THE SERVOMEX SOLUTION
SERVOPRO
MultiExact 4100 SERVOPRO
Chroma SERVOTOUGH
SpectraExact 2500
A multi-gas analyzer capable of utilizing several
sensing technologies, providing a solution for
O 2 assay analysis and impurity analysis for CO,
CO 2 and CH 4 . It uses a Paramagnetic cell for a
highly stable oxygen reading, with customized
Infrared Gas Filter Correlation (GFx)
technologies for the other measurements. The Chroma provides a nitrogen assay
measurement utilizing Thermal Conductivity
Detector (TCD) technology. When using
Flame Ionization Detection (FID) with a
methanizer, it also delivers impurity analysis
for carbon monoxide. This is tailored for purity analysis of CO 2
and N 2 O, using Infrared sensing and specific
calibration. Servomex recommends that
sample temperature, pressure and flow is
maintained for the most accurate analysis.
MONITORING PURITY DURING
MEDICAL GAS FILLING
MEDICAL GASES
Medical gases are defined as any gases
used for the medical treatment of humans,
and are regulated under the same rules as
medicinal drugs.
These regulations are set out in an official
publication known as a Pharmacopeia,
which specifies – among other things –
how each gas should be produced and
validated, the acceptable level of purity
and official measurement methods.
PROCESS MEASURING POINTS
Medical gas cylinders are filled either at
a facility adjacent to an Air Separation
Unit (ASU) or at specific cylinder filling
plants. The gas composition is measured
at the source of supply, while quality is
measured before and/or after the bulk
gas delivery.
Gases are delivered to the filling plant
via pipeline from an ASU or a tanker,
in a liquefied form which is stored in
a cryogenic tank. For EP regulations,
ASSAY OR
IMPURITY MEASUREMENT
TECHNOLOGY O 2 Assay Paramagnetic (MultiExact 4100) 20.4-21.4% 19.5-23.5%
CO Impurity Infrared Gfx 1 (MultiExact 4100) <5ppm <10ppm
CO 2 Impurity Infrared Gfx (MultiExact 4100) <500ppm <500ppm
Air, synthetic medicinal O 2 Assay Paramagnetic (MultiExact 4100) 21-22.5% N/A
Medical oxygen O 2 Assay Paramagnetic (MultiExact 4100) >99.5% >99.0%
CO Impurity Infrared Gfx (MultiExact 4100) <5ppm <10ppm
CO 2 Impurity Infrared Gfx (MultiExact 4100) <300ppm <300ppm
O 2 Assay Paramagnetic (MultiExact 4100) 90-96% 90-96%
CO Impurity Infrared Gfx (MultiExact 4100) <5ppm <10ppm
CO 2 Impurity Infrared Gfx (MultiExact 4100) <300ppm <300ppm
N 2 Assay GC TCD (Chroma) >99.5% >99.0%
CO Impurity Infrared Gfx (MultiExact 4100) <5ppm <10ppm
CO 2 Impurity Infrared Gfx (MultiExact 4100) <300ppm N/A
N 2 Assay GC TCD (Chroma) N/A >97.0%
CO Impurity Infrared Gfx (MultiExact 4100) N/A <10ppm
CO 2 Impurity Infrared Gfx (MultiExact 4100) N/A <300ppm
CO 2 Assay Infrared (SpectraExact 2500) >99.5% N/A
CO Impurity GC FID with methanizer (Chroma) <5ppm N/A
CH 4 Impurity Infrared Gfx (MultiExact 4100) <50ppm N/A
Medical air
Although they share some of the same
rules, the United States Pharmacopeia
(USP) and European Pharmacopeia (EP)
have different regulations, and the
acceptable concentration levels often vary.
O 2 93%
dedicated tankers do not need to be
sampled after filling a cryogenic vessel if
a certificate of analysis is provided with
the delivery.
The liquefied gas is vaporized into gas
and pumped to the filling manifold. The
quality is usually high enough that no
further purification is required.
There must be a dedicated manifold for
each single gas, and a dedicated
mixture manifold for two or more gases,
with control procedures to prevent
cross-contamination.
Medical N 2
For multi-cylinder manifolds, the gas
from at least one cylinder from each
manifold filling cycle is tested for identity
and assay each time the cylinders are
changed on the manifold. For single
gases filled one cylinder at a time, at
least one cylinder per cycle is tested.
N 2 97%
Air is classed as a single gas so long as it
is not mixed using N 2 and O 2 .
ACCEPTABLE
ACCEPTABLE
CONCENTRATION CONCENTRATION
(EP)
(USP/NF 4 )
ANALYTE
GAS MIXTURE
Carbon dioxide
Helium
Argon
Nitrous oxide
1
1
1
1
1
1
1
1
CO Impurity Detector Tube N/A <10ppm
O 2 Impurity Paramagnetic (MultiExact 4100) Not O 23 N/A
N 2 O Assay Infrared 2 (SpectraExact 2500) >98% >98.0%
CO Impurity GC FID with methanizer 1 (Chroma) <5ppm <10ppm
CO 2 Impurity GC TCD 1 (Chroma) <300ppm <300ppm
1 The detector tube is the measurement technology for impurities in the USP. Gas analyzers can be used as an alternative method if supported by validation tests.
2 GC TCD (Chroma) for the USP.
3 For medical argon, Servomex provides a solution that confirms it is not oxygen before it is measured using gas chromatography.
4 The National Formulary (NF) provides standards for medicinal N 2 and 93% N 2 in the US.
Find the right solution for your process: servomex.com/quotes-and-enquiries
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