Biomedical Engineering Reference
In-Depth Information
Out of Steam
For over a hundred years, the pharmaceutical and biotechnology industries
have had a stereotyped design: every company would have a boiler, a deion-
ization unit, a distillation unit, a storage tank for distilled water, and a stainless
steel loop running at 80°C to supply WFI to the point of use where it would
be cooled down to make it useable. There would also be huge autoclaves with
hundreds of square meters of shelf space fed by clean steam generated from
WFI. All of this is about to change in the bioprocessing industry. Today, it is
possible to design a facility without SIP/CIP systems and even without auto-
claves. This method of going bare will take a while for the industries to absorb,
but this is indeed the future of bioprocessing. The result: major savings, con-
servation of energy, and protection of the environment by conserving water.
Validation
The validation of disposable systems has not been put to the real test yet where
a regulatory agency would provide approval of a product manufactured using
disposable systems. There is also an unfulfilled need for protocols to run
process analytic technology (PAT) on disposable systems. While many new
devices have appeared in the market to monitor noninvasively the function
of bioreactors, many of these devices have yet to be fully validated. The stain-
less steel systems have long developed protocols for validation and, thus, are
favored by Big Pharma for its assuredness. While there are still some glitches,
most of the functions of disposable bioreactors can be readily monitored and
validation protocols run to prove their reproducibility. This is one area where
innovation has begun to payback heavily. There are now several new concepts
working here: the use of fluorescence to measure parameters from a distance,
and the same is done with near-IR spectra. Every parameter that is of value in
PAT will be monitored in a totally noninvasive manner in the future, and this
will allow manufacturers to place their products in the market sooner.
Leachables
The unpredictability of the leaching of chemicals from plastic materials will
continue to hound the industry in the near future. The issue is less important
in upstream processing and for all steps before purification, yet the barrage of
publications, not all of which are unbiased, regarding these problems has not
 
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