PDA Italy Chapter is pleased to announce “BLOW FILL SEAL TECHNOLOGY: STATE OF THE ART FOR THE ASEPTIC PRIMARY PACKAGING OF PARENTERALS” in association with Brevetti Angela. Two days fully dedicated to latest developments in the Blow-Fill-Seal technology and the manufacture of sterile pharmaceutical products with a deep focus on the impact of new regulations, on the challenges and advantages faced when filling pharmaceutical products in plastic, and on the possibilities given by such a process compared to traditional filling.
At this event, we will present and discuss new developments and expectations in BFS, which continues to be critical for the packaging of parenterals with high speed and reduced cost. This applies to small volumes for injectables, ophtalmics, sprays, but also to prefilled syringes and to large volumes like IV solutions.
Starting from the regulatory scenario, which continues to evolve rapidly with new or revised guidance, we will see how Annex 1 new requirements are met within the Blow Fill Seal process with a case study about vaccine filling.
We will examine the differences between traditional filling in glass ampoules and BFS, understanding pros and cons directly from the voice of a pharmaceutical company who has been using this technology for more than a decade.
We will also analyze the role of plastic in primary packaging, with special attention to medical grade granules and sustainability. Special attention will be given to the matter of extractables and leachables, and to the role of Container Closure Integrity Testing and Visual Inspection.