Particle concentrations in small volume parenterals produced by aseptic blow-fill-seal technology
2010 (English)In: European Journal of Parenteral and Pharmaceutical Sciences, ISSN 0964-4679, Vol. 15, no 3, 87-92 p.Article in journal (Refereed) Published
When producing sterile drugs or medicinal products by aseptic processing with blow-fill seal (BFS) technology it is important 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 BFS 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. This results in a downwards directed airflow, which creates a cleaner environment around the open ampoules during the filling process than the immediate surroundings within the machine region. The clean environment within the shroud also provides protection for the filling mandrel and nozzles. BFS machines which use hot knives for the cutting of plastic parisons are known to generate significant amount of particles and the regulatory requirements can sometimes be difficult to fulfil. These requirements do not take into account the short exposure time for small volume parenterals produced with BFS. This paper describes an experimental study performed on one BFS machine in order to increase the understanding of the relationship between airborne particle concentration and particle concentrations in filled small volume parenterals. The airborne particle concentration in the critical area of the BFS process was increased 1,000 fold (particles ≥0.5 micron) during filling with NaCl fluid. Following the particles challenge, samples of filled ampoules were analysed through light obscuration particle count. The result showed no increase of particles in the filled ampoules. Likely explanations to the result are the short exposure time and small exposure area.
Place, publisher, year, edition, pages
2010. Vol. 15, no 3, 87-92 p.
Airborne particles, Aseptic, Blow-fill-seal, Small volume parenteral
Other Civil Engineering
IdentifiersURN: urn:nbn:se:kth:diva-150256ScopusID: 2-s2.0-79953253903OAI: oai:DiVA.org:kth-150256DiVA: diva2:743088
QC 201409032014-09-032014-09-012014-09-03Bibliographically approved