XyPure Tote provides pharmaceutical-grade Sterile Water for Injection (WFI) packaged in robust, gamma-sterilized, single-use 3D bags housed within durable LLDPE totes. Designed for large-volume biopharmaceutical manufacturing and critical aseptic processes, these totes ensure ultra-pure, endotoxin-controlled water that meets USP, EP, and JP pharmacopeia standards.
Each tote features:
Sterility & Purity: Manufactured under strict cGMP guidelines with multi-stage purification and 0.2 µm sterile filtration, guaranteeing endotoxin levels below 0.25 I.U./mL and total organic carbon (TOC) below 0.5 mg/L.
High Capacity Options: Available in 50L, 100L, and 200L volumes to support scalable production needs.
Single-Use Convenience: Gamma-irradiated disposable bags reduce cross-contamination risks and eliminate cleaning requirements, enabling faster batch turnovers.
Durable Packaging: Industrial-grade LLDPE totes provide mechanical protection and facilitate safe handling and integration into bioprocess workflows.
Regulatory Compliance: Conforms to global standards (USP <71>, EP 2.6.1, JP <4.06>) ensuring suitability for injectable drug formulation, bioreactor rinsing, and other sterile pharmaceutical applications.
Ease of Use: Designed for seamless connection to fluid transfer systems, supporting efficient sterile water delivery in cleanroom environments.
Ideal for pharmaceutical and biotech production, cell therapy, parenteral drug formulation, and analytical laboratories, XyPure Tote delivers consistent, ready-to-use sterile water essential for maintaining product quality and process integrity.
