Description
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
