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Risk Mitigation When Evaluating Cleanroom Construction Materials

Source: G-CON Manufacturing

By Maik Jornitz, COO, G-Con

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.1 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.