In the aseptic manufacture of parenteral drug products and low bioburden, cell, and gene
therapy products, the control and monitoring of environmental-and personnel-associated …

For places where non-sterile drug production occurs, regulatory bodies recommend
monitoring of the environmental bioburden. This procedure provides information regarding …

A well-validated and holistic program that incorporates robust gowning, cleaning,
environmental monitoring, and personnel monitoring measures is critical for minimizing the …

Microbiological environmental monitoring is employed to confirm the effectiveness of the
operational controls in reducing microbial populations to acceptable levels. The …