Water
One partner, from research to beyond compendial
Three matched water grades for life-science and bioprocessing — research, GMP, and beyond compendial.
PAN-Biotech supplies Water for Injection and cell-culture water in three matched grades — research, GMP (EP/USP) and beyond-compendial. Water is the most underestimated raw material in life science — the base of nearly every buffer, medium and formulation, so its quality cascades through the whole process. PAN-Biotech offers three matched grades, so the right water supports every step from research to GMP to the most demanding biologics.
Choose your grade
Select the water grade that matches your current process, quality requirements and regulatory environment.
Sterile Water for Cell Culture
WFI Quality Water
WFI Beyond
One matched water portfolio — from routine research to advanced GMP manufacturing.
Compare the grades
| Property | Sterile Water for Cell Culture | WFI Quality Water | WFI Beyond |
|---|---|---|---|
| Standard | Ultrapure, sterile | EP/USP WFI quality | Beyond compendial + FDA DMF |
| GMP | Non-GMP (research) | GMP | GMP (Annex 1) + DMF-backed |
| Sterile filtration | 0.2 µm | EP/USP grade | 0.1 µm + gamma SAL 10⁻⁶ |
| Key extras | Low endotoxin | RNase-/DNase-free variant available | Nuclease-free, nitrosamine-free, 24-element profile |
| Formats | 500 ml, 1 L, 20 L | Bottles and bags | Bottles and single-use bags up to 1000 L |
Why water quality matters
In any biologics process, water is everywhere and noticed nowhere — the base of almost every buffer and medium, and the vehicle for the final formulation. Because it flows into nearly every step, a deficiency in the water is distributed across the whole process. “Meets WFI” tells you a water cleared the compendial floor; it does not tell you whether it was made for your molecule — which is why PAN-Biotech offers a matched grade for every stage.
Key terms
| Term | Meaning |
|---|---|
| WFI | Water for Injection — the pharmacopoeial grade of water permitted in injectable medicines (Ph. Eur. monograph 0169). |
| Endotoxin | Pyrogenic fragments of bacterial cell walls; the Ph. Eur. WFI limit is < 0.25 EU/mL. |
| TOC | Total organic carbon — a measure of organic purity; the WFI monograph limit is 0.5 mg/L. |
| Nuclease-free | No detectable RNase or DNase activity — protects RNA, DNA and mRNA payloads. |
| ICH Q3D | The international guideline that sets safe limits for 24 elemental impurities in medicines. |
| SAL 10⁻⁶ | Sterility Assurance Level of one-in-a-million — the pharmaceutical standard for terminal sterilisation. |
| DMF | Drug Master File — confidential data filed with the FDA that a customer references in its own submission via a letter of authorization. |
| GMP (EU Annex 1) | Good Manufacturing Practice for the manufacture of sterile medicinal products in the European Union. |
Frequently asked questions
Which PAN-Biotech water grade do I need?
For research and routine, non-GMP laboratory work, choose Sterile Water for Cell Culture . For GMP-regulated upstream and downstream processing at EP/USP quality, choose WFI Quality Water . For demanding advanced biologics, where performance beyond the monograph and a filed FDA DMF are required, choose WFI Beyond .
What is the difference between WFI Quality Water and WFI Beyond?
WFI Quality Water meets the Ph. Eur./USP Water-for-Injection requirements. WFI Beyond is controlled to exceed those requirements for endotoxin, total organic carbon, conductivity, nuclease activity and elemental impurities, and is backed by FDA Drug Master File MF044505.
Do you offer GMP water?
Yes. WFI Quality Water is manufactured under GMP to EP/USP requirements. WFI Beyond is manufactured under EU GMP Annex 1 by PAN-Celltech and is backed by an FDA Drug Master File.
What is Sterile Water for Cell Culture?
Sterile Water for Cell Culture is an ultrapure, sterile-filtered 0.2 µm research-grade water for media, buffers, reagents and analytical workflows where consistent quality and low endotoxin are needed, but pharmacopoeial WFI is not required.
Products: Sterile Water for Cell Culture · WFI Quality Water · WFI Beyond