Technical points for product compliance of high-efficiency air filters in biosafety cabinets

The compliance technical points of HEPA/ULPA filters in biosafety cabinets are the core of their safety and effectiveness. These key points are not only related to the filter itself, but also to the compliance certification of the entire biosafety cabinet. The following is a systematic summary:
core principle
High efficiency air filters are not standalone products, but undergo overall evaluation as key components of biosafety cabinets. Its compliance must meet the mandatory requirements for overall performance in medical device registration/certification.

• This is the basis for all technical points.

International mainstream standards:
EN 12469:2000 (Europe) - Performance standards for biotechnology equipment (biosafety cabinets).
NSF/ANSI 49:2022 (USA) - Certification Standard for Biosafety Cabinets (Class II).
ISO 14644-1&ISO 29463- Testing standards for clean rooms and related controlled environments, high-efficiency and ultra high efficiency filters.

• Chinese mandatory standards:

YY 0569-2011 "Level II Biosafety Cabinet" - a mandatory industry standard in China, with technical content equivalent to EN 12469:2000, and is the cornerstone of medical device registration in China.
GB 4793.1- General safety requirements for electrical equipment for measurement, control and laboratory use.
As a medical device (Class II, No. 22-04-02) for management, it needs to be registered with NMPA (National Medical Products Administration).

• Filtration efficiency:
• Core indicator: interception efficiency for specific particle sizes.
• Compliance requirements:
• HEPA filter (supply and exhaust): must meet the filtration efficiency of ≥ 99.99% (i.e. penetration rate ≤ 0.01%) for 0.3 μ m particle size thermally generated DOP (or similar) aerosols. This is the common bottom line between YY 0569 and NSF/ANSI 49.
• ULPA filters (for higher demand applications): The filtration efficiency for particles with a diameter of 0.1-0.2 μ m is usually ≥ 99.999% (or penetration rate ≤ 0.001%).
• Testing method: Scanning testing must be conducted in accordance with standards such as ISO 29463 and IEST-RP-CC034, and an authoritative testing report must be issued.
• Integrity:
• Core indicators: Ensure that the filter medium is not damaged and the frame is sealed without leakage.
• Compliance requirements: In situ scanning leak detection testing must be conducted before leaving the factory and during the certification of the entire biosafety cabinet.
• Test method: Use aerosols (such as PAO, DOP, DEHS) to generate dust upstream, and use a photometer probe to scan the entire process on the downstream side, frame, and sealing of the filter.
• Qualification assessment: The leakage rate at any point shall not exceed 0.01% (i.e. ten times the filter efficiency required by the overall standard). This is a mandatory veto item.
• Structure and Materials:
• Partition board: Anti corrosion materials (such as aluminum foil, stainless steel) should be used to ensure structural stability and prevent moisture damage.
• Filter material: usually made of glass fiber, it needs to have good water resistance (to prevent moisture failure) and flame retardancy.
• Sealing glue: The border sealing glue must be compatible with the filter medium and the safety cabinet body, maintain elasticity after curing, and not crack or peel off after long-term use. It should also be able to withstand fumigation with disinfectants such as alcohol and hydrogen peroxide.
• Frame: It should be sturdy, easy to install and seal. Metal frames (such as aluminum profiles and stainless steel) are the mainstream.

• Design compatibility:
• The rated air volume and initial resistance of the filter must be accurately matched with the performance curve of the safety cabinet fan to ensure long-term stable operation at the design wind speed (usually a face wind speed of 0.5m/s).
• The installation structure design must ensure that it can be replaced on site and still pass the integrity test after replacement.
• safety
• Exhaust filter: For B2 type or partial A2 type safety cabinets that require connection to external exhaust pipes, the exhaust filter is the final barrier to prevent environmental pollution. Its pressure bearing structure must be verified to withstand pressure fluctuations that may occur in the pipeline system.
• Monitoring and alarm: The entire machine should be equipped with airflow or pressure sensors. When the filter resistance increases to the set value (such as twice the initial resistance), an audible and visual alarm should be issued to prompt the user to perform detection or replacement. This is a clear requirement of YY 0569.
• Testing and certification documents:
• Filter unit test report: Manufacturers should provide efficiency test reports and leak detection test reports for each batch or filter.
• Complete machine type inspection report: When applying for product registration, safety cabinet manufacturers must submit a type inspection report issued by a qualified medical device testing institution. This report contains on-site in-situ leak testing data and results for all HEPA filters in the entire machine.
• NMPA Medical Device Registration Certificate: This is the final compliance certificate, which means that the model of biosafety cabinet (including the filters used) has passed the full set of performance, safety, and electromagnetic compatibility tests.

• Users should pay special attention to:
• Verification certificate: The supplier is required to provide the medical device registration certificate and attachments (including product technical requirements) for the biosafety cabinet.
• Verification report: It is required to provide a type inspection report that is consistent with the registered product model, and focus on reviewing the test data and conclusions in the "Efficient Filter Leak Detection" section of the report.
• On site acceptance: After installation, professional personnel must conduct on-site performance verification according to standards, among which HEPA filter integrity scanning and leak detection are mandatory items, and written reports are required.
• Subsequent maintenance: After regular annual maintenance or filter replacement, it is necessary to conduct integrity leak testing again and keep records.
• summary
• The compliance of high-efficiency air filters in biosafety cabinets is a full chain process from individual performance to system integration, and then to whole machine certification and continuous verification. The core of its technical points is:
• Based on mandatory standards such as YY 0569, with a filtration efficiency of ≥ 99.99% and a leakage rate of ≤ 0.01% as hard indicators, we ensure its ultimate protective effectiveness in biosafety cabinets through authoritative third-party testing and strict medical device registration processes.
• Any filter or safety cabinet claiming compliance must provide complete and traceable technical documents and testing evidence as mentioned above.

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