Steam quality testing

in steam sterilizers

osama kamel
egyptian engineering systems www.ees9.com
Requirements of pure steam system
 “It is essential that that the steam is delivered to
the point of use is of the correct quality and purity
for the process”
 Three areas of design should be considered;
 Production
 Distribution
 Point of use
Definition
Steam quality is the measurable aspects of steam used for
sterilization.
These include the usual measures such as temperature and
pressure, and the relationship between the two. Deviations
from established ranges of these aspects of the steam can
result in wet, damaged, or unsterile loads.
Steam phases Diagram
Steam sterilization cycle
Steam quality
1- steam dryness fraction (range 0-1)
2- super heat temperature (max allowable
temperature 25 C above boiling point)
3- non condensable gases (max allowable limit 3.5%)
Steam quality requirements
BS EN 285, the European Large Steam Sterilizer standard [1],
is the world’s baseline authority for steam quality acceptance criteria.
It is referenced in most standards and in ISO 17665 [2].
With the release of EN 285:2015, the bar has been raised.
The acceptance criteria are shown in the following table.
Non-condensable
Steam Dryness Superheat
gases
>0.95 w/w* ≤3.5% v/v ≤25K
*For laboratory autoclaves, >0.90 w/w is considered acceptable .
Steam quality requirements
 WHTM 01-01 Part C - Decontamination of medical devices
within acute services, Part C: Steam sterilization
point 3.74

 The requirements of steam should be met when

measuring the quality of steam. The steam supply is
measured at the supply line to each machine where
the condensate is collected and analyzed
Steam quality requirements

WHTM 01-01 Part C : 2013 Table 5

Steam quality Test Kit
Standard Test Elbow
1-Dryness
 Dryness of >95% is essential
 Excess moisture can cause;
 Damp loads in porous materials
 Uneven temperature distribution in non-porous loads
 Uncontrolled chemical composition of steam
 Will have the effect of not sterilising correctly
 Effects Of Poor Steam Quality

• Wet packs
• Damaged loads and instruments
• Sterilization indicator failures and sterility failures
• Staining and corrosion of instruments
• and containers
Condition of steam delivered to autoclave

Steam suitable for sterilization is defined in the European

standards (EN 285) as having a dryness value of greater
than 0.95
 (5% water – 95 % steam)
Wet steam as a result of engineering issues

• No/clogged steam filters, either letting condensate pass if no filter,

or causing a pressure drop that causes condensate to fall out,
• No/clogged steam traps/separators, in either case, condensate in
the steam line is not removed,
• Steam trap/filter too far from the sterilizer, allowing condensate to
be generated between the trap or filter and the sterilizer,
• Constriction in the flow path from the boiler to the sterilizer, which
can also cause a pressure drop and condensate.
Steam Dryness Measurement
Steam dryness is calculated by measuring the temperature change in a
known amount of water and the mass of steam that was required to
cause that temperature change. Ideally, the temperature rise would be
exactly what would result if the energy in perfectly saturated steam
was delivered to the water to heat it. This would result in a dryness
value of 1.0. Normally, the dryness value is less than 1.0, as there are
thermal losses in any piping system, and a sterilizer is no exception.
 D =(T1-T0)(4.18Mw+0.24) _ 4.18(Ts-
T1)
 LM L
 T0 = intial temp of water in flask
 T1 = final temp of water in flask
 Ts = average temp of water and
condensate in flask
 Mw = Initial mass of water in flask
 Mc = mass of condensate
collected (kg)
 L = latent heat of dry sat steam at
temp Ts (kJ kg-1)
Other causes of wet steam
Other causes of wet loads can be that they are too dense; that is, too
much weight in too small a volume. The AAMI standard for
sterilization containers has a limit of 25 pounds in a container, with no
specification of density. The European standard for containers, EN
868-8, has a limit of 10 kg (22.4 lbs.)
Wet steam as a result of engineering issues

