Biomedical Engineering Reference
In-Depth Information
also have biohazardous substances associated with them if the waste has not
been presterilized, and hence may cause an environmental risk. Extractables
may also be released from landfilled plastics over extended periods as
aggressive chemical conditions such as acidic, caustic, or even dilute solvent
microclimates may be established. Furthermore, high-temperature pretreat-
ment (presterilization) has the potential to convert extractables into leach-
ables. The assessment of the risk associated with extractables and leachables
has so far (by definition) been focused on the product and the associated
health risks and not on potential environmental risks.
Overall Environmental Impact
While it is generally believed that the environmental impact of conventional
stainless steel systems is lower than the disposable systems, the induction
of disposable technology carries a negative connotation, particularly in
the United States, where 5% of the world's population produces 95% of the
world's garbage.
There is a dire need to apprise manufacturers that it is the overall impact
on the environment that matters. Several comprehensive studies have
confirmed that a fully disposable biopharmaceutical factory can be envi-
ronmentally advantageous compared with a conventional stainless steel bio-
manufacturing for the following reasons:
• Disposable systems require 1/10th the water to process an equiva-
lent amount of product. Water is the most precious resource.
• The energy footprint of stainless steel systems far outweighs the
energy needed to incinerate plastic waste.
• Despite their long life, the disposal of stainless steel produces a
much higher impact since it is not possible to incinerate it.
• Disposable system factories run with much smaller energy require-
ments and thus add less to the carbon footprint.
• Disposable system factories are less labor intensive, mainly because
of elimination of the SIP/CIP and testing for validation.
Summary
One of the greatest impediments in the acceptance of disposable systems has
been their image as contributor to the carbon footprint and thus adversely
