Quality Assurance

 · ISO? 9001:2015 quality management system
 · ISO Class 7 clean zones
 · 100% leak testing for Lifecube 2D single-use bags
 · Meet the FDA Indirect Food Additive requirements cited in 21 CFR 177–182
 · Meet the requirement of USP<87>In Vitro Biological Reactivity Test
 · Meet the criteria of the USP<88>Biological Reactivity Test for Class VI plastics
 · Aqueous extraction contains < 0.25 EU/mL as determined by Limulus Amebocyte Lysate (LAL), USP<85>
 · Particulate matter in the product eluent meets the requirements in USP<788>for large volume parenterals

Features

 · Polypropylene material. Can be sterilized by gamma irradiation at 25-45 kGy or autoclaved 30 minutes at 126 °C
 · Withstand vacuum pressure at room temperature to 5.5 bar
 · Cobetter self-producted with short delivery time