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← Document libraryAseptic Filling
Fictional document for the demonstration.
§3.3 Gowning qualification
Operators in aseptic areas hold a current gowning qualification, renewed every 12 months. An operator without a current qualification does not enter the aseptic area.
§6.4 Process trends
Fill weight and other in-process data are trended. A run of seven consecutive points moving in one direction is a trend signal that is investigated even while results remain within specification.