Camfil introduces the Absolute D-Pyro. It’s the all new high temperature filter for depyrogenation tunnels. Familiar on the outside, ground breaking on the inside.
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
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.
To address this issue and to obtain consistent ISO Class 5 levels in all zones, Camfil stepped up particle efficiency with the Absolute D-Pyro to offer H14-grade filtration throughout the whole depyrogenation tunnel.
Depyrogenation now only requires Camfil’s Absolute D-Pyro H14 high-temperature filter to achieve consistent and reliable protection of the whole process.
We know how critical it is to keep aseptic filling lines up and running to maintain a profitable business. It is, therefore, crucial that the depyrogenation tunnels can be operational for as long as possible without interruptions.
To support the highest possible production yield and value, Absolute D-Pyro has been subjected to more than 200 test cycles in our R&D lab without efficiency failure or leaks.
This shows our effort to completely re-engineer our high temperature filter solution – and the result speaks for itself: D-Pyro has a totally renewed construction made of highly compatible materials which together offers maximum durability in the toughest conditions.
The quicker the temperature can be ramped up when starting up an aseptic filling line, the more can be produced in less time.
No tempering is required before the Absolute D-Pyro is placed in production. Unlike other HT filters, it can be “plugged in” to the process easily and used directly in temperatures up to 350°C.
Absolute D-Pyro has been tested to handle increases in temperature of up to 5°C per minute. This means it will reach the steady state faster than any other filter – contributing to a more productive process for our customers.
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.
To meet ISO Class 5 cleanroom requirements of zero emissions, D-Pyro offers a sealed airtight filter pack in a reinforced stainless-steel frame - free of any organic compound that could burn (no bisphenol A, phthalates or formaldehyde). The design also eliminates any need for tempering or cleaning when temperatures are ramped up and down.
For maximum productivity, depyrogenation tunnels needs to be operational for as long as possible without interruptions. This is why D-Pyro is designed to last longer than any other filter on the market. It has been subjected to more than 200 test cycles without efficiency failure or leaks.
D-Pyro remains reliable and leak-free in continuously high working temperatures up to 350°C, peaking at 400°C for one hour.
hoose depths of 150 or 292 mm.
D-Pyro is the first H14 high-temperature filter on the market offering H14-grade filtration (99.995%) throughout the whole depyrogenation tunnel. It is designed and manufactured to meet the demands of our industry-leading and unique ProSafe certification - offering full compliance with the stringent regulations of the Life Science industries.
Unlike other HT filters, D-Pyro can be “plugged in” to the process without tempering and used directly in temperatures up to 350°C. It has been tested to handle increases in temperature of up to 5°C per minute. This means it will reach the steady state faster than any other filter – contributing to a more productive aseptic process.
Absolute D-Pyro also saves energy by eliminating the need to maintain a constant temperature during downtime, or when the depyrogenation tunnel is not in operation. The annual energy savings can be up to several thousand U.S. dollars per tunnel.
Raw material qualification: FDA / REACH / EC1935:2004 / VDI6022 / ISO 846. Quality control: Entire filter is scanned according to EN 1822 with individual scan test report.