Lifecube 2D/3D Single-use Bags

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

Typical Applications

• Buffer and media storage and transfer after filtration
• Intermediates storage
• Stock solution storage
• Formulation filling
• Lifecube 2D/3D Single-use Bags
• 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