Description
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
