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HydroLinX® Water for Injection in Bags

HydroLinX® hydration products are bioprocessing water compliant with the ChP (2020 Edition) and USP requirements for water for injection (WFI) in bags, with quality inspection report provided. Buffer solutions and process liquids are prepared in two steps: 1) Mix standard-compliant chemicals (solid or liquid) with bioprocessing water of water for injection quality in a mixer to achieve the desired concentration and pH; 2) Filter the mixture to remove viruses.


These bioprocessing water, buffer solutions, and other process liquids are filled in ISO 14644 Class 7 compliant clean workshops using single-use irradiated storage bags with double packaging to ensure sterile application in single-use bioprocesses. We provide high-quality bag water for injection (WFI) in various volumes from 100 mL to 1000 L, including RNase-free, DNase-free, and RNase-free & DNase-free versions. To save space, we provide inclined insert logistics box for products in 5 L–20 L 2D storage bags and collapsible logistics box for products in 100 L–1000 L 3D storage bags. Additionally, we offer door-to-door recycling for collapsible logistics boxes to ease customer concerns.


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Features Specifications Applications Delivery Time Contact us

Features of HydroLinX® Water for Injection (WFI) in Bags

  • 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


Specifications of HydroLinX® Bag Water for Injection (WFI)

Comply with ChP 2025 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-SX201
HB-WFI-0100-SX1001
HB-WFI-0250-SX2501
HB-WFI-0500-SX5001
HB-WFI-1000-SX10001


Comply with USP requirements



Product Name



Cat. No.



Volume (L)



Package


HydroLinX® water for injection in bags

HB-WFI-0020-P1

20

1


HydroLinX® sterile water for injection in bags

HB-WFI-0020-PS

20

1

HydroLinX® sterile water for injection

in bags

(RNase-free)

HB-WFI-0020-PR

20

1

HydroLinX® sterile water for injection

in bags

(DNase-free & DNase-free)

HB-WFI-0020-PX

20

1

Applications of HydroLinX® Water for Injection (WFI) in Bags

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


Delivery Time of HydroLinX® Bag Water for Injection (WFI)

  • Water for injection: 4 weeks (microbial limit test)

  • Sterile water for injection: 6 weeks (sterility test)


**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.

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