Choosing the Right Sterile Water for Pharmaceutical, Biopharmaceutical, and Medical Device Manufacturing
Different grades of water quality are required for manufacturing therapeutics and medical devices.
Water is the most widely used substance, raw material, or starting material in the formulation, processing, and production of these products. It has unique chemical properties due to its polarity and hydrogen bonds, enabling it to dissolve, absorb, adsorb, or suspend many different compounds.
These compounds may include contaminants that represent hazards themselves or that may react with substances in the intended products to create a health hazard. Choosing the correct grade of water is also important for complying with GMP, ISO, and USP requirements.
Chemical purity, endotoxin content, and particulate content are important considerations when choosing the correct water. Basic guidance on appropriate applications for water can be found in USP <1231>. These attributes should be considered the “minimum” requirements, and more stringent controls may be needed to ensure suitability for specific applications and products.
Because microbiological content control is a significant aspect of water quality, sterile water is considered the highest grade and requires the most validation and process controls. Sterile water is packaged and sterilized to help preserve microbial quality throughout its shelf life.
Intermountain Life Sciences offers a full portfolio of USP Sterile Water in quantities from 500 mL to 200 L. These products are manufactured under cGMP and ISO 13485 guidelines in an FDA-registered facility. They’re suitable for upstream and downstream media and buffer preparation in your biopharmaceutical manufacturing applications.
Sterile Water for Injection, EP/USP Grade
- Complies with the USP and EP monographs for water for injection
- Terminally distilled, sterile, and non-pyrogenic
- Contains no bacteriostat, antimicrobial agent, or added buffer
Sterile Water for Injection, USP Grade
- Terminally distilled, sterile, and non-pyrogenic
- Contains no bacteriostat, antimicrobial agent, or added buffer
Sterile Water for Irrigation, USP Grade
- Prepared by terminal distillation
- Contains no antimicrobial or bacteriostatic agents or added buffers
- Sterile, hypotonic, and non-pyrogenic
Sterile Purified Water, USP Grade
- For use as an excipient in the production non-parenteral preparations, cleaning equipment, and non-parenteral product contact components
| Description | Grade | Cat. No. | Quantity | Packaging |
|---|---|---|---|---|
Water for Injection, Sterile | USP/EP | Z0104 WFI-EPZ-20L WFI-EPZ-2XL | 4x4 L 20 L 200 L | Biotainer Bioprocess Bag Bioprocess Bag |
Water for Injection, Sterile | USP | WFI-USP-5XM WFI-USP-1X6 WFI-USP-10L WFI-USP-20L WFI-USP-1XL WFI-USP-2XL | 6 x 500 mL 6 x 1 L 10 L 20 L 100 L 200 L | PET Bottles PET Bottles Bioprocess Bag Bioprocess Bag Bioprocess Bag Bioprocess Bag |
Water for Irrigation, Sterile | USP | WIR-USP-5XM WIR-USP-1X6 Z0304 WFI-USP-20L WFI-USP-2XL | 6 x 500 mL 6 x 1 L 4x4 L 20 L 200 L | PET Bottles PET Bottles Biotainer Bioprocess Bag Bioprocess Bag |
Purified Water, Sterile | USP | WPW-USP-1X6 WFI-EPZ-20 WFI-EPZ-20XL | 6x1 L 20 L 200 L | PET Bottles Bioprocess Bag Bioprocess Bag |
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