Quality Assurance
· ISO® 9001:2015 quality management system
· ISO Class 7 clean zones
· 100% leak testing
· 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
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 choices for sampling application
Typlcal Application
· Sampling with single-use bags
· Secondary sampling from sampling bag
· Store samples after sampling