As defined by the ISPE in 2005, a RAB system is to include:
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Rigid wall enclosure
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ISO 5 UAF environment
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Gloves for set up and interventions
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Automation of the process wherever possible
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High level disinfection
•Rare open door interventions
RABs qualification will be similar to a clean room and includes:
•Air exchange rates
•Airflow velocity
•Pressure differential
•Smoke tests
•Environmental monitoring