Bosch Packaging Technology is pleased to announce the publication of Part 2 of its ongoing aerosol generation at the point of fill characterization study in poster format at the upcoming 2018 ISPE Annual Meeting & Expo to be held in Philadelphia on November 4-7. The following is a preview:
Personnel health and safety are paramount to liquid pharmaceutical manufacturers producing cytostatic, cytotoxic, or otherwise hazardous biological products, with the first step towards assurance being a comprehensive barrier system suitability evaluation based on the specific products and processes involved. Such an evaluation ideally includes a proper assessment of product and operator safety risk attributable to aerosolization at the point of fill. In order to make an educated assessment of this risk, however, one must first understand whether routine vial filling generates aerosols and what their size distribution is, and then how these aerosols propagate within barrier systems and other spaces where personnel might be affected during routine operation or cleaning. In this part of the study, we investigate the former: Are aerosols generated at the point of fill? And, if so, what factors influence their formation? We characterize the aerosolization at the point of fill as a function of flow speed, vial head-space, needle motion profile, and fill medium properties.
Are aerosols generated at the point of fill? We were able to demonstrate a strong dependence of measurable aerosol counts on the flow speed, vial head-space, and needle motion filling parameters. It was determined that a clear power law relationship between particle counts and Reynolds number/fluid speed in the needle exists and can be used to calculate approximate relative levels of aerosol generation based on the filling parameters employed. The bottom-up filling functionality was confirmed to substantially reduce, but not eliminate, aerosolization.
What does the size distribution of the generated aerosols mean? The overwhelming predominance of collected particles having been determined to be in the sub-5 µm range indicates that a substantial portion of aerosols generated at the point of fill are fully respirable into the deep lung. There is indeed operator safety risk attributable to aerosolization at the point of fill.
What factors influence aerosol formation and how? Apart from the filling parameters, the trials demonstrate that the fluid properties can also substantially influence the extent of aerosol formation. The dynamic surface tension in particular appears to have a dominant effect.
We look forward to seeing you in Philadelphia! For those of you who can’t make it, the poster will be available for download on this page following the conference.
Author: Christian Lavarreda
Header Image – Measurement apparatus: Particle counter with sampling tube reaching horizontally to the sampling location (vial opening)