Pharma

PharmaiconA pharmaceutical stainless steel surface requires an intact, homogeneous passive layer to ensure optimum functionality. This passive layer largely guarantees the stainless steel’s resistance to corrosion. This, in turn, serves as a guarantee that the pharmaceutical medium will not become contaminated with corrosion products. This is why the surface finish of the material is of critical importance in aseptic production areas in particular. Contamination of the medium or the pharmaceutical products with foreign particles should be avoided at all costs.

Expert electropolishing is the best method for achieving the desired surface state. It optimises the surface in terms of

  • Topography
  • Morphology
  • Energy level/potential

We have over 30 years of experience in processing pharmaceutical stainless steel surfaces and apply our expertise to all of your products.

Services for the pharmaceutical industry

We electropolish tubes, fittings, vessels and heat exchanger devices

  • DIN, ISO and imperial tube dimension ranges (from an internal diameter of 2 mm)
  • Tube lengths up to 18 metres (including U-tubes)
  • Vessels up to 150 m³ in volume
  • On-site electropolishing for vessels is available
  • Materials 1.4404, 1.4435, 1.4539, Hastelloy®, etc.
  • Surface roughness up to Ra 0.2 µm
  • Pharmaceutically compliant processing documentation

Learn more about electropolishing here.

Pharmabehälter elektropoliert

Passivation of new pharmaceutical plants

Before putting new systems into operation for the first time, passivation is recommended in order to achieve the optimum surface conditions. The process flushes out impurities and contaminants that accumulate during the installation of the system.

Our services include:

  • Plant/system inspection
  • Preliminary cleaning (degreasing)
  • Wet-chemical passivation
  • Chemicals produced in accordance with GMP
  • Documentation of processes in accordance with GMP
  • Expert processing of waste chemicals and chemical solutions / water used for rinsing

Derouging and repassivation

The use of ultrapure water or pure steam as media in stainless steel systems leads to rouge deposits inside the systems due to various thermodynamic / chemical processes. The failure to remove these coatings in good time may mean that the established specification goal of being “visually clean” can no longer be achieved, thereby causing the pharmaceutical medium to become contaminated. Another consequence is that the coatings can be carried over into the production systems. As a result, the patches of rouge have to be removed from the entire system, which is expensive and highly time-consuming. It is therefore recommended to remove these rouge deposits in good time and at regular intervals.

Our services for you:

  • Plant/system inspection
  • Preliminary cleaning (degreasing)
  • Removal of coatings
  • Subsequent repassivation of surfaces
  • Safety management
  • Chemicals produced in accordance with GMP
  • Expert processing of waste chemicals and chemical solutions / water used for rinsing

Learn more about derouging and repassivation here.

Rouge monitoring

Given that rouge deposits always recur and cleaning them has become a routine occurrence in the pharmaceutical industry in terms of processing and quality, we have developed the HENKEL Passive Layer Guard. The device is assembled inside pharmaceutical water systems and identifies instances of rouge discolouration on the surface of the tube system via an opto-electronic process. Depending on the degree of discolouration identified, the HPLG will display a discolouration status and inform you about the condition of your tubing.

HPLG-CTO:

Find out how the HPLG works and how it can help you with the inspection of your equipment.

HPLG Messsensor und Kontrolleinheit