Derouging & Passivation Services
Auxiliary and secondary equipment in the pharmaceutical and biotechnology industries such as tube systems for clean water (AP, PW, HPW, WFI, etc.), production destillers, storage tanks, clean steam systems, clean steam generators, autoclaves and dry freezers usually consist of austenitic stainless steel (e.g. 1.4404, 1.4435, 316L, etc.).
After operating periods of 6 – 12 months, the inner surfaces of these systems often show red-brown, rusty surface contamination, which can be detected with a white cloth test. These are usually heavy metal particles resulting from a change in the stainless steel surface, so-called rouging.
Downstream production systems such as fermenters, batch and mixing vessels, together with their tube systems, are contaminated by the spread of the rouge particles. Even with the regular CIP cleaning of these systems, the heavy metal particles cannot be cleaned.
Expert removal of rouging, i.e. derouging, is possible through targeted cleaning measures. Such operations should be planned in the long term. Optimised cleaning methods in conjunction with active rouge monitoring allow for ratios that correspond to effective rouge avoidance.
On-site work is carried out by our specially trained teams for the GMP-relevant area.
Only state-of-the-art equipment and safety technologies are used. The cleaning chemicals are specially developed for use on sensitive pharmaceutical production plants. All work is thoroughly documented and the rinsing water produced is processed in an environmentally responsible and professional manner with certificate.
Besides the well-known electrochemical processes also the sole chemical procedures and chemicals have consistently been enhanced following customers respective demands.
The new bioderouging solutions are diluted organic saline solutions in a pH-range between 6 and 8. Depending on the nature and intensity of the rouge contamination the pH-neutral solutions are applied between 1 and 10 w/w-% at 40 …85°C for a period of 1…10 h.
The appliance on site is carried out by filling the vessel/tube system with the solution and heating it respectively recirculating the system. The pumping into a biological purification plant, after consultation with the responsible person is possible without any further pretreatment.
- known rouge appearances are removed securely
- the disposal of the derouging solution is cost-saving
- a neutralization of the rinsing water is no longer necessary
Available HENKEL chemicals for bioderouging are
- HC 4200
- HC 4000 (Biopassivation Solution)
- Equipment inspection
- Electrochemical derouging
- Chemical passivation
- GMP-conform manufactured chemicals
- GMP-comform process documentation
- Professional waste water treatment and waste disposal