In addition, we also will be featuring our latest version
of the PSI-L Isolator that won an Innovation Award
at INTERPHEX 2016, but it continues to evolve. The
system is now available with much faster decon times
thanks to SKANFOG and the NANOX catalyst, which
only encourages more and more uses for this flexible
Q:What key factors led to the development and introduction of this particular line of equipment?
Regulatory requirements, changing market demand,
Edwards: The new generation of airlocks and isolators is a
natural evolution of the available technology, as well as a
push from customers and regulators. Customers constantly
push SKAN to increase performance and shorten turnaround time to increase process efficiency.
Regulators are getting more and more stringent about
requiring manufacturers to adopt these advanced technologies, but they can only do that when they are affordable,
reliable, and readily available on the market.
Q:Since the NANOX catalyst technology launch, how has it been received in the market?
Edwards: SKAN’s 2017 launch of the NANOX catalyst
technology was really a promise of things to come—
greater efficiency and better performance. In 2018, SKAN is
delivering on that promise with our new generation of
airlocks and isolators.
Q:Are you in the process of developing upgrades or further advancements in the NANOX technology
concept? If so, what is on the drawing board?
Edwards: Although not officially launched, there already is a
new version of the NANOX catalyst technology in 2018 with
an even better performance profile. Not only is there now
even higher efficiency, but lower pressure drop through the
catalyst bed. This product enhancement will allow for even
more applications and increased performance on prior equipment systems, particularly in the areas of large-scale/large-vol-ume systems like large isolators and rooms.
Q:What are the biggest developments in cleanroom design today and how does SKAN technology
adapt to those changes?
Edwards: Cleanrooms, like isolators, are becoming more
specialized and modularized. The needs have evolved to
work with potent compounds as well as flexible manufacturing platforms for cost-effective production of multiple
products in a single facility.
Our customers also are upgrading their facilities to utilize
these technologies at an accelerating rate, using our material airlocks for transfers that were previously acceptable
with a “Spray and Pray” manual decon process.
Cell and gene therapy also have opened up a whole new
world to unique, single-patient processes with rigorous requirements for cross-contamination prevention while maintaining efficiency and throughput. SKAN’s new products fit
neatly with these new cleanroom requirements as well.
Q:With the push to bring pharma products to market more quickly, does the contamination risk
increase during testing and research, and if so, how is
technology changing to reduce those risks?
Edwards: SKAN’s answer to contamination prevention has
not changed, but the “package” in which it is presented
has changed dramatically. With our small and modular
VarioSys isolator systems, the typical R&D filling environment can now adopt the cGMP production standards at an
appropriately small scale at a reasonable cost as well.
When scale up (or scale OUT) is required for commercial
production, there is a natural path defined using the same
technologies already proven in the R&D phase, thereby
assuring success and reducing the need to additional process development steps for commercial scale-up.
Q:Taking that a step further, as interest in biosimilar development grows, what challenges are taking
place in microbiological testing and how are those
challenges being addressed?
Edwards: Microbiological testing methods have
evolved over the past decade, but the rigorous quality standards that go into assuring that a product is
produced without contamination remain unchanged.