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

Related Vendors

DÜPERTHAL Sicherheitstechnik GmbH & Co. KG

Turck_Your_Global_Automation_Partner.jpg ()

In all the parameters, WFI from membrane systems offers a better water quality with conspicuously higher safety reserves and elbow space for action for alarm- and action limits during storage and distribution up to the consumption centres. But how should a robust, reliable and safe system of cold WFI production look like?

BWT Pharma & Biotech has developed the Osmotron for PW- and HPW production. All the process steps of softening, reverse osmosis right up to electrode ionization (DI) are installed on a compact frame. Osmotron Pro WFI is based on the experience gained with more than 1000 units worldwide.

Additional Information

What is New in Monograph 0169?

Three Changes for the Operator

1. As a further option besides distillation, the revised Ph. Eur. will permit the manufacture of WFI from 1st April 2017 “by reverse osmosis, which may be single-pass or double-pass, coupled with other suitable techniques such as de-ionisation and/or ultra-filtration“.
2. It was added that the following is applicable to all WFI systems: “Correct operation monitoring and maintenance of the system are essential.” While the
significance of regular GMP-conforming main-
tenance was already been recorded in the existing monograph, monitoring of the correct plant operation has been fixed as an essential component.
3. A freshly added feature is the regular measurement of organic substances (total organic carbon, TOC). Only the micro-biological control in the germinal units (KBE) and the continuous measurement of the conductivity were promoted earlier.

Cold WFI Production

There are two micro-biologically critical points in the classical pharma water system: The pre-treatment including softening and the storage tank. Safety during softening is guaranteed by continuous operation, selection of a suitable sanitation process, monitoring and use of the best available technologies like multi-block valves with optimised pipe guidance and minimized dead spots. This enables an efficient operation, with enhanced safety through the alternating operation of the softening columns as working and safety filters.

Microbiological growth in cold storage tanks is prevented safely by the continuous sanitization with ozone produced in-situ in very low concentrations of 20 ppb. Systems with three membrane barriers offer an economical and safe solution for cold WFI production. The hardness of the water is retained through the addition of antiscalant in the solution and separated via a two-phase reverse osmosis. This solution is more environment friendly and more sustainable, because increase in salinity is avoided, which is necessary for the regeneration of softeners.

After the first and second membrane, electrode ionization takes place for the final desalination with Septron Biosafe, which safely separates all endo-toxins, microbes and particles that could still remain in the water through an integrated UF as a third membrane phase and final barrier with a 5 log reduction (> 99.999 %).

(ID:44287831)

Water for Inhjection (WFI) in Pharma

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

Cold WFI Production