AAF has launched the AstroCel I HTP high temperature HEPA filter, which has been developed to safeguard a flawless performance of sensitive dry heat sterilisation 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.
AAF says dry heat sterilisation is one of the most critical process steps in medicine manufacturing, by which sterility of pharmaceutical sterile and aseptic preparations can be ensured. Inside such sterilisation tunnels, HEPA filtration plays an indispensable role in protecting containers, such as vials or syringes, from contamination that might result in health risks 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 these challenges and not 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 has identified the critical characteristic requirements for high-temperature HEPA filters which directly influence the productivity of a sterilisation tunnel.
The AstroCel I HTP comes with corrugated stainless steel separators and stainless steel support bars and stays
Marc Schmidt, Business Development Manager Pharma at AAF International, said the company conducted in-depth interviews with tunnel and medicine manufacturers.
'They have given us a perfect understanding of how HEPA filtration can optimise high temperature processes,' he said.
'Two HEPA filter requirements – high durability of construction and proven performance on efficiency – were found most critical and the AstroCel I HTP provides the right answer to both.'
The AstroCel I HTP comes with corrugated stainless steel separators and stainless steel support bars and stays. This gives a high overall durability, which is less prone to oxidation. The risk of oxidised particles shedding off the separators on the air leaving side is reduced. The separators are placed in a staggered position to increase media pack stiffness and to prevent separators from nesting.
The new filter design also includes an elastic fibreglass sealant rather than a more vulnerable ceramic sealant, normally found in traditional air filter types. This leaves the HEPA filter 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, the company said.
AstroCel I HTP provides a high air quality level at temperatures of 350°C with an efficiency of ≥99,99% for 0.3μm particles and ≥ 99,95% for MPPS. The air filter can be operated at a high airflow rate of 1,440m3/h in 150mm depth execution and 2,100m3/h in 290mm depth execution. This allows for 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.
AAF is offering an exclusive webinar in which critical success factors for dry heat sterilisation processes are discussed and the proven performance of the new filter design is presented.
The webinar is presented by Marc Schmidt. Special guest Lothar Gail, a well-respected GMP and cleanroom expert, will share the insights that he gained from his many years of experience in contamination control and cleanroom design.
Exclusively for the webinar participants, AAF will distribute a digital copy of a new whitepaper that contains detailed insights into high temperature HEPA filtration for dry heat sterilisation tunnels.
To register for the webinar and to download a preview of the whitepaper, click here.
