XyPure Flex offers pharmaceutical-grade Sterile Water for Injection (WFI) in convenient, disposable 2D flexible bags designed for aseptic fluid storage and transfer. Manufactured under strict cGMP conditions with sterile filtration and gamma irradiation, these single-use bags ensure endotoxin-controlled, ultrapure water compliant with USP, EP, and JP pharmacopeia standards.
Key features include:
Sterile & Ready-to-Use: Pre-sterilized via gamma irradiation with 0.2 µm filtration to guarantee sterility and ultra-low endotoxin levels.
Flexible Packaging: Available in multiple volumes (1L to 20L), providing scalable solutions for laboratory and biopharmaceutical applications.
High-Quality Biopharma Membranes: Constructed from multilayer biocompatible membranes ensuring chemical resistance, low extractables, and contamination-free fluid handling.
Single-Use Design: Eliminates cleaning and sterilization steps, reducing risk of cross-contamination and improving process efficiency.
Aseptic Fluid Transfer: Designed with integrated connections for easy sterile integration into fluid handling systems and bioprocess workflows.
Regulatory Compliance: Meets or exceeds USP <71>, EP 2.6.1, and JP <4.06> standards, supporting injectable drug formulation, analytical testing, and bioprocess buffer preparation.
XyPure Flex delivers reliable, ultrapure sterile water in a convenient, flexible format ideal for pharmaceutical manufacturing, clinical laboratories, and research facilities demanding stringent aseptic conditions.
