The surfaces should also be monitored for viable particles. Both areas must be carefully cleaned and sanitized. Operations should be performed by thoroughly trained personnel, which have been validated to perform aseptic processing. The level of environmental control can be evaluated by measuring the viable and the total number of particles in the environment. For aseptic processing, you must evaluate viable particle readings, but total particle evaluations are optional.
Particles floating in the air are highly likely to come in contact with a critical site.
Those on surfaces have settled from the air, reducing but not eliminating the likelihood of product contamination. Surface monitoring can provide an indirect measurement of airborne contamination. Total Particle Counts Total particle counts are typically measured using an electronic instrument that draws air through it by vacuum into a measuring cell at a known rate. The count from these instruments is given as the number of particles per unit volume of air. These devices give rapid results, but do not differentiate between viable and non-viable particles.