RT Journal Article
SR Electronic
T1 Current Practice in the Operation and Validation of Aseptic Blow-Fill-Seal Processes
JF PDA Journal of Pharmaceutical Science and Technology
JO PDA J Pharm Sci Technol
FD Parenteral Drug Association (PDA)
SP 254
OP 258
VO 60
IS 4
A1 Bengt Ljungqvist
A1 Berit Reinmüller
A1 Anders Löfgren
A1 Eric Dewhurst
YR 2006
UL http://journal.pda.org/content/60/4/254.abstract
AB In order to illustrate current practice in aseptic blow-fill-seal (BFS) technology, a worldwide survey was performed by the BFS International Operators Association. The results are summarized and compared to the media fill data from the Product Quality and Research Institute (PQRI) survey reported in 2003. The survey highlights the differences and shows the robustness of the BFS technology. Compared to the results from the PQRI survey, the BFS survey shows a tenfold lower frequency of contaminated media fills.