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.
Do you need different packaging, size, label or a regular supply? Please Contact us.
Price: 13.55 € – 942.09 €
Detailed information:
Advantages & Features
- Reliable: manufactured in an ISO 13485:2016 and GMP-certified facility to guarantee lot-to-lot consistency.
- Versatility Empowered: caters to a wide range of applications inside Manufacturing and Research.
- High Purity: due additional steps to eliminate impurities, offering low levels of endotoxins, and microbial contaminants.
- Quality Guaranteed: CoA for each lot of products manufactured supplied upon request.
- 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 eliminates 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. |
| pH | 5.0 – 7.0 | Ph Eur 2.2.3 |
| Conductivity | < 5 µS·cm | 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 MSDSApplications
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.
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
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