Operating instructions
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ix
batches must be tested and may only be authorized for use after the laboratory results have
been received and evaluated. Compliance with the tolerances listed in section 7.5 for the
individual components is decisive for the authorization.
• For all of the following batches, the laboratory control is only needed if requested by the
ECOM
ix. This is no longer part of the validation.
7.2.1 Deviation from the validation scheme
If the dialysis facility wishes to deviate from these specifications for validation, this is only permitted
after consultation with Intermedt as the manufacturer.
7.3 Implementation of the laboratory analysis
The taking of samples is described in section 4.4.13.
The analysis must be carried out in a suitable laboratory. The laboratory should have been checked
before the first analysis (e.g. by sending in a sample with liquid concentrate prior to installation).
Environmental laboratories are rarely able to measure concentrates of this composi-
tion with sufficient accuracy. Laboratories that specialize in blood samples can often
achieve this with a slight change in their methodology (e.g. predilution).
7.3.1 Scope of laboratory analysis
The ideal analysis includes a determination of the concentrates of all components contained in the
concentrate, given in g/l (glucose) and mmol/l (all other ions). However, suitable laboratories that
can carry out this analysis in the concentrate with appropriate accuracy are not available everywhere.
Therefore, the analysis of the concentrations of Na, K, Ca, Mg, and Chloride is defined as the
standard.
If no suitable laboratory is available that can analyse all of these ions, as many ions as possible must
be measured, whereby at least two other components in addition to sodium must be included. If these
restriction occurs during the validation phase, samples with 50 ml each of 2 of the 5 concentrates
produced in the validation phase must be sent to Intermedt with a corresponding note for testing.
7.3.2 Identification of samples for analysis
Samples for laboratory analysis should always be marked with the batch identifier of the associ-
ated
ECOC
art for identification (e.g. A98765ML-EC767). If the sample is labelled differently for
the analysis (e.g. batch number of the dialysis), the batch identification must also be stated in
correspondence with Intermedt.
When sending samples or results for evaluating results to Intermedt, the following data is required:
• Batch ID
• Dialysis facility with location or serial numbers of
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• Date of production
• Density or density deviation according to
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State: April 2021
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4.9.1., I Manual ECOMix Original (EN), 7, F: M. Lorek, 06.04.2021