Air Sampling System for Use in Monitoring Viable and Non-viable Particulate Air Quality Under Dynamic Operating Conditions of Blow/Fill/Seal Processing

Abstract

An Air Sampling Link (ASL), employed in conjunction with an Air Sampling Device (ASD) or a laser particle counter, has been developed for sampling flowing air for viable and non-viable particulate analyses. Typically, the ASL could be used to sample filtered air supplied to an air shower of a Blow/Fill/Seal machine operating in the dynamic state. The ASL allows sample volumes of air to be taken from flowing air without significant loss from the sample flow of airborne particles possessing aerodynamic sizes relevant to those found in practice. The link has no moving parts, is steam sterilizable in-situ, and allows for the taking of continuous samples of air without the need for intervention into the ‘critical zone’of the filling machine. This article describes (i) the design criteria for the ASL and the ASD, (ii) the rationale underlying the concept of the ASL design, (iii) the collection performance of the ASL against that of a conventional sampling arrangement, and (iv) a functionality assessment of the ASL-based sampling system installed on a Rommelag style 305 B/F/S machine over a seven week period.