Environmental Monitoring Establishing A Program

Regulatory agencies require that environmental monitoring programs for sterile manufacturing facilities be defined and documented, with respect to where and how often samples should be taken. In Europe, proposals were put forward by the Parenteral Society in 1990 (Parenteral Society, 1990). In the U.S., Agalloco (1996) published a table of "possible sample frequency for routine monitoring." Both sets of general recommendations implicitly consider facilities in frequent or constant use. Neither makes any specific reference to those facilities in which sterile products are manufactured infrequently, or on a campaign basis.

Both sources may be used as guidance to establishing an environmental monitoring program, but they cannot be seen as definitive. Each sterile manufacturing facility is unique — in technology, manning, design, and in use. The following principles are valuable in designing specific environmental monitoring programs.

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