At CG Pharma & Biotech, there are no compromises when it comes to quality.
Highly pure water is an essential component of our portfolio, serving as an internal raw material source to produce our GMP-compliant buffer and process solutions as well as a pure element itself.
- No compromises on quality: our purified water and water for injection meet the highest EP/USP standards
- Essential for GMP-compliant buffer and process solutions, equipment cleaning and cell culture media – used throughout upstream and downstream processes
- In-house production and rigorous quality control at our GMP-certified facility in Germany, with manufacturing authorisation (AMG §13)
- Continuous monitoring and batch release by qualified personnel ensure compliance and safety
- Large storage capacities for purified water and water for injection, with advanced temperature control and monitoring systems
- Flexible supply tailored to your production needs, supporting seamless and efficient biopharmaceutical manufacturing
UTILISING WATER FOR INJECTION IN SINGLE-USE BAGS
Using water for injection (WFI) supplied in single-use bags offers several advantages compared to in-house WFI generation.
Firstly, it eliminates the need for complex and costly water purification systems, saving on capital investment and maintenance expenses.
Additionally, using pre-packaged WFI in single-use bags reduces the risk of contamination and human error associated with on-site generation, enhancing product safety.
The convenience of ready-to-use WFI minimises downtime and speeds up production processes.
This approach also allows for flexible scalability, as you can adjust the quantity of WFI required without adjusting in-house equipment.
Overall, utilising single-use bags for WFI streamlines operations, ensures consistent quality and optimises resource utilisation.
PACKAGING OPTIONS FOR WATER FOR INJECTION
- 2D and 3D single-use bags ranging from 5 l to 1,000 l in volume
- Customised bag design in collaboration with business partners
- Preconfigured standard design available for fast-track development
- Bag film material: multilayered film (including ULDEP, LLDPE, EVOH, PE)
- Bag sterilisation: gamma irradiation (up to 25 kGy)
- Tubing material: TPE
- Connector for main bag: MPC/MPX male
- Connector for sample bag: luer female + clave connector
- Sterile filtration with a 0.2 μm filter
- Storage and transport packaging for 2D and 3D single-use bags
- In-house development of the returnable plastic transport container: CG Tainer for bags ranging from 100–1,000 l
