Currently, high-temperature-resistant HEPA filters with a tolerance of up to 350°C are gaining widespread attention in the pharmaceutical industry. These filters have become a key component in high-temperature sterilization, drying, and exhaust gas treatment processes due to their outstanding performance.
In dry heat sterilization systems, these high-temperature-resistant HEPA filters are widely used in depyrogenation tunnels and dry heat sterilizers. They effectively remove endotoxins from glass vials, ensuring that the containers achieve Class A cleanliness after sterilization. The filters operate within a temperature range of 250°C to 350°C, with a peak tolerance of up to 400°C. They are constructed with a stainless steel 316L frame and glass fiber filter paper with PTFE coating, providing excellent high-temperature resistance.
In fluid bed drying and exhaust gas incineration processes, these filters prevent the leakage of active pharmaceutical ingredient (API) particles, meeting the strict cross-contamination control requirements of GMP. They also effectively filter particulates from exhaust gases containing organic solvents, protecting the regenerative thermal oxidizer's (RTO) heat storage bodies.
For special process requirements in the production of sterile injectables, traditional Chinese medicine extraction, and biopharmaceuticals, high-temperature-resistant HEPA filters comply with EU GMP Annex 1, the Chinese Pharmacopoeia, and FDA 21 CFR Part 211, ensuring both the sterility and environmental compliance of pharmaceutical production.
In terms of selection, the filters must achieve H13-H14 efficiency levels, with a filtration efficiency of 99.95%-99.995% for particles of 0.3μm. They should also possess good structural strength and chemical compatibility to withstand frequent high-temperature cooling cycles and acid/alkali cleaning processes.
Renowned brand SAF offers reliable high-temperature-resistant HEPA filters for the pharmaceutical industry. Regular leak testing, appropriate replacement cycles, and comprehensive documentation are essential maintenance practices to ensure the normal operation of the filters and meet audit requirements.
The application of high-temperature-resistant HEPA filters not only enhances the sterility level of pharmaceutical production but also helps companies achieve environmental compliance, providing strong support for the sustainable development of the pharmaceutical industry.
