空调系统停机风险评估
6页1、1PHARMACEUTICAL ENGINEERING JANUARY/FEBRUARY 2014facilities and equipmentControlled Manufacturing Environments1JANUARY/FEBRUARY 2014 PHARMACEUTICAL ENGINEERINGEvaluation of Controlled Manufacturing Environments following an Air Handling Unit Shutdownby Catherine E. Anderson and Brian J. Lloyd, PhDThis article provides a methodology to evaluate the environmental impact of an air handling unit shutdown in a GMP manufacturing environment. E nvironmental control within the bio- pharmaceutical and me
2、dical device industries usually involves a continual cycle of steady state activities interrupted by maintenance and recovery measures. Systems and practices, such as air tem- perature and humidity control, number of air exchanges, and room cleaning prac- tices, are in place to maintain the overall environmental control. When the environment is challenged or breached, recovery measures are in place to ensure the controlled classified area returns to the qualified state with minimal impact to the
3、 environment and product. In many cases, the recovery measures may involve significant clean- ings, limited access, and additional environmental monitor- ing which can reduce manufacturing time and increase cost. This case study evaluated the impact of a short term breach to a biopharmaceutical controlled classified manufacturing cleanroom areas and determined how long it would take these areas to recover with minimal recovery measures and intervention.Introduction Air Handling Units (AHUs) are
4、the primary engineering control for classified controlled environments. They provide humidity/temperature control as well as the filtration and air exchanges necessary to ensure an environment meets its classified requirements. These units must be shut down periodically to allow routine maintenance, calibration activi- ties, or planned construction. An example of the activities required to shut down a GMP AHU are listed in Table A.The average costs associated with AHU shutdowns include two to fo
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