equipment. This uni-directional airflow from above to
below, restricts the particles
produced by the filling operations from contaminating
the terminal HEPA filters
above the chamber. This ISO
5 environment in the isolators replaced the previous
method of operation in a
traditional cleanroom of ISO
5 classification. The stainless
steel and glass barrier and
a leak tight chamber, added
additional protection for the
product, operators and the
environment. In addition,
the isolators could operate
in positive or negative pressure. Normally, during the
liquid fill portion of a cycle
for aseptic/toxic products,
the isolators, including the
freeze dryer loading and unloading units operate in positive
pressure. Depending on the toxicity of the product, many
companies choose to operate the isolator over the freeze
dryer unloading operation in negative pressure, since there
New filters can be changed from the outside and features many safety features.
room, since normally all process rooms are the same level,
eliminates the need for airlocks between these rooms. In a
“greenfield site”, this could represent a savings of up to 35%
of the floor space.
DECONTAMINATION OF ISOLATORS USING H202
In the beginning of the use of isolators for these applications and continuing today, decontamination using vaporized hydrogen peroxide is the material of choice. Materials
of construction of the isolators were tested for the best
compatibility with H2O2. Glass and stainless steel are very
good for the de-contamination cycle, while aluminum and
some plastics lengthen the cycle. Gloves made of Chlori-Sulfate-Polyethylene (CSM), formerly Hypalon, have been
determined to best suited for H2O2 decontamination.(1)
Decontamination of the isolators in the early stages of development was accomplished using remote generators delivering vaporized hydrogen peroxide. These generators were
being offered by companies independent from the isolator
manufacturers. In 1997, the first fully integrated system was
offered, combining the delivery system with the isolator using the same control systems.
Isolators for sterile filling applications have uni-directional
airflow in the working chambers from the ceiling to the
floor. It is necessary to maintain a Class A (ISO 5) over the
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