Water for Injection & cell-culture water - one standard, three grades
Water is the one input shared by every buffer, every medium and the final formulation - so its quality sets the ceiling for everything built on it. PAN supplies water across the full range: research-grade sterile water for the bench, GMP WFI-quality water, and WFI Beyond - Water for Injection engineered beyond the Ph. Eur./USP monograph and backed by a filed FDA Type IV (excipient) Drug Master File.
In brief. Qualify one water and scale it. The research grade (P-series) and the GMP grades (CT-series) share a matched continuum, so a programme can develop in research grade and move to the identical qualified GMP water without re-qualifying it. WFI Beyond is opt-in - ordered exactly where a molecule earns it - and is for further manufacturing / excipient use, not for direct human use.
Qualify once, scale without re-qualifying
The same water runs on a matched continuum from the bench to commercial fill. Upgrade the quality ceiling with WFI Beyond wherever a sensitive molecule earns it.
The three grades at a glance
One decision table. All three are animal- and antibiotic-free, sterile-filtered and made in Germany.
| Sterile Water for Cell Culture | WFI Quality Water | WFI Beyond | |
|---|---|---|---|
| Grade | Research (RUO) | GMP · WFI (EP/USP) | GMP · beyond-compendial |
| Endotoxin | research grade | ≤ 0.25 EU/mL (monograph) | < 0.005 EU/mL · >50× below |
| Total organic carbon | research grade | ≤ 0.5 mg/L | ≤ 0.05 mg/L · 10× below |
| Conductivity (20 °C) | research grade | ≤ 1.1 µS/cm | ≤ 0.2 µS/cm · >5× below |
| Nuclease (RNase/DNase) | – | on request | not detected |
| Elemental impurities (ICH Q3D) | – | on request | all 24 by ICP-MS on every CoA |
| Sterility | sterile | sterile | sterile · SAL 10⁻⁶ |
| Regulatory | research use | CoA per lot | Type IV DMF (MF044505) · CoA per lot |
| Typical use | bench & research; DMSO-free options | GMP media, buffer & formulation prep | the quality-critical inputs of a sensitive biologic |
| Article family | P04-99… | CT-99… | CT-98… |
Fold-differences are WFI Beyond specification vs. the Ph. Eur./USP Water-for-Injection limit; typical measured results are lower still (see the proof table below). WFI Quality Water can be prepared with WFI Beyond on request.
Sterile Water for Cell Culture
Choose it for research and early development at the bench - with a direct, no-reformulation path to the identical product in GMP.
View productWFI Quality Water
Choose it for GMP media, buffer and formulation preparation to WFI specifications (EP/USP) - with a CoA on every lot.
View productWFI Beyond
Choose it where a molecule earns it: ultra-low endotoxin, nuclease-free, ICH Q3D-characterised and DMF-backed.
View WFI BeyondThe WFI Beyond standard, in three columns
The pharmacopoeia floor, the WFI Beyond specification, and a typical measured result from a production-lot Certificate of Analysis (Art. CT-981000, 1000 mL) - so the gap is visible, not asserted.
| Attribute | Ph. Eur. 0169 limit | WFI Beyond spec | Typical result |
|---|---|---|---|
| Conductivity (20 °C) | ≤ 1.1 µS/cm | ≤ 0.2 µS/cm | 0.128 µS/cm |
| Total organic carbon | ≤ 0.5 mg/L | ≤ 0.05 mg/L | 0.011 mg/L |
| Endotoxin | ≤ 0.25 EU/mL | < 0.005 EU/mL | < 0.005 EU/mL |
| Elemental impurities | not in monograph | < ICH Q3D limit | 24 elements by ICP-MS; 22 < LOQ |
| Nuclease activity | not in monograph | none detected | RNase & DNase not detected |
| Sterility | – | sterile · single-use | no growth |
| Animal origin | – | animal-component-free | TSE/BSE safety (signed declaration) |
| Regulatory | – | Type IV DMF | MF044505 (FDA excipient) |
LOQ = limit of quantification - the level below which a value cannot be reliably measured, i.e. effectively not detectable. Against the pharmacopoeia the specification sits >5× below on conductivity, 10× below on TOC and >50× below on endotoxin; typical measured results are lower still.
