Clean equipment quality assurance system
Our company focuses on the manufacturing of clean equipment such as FFU, air shower room, cargo shower room, clean shed, biological safety cabinet, etc., and uses a full-link quality control system to ensure that product performance is accurately matched with industry standards. The core control process is as follows:
1. Strict selection and verification of raw materials
Core component traceability: HEPA/ULPA filters use ISO 16890 certified filter materials, the fan undergoes dynamic balancing test before assembly, and the stainless steel plate passes SGS corrosion resistance test.
Supplier classification management: Cooperate with global top suppliers such as 3M and AAF, each batch of materials is accompanied by a third-party test report, and the sampling rate before storage reaches 100%.
2. Standardized control of production process
Digital manufacturing: CNC precision machining ensures that the equipment structure error is ≤0.5mm, and the laser welding process ensures sealing (air leakage rate <0.01%).
Key process monitoring: Air shower room/cargo shower room wind speed calibration (20-25m/s), FFU noise control (≤55dB), and biological safety cabinet negative pressure stability (±5Pa) are recorded and traceable in real time.
3. Full-scale testing of finished products
Performance measurement: FFU runs at full load for 72 hours to verify air volume uniformity (±10%), clean room particle count (≥0.5μm particles ≤3.5 particles/L), and biosafety cabinet aerosol protection (KI-Discus method ≥99.99%).
Compliance certification: 100% passed ISO 14644 cleanliness, GMP dynamic testing and EN 12469 biosafety cabinet international certification.
4. Quality traceability and continuous improvement
One-item-one-code system: Each device generates an independent QR code to record production batches, quality inspection data and maintenance records.
Customer feedback closed loop: After-sales response within 48 hours, quality problem analysis report issued within 24 hours, annual quality control iteration ≥2 times.
Commitment: From design to delivery, the "zero defect" quality control standard is implemented throughout the process to ensure the stable performance of clean equipment within the 10-year life cycle, and help customers pass strict audits such as FDA and ISO.