Single-use system compliance

• Factory quality management system certification: ISO9001, ISO13485

• Quality system compliance: cGMP/GMP,

• Production environment: ISO Class 7 (Class 10000 / Class C) purification plant production, high clean bags are produced in isolators

• 100% of the products are inspected by lights

• Closed pocket 100% use precision instruments for integrity testing

The standard that the product meets

• -- USP <87>: Biological adverse reaction test, cytotoxicity test

• -- USP <88>(Class VI): Biological adverse reaction test, in vivo test

• -- USP <661>*: Testing of physicochemical properties and migrants of plastic packaging systems and their constituent materials

• -- USP <788>: insoluble particle detection

• -- USP<85> : endotoxin test

• -- E&L Test: 50% ethanol, water, 1N NaOH, 1N HCl, 5M NaCl, 1% Tween-80

• -- ISO 11737, Microbial limit testing

• ISO 11137, Verification of Irradiation sterilization of medical products

• - ADCF statement