Pharmaceutical & Biopharmaceutical

At HANS Scientific™, we specialize in delivering high-purity Water for Injection (WFI) solutions tailored to meet the rigorous demands of the pharmaceutical and biopharmaceutical industries. Understanding that sterility, purity, and uncompromising quality are non-negotiable in your processes, our systems are manufactured in an ISO 13485 compliant and cGMP-certified facility in conformance with a comprehensive quality system meeting the most stringent USP compendial grade specifications. In fact, the water treatment system utilized to produce WFI is the only water treatment system that has been tested and certified to the new ASSE/IAPMO IGC376-2023 standard.

Pharmaceutical & Biopharmaceutical Applications

Injectable Drugs & Parenteral Solutions – Used as a solvent or diluent in IV drugs, vaccines, and biologics.  
Biopharmaceutical Manufacturing – Used in cell culture, fermentation, purification, and formulation processes.  
Vaccines Production – Essential for formulation, reconstitution, and sterility assurance. 
Dialysis Solutions – Used in the preparation of hemodialysis fluids.  
Sterile Ophthalmic & Nasal Products – Found in eye drops, nasal sprays, and contact lens solutions.  
Infusion Therapy & Total Parenteral Nutrition (TPN) – Used in IV nutrition formulations.  
Inhalation & Nebulization Solutions – Used in respiratory therapies and aerosol medications.  
Blood Derivatives & Plasma Fractionation – Used in processing plasma-derived medicines like albumin and immunoglobulins.

WFI Quality Water Grades

HANS Scientific™ Water for Injection (WFI) is available for purchase online in three quality water grades.

Water for Injection, USP**
Water for Injection, USP – Sterile
Water for Injection, USP – Sterile/DNase/RNase Free

See table below for specifications.

Buy WFI Online

Water for Injection, USP**
Available in 20L Bag / 200L Drum

Water for Injection, USP – Sterile
Available in 20L Bag / 200L Drum

Water for Injection, USP – Sterile/DNase/RNase Free
Only Available in 20L Bag

Classification		WFI Quality Water Grades			Options
Test	Test Method	Water for Injection, USP**	Water for Injection, USP-Sterile	Water for Injection, USP- Sterile/DNase/RNase Free	Size
Conductivity @25 C (µs/cm)	USP <645>	≤ 1.3	≤ 1.3**	≤ 1.3**	20L / 200L Bag
TOC (mg/L)	USP <643>	≤ 0.5	≤ 0.5	≤ 0.5	20L / 200L Bag
Endotoxins (EU/mL)	USP <85>	< 0.25	< 0.25	< 0.25	20L / 200L Bag
Sterility	USP <71>	*	No Growth	No Growth	20L / 200L Bag
DNase/RNase Free	Fluorometric Assay	*	*	No Detected	20L

Meets USP monograph for Water for Injection at point of fill. Not intended for parenteral administration. WFI QUALITY WATER IS INTENDED FOR FURTHER MANUFACTURING OR RESEARCH USE. NOT FOR DIAGNOSTIC USE OR DIRECT ADMINISTRATION INTO HUMANS OR ANIMALS.

*Not Specified, Not Required, Not Applicable or No Limit
**Meets USP Monograph at Point of Fill

BioProcess Container (BPC) Features:

The WFI Quality Water is stored and shipped in BioProcess Containers (BPCs). BPCs are utilized to meet single-use upstream and downstream bioprocessing needs. The containers utilize films that are engineered to meet the most demanding requirements of bioproduction processes. The standard 200L container utilizes CX5-14 film and the 20L utilizes ASI 28 EVA film. These containers/films are developed specifically for liquid handling, storage, and transportation. Other types or brands of BPC can be utilized to meet specific requirements.

Meets or exceeds USP standards and monograph requirements
FDA-registered cGMP manufacturing facility
U.S. Pharmacopeia (USP<1231>) and ISO 13485:2016 compliant
The only water treatment system that has been tested and certified to the new IGC376 standard

At HANS Scientific, we take the time to understand your unique requirements and tailor our services to match your scope and scale. Reach out today to start the conversation—we’re ready to support your goals.

Pharmaceutical & Biopharmaceutical