20% Ethanol With WFI In Single Use Bags

When your chromatography workflow depends on consistent resin regeneration and storage conditions, the quality of your ethanol-WFI solution is not a variable you want to manage in-house. This ready-to-use 20% ethanol with WFI is manufactured using USP-grade ethyl alcohol and USP-grade water for injection, filled in a cleanroom, and 0.2 μm filtered before being packaged into 20 L or 200 L single-use bags. Each lot is released against a comprehensive Certificate of Analysis that includes assay confirmation at 19.0–21.0% v/v, bacterial endotoxins at ≤0.25 EU/mL, and bioburden controls of ≤10 CFU/100 mL for both plate count and yeast and mold.

Production is GMP-compliant to IPEC and ISO 9001, with validated processes throughout. The bag assembly includes an AseptiQuik G connector with HFC disconnector for aseptic dispensing, an MPC coupling insert for flexible connections, and a needleless injection valve for direct sampling, reducing open-system exposure at every touchpoint.

With a 12-month shelf life and HDPE overpacking for transport integrity, this format suits pilot-scale development through GMP manufacturing suites. Download the brochure below to learn more.