The use of computational fluid dynamics for the study of particle dispersion routes in the filling area of a blow-fill-seal process
2010 (English)In: European Journal of Parenteral and Pharmaceutical Sciences, ISSN 0964-4679, Vol. 15, no 1, 5-11 p.Article in journal (Refereed) Published
An important issue when producing sterile drugs or medicinal products by aseptic processing with blow-fill-seal technology is to achieve an airborne particle cleanliness of ISO Class 5 for particles ≥0.5 micron for US and EU, and ISO Class 4.8 for particles ≥5.0 micron for EU compliance in the critical area, which includes the filling zone. Most blow-fill-seal machines are equipped with a filling shroud in the filling area, above the ampoules. The shrouds are often pressurised using either HEPA-filtered air or sterile filtered air. The pressure inside the shroud results in a downwards directed airflow, which creates a cleaner environment around the open ampoules during the filling process than the immediate surroundings in the bowels of the machine. The clean environment within the shroud also provides protection for the fillingmandrel and nozzles. This paper describes the use of computational fluid dynamics to simulate air velocity magnitudes andmass flow rates as ameans of better understanding particle dispersion routes in the filling area of a blow-fill-seal process and the impact different parameter settings can have on airborne particle concentrations in the filling area. The results show that the movements of the mandrel, together with its nozzles, is the main cause of particles present in the filling shroud during the manufacturing process. The computational fluid dynamics results suggest that particle concentrations can be reduced by changing the mandrel velocity and the mandrel shape. It should be noted that results presented in this paper are limited to one type of BFSmachine.
Place, publisher, year, edition, pages
2010. Vol. 15, no 1, 5-11 p.
Airborne particles, Blow-fill-seal, CFD, Computational fluid dynamics, Shroud
IdentifiersURN: urn:nbn:se:kth:diva-27389ScopusID: 2-s2.0-77953339275OAI: oai:DiVA.org:kth-27389DiVA: diva2:377048
QC 201012132010-12-132010-12-132010-12-13Bibliographically approved