Everything a qualification needs
Specification, a representative Certificate of Analysis, the BSE/TSE & ICH Q3 declaration, and a DMF Letter of Authorization on request.
DMF backing applies to WFI Beyond (MF044505) and DPBS (MF044371). Manufactured to GMP in an EU Annex 1 facility (a capability, not a certification); ISO 9001-certified QC laboratory.
In-Depth · Industry Edition 01 · Water
The full water story - why "meets WFI" is a floor, not a ceiling; the beyond-compendial proof with a representative Certificate of Analysis; and what it means for monoclonal antibodies, mRNA & LNP, cell & gene therapy and vaccines - written by function for developers, production, procurement, QA, regulatory, decision-makers and CDMOs.
What matters most changes; the water standard answers all of them
Formats and article numbers
Bottles and single-use, gamma-irradiated bags. Larger formats, custom fills (from 1 mL tubes) and connector configurations on request. In-stock catalogue items dispatched in 24 h; larger and custom formats are made to order.
Sterile Water for Cell Culture - research (RUO)P04-99 series
- 500 ml bottleP04-991500
- 1000 ml bottleP04-991000
- 20 L bagP04-99200B
WFI Quality Water - GMP (EP/USP)CT-99 series
WFI Beyond - GMP, beyond-compendialCT-98 series
Water, answered
What is the difference between WFI-quality water and WFI Beyond?
Both are Water for Injection quality, made by a membrane-based process (reverse osmosis, ultrafiltration, electrodeionization and a final sterile filtration), not distillation. WFI Quality Water meets the Ph. Eur./USP monograph. WFI Beyond is engineered beyond it - endotoxin >50× below the limit, TOC 10× below, conductivity >5× below, nuclease-free, all 24 ICH Q3D elemental impurities quantified on every CoA, and backed by a filed FDA Type IV (excipient) DMF (MF044505).
Is WFI Beyond a compendial Water for Injection?
WFI Beyond meets the Ph. Eur./USP Water-for-Injection requirements and is controlled beyond them on the attributes that matter to sensitive biologics. It is supplied for further manufacturing / as an excipient - for compounding media, buffers and as a diluent - and is not Sterile Water for Injection for direct reconstitution or direct human use.
Do you provide a Certificate of Analysis, and what does it cover?
Yes - a CoA on every lot. For WFI Beyond it reports appearance, conductivity, TOC, endotoxin, RNase/DNase activity, sterility and all 24 ICH Q3D elemental impurities by ICP-MS, sampled at the beginning and end of fill. A representative CoA is available on request, with a downloadable example coming shortly.
Is the water animal-free, and is TSE/BSE covered?
Yes. The water is manufactured animal-component-free. A signed BSE/TSE & ICH Q3 declaration confirms non-animal origin (out of scope of EMA/410/01 Rev. 3) and documents a risk assessment for residual solvents, nitrosamines and elemental impurities across every product-contact material.
Can I reference the Drug Master File in my submission?
Yes. WFI Beyond is backed by a filed FDA Type IV (excipient) DMF (MF044505); DPBS carries a companion Type IV DMF (MF044371). You cross-reference them through a Letter of Authorization, so the material is referenceable as exactly what it is in the drug product without rebuilding a dossier.
Which formats and article numbers are available?
Bottles (500 & 1000 ml) and single-use, gamma-irradiated bags from 1 to 1000 L, plus custom fills from 1 mL tubes on request. WFI Beyond spans CT-981500 to CT-981000B; WFI Quality Water CT-991500 to CT-99500B; Sterile Water for Cell Culture P04-991500 to P04-99200B. The full list is in the portfolio section above.
Can I develop in research grade and move to GMP later?
Yes - that is the point of the continuum. The research grade (P-series) and the GMP grades (CT-series) are matched, so you qualify once and scale to the identical GMP water with no reformulation, from bench to commercial fill.