More Flexibility for Pharma: Why WFI is About to Unleash its True Potential

Related Vendors

DÜPERTHAL Sicherheitstechnik GmbH & Co. KG

TURCK GmbH

ProMinent GmbH

BWT Pharma & Biotech GmbH

Saving Money on WFI

For manufacturers of medical products and the users of WFI, the novelty of investment in new systems means a large savings potential in terms of the Total Cost of Ownership, while at the same time guaranteeing better product quality and improved ecological balance. As compared to the membrane process, cold WFI production is more efficient economically as well as ecologically, because investment as well as operating costs are lower. The water quality is better and the safety reserves are bigger. Rouging is not possible in cold systems.

Distillation plants for WFI production require at least desalinated water from a one-stage RO, frequently even Purified Water (PW) as feed water. Even in the most efficient distillation plants with six to eight columns, the biggest single items are the costs of the superheated steam and the feed water along with pre-treatment and depreciation of the plants. Potable water is sufficient for WFI production with Osmotron Pro WFI.

In the system of BWT presented in the table, the cost of one cubic meter WFI at min. the same product quality is reduced by 50 to 70 %. The annual savings potential with cold plants frequently lies in the range of several ten thousands to a few hundred thousand Euro, as has been demonstrated in the two sample calculations.

Membranes Do Better

The economical and resource-saving execution and operation of purest media systems is described expressly in the ISPE Sustainability Manual of December 2015 (Chapter 15.1). The manual is in the context of steam and water baseline, but it gives concrete instructions on how a sustained handling of resources can be achieved when creating PW, WFI and RD - e.g., through effluent recycling, and intelligent, as far as possible continuous efficiency control or sliding efficiency control.

At this place it is necessary to mention how many consumption centres also require hot WFI. For cold-produced WFI, these are then supplied via a hot sub-loop, heat exchangers the take the water to the required temperature. In a cold WFI system of BWT, one can expect a water quality with colony-forming units (KBE) < 1/100 ml and endotoxin values of < 0.005 EU/ml at a conductivity at the outlet of the generator of < 0.1µS/cm and TOC values below 20 ppb. In other words, operators remain well below the currently valid values of Ph. Eur. and USP (< 10 KBE/100 ml, < 0.25 EU/ml, <1.1 µS/cm at 20 °C, <500ppb TOC) in all the areas clearly.

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