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Contamination Risk of Filling Technologies
Aseptic Technologies has produced a report on the contamination risk of filling technologies. Benoit Verjans and Charles Reed have compared four recognized aseptic filling technologies, ampul, open vial, blow-fill-seal (BFS) and prefilled syringes to the Crystal® closed-vial technology in regards to the exposure risk viable particles from the air supply.
The containers (i.e. vial, syringe barrel, ampul), container closures (i.e. stopper, plungers) and filling needles have been taken into consideration and weighted by exposure time and exposed surface.
The analysis demonstrated that two technologies, closed vial technology and BFS, substantially lower the risk of contamination due to exposure to the environment.
A recent article published in the Pharmaceutical Technology Europe has mentioned the risk of contamination due to exposure of internal surfaces of the container throughout the filling process. The article explained the model of an environmental risk approach established on laminar airflow that is prone to carrying viable particles. The preliminary analysis was done using only three kinds of containers, large vial, small vial and ampuls and took into account entry of the bacteria through the container neck.
Our analysis into the contamination risk of filling technologies has broadened this to involve extra packaging types employed for aseptic filling of liquid products ie., vials, ampuls, blow-fill-seal containers, prefilled syringes and closed vial technology. The contamination sources have been methodically screened. The report concentrates on risk arising from environmental contamination during filling operations.
The analysis concluded that aseptic filling definitively contains an element of risk introduceddue to potential presence of living organisms into the production environment. It is estimated that at least 300,000 people worldwide face contamination each year due to contaminated sterile drugs according to analysis from Vonberg and Gastmeier. Cutting edge technologies like Crystal® closed vial technology and BFS can lower the risk of product contamination by more than two logs compared to classical technologies such as open vial filling. This is obtained by reducing the exposure to the environment.
Our analysis shows that invested patient safety can be strongly increased through the use of Crystal® closed vial technology and BFS compared to other open container technologies. Further to this, the pharmaceutical industry will gain from more robust and easier to use technologies.
For more information or to discuss the contamination risk of filling technologies please contact us directly.