HydroLinX® hydration products are bioprocessing water compliant with the ChP (2020 Edition) and USP requirements for water for injection, with quality inspection report provided. Buffer solutions and process liquids are prepared by two steps:
1. Mix bioprocessing water of water for injection quality with standard compliant chemicals (solid: solid-liquid mix, liquid: liquid-liquid mix) in a mixer to the desired concentration and pH.
2. Remove virus from the mixture by filtration. Bioprocessing water, buffer solutions, and other process liquids are filled in ISO 14644 Class 7 compliant clean workshops with Single-use irradiated storage bags and double packaging to ensure the sterile application in Single-use bioprocess. Different volumes from 100 mL to 1000 L are available, with products for RNase free, DNase-free, and RNase-free & DNase-free versions provided. Our inclined insert logistics box (match with products in 5 L–20 L 2D storage bags) and collapsible logistics box (match with products in 100 L–1000 L 3D storage bags) save space and we provide door-to-door recycling for collapsible logistics boxes to save customers' worries.
Consecutive tests and validations of water for injection at all points for 15 days Routine weekly testing
Routine weekly testing
Filling after sterilization and filtration
Testing and release of the first and last samples
Validity period validation
Customized connection methods to support customer needs
Free of animal-derived component
US DMF filing
Transport test
Comply with ChP 2020 requirements for water for injection
Product Name | Cat.No. | Volume (L) | Package | ||
HydroLinX® water for injection in bags | HB-WFI-0020-11 | 20 | 1 | ||
HB-WFI-0100-11 | 100 | 1 | |||
HB-WFI-0250-11 | 250 | 1 | |||
HB-WFI-0500-11 | 500 | 1 | |||
HB-WFI-1000-11 | 1000 | 1 | |||
HydroLinX® sterile water for injection in bags | HB-WFI-0020-1S | 20 | 1 | ||
HB-WFI-0100-1S | 100 | 1 | |||
HB-WFI-0250-1S | 250 | 1 | |||
HB-WFI-0500-1S | 500 | 1 | |||
HB-WFI-1000-1S | 1000 | 1 | |||
HydroLinX® sterile water for injection in bags (RNase-free) | HB-WFI-0020-SR | 20 | 1 | ||
HB-WFI-0100-SR | 100 | 1 | |||
HB-WFI-0250-SR | 250 | 1 | |||
HB-WFI-0500-SR | 500 | 1 | |||
HB-WFI-1000-SR | 1000 | 1 | |||
HydroLinX® sterile water for injection in bags (RNase-free & DNase-free) | HB-WFI-0020-SX | 20 | 1 | ||
HB-WFI-0100-SX | 100 | 1 | |||
HB-WFI-0250-SX | 250 | 1 | |||
HB-WFI-0500-SX | 500 | 1 | |||
HB-WFI-1000-SX | 1000 | 1 | |||
BioLink HydroLinX® water for injection has established cooperation with many pharmaceutical companies in China and is widely applicable in upstream and downstream bioprocessing, including:
• Cleaning of equipment containers, piping (disposable, stainless steel), filters, etc.
• Preparation of buffer solutions and other process liquids
• Preparation of cleaning agents such as sterile disinfectants
• Preparation of culture media and other liquids
• Bio-Link packaged water for injection has established cooperation with many pharmaceutical companies in China
• Filling after sterilization and filtration
• Filling bags, chemicals, and testing items are customizable according to your needs
• Long-term supply agreement/VMI
• Can be used together with BioLink ChromaX® resins for optimation, providing one-stop total solution for chromatographic purification
• Complete validation tests (biocompatibility test, particulate matter test, bacterial endotoxin test, validity period validation, etc.)
**Please be advised that this product is only available for sale and after-sales support in certain regions. For further details, kindly consult with your local sales representative. Thank you for your understanding.
Link With Us Now!