Current practice in the operation and validation of aseptic blow-fill-seal processes.
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.
Ljungqvist
Bengt
B
KTH, Stockholm, Sweden.
Reinmüller
Berit
B
Löfgren
Anders
A
Dewhurst
Eric
E
D001207:Asepsis / Q000295:instrumentation / Q000379:methods / Q000592:standards; D004340:Drug Contamination / Q000517:prevention & control*; D004345:Drug Industry / Q000295:instrumentation / Q000379:methods / Q000592:standards; D004356:Drug Storage / Q000379:methods / Q000592:standards