Polypropylene (PP) material, compatible with leading industry single-use bags.
Resins ensure heat sealing with polyethylene bag.
· Manufactured in ISO Class 7 clean room
· ISO 9001:2015 Quality Management System
· 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 LAL, USP <85>
· Particulate matter in the product eluent meets the requirements in USP <788> for large volume parenteral