By Saeed Bhutta
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Managers rarely enter aseptic areas and when they do they most often associate the difficulties they experience with their own awkwardness © 2004 by CRC Press LLC Chapter2 10/5/04 7:45 pm Page 39 Microbiological Environmental Monitoring • • 39 rather than with the facilities provided. Floor sampling, although supported by the FDA, is relatively meaningless. Passive air and surface sampling should be done in “white” change rooms on every operational day or shift. Active air sampling may give unreliable results in change rooms while personnel are changing.
50 1 INTRODUCTION The two main expressions used in relation to the operation of pharmaceutical clean rooms are not synonymous: environmental control and environmental monitoring. 50 © 2004 by CRC Press LLC © 2004 by CRC Press LLC 23 Chapter2 10/5/04 7:45 pm Page 24 24 Microbiological Contamination Control in Pharmaceutical Clean Rooms Environmental control describes the systems functionally ensuring that clean rooms operate within predetermined limits. There are many such systems, integrated and overlapping, described in Chapter 3.
36 5 Environmental Monitoring: Establishing a Program . . . . . . . . 37 6 Environmental Monitoring: What to Do with the Data . . . . . . . 1 Responses to Infringements of Limits . . . . . . . . . . . 2 Review of Environmental Data as Part of Batch Release . . . . 3 Overview of Trends in Environmental Data . . . . . . . . . 45 7 Documenting Environmental Monitoring . . . . . . . . . . . . 1 Site Environmental Monitoring Policy Document .