Quality Assurance

 · ISO® 9001:2015 quality management system
 · ISO Class 7 clean zones
 · 100% leak testing for Lifecube 2D single-use bags
 · ADCF raw materials
 · 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
 · Verify gamma irradiation dose according to ISO® 11137
 · Provide product Validation Guide and Certificate of Quality

Features

 · Good physical strength and excellent biological safety
 · Integrated bag body designed for Lifecube 2D single-use bags and less residual liquid
 · Double-layer sterile packaging sterilized by 25-45 kGy gamma irradiation
 · Local supply. Variable and flexible customized services
 · Various and scalable

Typlcal Application

 · Buffer and media storage and transfer after filtration
 · Intermediates storage
 · Stock solution storage