling of potent products for chemotherapy and other
containment challenges like antibody drug conjugates (ADCs).
What this means is not only changes to our isolator
technology, but support in the testing and qualification of
cross-contamination prevention. SKAN has published numerous presentations and journal articles with our clients
and partners regarding these testing methods.
Q:SKAN establishes a powerful presence each year in the INTERPHEX exhibit hall. How important
has INTERPHEX been for the unveiling of new products
Edwards: INTERPHEX is SKAN’s premier annual event for the
North American market. No other venue provides the platform and support to launch new products and technologies or
showcase the capabilities of SKAN to the marketplace.
Q:As you look ahead to INTERPHEX 2019, can you hint toward any particular technology or service
areas that you already are considering for introduction
Edwards: Looking to 2019, deploying our new technologies is always our goal as is our commitment to testing and
integrating these systems for the best use of the customer.
SKAN has many new products in the pipeline as well as
new services related to the validation of cross-contamination prevention.
I expect that you will see the launch of a host of new
products and services in 2019 with new applications of
existing products as well.
Two-chamber PSI-L VarioSys