5 Putting into operation
48 R-220 SE Operation Manual, Version F
The following concentrations per germ were applied for every contaminant:
10
3
germs/ml
10
4
germs/ml
10
5
germs/ml
10
6
germs/ml
5.11.1 Controlled contamination and distillation
5 l of sterile distilled water were filled into the evaporating flask, contaminant was added to reach the
corresponding concentrations per germ and 1 l was distilled off under the following conditions:
Heating bath set to 60 °C, vacuum set to 42 mbar (corresponds to a boiling point of water of 30 °C),
chiller set to 7 °C.
Afterwards a sample of the distillate was taken (Sample 1 in the table) by means of a sterile pipette
and bottle for determination of germ count.
5.11.2 Disinfection
The evaporating and the receiving flask were emptied and the evaporating flask was rinsed with
water.
1.5 l of isopropanol were filled into the evaporating flask and the evaporation was started under the
following conditions:
Heating bath set to 60 °C, vacuum set to 250 mbar (corresponds to a boiling point of isopropanol of
50 °C), chiller set to 7 °C.
At first, the chiller was switched off until the vapor passed the whole instrument. Then the chiller was
switched on again and 0.75 l were distilled off. Afterwards the evaporting and the receiving flask were
emptied and the instrument was dried at a vacuum of < 20 mbar.
5.11.3 Sampling for determination of the germ count
The evaporating flask was filled with 2 l of sterile distilled water and 0.75 l were distilled off under the
following conditions:
Heating bath set to 60 °C, vacuum set to 42 mbar (corresponds to a boiling point of water of 30 °C),
chiller set to 7 °C.
A sample of the distillate (Sample 2 in the table) and of the residue within the evaporating flask
(Sample 3 in the table) was taken for the determination of the germ count.
5.11.4 Final cleaning and drying
The evaporating and the receiving flask were emptied and the evaporating flask was rinsed with
water.
1.5 l of isopropanol were filled into the evaporating flask and the distillation was started under the
following conditions:
Heating bath set to 60 °C, vacuum set to 250 mbar (corresponds to a boiling point of isopropanol of
50 °C), chiller set to 7 °C.
At first, the chiller was switched off until the vapor passed the whole instrument. Then the chiller was
switched on again and 0.75 l were distilled off. Afterwards the evaporting and the receiving flask were
emptied and the instrument was dried at a vacuum of < 20 mbar.
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