In
the past three to five years, there have been a number of advances in single-use
sterile, disposable technologies, which have helped to both reduce the risk of
contamination and to streamline process operations. The majority of these
technological developments are oriented towards the manufacturing of sterile
products, particularly aseptically filled products.
In
relation to this, Tim Sandle has written a review paper. The introduction is:
The
advantages of single-use technology can be summarised as: eliminating the need
for cleaning; removing the requirements for the pharmaceutical company to
perform in-house sterilization (typically by autoclaving) for all components;
reducing the use of cleaning chemicals; assisting with storage requirements;
lowering process downtime; and increasing process flexibility and reducing
risks of cross contamination. However, single-use technology is still, to an
extent, in its infancy and there are a number of validation steps which need to
be undertaken before such technology is adopted by a pharmaceutical
manufacturer11. These include assessing any leachables or extractables which
might arise when the product comes into contact with the single-use technology.
The presence of extractables could lead to adulterated product or to the
inhibition of any microbial contamination (leading to a false negative result).
Other disadvantages are in the availability of the technology (in that not all
sizes or types required by pharmaceutical manufacturers are available) and
development costs.
This
paper examines some of the types of single-use technology available and
addresses some of the steps required by pharmaceutical manufacturers to bring
the technology online.
Posted by Dr. Tim Sandle,
Pharmaceutical Microbiology
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Pharmaceutical Microbiology