Tuesday, September 8, 2015

Where should airflow velocity measurements be taken, with respect to a filling line or other aseptic processing areas?


Airflow velocity measurements should be taken at locations where meaningful and reproducible results can be obtained. This typically at a distance of 15-30 cm from the filter face.

Rationale for Recommendation

The primary reason for airflow velocity measurements in unidirectional airflow areas (e.g, area where products , product contact packaging components, and product contact surfaces are exposed) is to ensure adequate airflow to protect the materials from external airborne contamination and to verify continued compliance with qualified conditions. The adequacy of the environment can be determined, in part, from airflow velocity and air flow pattern studies, and from particulate matter monitoring (at the working position).
Accurate measurements can be taken ad changes over the detected when air flow velocity are evaluated at a predetermined distance from filter surface, which is sufficiently close to the filter surface to be reproducible to detect changes in the performance of the filter.
The airflow velocity depends on the design of the filling line, room design, and air-handling system. Once velocity is determined, it is important to ensure that the velocity stays within the specific parameters. Routine air velocity measurements should be taken at the same locations used during the initial airflow studies to ensure consistency.

Featured Post

Complication in Pharma industry with stability issue and salary expectation in Indian scenario

Now a days the pattern of interview is very interesting in pharma industry. The main argument comes with following points, Exp...