Lifecube SA Single-use Assemblies

Quality Assurance

• Lifecube SA Single-use Assemblies
• 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 of sterile packaging according to ISO® 11137

Typical Applications

• Connect single-use system to stainless steel system
• System connections with different connectors
• Easy to connect with different brands bags

Order Information