Clean Air, Safe Science: The Irreplaceable Role of HEPA Filters in Biotech
The core filtration performance of HEPA and ULPA filters far exceeds that of other filter types, which is the fundamental reason why they dominate the biotechnology industry. For example, according to the international standard EN 1822, a HEPA filter provides no less than 99.97% efficiency for 0.3-micron particles, while ULPA filters can further increase the efficiency to 99.9995% for 0.1-micron particles. This outstanding ability to intercept ultra-fine particles effectively removes microorganisms, harmful aerosols, and particulate contaminants from cleanrooms in biotech facilities.
The biotechnology industry covers critical sectors such as pharmaceutical manufacturing and biosafety laboratories, which are strictly regulated by national and international standards—further reinforcing the dominant position of high-efficiency filters. In pharmaceutical production, for instance, GMP regulations in various countries impose stringent cleanliness requirements for sterile drug production environments.
In the field of biosafety laboratories, such as BSL-3 and BSL-4 labs, the “Construction Standard for Biosafety Level 3 Laboratories” mandates three-stage filtration systems (pre-filter + medium filter + HEPA filter) for both supply and exhaust air. These labs must maintain ISO Class 7 or better in static conditions, and exhaust air must pass through HEPA filters before being released, preventing the escape of pathogenic microorganisms. Such strict regulatory requirements make high-efficiency filters indispensable in the design and operation of biosafety laboratories, securing their leading role in the industry from a compliance perspective.
High-efficiency filters are widely used and absolutely essential across various scenarios in the biotech field. In cell culture, for instance, CO₂ incubators equipped with HEPA filters can complete one air change every five minutes, improving internal cleanliness to ISO Class 5. This significantly reduces the risk of contamination and raises the success rate of cell cultures from 85% to 97%, providing a stable environment for research and production in cell engineering and regenerative medicine.
E-FILT Success Cases
In the biopharmaceutical sector, a pharmaceutical plant improved the microbial pass rate of its sterile drug formulations from 98.5% to 99.9% by upgrading to liquid-sealed HEPA filters. This also dramatically reduced batch rejection rates due to contamination, cutting production costs and increasing overall efficiency. Furthermore, in biosafety cabinets, dual-stage filtration (pre-filter + HEPA) boosts filtration efficiency for 0.3-micron particles to 99.99%, providing dual protection for both personnel and experimental environments, ensuring research safety. These real-world cases highlight the irreplaceable role of high-efficiency filters across all links in the biotech industry, securing their dominant position.
Determining Clean Zone Classification and Particle Size Requirements
- Pharmaceutical Cleanrooms (e.g., GMP Grade A/B Zones): Require ≥99.995% filtration efficiency for 0.3 μm particles, typically using H14 HEPA filters (EN 1822) or U15 ULPA filters for 0.1–0.2 μm particles.
- Cell Culture / Gene Therapy Workshops: Require control of microorganisms such as mycoplasma and fungi as well as fine particulates. Filters should intercept 0.1–0.5 μm particles, with H14 HEPA or above, and must resist 37°C and 50% RH conditions.
- Biosafety Laboratories (BSL-3/4): Require dual high-efficiency filtration (supply and exhaust). Exhaust filters must pass bioaerosol challenge tests and support in-situ sterilization such as formaldehyde fumigation or high-temperature disinfection.
Filter Grade Selection According to International Standards
- H13: ≥99.97% for 0.3 μm particles. Suitable for ISO Class 7 cleanrooms (e.g., general biologics production).
- H14: ≥99.995% for 0.3 μm particles. Suitable for ISO Class 7–5 zones (e.g., aseptic drug production, vaccine filling).
- ULPA (U15–U17): ≥99.9995% for 0.12 μm particles. Used in ultra-clean environments (e.g., nucleic acid drug filling, gene therapy production).
HEPA Service Life and Replacement Cycle
Under cleanroom conditions, standard HEPA filters typically last 2–3 years. In environments with high dust or aerosol concentrations (e.g., fermentation exhaust), the service life may reduce to 1–1.5 years. In such cases, it is recommended to use washable pre-filters combined with high-efficiency filters to extend the life of the main filter.
It is also advisable to install differential pressure sensors for real-time monitoring. When pressure drop exceeds twice the initial value, a replacement alarm should be triggered.
Conclusion: Partner with a Trusted Air Filter Manufacturer for Biotech Excellence
As a professional air filter manufacturer, E-FILT provides industry-certified filtration products that meet global standards such as EN 1822, ISO 29463, and GMP. With extensive experience serving pharmaceutical factories, cell therapy labs, and biosafety facilities, E-FILT delivers custom solutions that ensure optimal air purity and long-term reliability.
Choose E-FILT—the air filter manufacturer trusted by biotech leaders for cleanroom innovation, regulatory compliance, and peace of mind.
