The Mazda Pharma Guide 7th October to 13th October | Page 75

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MACHINERY ARTICLE
ISOLATOR TECHNOLOGY: FOR OPTIMUM USE OF SPACE
IN PHARMA MANUFACTURING

I

solator technology is emerging as an
alternative to classified space in the
manufacture of pharmaceutical and
biological products. Isolators' principal value is
a reduction in the need for classified space,
which is expensive to build and manage.
Several pharmaceutical companies have
facilities that manufacture highly potent, sterile
anticancer drugs as liquids, crystallates, dry
powders, and as lyophilized products. Some of
the new plants are being designed for isolator
technology. In such plants, all mixing,
formulation, and compounding operations are
performed inside negative-pressure isolators.
Lyophilization equipment serves as its own
isolator, but its products may be transferred to
either a negative- or positive-pressure isolator
for further processing.
Companies normally rely on
automatic transfer systems from several
vendors or the other option is a manual transfer
system to move product from one isolator to
the next. The transfer systems provide
processes with a high degree of flexibility and
permit sterile processes even in non-sterile
Class D environments.
Sterile filtration and filling are
performed under positive-pressure isolation to
keep out contaminants. Filling isolators employ
controllers for temperature, differential
pressure, and humidity as well. Since physical
volumes are smaller with isolators than with
cleanrooms, personnel do not enter the
classified space, so processing is more
economical.
The isolator, transfer, and filling
systems were custom-built for individual
processes and machinery by vendors. Noncustom isolators lack flexibility.
The result is a huge improvement in
microbiologic and particle contamination, and
hence product quality. There has not been any
case of microbiologic or particulate
contamination inside isolators since the plant
opened. These days, isolators are sterilized
using vaporized hydrogen peroxide.
The only drawback to isolators is their
relative lack of flexibility in processes that
entail many manual operations or that are
adjusted on the fly. Non-custom isolators are
even less adaptable.
The current pinnacle of aseptic
processing capability is isolation technology, in

which personnel have been removed from the
aseptic environment almost entirely. In the
most advanced isolator installations, operators
perform only a limited number of tasks roughly
equal in number to those re