Bosch Packaging Technology is pleased to announce the publication of Part 1 of its recent aerosol generation at the point of fill characterization study in poster format at the upcoming Interphex 2018 conference to be held in New York City on April 17-19.
A comprehensive barrier system suitability evaluation based on the products and processes involved includes an assessment of product and operator safety risk attributable to aerosolization at the point of fill. The audience at Interphex will benefit from learning how Bosch, having placed well over a hundred filling lines with each of the various barrier system types to date, has characterized this aerosolization (as a function of flow velocity, vial head-space, needle motion profile, and fill medium properties) and the implications on barrier system selection. Previous and foundational work was published, also by Bosch, in TechnoPharm 3, Nr. 1, 28-32 (2013).
Abstract: Over fifteen years have now passed since the Isolation Technology Task Force of the Parenteral Drug Association (PDA) published the influential Technical Report No. 34 (TR 34), “Design and Validation of Isolator Systems for the Manufacturing and Testing of Health Care Products,” yet considerable confusion still surrounds the suitability and favorability of the different types of Restricted Access Barrier Systems (RABS) and isolators in pharmaceutical fill-finish operations. Part of this confusion stems from an incomplete understanding and poor awareness of the size distribution of the particles that can be generated by the fill-finish equipment during routine operation, the flight trajectory of the particles based on their point of origin, and their eventual location of deposition based on the barrier system design. In Part 1 of this study we use light scattering to characterize the particle size distribution of the fill medium aerosolized at the point of fill (as a function of flow velocity, vial head-space, needle motion profile, and fill medium properties) while using computational fluid dynamics (CFD) to qualify the measurement method. Part 2 of this project, the characterization of the flight path and location of deposition of the aerosol generated at the point of fill, as well as the elaboration of corresponding recommendations for action, is ongoing and will be presented separately.