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.
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
Until now, the hot zone in depyrogenation tunnels – which can reach 350°C – has typically been protected by H13 high-temperature filters. However, the cool zone is usually protected by H14 filters.
Regulatory authorities have questioned how H13 and H14 filters with different characteristics could deliver the same performance when it comes to cleanliness.
Absolute D-Pyro is a totally new innovative air filter construction for high temperature environments requiring maximum production uptime and safety. And it achieves H14 in the production “hot zone” with zero emissions, zero tempering and zero cleaning.
Netherlands
