Operating instructions
ECOM
ix
Figure 4.22:
Alternative options to the release of a concentrate
4.4.12 Production protocol
The production protocol is used to document the use of the medical device and must be archived
for a minimum of 10 years. It is located on top of each
ECOC
art below the upper cover. On the
right side next to the protocol is a sticker with the most important production data.
You must start to fill in the protocol at the start of the production process and complete it after
authorisation.
Liquid concentrates have a shelf life of 24 months.
4.4.13 Taking samples
Laboratory samples are required in the validation phase and in case of deviations of the measured
density. To take samples, the sampling valve must be in a horizontal position. After that, approx.
200 ml should be drained and discarded to remove the residues of previous samples. After this, the
sample can be filled into a sample tube.
For information about the interpretation of results, see chapter 7.
"
Caution
Before taking a sample, drain approx. 200 ml of the solution.
In order to avoid erroneous measurements, an analysis/measurement of
the sample can only be performed after 2 hours or more.
38
State: April 2021
4.9.1., I Manual ECOMix Original (EN), 7, F: M. Lorek, 06.04.2021