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
Sterile Water for Cell Culture
WFI Quality Water
WFI Beyond
Compare the grades
| 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 | Nuclease-free, nitrosamine-assessed, 24-element profile |
| Formats | 500 ml, 1 L, 20 L | bottles & bags | bottles + single-use bags 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 (metal) 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 their own submission via a letter of authorization. |
| GMP (EU Annex 1) | Good Manufacturing Practice for the manufacture of sterile medicinal products in the EU. |
Frequently asked questions
Choosing a grade
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 the most demanding advanced biologics, where you need performance beyond the monograph and a filed FDA DMF, 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 monograph. WFI Beyond is controlled to exceed that monograph on endotoxin, total organic carbon, conductivity, nuclease activity and elemental impurities, and is backed by a filed FDA Drug Master File (MF044505).
Do you offer GMP water?
Yes. WFI Quality Water is manufactured under GMP to EP/USP, and WFI Beyond is manufactured under EU GMP Annex 1 by PAN-Celltech and backed by an FDA DMF.
What is Sterile Water for Cell Culture?
An ultrapure, sterile-filtered (0.2 µm) research-grade water for media, buffers, reagents and analytical work — where low endotoxin and consistent quality are needed but full pharmacopoeial WFI is not required.
Quality, documentation and audits
Is a Certificate of Analysis provided for every batch?
A batch-specific Certificate of Analysis is provided for every batch.
Are the testing methods traceable through the Certificate of Analysis?
Yes, the Certificate of Analysis includes all release-relevant test methods with reference to the corresponding monograph (where applicable), the specification, and the result.
Are complete batch traceability and documentation available?
Yes, batch-specific documentation of production and quality control exists for every batch manufactured. This can be reviewed upon request.
Which certifications and audits are available?
The quality system is ISO 9001 certified and operates according to the GMP guideline. Audits with focus on GMP are regularly conducted by customers.
Can customers audit the manufacturing site?
Yes, an audit is possible by appointment.
Manufacturing and sterility
Is the WFI/Sterile Water produced in batches or continuously?
The product is filled and released batch-wise: each batch is tested and released before shipment (maximum batch size 1,000 L).
Is filter integrity tested before and after filling?
Yes, filter integrity is tested before and after filling.
Is additional sterile filtration required at the customer's facility?
No. The product is supplied sterile (sterile-filtered — WFI at 0.1 µm, Sterile Water for Cell Culture at 0.2 µm — aseptically filled and sterility-tested per batch), so no additional sterile filtration is required at the customer's facility.
Storage and handling
Does it require protection from light?
No specific light protection is required; the product is stored at +15 °C to +25 °C as stated on the label.
How long can an opened or connected container be used?
If handled under sterile conditions and within storage temperatures the product can be used until the expiration date.
Can the product be frozen?
Freezing of the product should be avoided.
Which measures should be taken to prevent recontamination?
Work under aseptic conditions following good laboratory/manufacturing practice: keep the container closed, withdraw material aseptically (e.g. via a sampling port on single-use bags), avoid repeated opening, and do not return withdrawn material to the container.
Formats, ordering and supply
Which container sizes are available?
500 ml bottle, 1000 ml bottle, and 1 L, 5 L, 10 L, 20 L, 50 L, 200 L, 500 L and 1000 L bags.
What are the typical lead times and minimum order quantities?
Bottles are off-the-shelf products and are available without lead time. Bag formats are manufactured upon order.
Are framework agreements or reserved production capacities available?
Yes, can be arranged upon individual agreement.
To which countries can the WFI be supplied?
Worldwide — PAN-Biotech ships worldwide.
Products: Sterile Water for Cell Culture · WFI Quality Water · WFI Beyond