12
chemical equipment update
Fully automatic pure steam
condensate sampling system
Thomas Schulz reports on a new automatic
is classified by the FDA as suitable for pharmaceutical
system for sterile sampling of pure steam
production. An aseptic quick-action coupling connects
the stainless steel or glass sampling bottle to this block.
condensate.
A further small multi-port valve, the sampling unit,
is positioned on the bottle; it controls sterilisation of
n order to monitor the quality of pure steam the connection, condensate removal as well as hermetic
I
in sterile plant in the pharmaceutical, food sealing of the bottle after sampling. The valve actuators
and beverage industries, samples are regularly on this block are likewise controlled pneumatically.
drawn from the steam pipes and analysed in The entire electrical control of the system is
the laboratory for a possible contamination. decentralised in a small electric control cabinet with
For this purpose, there are various systems, in integrated keyboard. This electrical control cabinet is
which sampling is carried out manually or semi- installed directly next to the sampling multi-port valve,
automatically. The most important issues are that: so that the operator has direct access to the overall
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system during production at any time. If required, the
The various systems do not really permit
complete system can be installed on a mobile stand, so
contamination-free sampling.
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that it can be used flexibly at various sampling points
The space requirement of conventional tubular
in the production. The system requires a power supply
coolers in order to condense the pure steam is
of 230V 50/60Hz and a compressed air connection
relatively large due to their design.
v
(max 10 bar). If required, the system can also be used
The design of some systems entails increased risk of
for sampling of, for example, water for injection (WFI)
scalding for the user.
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or aqua purificata (AP).
The plant operator or laboratory technician must
During sampling and transport of the sample from
normally supervise the entire sampling procedure
the sampling point to the laboratory there is the danger
in nearly all of the
of sample contamination in several process steps.
sampling systems currently
Conventional sampling systems have several weak
available on the market.
spots depending on the procedure. These dangers are
Understanding the above-
on the one hand due to the technology of the sampling
mentioned problems, GEMÜ
components or systems and on the other hand due
has developed an automatic
to operating personnel. The system should support
system for sterile sampling
the operating personnel during the critical phases
of pure steam condensate.
or be designed in such a way that no operator errors
System design
can occur. Errors by operating personnel can never
completely be excluded, however, if they should occur
The complete automated
then they should have no negative effect on the sample.
pure steam sampling
Conventional sampling procedures can expose
system consists of a multi-
the sample to the atmosphere and/or even partly
port valve with pneumatic
draw the sample in non-sterile ‘grey’ area, since the
actuators, a sampling bottle,
ambient air at the sampling point does not correspond
a compact control unit,
to cleanroom requirements. The sampling bottles are
installed ready-to-
normally autoclaved or pyrogenised, brought to the
connect on a
sampling point and then connected to the sampling
mobile stand
point. For this purpose, the sampling bottle must be
or as stationary
opened and connected to the sampling point. The
version.
GEMÜ system excludes this risk. The sampling block
The multi-port
is firmly connected to the closed ring main. After
valve is based on
autoclaving, the bottle is hermetically sealed against
diaphragm valve
the environment by means of the multi-port valve and
technology, whose
is transported and connected as such to the sampling
sealing system
Fig. 1. GEMÜ Biostar Steam Sampler, automated point. The operator then starts the system; sterilisation
is certified by
sterile clean steam sampling system, large mobile is the first process step. This procedure sterilises the
the EHEDG and
version. entire sampling block and the particularly critical area
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