Gary
Partington has written an article on isolators and aseptic processing for
Pharmaceutical Online.
Here
is an extract:
“Isolators
have been around the Pharmaceutical Industry since the early 1980s and in the
Nuclear Industry (glovebox technology) since the 1950s. The intent of isolators
is to create an airtight barrier or enclosure around a piece of equipment or
process which provides absolute separation between the operator and product.
The operator can perform tasks through half-suits or glove ports. Isolators
provide a specific environment inside the isolator using HEPA filters. The
environment can be positive pressure or negative, can have humidity control,
oxygen control, use unidirectional airflow, and can either protect the product
from the operator as with aseptic processes, or protect the operator from the
product as with potent product handling. The earliest uses of aseptic isolators
were for sterility testing. Sterility test isolators make up most of the
aseptic isolators in use and are available in many different sizes and
configurations. Sterility test isolators do not need to be installed in a
classified area. No formal requirement exists for a Grade D environment, but
the area should be controlled to allow only trained personnel. The room should
also have temperature and humidity control.
Autoclaves
(steam sterilizers) used to prepare media for sterility testing were interfaced
with isolators to keep the entire sterility test process under isolator
conditions. Additional uses for aseptic isolators include component transfers,
charging of sterile powders, and interface isolators for filling machines,
depyrogenation ovens, and lyophilizers.”
Posted by Tim Sandle
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