Technical Bulletin

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Copyright by Henkel 2005. All rights reserved.

Data shown is typical, and should not be construed
as limiting or necessarily suitable for design. Actual
data may vary from those shown herein.

INVESTIGATION OF THE DURABILITY OF

STAINLESS STEEL SURFACES IN THE FIELD
OF PHARMACEUTICAL EQUIPMENT

Essay No 14 / Rev. 00

Georg Henkel, MSE, PhD

Benedikt Henkel, MSE
The component‘s
value is assured
by its surface

info@henkel-epol.com www.henkel-epol.com
ESSAY NO 14 / REV. 00 INVESTIGATION OF THE DURABILITY OF
STAINLESS STEEL SURFACES IN THE
FIELD OF PHARMACEUTICAL EQUIPMENT

PAGE 1 / 2
______________________________________________________________________________________________________

INVESTIGATION OF THE DURABILITY OF STAINLESS STEEL

SURFACES IN THE FIELD OF PHARMACEUTICAL EQUIPMENT

This paper proposes to investigate primarily the quite commonly used alloy types 316L
(1.4404 or 1.4435), with the reason for the investigation being that uncertainties still exist
with regard to strengths, design qualities, and the associated financial aspects. Surprising
cases of failure often contribute significantly to this uncertainty.

If one disregards questions of solidity, stainless steel surfaces should have a series of basic
properties in their media-contacting surfaces:

• Corrosion resistance
• Neutral or inert behavior towards the medium
• Residue-free CIP cleanability in accordance with hygienic and sterility regulations

The scope of the investigation could be restricted considerably because electrochemically

polished stainless steel surfaces have been used for several years in the field of
pharmaceutical equipment, particularly in areas involving media contact, because they are
substantially superior to mechanically finished surfaces due to technical quality (topography
and morphology).

All media that do not impair the corrosion resistance of the surrounding stainless material
(e.g. 1.4435) exhibit optimal, satisfactory, and largely sufficient behavior with the regard to
assessments of residue-free cleaning and neutral behavior in connection with properly
electrochemically polished surfaces. Application-oriented investigations of germ count
developments such as pyrogenity of test substances confirm these propositions in an
impressive manner.

Similarly, assessments of the corrosion resistance of stainless steel surfaces in conjunction

with various media have also shown that electrochemically polished surfaces allow
achievement of substantially better values than mechanically treated surfaces, which can
plausibly be explained as a measurement result by the significantly more compact and more
even formation of the chromium oxide passivation layer. Electrochemically polished surfaces
allow practically unrestricted utilization of the theoretical corrosion resistance of the
respective alloy, which allows a high degree of design and planning security.

Extensive investigations of and practical experience with alloy 1.4435 show that above all the
following operating conditions enter into the limit ranges for utilization of this material

• Solutions containing chloride (particularly sodium chloride), whereby concentration,

temperature, exposure time, and movement status are essential parameters;

• Desalinized water, where conductivity, temperature, oxygen content, etc. are essential
parameters;

______________________________________________________________________________________________________

Georg Henkel, MSE, PhD / Benedikt Henkel, MSE info@henkel-epol.com

ESSAY NO 14 / REV. 00 INVESTIGATION OF THE DURABILITY OF
STAINLESS STEEL SURFACES IN THE
FIELD OF PHARMACEUTICAL EQUIPMENT

PAGE 2 / 2
______________________________________________________________________________________________________

• Ultra-pure steam

• Reducing alkaline media (e.g. sodium hydroxide), where concentration, temperature,

exposure time, etc. are key parameters.

Exposure of these media to stainless steel surfaces such as 1.4435 or 1.4404 quite often
leads to defects in practice, often due to errors in professional practice (in the manufacture or
installation of the components), which lead to correspondingly unpleasant consequences.

However, it should be noted here that, from the point of view of corrosion studies and
mechanics, these problematic application cases represent limit ranges in which even slight
pre-processing or operating system errors can cause damaging or destructive corrosion.
These types of corrosion (pitting, intercrystalline corrosion, crevice corrosion) are diverse and
usually represent combinations of effects.

In general, for the described exposures, the protective chromium oxide passivation layer is
attacked and, where it is destroyed (even locally), local (pitting) or wide area (rouging)
corrosion processes start and spread unchecked, usually at considerable speed. Repairs to
these conditions usually involve substantial effort and are sometimes impossible.

Laboratory investigations have confirmed the practical experience that, in general, welding
seams and the areas around them are substantially more susceptible than the surrounding
basic material and that the corrosion processes usually start in this environment, often
setting in motion self-catalyzing processes.

In particular, the mold-shaped and therefore usually somewhat less homogeneous structure
of the welding seam in connection with thermodynamically explicable morphology-changing
diffusion processes, as well as the formation of structural material islands (e.g. delta ferrites)
here form the basis for further system investigations in this field.

However it is always strongly advisable to take special care in planning and manufacture and
to make appropriate tests when using the media described above.

Please contact us for further information

______________________________________________________________________________________________________

Georg Henkel, MSE, PhD / Benedikt Henkel, MSE info@henkel-epol.com

Technical Bulletin

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