In order to guarantee patient safety, aseptic filling lines have some of the toughest cleanliness requirements on the planet. ISO Class 5 cleanroom conditions are required throughout the depyrogenation tunnels, where glass vials, ampoules and syringes are sterilized before they are aseptically filled.
To achieve ISO Class 5 level cleanliness has, until now, required filters to be baked or tempered before they could be safely used in the production. These processes caused outgassing of smoke and fumes, resulting in downtime when the fumes were exhausted and the hot zones cleaned. Absolute D-Pyro requires no baking or tempering - eliminating the need for cleaning, minimizing the downtime and contributing to a higher production yield.
In addition, the sterilization process means burning away endotoxins at high temperature (>280°C). Unfortunately, some HT filters tend to “emit” particles when tunnel temperatures are ramped up or down, or when the temperature varies in steady-state conditions at high temperatures. These particle emissions impact output and quality negatively and result in expensive downtime and filter changes.
To eliminate these problems, Camfil’s filtration experts designed Absolute D-Pyro to be free of any organic compound that could burn and with zero emissions. And also with no requirement for tempering or cleaning when temperatures are ramped up and down