Water for Injection (WFI) is an important raw material. It is often required in large quantities and therefore has to be generated on-site, directly from the available potable water. The European Pharmacopoeia, as well as the United States Pharmacopoeia and the Chinese Pharmacopoeia, set out clear quality criteria. Water purity is clearly defined with threshold values for the microbiological load in the form of colony-forming units, conductivity and quantity of organic carbon.
WFI is used:
Pure Steam is gaseous WFI and is used for sterilization, drying, and humidification. The degree of steam saturation, dryness, and quantity of non-condensable gases must be determined for the individual application or the applicable regulations set out in EN 285.
|TOC||ppm C||≤ 0.50||≤ 0.50||Same as Ph. Eur.|
|Conductivity||µS/cm||≤ 1.3 (25°C)||≤ 1.1 (20°C)||Same as Ph. Eur.|
|Nitrate (NO3)||-||≤ 0.2 ppm||≤ 0.000006%|
|Aerobic bacteria||CFU/100 ml||≤ 10||≤ 10||Same as Ph. Eur.|
|Bacterial Endotoxins||/ml||≤ 0.25 EU||≤ 0.25 IU||≤ 0.25 EUI|
Products for Water for Injection and Pure Steam
BWT is the best choice when it comes to the generation, storage, and distribution of Water for Injection. Compact, standardized systems combine all necessary process steps and technologies to reliably ensure the highest levels of safety within the process.
Systems are fully tested (FAT), prevalidated, and documented prior to delivery.
The costs per m³ WFI depend on many factors: Unit design is heavily influenced by the individual consumption profile and required WFI temperature, whilst media costs also vary widely. BWT experts will consult you finding the right sizing and generation process. For example the following costs are incurred for potable water until it comes to the WFI tank inlet:
|Distillation unit, 8 columns||Membrane unit, 2xRO-EDI/UF|
|3 m³/h WFI*||€13.77/m³||€8.55/m³|
|9 m³/h WFI*||€12.28/m³||€5.84/m³|
|WFI temperature (inlet tank)||>85°C||10...20°C|
*Assumptions: Production 16 hrs/day; 5 days/week; 52 weeks/year
BWT will gladly advise you on your individual requirements whilst taking your situation into account. Simply reach out to your BWT contact. Together, we'll find the perfect solution.
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