Unit 9: Clean Room Classification
Clean room classification ensures controlled environments for sterile pharmaceutical manufacturing by defining particle and microbial limits. Standards include ISO 14644, EU GMP Grades, and USP <797> for compounding sterile preparations.
Definition
Clean rooms are controlled environments designed to maintain low levels of airborne particles and microbial contamination, essential for sterile and critical pharmaceutical manufacturing.
Clean room classification is based on particle count per cubic meter of air, as defined by ISO standards and GMP guidelines. Proper classification ensures compliance with regulatory requirements for sterile product manufacturing.
Key Points
ISO 14644 defines clean room classes based on particle concentration
EU GMP and US FDA provide guidelines for sterile manufacturing areas
USP <797> applies to compounding sterile preparations
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