Thursday, 30 March 2017

Risk Mitigation When Evaluating Cleanroom Construction Materials

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.

The paper can be accessed here.

Posted by Dr. Tim Sandle