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Is gowning required even in an isolator? Should the isolator be located in a specific cleanroom?

April 26, 2017cleanroom gowning isolator located

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Is gowning required even in an isolator? Should the isolator be located in a specific cleanroom?

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See question 52. If the isolator does not meet the requirements set forth in the Chapter for maintenance of ISO Class 5 conditions during dynamic use, then yes, it must be placed in an ISO Class 7 environment (i.e. clean room) and gowning is required.