Hwato Acupuncture Needle Quality

Full-Process Cleanroom Control

Overview: The entire production process is carried out in a 10,000㎡ ISO Class 8 cleanroom, with controlled conditions of 18–28°C and 45–65% relative humidity. The microbial settle plate count is ≤10 CFU/plate.

Cleanroom Parameters Comparison:

Parameter	Hwato Standard	ISO Class 8 Standard
≥0.5μm Particle Count	≤3,500,000/m³	≤3,520,000/m³
Settle Plate Bacteria	≤10 CFU/plate	Not Specified

Two-Stage Cleaning Process

First Cleaning: After winding the needle onto the handle, it undergoes ultrasonic cleaning (40kHz) using medical-grade surfactants and purified water (resistivity ≥18MΩ·cm), followed by triple-stage filtration. This process achieves ISO 16232 C15 cleanliness level.

Second Cleaning: The needle is further cleaned using precision-filtered pure water and nano-level ultrasonic processing to ensure no residual metal particles remain on the tip.

Sterilization & Residual Gas Control

Sterilisation: Ethylene oxide (EO) at 50°C, 600mg/L, monitored in real-time via PLC (in compliance with ISO 11135).

Residual Control: Uses patented catalytic decomposition (ZL201510309099.X) to achieve EO <0.1 ppm, ECH <0.2 ppm — far below the ISO 10993-7 safety limits.

Data Traceability: Up to 30 years.

Residual Value Comparison:

Parameter	Hwato Value	ISO 10993-7 Limit
EO	<0.1 ppm	≤4 ppm
ECH	<0.2 ppm	Not Specified

Needle Body & Tip Quality

Material: Japanese SUS medical-grade stainless steel
Straightness Control: AI-based visual inspection system
Needle tip: under 2000X SEM