Have new types of products influenced the design and
operation of freeze dryers?
TN Thompson, President, Millrock Technology, Inc.: The
need for smaller and more sophisticated freeze dryers continues to grow. As technology progresses, drug potency increases
and the amount of overall product in each vial is significantly
reduced. Thus, smaller vials are being used more frequently and
the value of the product
is ever increasing. In most
cases, the higher potency
drugs require safer handling, and therefore, interfacing to isolators and
sterilization are becoming
more popular features.
Christine Palus, VP of Sales & Marketing, LSNE: We have
seen an increase in the need for the use of organic solvents
and thus the need for lyophilizers that can handle those solvents. With the changing regulatory environment, sterility
assurance is very important and clients focus on past media
fill results to assure their product will be sterile.
Joerg Zimmermann, Director of Process Development and
Implementation, Vetter Pharma-Fertigung GmbH & Co. KG: The
design and operation of the freeze drying process has evolved
largely as a result of the introduction of new compounds. One
new approach is the use of liquid nitrogen instead of the conventional compressor cooling to produce the cooling energy in
the freeze-dryer. One of liquid nitrogen’s benefits is that a shelf
temperature of - 60 ° C can consistently be achieved.
Are pharma companies looking for complete lines – not
just a “freeze dryer”?
Palus: Over the last couple of years we have experienced
a trend towards a more “turn-key” approach to outsourcing.
Some companies are definitely looking for their CMO to handle the manufacturing process from beginning to end and
there are certainly advantages to having only one CMO to
manage rather than multiple relationships.
Thompson: Most freeze dryers are still sold as stand-alone
units. The applications for freeze dryers can vary greatly,
making it necessary to design each to meet the specific needs
of the customer. “Complete lines” or “turn-key solutions” are
typically used to satisfy very large production systems where
the cost of automation can be justified by the large volumes
of vials as well as product costs. For startups, R&D, biotech,
bone and tissue, and moderate production sizes, stand-alone
freeze dryers with sophisticated capabilities are in demand.
Zimmermann: There are now providers in the market that
offer complete lines, and
while this is certainly a
good solution as a com-
plete package, there are
some tradeoffs; namely
that each manufacturer
has varying degrees of
experience and expertise, which the purchasing company
has to determine before making a decision. The alternative is
putting together machines from different manufacturers using
the best equipment available on the market. This offers the
opportunity to choose the best machinery available in the re-
spective area, but it also requires the expertise for the quali-
fication and validation to integrate different systems.
Have you seen any movement away from traditional glass
vials/syringes to other materials?
Zimmermann: The market is the driving force, of course,
changing the requirements for the systems being filled, as
well as the systems themselves. Solutions made of traditional materials are, therefore, continuously evolving, in
parallel, new materials are also coming of age. Cyclo olefin
polymers and cyclo olefin copolymers are being developed
or are even already in use commercially, and we have initiated some projects with polymer based containers. These
systems do present their own set of challenges e.g. gas permeability and pricing. The newer materials are interesting
when special requirements are involved, and could be a way
toward a prefilled-syringe-autoinjector combination based
on the dimensional precision and possibilities, for example.
Palus: We have seen some movement away from traditional
glass vials, specifically towards the Crystal Zenith resin vials.
They are a good alternative because their dimensions are
very similar to the standard glass vials so they can be filled
■ By Nikita Ernst, Associate Editor
Experts in lyophilization weigh in on recent trends and share
their views on the future of freeze drying technology.
Staying Cool With
■ 18 JULY/AUGUST 2014 | PHARMACEUTICAL PROCESSING
■ PHARMPRO. COM
“We have seen significant growth in the need for
lyophilization over the last decade and we anticipate
that this growth will continue over the next 5 years.”