HydroLinX® Buffer Solutions and Process Liquids

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 the customers' worries.

• Consecutive tests and validations of water for injection at all points for 15 days

• 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

• Filling after sterilization and filtration

• Filling bags, chemicals, and testing items are customizable according to your needs

• Long-term supply agreement/VMI

• Combined with BioLink's ChromaX® resin optimization, providing one-stop total solution for chromatographic purification

• Complete validation tests (biocompatibility test, particulate matter test, bacterial endotoxin test, validity period validation, etc.)

For more information please visit Bio-Link website.