Water for Injection (WFI) Quality Water
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Water for Injection (WFI) Quality Water for Pharmaceutical and Bioprocess Manufacturing
ILC Dover supplies Water for Injection (WFI) quality water for pharmaceutical, biopharmaceutical, diagnostic, and medical device manufacturing, where purity, consistency, and documented quality matter as much as the water itself. Part of the ILC Dover High Purity Chemical Solutions range, it is USP Monograph compliant, produced in an ISO 13485:2016 and 21 CFR 820 certified facility in Lillington, North Carolina, and available in formats from 1L bottles for the laboratory to 200L drums for production.
Intended use
For manufacturing and laboratory use only. This product is not for direct injection, ingestion, or inhalation in humans or animals.
How ILC Dover WFI Quality Water Is Produced
The water is purified in several stages, with no added substances:
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1
Reverse osmosis and deionization
The water is first treated by reverse osmosis and deionization.
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2
Steam distillation
It is then purified by steam distillation.
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3
0.2 micron filtration
Finally, it passes through a 0.2 micron filter at the point of use.
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4
Validated filling
Filling takes place under validated conditions from a water system that meets current USP specifications.
Quality Testing and Compliance
- Quality standard USP Monograph compliant Water for Injection quality water
- Quality control testing Conductivity, total organic carbon (TOC), bacterial endotoxins, and bioburden
- On-site testing Analytical and microbiology testing for quality assurance
- Certification Manufactured in an ISO 13485:2016 and 21 CFR 820 certified facility
- Manufacturing Produced in a cGMP-compliant facility in the United States
Choose the Right Packaging Format
Four standard formats cover everything from bench work to production supply, so teams can match container size to how much water they actually use.
6 × 1 L
Six 1L bottles
For analytical testing, QC laboratories, and small-volume preparation.
4 × 4 L
Four 4L bottles
For buffer preparation, media formulation, and pilot-scale work.
10 L
A 10L bag
For process work, equipment cleaning, and larger bench-scale batches.
200 L
A 200L drum
For production-scale pharmaceutical and biopharmaceutical manufacturing.
Custom packaging configurations up to 1,000L are available on request for recurring or higher-volume supply. Request a quote to discuss your requirements.
Applications in Regulated Manufacturing
Purchasing teams, quality managers, and production specialists use ILC Dover WFI quality water wherever a process calls for high purity water with documented quality:
- Buffer preparation and buffer exchange
- Cell culture media formulation
- Cleaning of surfaces and process equipment
- Analytical testing and laboratory workflows
- Manufacturing of high purity aqueous reagents
- Further manufacturing of diagnostic, biopharmaceutical, and medical device products
Frequently Asked Questions
What is WFI quality water?
WFI quality water is high purity water that meets the USP monograph for Water for Injection. In pharmaceutical and biopharmaceutical manufacturing it is used for buffer and media preparation, equipment cleaning, analytical testing, and further manufacturing. ILC Dover WFI quality water is intended for these manufacturing and laboratory uses.
How is WFI quality water different from purified water?
Water for Injection is held to stricter requirements than purified water, including a limit on bacterial endotoxins that purified water does not carry. That is why WFI quality water is specified for processes where endotoxin control matters, such as preparing buffers and media for biopharmaceutical production.
How is ILC Dover WFI quality water produced?
It is treated by reverse osmosis and deionization, purified by steam distillation, then filtered through a 0.2 micron filter at the point of use, with no added substances. Filling takes place under validated conditions from a water system that meets current USP specifications.
What quality testing is performed?
Quality control testing covers conductivity, total organic carbon (TOC), bacterial endotoxins, and bioburden, supported by on-site analytical and microbiology testing.
Which packaging sizes are available?
Four standard formats: 6x1L bottles, 4x4L bottles, a 10L bag, and a 200L drum. Custom packaging configurations up to 1,000L are available on request.
Can this water be used for injection in humans or animals?
No. This product is not for direct injection, ingestion, or inhalation in humans or animals. "Water for Injection" describes the quality standard the water meets, not how it may be used.
Where is ILC Dover WFI quality water manufactured?
In Lillington, North Carolina, in an ISO 13485:2016 and 21 CFR 820 certified facility.
How do I order larger volumes or custom packaging?
All four standard formats can be ordered online from this page. For recurring supply, custom configurations up to 1,000L, or quantities beyond the standard formats, request a quote or call ILC Dover on 469-822-8981, Monday to Friday, 08:00-16:30 CST.
Whether you need a few liters of WFI quality water for routine laboratory use or dependable supply for production, ILC Dover High Purity Chemical Solutions combine documented quality with packaging that fits the way your team works.
Need recurring supply or custom packaging?
Talk to the team about recurring supply, custom configurations up to 1,000L, or quantities beyond the standard formats. Monday to Friday, 08:00-16:30 CST.