AAF introduces the AstroCel® I HTP high temperature HEPA filter for dry heat sterilization processes
Produktfoto des AstroCel I HTP / Product photo AstroCel I HTP
- New filter design that answers to the challenges identified by the pharmaceutical industry
- Demonstrated high durability of construction and proven performance on efficiency
- Exclusive webinar and new whitepaper available via www.hthepa.aafeurope.com
- Launched at TechnoPharm 2014
On the first day of TechnoPharm 2014 in Nuremberg (Germany), AAF has launched the AstroCel® I HTP high temperature HEPA filter. The air filter is specifically developed to safeguard a flawless performance of sensitive dry heat sterilization processes during pharmaceutical sterile manufacturing. With a high durability of construction and proven performance on efficiency, the AstroCel I HTP resolves key air filtration challenges identified by the pharmaceutical industry. An exclusive webinar can be viewed, during which critical success factors for dry heat sterilization processes are discussed and the proven performance of the new filter design is presented.
Critical process step in sterile manufacturing
Dry heat sterilization can be considered one of the most critical process steps in medicine manufacturing, by which to ensure sterility of pharmaceutical sterile and aseptic preparations. Inside such sterilization tunnels, HEPA filtration plays an indispensable role in protecting containers, such as vials or syringes, from contamination that might result in severe health risk for patients. Where the installed HEPA filter has to withstand frequent temperature fluctuations between ambient and up to 350 ˚C, operating conditions are challenging.
To control the challenges, and therewith not to affect manufacturing throughput and product quality and safety, a careful selection of the high temperature HEPA filter is required. Based on detailed customer insights, AAF was able to identify the critical characteristic requirements for high temperature HEPA filters which directly influence the productivity of a sterilization tunnel. Dr.-Ing. Marc Schmidt, Business Development Manager Pharma at AAF International: “We conducted many in-depth interviews with tunnel and medicine manufacturers over the last year. They have given us a perfect understanding of how HEPA filtration can optimize high temperature processes. Two HEPA filter requirements, being high durability of construction and proven performance on efficiency, were found most critical and the AstroCel I HTP has proven to provide the right answer to both.”
A new filter design for unsurpassed performance
The new AstroCel I HTP high temperature HEPA filter from AAF comes with corrugated stainless steel separators and stainless steel support bars and stays. This design gives a high overall durability, which is less prone to oxidation. Risk of oxidized particles to shed off the separators on the air leaving side is reduced. The separators are placed in staggered position to increase media pack stiffness and to prevent separators from nesting.
In addition to stainless steel separators and stiffeners, the new filter design includes an elastic fibreglass sealant in contrast to the more vulnerable ceramic sealant, such as found in traditional air filter types. With the inclusion of an elastic fibreglass sealant, the HEPA filter is better able to compensate the forces from heat stretching of components. Integrity breaches from stress cracks are prevented, by which risk of bypass, particle shedding and process contamination is mitigated.
AstroCel I HTP provides a high air quality level at temperatures of 350 °C with an efficiency of ≥ 99,99% for 0,3 μm particles and ≥ 99,95% for MPPS. The air filter can be operated at a high airflow rate of 1440 m3/h in 150 mm depth execution and 2100 m3/h in 290 mm depth execution. This allows for a speedy temperature control, through which time for heating up can be significantly reduced. With AstroCel I HTP, operational readiness is improved and cycle times of batch processes are shortened. The high durability of construction limits risk of process downtime, while the low operating resistance of ≤ 250 Pa gives reduced energy costs.
The AstroCel I HTP is compatible with equipment of market leading sterilization tunnel manufacturers.
A dedicated webinar and whitepaper for detailed insights
AAF has just released a new webinar during which the critical success factors for dry heat sterilization processes are discussed. Subsequently, the proven performance of the new filter design of the AstroCel I HTP is presented. The webinar is presented by AAF‘s Business Development Manager Pharma, Dr.-Ing. Marc Schmidt. Special webinar guest is the well-respected GMP and cleanroom expert Dr.-Ing. Lothar Gail, who shares the insights that he obtained from his many years of experience in the field of contamination control and cleanroom design.
Exclusively for the webinar viewers, AAF will distribute a digital copy of a new whitepaper that contains detailed insights into high temperature HEPA filtration for dry heat sterilization tunnels. The registration for the webinar and the download of a preview of the whitepaper can be done via: www.hthepa.aafeurope.com.
