INTRODUCTION TO

CLEAN STEAM





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INTRODUCTION TO CLEAN STEAM
Today, steam remains the prime carrier of heat within the process industry, ranging from food and
dairies through to biotechnology and pharmaceuticals. Steam is used for the heating of processes,
sterilization of products and equipment and for the humidification of air. Plant steam, which may
contain small quantities of boiler, feed water chemicals, traces of pipe scale and other debris is
perfectly acceptable for many of these applications. However, an increasing number of industrial
applications require steam and other process fluids to have a high level of purity, to minimize the
risk of contamination. The term 'clean steam' is used to describe a wide variety of purities, ranging
from pure, pyrogen-free, steam for the biotechnology and pharmaceutical industries to filtered,
culinary grade and steam for the food industry. The objective of this document is to introduce the
general characteristics and requirements of clean steam systems and to help readers understand the
differences between the varying grades of clean steam.
Plant steam contaminants
In order to understand the need for clean steam it is necessary to appreciate the nature of potential
contaminants in plant steam and their sources. There are many different substances, which may be
considered as contaminants; in general, they can be classified into four groups:

1. Chemical contaminants:
Include chemical substances that are found in the boiler feed water. For example, heavy metals such
as mercury, cadmium and lead which affect human health, as well as substances which may damage
the steam system, such as chlorides, which cause stainless steel to corrode. In addition, various
chemicals are added to the boiler feed water, and can be carried over in the steam. These include



filming amines that are used to prevent corrosion in the condensate return lines and feed water pre-
treatment additives.
2. Biological contaminants:
Most water supplies contain microorganisms such as bacteria, viruses, fungi and yeasts. The local
water authority controls their levels, ensuring that the water is potable (of drinking quality)
however, this may not be sufficient for a number of applications. This is of particular concern in the
production of medical devices or medicinal products. Since these products may bypass the human
body's natural defense mechanisms, such as the skin and the mucous membrane s, they can introduce
contaminants directly into parts of the body that would otherwise be protected. For example, water
that is safe to drink may not be considered safe if it is directly injected into the blood stream. The
high temperatures associated with steam are generally sufficient to destroy most living pathogens
(disease-producing agents such as bacteria and viruses) present in boiler feed water. However, living
bacteria can produce harmful substances known as 'pyrogens', which are thermally stable, and can
withstand a temperature of up to 180C for several hours. This means that heating in a boiler will
not necessarily destroy them and they must be removed from the feed water.
3. Non-condensable gases (NCGs):
Oxygen, ammonia, carbon dioxide and other gases dissolved in the feed water or introduced by
other means may produce undesirable effects in clean steam systems. For example, cold spots in
steam sterilizers and reduced heat transfer efficiency.
4. Pipe scale rust and debris:
Pipe scale results from the presence of carbonates and sulphates of calcium and magnesium, which
are naturally, present in the public water supply. As plant steam systems are typically of iron or steel
construction rust will often be present.




CLEAN STEAM CLASSIFICATION
The term 'clean steam' is generally used to refer to three categories of steam those are cleaner than
plant steam:
1. Filtered steam
(Also referred to as clean steam, culinary steam, food grade steam, potable steam and 3A's steam) is
produced by passing plant steam through a high efficiency filter. A typical specification would call
for the removal of all particles greater than 5 microns in size, including solids and liquid droplets.
2. Clean steam
(Also referred to as hospital steam, HTM 2031 steam, EN 285 steam and simple clean steam) - This
middle band of 'clean steam' encompasses a wide range of purity and quality requirements, ranging
from:
- Very basic clean steam, where user requirements may be for 'Boiler feed water chemical' free
steam, for perhaps simple building humidification, to:
- Regulated clean steam, where user requirements have very specific purity and quality
characteristics, so as to not contaminate the end product or process. Sterilization is a good
example of this where standards such as HTM 2031 and EN 285 are in place. Non-critical
humidification within the biopharmaceutical industry is another example, where pharmacopeia grade
'purified water ' criteria are often adhered.
All types of clean steam will be generated in an independent generator but may
use either softened potable, De-Ionized (DI) or Reverse Osmosis (RO) as the feed water, depending
on the end user requirements. The type of feed water used will have a significant impact on the
materials of construction and the design of the generator. For example; Mild steel or copper may be
used where the feed water is potable, but 316L stainless steel must be used where the feed water is
aggressive or ion hungry in nature, such as DI or RO.



3. Pure steam
(also referred to as clean steam, WFI steam, high purity steam, sanitary clean steam,
pharmaceutical clean steam, GMP clean steam and pyrogen free steam) is similar to clean steam;
however, the resulting condensate must meet the standards of USP grade water for injection (WFI)
and contain no bacteria or pyrogens. Pure steam must be produced by a pure steam generator; which
is classed as sanitary in design, or from a multiple effect still.