WFI Quality Water

Accelerate your Biologics Manufacturing with a high-quality solution that meets stringent USP and Ph. Eur. standards

Water for Injection (WFI) Quality Water is an animal-derived component–free grade that meets the strictest United States Pharmacopoeia (USP) and European Pharmacopoeia (Ph. Eur.) specifications.

Manufactured in an ISO 13485:2016 and GMP-certified facility, located in Boecillo, Valladolid (Spain), under ISO9001:2016, it ensures exceptional purity, consistency, and reliability across biopharmaceutical and molecular biology applications. Its controlled production and secure supply chain guarantee reproducible performance and full compliance with international quality standards, providing confidence in every process.

Do you need different packaging, size, label or a regular supply?  Please Contact us

Price: 14.00 966.70 

SKU: E0335 Categories: ,

Detailed information:

Advantages & Features

  • Reliable: manufactured in an ISO 13485:2016 and GMP-certified facility, under ISO9001:2016 ensuring consistent quality in every batch.
  • Versatile: Designed to support a wide range of applications in manufacturing and research.
  • Superior Purity: Advanced processes remove impurities, minimizing endotoxins and microbial contaminants.
  • Quality Guaranteed: Certificate of Analysis available for every batch, reinforcing product excellence.
  • Optimized supply chain: Strategic location and global regulatory expertise ensure seamless delivery worldwide.
  • Enhanced efficiency & cost savings: Streamline processes, reduce QC testing costs with larger batch volumes, and minimize cycle times with just-in-time solutions.
  • Regulatory & technical expertise: Our deep industry knowledge eliminates raw material risks and ensures batch-to-batch consistency.

Specifications

Test  Specification /Units Method references
Appearance clear and colourless liquid Ph. Eur. 2.2.1; 2.2.2 and 2.9.20
pH 5.0 – 7.0 Ph. Eur. 2.2.3
Conductivity ≤ 4.7 µS/cm, stage 3, at 25 °C Ph. Eur. 2.2.38
Bacterial endotoxins < 0.25 EU/mL Ph. Eur. 2.6.14
Bioburden < 0.1 CFU/mL Ph. Eur. 2.6.12

Includes

Includes for 1L:

-1,000 mL of WFI Quality Water served in PET Bottle.

 

Includes for 20L:

-20L of WFI Quality Water served in a graduated square container.

 

Includes for 200L:

-200L of WFI Quality Water served in Single-use container with Plastic Drum.

 

To know more about our Packaging or request a different one, please Contact us.

Download documentation

Datasheet
MSDS

Applications

WFI Quality Water, is a versatile solution designed for a wide range of Further Manufacturing and Research applications:

  • Buffer Preparation.
  • Cell Culture, supplements, and salt solutions Hydration.
  • Reconstitution and rehydration of product during synthesis.
  • Rinsing of primary packaging, production vessels, equipment, and room surfaces.

Tables & Figures

Quality Control

Manufactured in an ISO 13485:2016 and GMP-certified facility, located in Boecillo, Valladolid (Spain), under ISO9001:2016 procedures to ensure the highest quality standards. Our processes include:

    • Batch-to-batch consistency.
    • Facilities audited regularly Quality audits.
    • Lot specific CoAs and QA review previously to release a product.
    • Material traceability, documented procedures and documented employee training.
    • Equipment maintenance and monitoring records.

Request a Certificate of Analysis (CoA)

Advice

At Canvax, we are at the forefront of reagents manufacturing for RUO, IVD or Clinical Grade, driven by a passion for Excellence. With 20+ years of industry expertise and a commitment to innovation, we deliver superior Buffers & Liquid Solutions up to GMP Grade, for your manufacturing applications.

Storage, Shipping & Guarantee

  • Shipment at Ambient Temperature.
  • Storage: Room Temperature.
  • Shelf life: 24 months from data of manufacturing, based on our Accelerated Stability Testing Program, with both Normal and Accelerated Stability Testing Programs ongoing.

Citations

Safety Statements

This product is developed, designed and sold exclusively for Research purposes and in vitro use only (RUO) and Further Manufacturing. The product was not tested for use in diagnostics, drug development, terapeutic use, nor is it suitable for administration to humans or animals. For more info, please check its Material Safety Data Sheet available in this website or Contact us.

Customers Review

FAQs

1. What is WFI Quality Water and what is it used for?
WFI Quality Water is a highly purified, endotoxin-free water that meets USP and Ph. Eur. standards. It is designed for demanding laboratory applications such as reagent preparation, buffer dilution, and cell culture media formulation.

2. How should WFI Quality Water be stored and handled?
Store tightly closed at room temperature (15–25 °C), protected from light and contamination. Once opened, it should be used promptly or under aseptic conditions to preserve purity.

3. Is WFI Quality Water free from animal-derived components?
Yes. It is 100 % animal-component-free, ensuring safety, consistency, and compatibility with sensitive biological and molecular biology workflows.

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