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, Animal-derived component-free, meets the most stringent United States Pharmacopoeia (USP) and/or European Pharmacopoeia (Ph. Eur.) compendial grade specifications. Manufactured in a ISO 13485:2016 and GMP-certified facility, located in Boecillo, Valladolid (Spain), following GMP compliant procedures to ensure the highest quality standards. It provides you the confidence to achieve exceptional results, with unparalleled purity and reliability with a secure supply chain.
For a Custom Packaging or OEM solutions, please Contact us.
Price: 25.60 € – 1,396.00 €
Detailed information:
Advantages & Features
- Reliability beyond Measure: manufactured in our ISO 13485:2016 and GMP-certified facility, meeting the USP/EP specifications.
- Versatility Empowered: caters to a wide range of applications inside Pharmaceutical Manufacturing and Research.
- Unmatched Purity: due additional steps to eliminate impurities, offering low levels of endotoxins, conductivity, and microbial contaminants.
- Quality Guaranteed: including CoA for each lot of products manufactured.
- Supply Chain Guaranteed: due our strategic location, and deep expertise managing regulatory agencies and shipping globally.
- Increase process Efficiency and Reduce Costs: improve efficiency and reduce QC testing with larger batch volumes, reduce cycle times with just-in-time solutions and capacity constraints.
- Highly experienced Regulatory and Technical expertise: that eliminate raw material risks and batch-to-batch inconsistencies.
Specifications
| Test | Specification /Units | Method references |
| Appearance | clear and colourless liquid | Ph. Eur. 2.2.1; 2.2.2 and 2.9.20. |
| Nitrates | maximum 0.2 ppm | According to Ph. Eur |
| Aluminium | maximum 10 ppb | Ph. Eur. 2.4.17 |
| Heavy metals | maximum 0.1 ppm | Ph. Eur. 2.4.8 |
| pH | 5.0 – 7.0 | Ph Eur 2.2.3 |
| Conductivity | maximum 5 µS·cm | Ph. Eur. 2.2.38. |
| Bacterial endotoxins | maximum 0.25 EU/mL | Ph. Eur. 2.6.14 |
| Oxidisable substances | Not Detected | According to Ph. Eur |
| Total Organic Carbon | maximum 0.5 mg/l | Ph. Eur. 2.2.44 |
| Ammonium | maximum 0.2 ppm | According to Ph. Eur |
| Chlorides | maximum 0.5 ppm | Ph. Eur. 2.4.4 |
| Bioburden | maximum 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 Single-use 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
DatasheetMSDSApplications
WFI Quality Water, is a versatile solution designed for a wide range of Further Manufacturing and Research applications:
- Buffer Preparation: Achieve reliable results in rinse, purification, and chromatography processes. It provides the essential foundation for preparing buffers, ensuring accurate and efficient sample separation and purification.
- Cell Culture Hydration: Experience optimal cell culture performance by using for the hydration of cell culture media, supplements, and salt solutions. It provides the necessary purity to support healthy cell growth and accurate experimental results.
- Synthesis Reconstitution and Rehydration: perfect choice for reconstituting and rehydrating products during synthesis. Its exceptional purity and reliability make it an ideal solvent, allowing for precise and consistent results.
- Thorough Rinsing: Ensure the utmost cleanliness and sterility of primary packaging,production vessels, equipment, and room surfaces. Its high-quality guarantees effective rinsing and helps maintain the integrity of your processes.
Tables & Figures
Quality Control
WFI Quality Water is manufactured in an ISO 13485:2016 and GMP-certified facility, located in Boecillo, Valladolid (Spain), following GMP compliant 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.
WFI Water is manufactured and tested in accordance with Ph. Eur. 5.2.12 for “Raw materials of biological origin for the production of cell-based and gene therapy medicinal products” and USP <1043> on ancillary materials.
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 critical 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
You may also like…
-
PBS (pH 7.4) – 5 L
Price: 174.60 € BR0344Add to basket -
UltraPure Water, DNASE/RNASE – Free
Price: 26.64 € – 41.07 € E0322Select options This product has multiple variants. The options may be chosen on the product page -
PBS (pH 7.4) – 20 L
Price: 698.40 € BR0347Add to basket -
PBS (pH 7.4) – 100 L
Price: 2,095.20 € BR0350Add to basket
