Pharmaceutical companies have to adhere to strict regulatory requirements when operating a clean room. In the United States, the United States Pharmacopeia (USP) sets the industry standards for cleanrooms. The USP outlines the guidelines that must be followed to ensure quality assurance.
International Organization for Standardization (ISO) can also be implemented to ensure that cleanroom practices meet specific standards. ISO 14644-1 outlines the minimum requirements for cleanroom design, construction, operation, and maintenance.
Other essential considerations that must be taken into account include:
Airflow and differential rooms pressure
The number of air changes required per hour
Strict procedures for workers to follow
The type and quality of filters to use
Equipment sterilization and cleaning procedures.
In conclusion, to achieve quality assurance and maintain the purity of drugs, the pharmaceutical industry must follow strict regulations governing cleanrooms and operating practices. Adhering to the regulations ensures that the pharmaceutical company clean room products are safe and effective.
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