This guide provides essential insights into selecting the right cleanroom solution for pharmaceutical manufacturing. It covers the importance of cleanroom functionality, regulatory compliance (ISO 14644, GMP), and key factors like airflow systems, filtration, and cleanroom classification. The article emphasizes the consequences of improper cleanroom selection, including contamination risks and regulatory issues. A step-by-step implementation process is outlined, from risk assessment to design and installation, with a focus on ongoing validation and maintenance. Additionally, the guide highlights emerging trends in cleanroom technology, such as AI, automation, and sustainable solutions, ensuring optimal performance and compliance.
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