Maik Jornitz, President, G-Con, has written an interesting white paper on cleanroom construction materials.
The introduction reads:
Reducing the cost of goods sold has
become a focus of pharmaceutical facility, cleanroom, and process design,
especially as blockbuster patents have begun to expire and generic competition
has intensified. The need to minimize manufacturing costs sparked a multitude
of creative ideas.
Unfortunately, this creativity has resulted
in almost as many concerns. For example, eliminating redundant facilities or
processes has resulted in single dedicated facilities, which can increase the
risk of drug shortages.
Cleanroom ballroom designs with a lower
cleanroom classification have been promoted, especially those utilizing single-use
equipment processes. However, if designs are not well thought out, problems
such as cross-contamination and batch rejections can result. Taking a
short-term view to reducing capital expenses may result in cutting corners on
the quality of the facility construction materials. These shortcuts can cause
major manufacturing disruptions and quality problems. Cleanroom designs require
thorough reflection on the intended purpose. In some cases, short-term solutions
or lower-quality materials may be used when the process is expected to have a
short life expectancy or the process environment does not pose critical risks.
However, high-quality cleanrooms demand high-quality materials for wall and
ceiling structures, doors, windows, electrical outlets, pipework, flooring,
filters, duct work, etc.
Posted by Dr. Tim Sandle
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