SaiPress® HF Sterilizing-grade Hydrophilic Disk Filter

TOC and conductivity: The detected TOC value is ≤0.5mg/L, and the electrical conductivity value is ≤1.3us/cm
Cleanliness: Meets the "no fiber release" filter standard as defined in 21 FR210.3 (b) (6)
Bacterial endotoxin: The endotoxin content of the filter solution was determined, and the content of endotoxin in the filter solution was lower than 0.25EU/ml
Biosafety testing: All materials of the filter cartridge meet the biosafety assessment of USP < 88 >, ClassVI-70°C grade plastic materials
Bacterial retention: The test method of ASTMF838 and defective Pseudomonas (ATCC19146) were used for bacterial retention of this product. The results showed that the minimum retention rate was 10⁷cfu/cm²
Regulatory compliance: Product production and quality management in accordance with ISO:9001 (2015)
Shelf life: 3 years
Storage and transportation: This product should be stored in an environment of 0 to 30°C, avoiding freezing and high temperature (>40°C) conditions. The internal bag should be kept intact to prevent external particles or moisture from entering
Insoluble particles: Unless otherwise specified, the number of particles containing 10μm and more than 10μm in each 1ml filter rinse solution shall not exceed 25 particles, and the number of particles containing 25μm and more than 25μm shall not exceed 3 particles