06/15/2005

Water for Injection (WFI; Aqua ad iniectabilia)

WFI is specified as 'water that can be used to manufacture intervenous or parenteral drugs (WFI in bulk)'. According to European Pharmacopoeia, the only allowed method to manufacture this type of water will be distillation (in contrast to the US Pharmacopoeia, which also allows reverse osmosis). During manufacture, storage, and shipment, the number of aerobic colony forming units needs to be well controlled. Under normal conditions, the CFU should not exceed 10 per 100 ml, determined by means of membrane filtration, followed by 5 days' incubation at 30 - 35°C. Even more strict levels might be required for some aseptic preparations. Conductivity of WFI must be below 1.1 µS per cm at 30 - 35°C, and the content of organic carbon must be well below 0,5 mg per litre. Level of bacteria endotoxins must be below 0.25 EU/ml. To ensure a sufficient level of quality within this specification, the whole procedure needs to be carefully validated, and in-process controls will allow for close monitoring for all specification values.

Biochrom's WFI in Bulk is additionally sterile filtered; storage, and shipment in specifically designed bags/containers. Based on its capacity to manufacture WFI in bulk quantities, Biochrom offers WFI for bioprocessing purposes delivered 'just-in-time', with a normal shelf life of 3 months. Appropriate single-use bags (10 - 1000 litres) are used to store, and ship the water

Ask for details regarding quantities, and conditions.
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Biochrom AG

Leonorenstr. 2 -6
12247 Berlin

Phone: 030/779906-0
Fax: 030/7710012