Cleanroom Classification
The current demands in today’s pharmaceutical industry for quality control and quality assurance have been driven by the aspiration to deliver consistently high quality and safe products to the consumer. The standards that are set to meet this goal are exorbitant and tightly controlled both internally and externally.
Cleanroom environments are a crucial area for the process and manufacture of pharmaceutical products. Cleanrooms are controlled and maintained using very stringent protocols and guidelines outlined by different organization. To monitor the quality of a room, proper standards have to be established. Different room classes are necessary for the different production areas as regards the different production steps.
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Area
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Requirement
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Critical Area A
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sterile products – sterilised in the final container closure system
– filling
sterile products – aseptic preparations
aseptic preparation
aseptic filling
transfer of partially closed containers (lyophilisation)
preparation of creams, ointments, suspensions, emulsions
filling of creams, ointments, suspensions, emulsions
production steps with high risk: filling area, container for the stoppers, open ampoules and vials
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Critical Area B
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sterile products – aseptic preparations
background areas for zone with class A
transfer of partially closed containers (lyophilisation in sealed transfer rackets)
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Controlled Area C
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sterile preparations – sterilised in the final container closure system
preparation of solutions (production step with high risk)
filling process
background area for zone with room class A for filling of preparations
(production step with high risk)
preparation of ointments, creams, suspensions, emulsions
sterile preparations – aseptic preparations
preparation of the solution to be filled
background area for blow-fill-seal-machines
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Area with
Requirement D
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sterile preparations – sterilised in the final container closure system
preparation of solutions and components for filling
background area for blow-fill-seal-machines
sterile preparations – aseptic preparations
handling of components after the washing process
background area for an isolator
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