Water for Injection (WFI) Quality Water
according to WFI specifications (EP, USP)
Water for Injection (WFI) Quality Water, according to WFI specifications (EP, USP) – Water for Injection quality water for media, buffer and formulation preparation, filled from 10 ml tubes to 1000 L bags in an animal- and antibiotic-free facility. A beyond-compendial version, WFI Beyond, is available on request.
One GMP quality. Water for Injection (WFI) Quality Water, according to WFI specifications (EP, USP) is a GMP-grade catalogue product (CT-991500), manufactured or assured by PAN-Celltech and released against a defined quality-control panel on every lot.
Why
WFI quality
For media, buffer and formulation preparation.
Wide fill range
10 ml tubes to 1000 L bags.
Beyond compendial option
WFI Beyond on request.
Specification
| Property | Detail |
|---|---|
| Composition | Water for Injection quality water |
| Form | Liquid |
| Facility | Animal- and antibiotic-free |
| Grade | GMP |
| Storage | 15-25 °C (room temperature) |
Beyond compendial – on request. Like every PAN process liquid, Water for Injection (WFI) Quality Water, according to WFI specifications (EP, USP) can be prepared with WFI Beyond – Water for Injection engineered beyond the Ph. Eur./USP monograph – for the most demanding endotoxin and purity requirements. Available on request.
Formats and article numbers
WFI Quality Water meets the Ph. Eur./USP Water-for-Injection monograph, with a Certificate of Analysis on every lot. Bottles and single-use, gamma-irradiated bags; larger formats and custom fills (from 1 mL tubes) on request. In-stock catalogue items dispatched in 24 h; larger and custom formats are made to order.
WFI Quality Water - GMP (EP/USP)CT-99 series
Need it tighter? Step up to WFI Beyond
WFI Quality Water meets the monograph. WFI Beyond is engineered beyond it - endotoxin more than 50× below the limit, TOC 10× below, nuclease-free, all 24 ICH Q3D elemental impurities specified and measured on every lot, and backed by a filed FDA Type IV DMF (MF044505). Same water family (CT-series): qualify once and scale without re-qualifying.
Supplied for further manufacturing / as an excipient - for compounding media, buffers and as a diluent - not Sterile Water for Injection for direct human use. Manufactured to GMP in an EU Annex 1 facility (a capability, not a certification); ISO 9001-certified QC laboratory.
Where this product is used
Water for Injection (WFI) Quality Water, according to WFI specifications (EP, USP) is used in the following PAN application processes:
Frequently asked questions
What grade is Water for Injection (WFI) Quality Water, according to WFI specifications (EP, USP)?
It is offered at GMP grade (article CT-991500).
Is the product compendial WFI or “WFI-quality water”?
The product WFI Beyond meets all requirements for WFI in bulk according to the currently valid monograph 0169 of the European Pharmacopoeia and is therefore compendial. Since aluminum is not tested, it is not suitable for the manufacture of dialysis solutions. WFI Quality Water is released to EP/USP WFI specifications for research and further manufacturing, but is not the finished ‘Sterile Water for Injection’ dosage form.
Can PAN-Biotech enter into customer-specific quality agreements?
Yes, a customer-specific Quality Assurance Agreement (QAA) is possible and needs to be discussed individually.
Is the WFI produced by distillation or by a membrane-based process?
By a membrane-based process, not distillation: reverse osmosis, ultrafiltration, electrodeionization and a final sterile filtration. The water meets/exceeds Ph. Eur./USP requirements.
How does WFI differ from Purified Water (PW)?
The acceptance criteria for microbiological monitoring and conductivity are set significantly tighter for WFI/WFI Beyond. In addition, WFI/WFI Beyond is subject to a bacterial endotoxin limit (<0.25 EU/mL), which Purified Water is not.
Is a supplier qualification package available?
Yes, suppliers and service providers are qualified and audited in accordance with internal SOPs.
Which documents does PAN-Biotech provide to support supplier qualification?
Supplier Qualification Guide, ISO certificates, additional documents information upon request.
Which analytical methods and pharmacopoeial chapters are applied?
For WFI Quality Water: conductivity Ph. Eur. 2.2.38, TOC 2.2.44, bacterial endotoxins 2.6.14 (Method C), sterility 2.6.1 / USP-NF <71>. Elemental impurities are determined by ICP-MS per ICH Q3D (WFI Beyond). Testing is performed in PAN’s ISO 9001-certified QC laboratory. Nuclease freedom (WFI Beyond) is verified by fluorometry.
Can it be used directly as an excipient in a medicinal product?
Yes, the product is intended for further manufacturing, including of medicinal products, and can be used without further processing. It is not approved for direct use in humans.
Can the WFI be used in clinical and commercial manufacturing?
Yes, the product is intended for further manufacturing, including of medicinal products. It is not approved for direct use in humans.
Is it suitable for the final formulation of a parenteral drug product?
The product is intended for further manufacturing, including of parenteral medicinal products. For example, it can be used to prepare formulation buffers. It is not approved for direct use in humans (e.g., reconstitution of lyophilized medicinal products for injection).
Can customized bag, tubing, or connector configurations be provided?
Yes. Customized bag, tubing and connector configurations are available on agreement.
Which connectors and connection systems can be supplied?
Single-use 2D/3D bags can be supplied with customizable tubing lengths and connectors; specific connector types on request/agreement.