Face Mask Bacterial Filtration Efficiency (BFE) Tester
Face Mask Bacterial Filtration Efficiency (BFE) Tester ToronFM™ BFE is designed to evaluate the filtration efficiency of masks. It is suitable for use in calibration labs, research institutions, mask production facilities, and other relevant sectors.
Standard
- ASTM F2100 Standard Specification for Performance of Materials Used in Medical Face Masks
- ASTM F2101 Standard Test Method for Evaluating the Bacterial Filtration Efficiency (BFE) of Medical Face
- YY 0469 Technical requirements for surgical mask
- BS EN 14683 Medical face masks - Requirements and test methods
- Mask Materials, Using a Biological Aerosol of Staphylococcus aureus
- NBR 15052
The Torontech ToronFM™ BFE is a specialized instrument for determining the Bacterial Filtration Efficiency (BFE) of medical face mask materials, in full compliance with standards like ASTM F2101 and EN 14683. Its primary application is to provide a precise, quantitative measure of a material's ability to act as a barrier against bacterial aerosols. This is a fundamental performance parameter for classifying medical masks and is essential for regulatory approval and ensuring the protection of both healthcare professionals and patients.
This critical performance test is a cornerstone of quality assurance and safety in:
- Medical Device Manufacturing: As a mandatory quality control and lot release test for manufacturers of medical and surgical face masks, providing the definitive data required to certify their products to the required BFE performance levels (e.g., Type I, II, or IIR).
- Third-Party & Regulatory Testing: For independent laboratories and government agencies to verify that face masks being sold in the market meet national and international public health and safety standards.
- Non-Woven & Filter Media R&D: As a primary research tool for developing and validating new filter materials, providing the quantitative data needed to prove their efficacy and optimize their performance for medical applications.
- Healthcare & Institutional Procurement: To perform incoming quality assurance and supplier validation, ensuring that the masks procured for use by healthcare workers and in sterile environments provide the claimed level of bacterial filtration and meet institutional safety protocols.
The negative pressure testing system ensures operator safety.
A peristaltic pump is integrated within the negative pressure cabinet, featuring two A & B routes and a 6-stage Andersen sampling head.
The peristaltic pump's flow rate is adjustable, as is the spray flow of bacterial liquid within the specialized microbial aerosol generator.
Key features include:
- Excellent atomization performance.
- Embedded high-speed industrial microcomputer control.
- 13.3" high-brightness color touch screen display.
- USB connector for data archiving.
- High-brightness lighting inside the cabinet.
- A front glass door with a sliding mechanism for easy observation.
| Model | ToronFM™ BFE | ||
|---|---|---|---|
| Key Specification | Specification Range | Resolution | Max. permissible errors |
| A Route Sampling Flow | 28.3L/min | 0.1L/min | Within ± 2.0% |
| B Route Sampling Flow | 28.3L/min | 0.1L/min | Within ± 2.0% |
| Spray Flow | (0.1~10)L/min | 0.1L/min | Within ± 5.0% |
| Peristaltic Pump Flow | (0.001~3.0)mL/min | 0.001mL/min | Within ± 2.0% |
| Negative Pressure of the Chamber | (-90~120)Pa | 0.1Pa | Within ± 1.0% |
| Working Temperature | 0-50℃ | ||
| Data Save Ability | >500000 sets (Scalable capacity) | ||
| High Efficiency Particulate Air Filter Properties | ≥99.995%@0.3 μm, ≥99.995%@0.12 μm | ||
| Median diameter of aerosol generator mass | Average diameter: (3.0 ± 0.3) μm; Geometric Standard Deviation ≤1.5 | ||
| Double Routes 6-level Andersen Sampling apparatus | Level I: >7 μm; Level II: (4.7~7) μm; Level III: (3.3~4.7) μm; Level IV: (2.1~3.3) μm; Level V: (1.1~2.1) μm; Level VI: (0.6~1.1) μm | ||
| Size of Aerosol Chamber | 600 × 80 × 3mm (Length × Diameter × Thickness) | ||
| Total number of positive quality control sampler particles | (2200 ± 500)cfu | ||
| Negative Chamber Flow Speed | ≥5m³/min | ||
| Size of Main Machine | 1300 × 700 × 2100mm (L × W × H) | ||
| Voltage | AC220V ±10%, 50Hz (110V is also available) | ||
| Noise of the Tester | <65dB(A) | ||
| Weight | 300kg | ||
| Power Consumption | <1500W | ||