Blow-fill-seal is the advanced aseptic technology for the efficient production of containers (e.g. bags or bottles) for large volume parenterals /1/. It allows compact and fast production of LVP containers ranging from 50 to 1000 ml. The favored practice when administering an infusion is to avoid venting the container to minimize patient risk /2-5/. This can be accomplished by using low density polyethylene (LDPE) containers that collapse as the solution is withdrawn. However, if terminal sterilization at 121°C / 20 min is preferred, the use of polypropylene (PP) is required. Well suited for this application are new, so called soft PP materials with bottle geometries that support easy folding during administration.
Some insight into the development process of LVP-PP bottles will be given including design optimization from an intuitive approach, to Finite-Element-Analysis (FEA), as well as the method development to characterize the administration / discharge behavior.
/1/ FDA guidance for Industry: Sterile drug products produced by aseptic processing – current GMP Annex 2 – September 2004
/2/ N. Barsoum, C. Kleemann: Now and then, the history of parenteral fluid administration, American journal of Nephrology 22, 2-3, 2002, p 284-289
/3/ C.M. Thorpe, D.H.T. Scott: Air inlets for infusion bottles Anaesthesia 1994, 49: 610-612
/4/ N. Graves, A.G. Barnett, V.D. Rosenthal: Open versus closed IV infusion systems… BMJ Open 2011;1: e000188 doi:10.1136/bmjopen-2011-000188
/5/ G.A. Sacha, M.J. Akers et al. Practical fundamentals of glass, rubber, and plastic sterile packaging systems Pharmaceutical Development and Technology 2010; 15:1, 6-34
This presentation was recorded on March 24 and is part of a series.