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Misconceptions and Essential Requirements for Pharmaceutical Cleanrooms
Release time:
2018-03-10
As China’s pharmaceutical industry continues to develop, domestic pharmaceutical companies have achieved phased results in their GMP upgrades; however, this process has also revealed misconceptions regarding the application of cleanroom technologies.
Common Misconceptions About Pharmaceutical Cleanrooms
As China’s pharmaceutical industry continues to develop, domestic pharmaceutical companies have achieved phased results in their GMP upgrades; however, this process has also revealed misconceptions regarding the application of cleanroom technologies.
Many people mistakenly believe that “GMP renovation and certification for pharmaceutical manufacturers” simply means improving the environment of cleanrooms in pharmaceutical factories to meet the required cleanliness standards. This understanding is overly simplistic.
The essential requirements for pharmaceutical cleanrooms
The primary purpose of environmental control in pharmaceutical manufacturing is to prevent any conditions—such as contamination or cross-contamination—that could compromise the quality of pharmaceutical products. This production environment is a dynamic concept, representing the combined effects and outcomes of various environmental control measures. It is by no means sufficient simply to build a cleanroom facility according to regulations and pass the acceptance inspection. In essence, dynamic control of cleanrooms is even more critical, including the management of pressure differentials between different cleanliness levels as well as between different functional areas within the same cleanliness level.
The official FDA audit in the United States focuses on dynamic auditing—continuous monitoring and real-time approval of each step in pharmaceutical manufacturing. This includes dynamic monitoring of pressure differentials between different rooms in cleanrooms, airlock control in critical buffer zones, and tracking the trends and magnitudes of pressure differential changes as personnel move between various areas. The fundamental requirement for pressure differential design and control in pharmaceutical cleanrooms is precisely dynamic pressure control and continuous visual oversight.
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