 Too great a pressure drop across a regulator or

between the jacket and chamber, which causes
the “extra” water in the steam at the higher
pressure to fall out as condensate,
Wet steam as a result of engineering issues
• Bad/missing/inadequate insulation in the sterilizer, allowing
energy loss and condensation
• Low sections of piping between the pure steam generator
and the sterilizer, allowing condensate to pool and be picked
up by steam flowing across the condensate
Failure mode
Parameter Definition Failure Mode
Steam
 The measure of the Wet steam can cause an
Dryness water content of unsterile load in two ways:
steam. Acceptable •Insufficient energy delivered
values are >0.95 to the load to sterilize.
(<5% water) for •“wet packs”, making the
metal loads. sterile barrier material
surrounding the load less of a
barrier and compromising
sterility assurance.
2-Steam superheat Degree testing
 Expansion chamber with Pitot tube
Steam Superheat Testing procedure

Superheat content =
temperature of steam
in the expansion tube –
temperature of boiling
water at local
atmospheric pressure
Superheat Problems

Superheat is the situation of having more energy in the

steam than the steam temperature would lead you to
expect. Conversely, superheat is also a situation in which
the temperature of the steam is higher than the saturation
temperature for its actual water content.
Superheat Problems
 Superheat should not exceed 25 C

Problems incurred with Superheat include

 Poor heat penetration resulting in Failure to

sterilise
 Scorching of textiles and paper
 Rapid deterioration of rubber
Sources of super heat
• Jacket temperature/pressure too high
• Steam pressure/temperature too high entering the
sterilizer
• Steam flowing through a small orifice between its
source and the chamber causing a large pressure
reduction.
Effect of superheat
 Super heat is a high energy in the steam If this energy is
released in the load, damage can occur to instruments as
their temperature rises above the recommended
processing temperature. The temperature shown on the
sterilizer controls is generally not sensitive to superheat,
as it is measured in the drain of the sterilizer chamber, and
superheat will have been dissipated into the load,
chamber wall, or door before it reaches the drain.
Failure mode
Parameter Definition Failure Mode
Superheat A situation in which Superheat has two potential
the temperature of effect:
the steam is higher •Unsterile loads due to insufficient
than the saturation energy being delivered to the
temperature for its load, since the steam is too dry.
actual water content. •Damage to the load if the
(This is the opposite superheat is generated where the
of wet steam) temperature reached by the load
is higher than its materials can
withstand.
3-Steam Non condensable gases content
 Sample taken from higher
 Point in test elbow
 Balance between cooling Water and steam flow
 Fraction of NCG =
vol of gas collected in the
burette / vol of water
collected in the measuring
cylinder.
Failure mode
Parameter Definition Failure Mode
Non- A measure of High non-condensable gas content can
condensable air or other cause an unsterile load in two ways
gases gases •Insufficient energy delivered to the load
entrained in to sterilize.
the steam. •Gases do not deliver the same latent
Expressed as heat energy as steam.
a percentage •Pockets of gas can form that provide
by volume of “islands” of un-sterility.
gas in the •Unless the indicator is in such an island,
steam. their presence will go undetected.
Steam Generation Maintenance Checklist
 ††Routine steam quality testing
 ††Routine feed water quality testing
 ††Preventive maintenance of steam traps
 ††Preventive maintenance of piping shut-off valves
 ††Preventive maintenance of inline steam filters
 ††Preventive sterilizer maintenance
 ††Routine chamber cleaning / de-rouging program
Testing frequency
 WHTM 01-01 Part C - Decontamination of medical devices within
acute services, Part C: Steam sterilization recommends to

 arrange for periodic tests of the steam quality at

intervals coinciding with periodic tests on the
sterilizer
Testing frequency
 steam quality May be tested as part of the annual revalidation
exercise for each sterilizer. Where steam systems are either
routinely or irregularly shut down, large quantities of air will
be present in the distribution system on restarting. It is
recommended that in such circumstances a comprehensive
and validated venting procedure should be applied and testing
for non-condensable gases may be appropriate.
References
BS EN 285:2015
Sterilization – Seam sterilizers – Large sterilizers

ANSI/AAMI ST79:2010/A4:2013
Comprehensive guide to steam sterilization

WHTM 01-01 Part C : 2013

Decontamination of medical devices within acute
services, Steam sterilization
 Questions ?

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