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HTA HT2800T - 11 Appendix A - Glossary; 11.1 Headspace mode

HTA HT2800T
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11 Appendix A – Glossary
11.1
Headspace mode
Head Space Technique
Head Space technique is an indirect method to inject components with low boiling points from
liquid or solid samples. The method is based on the analysis of vapours released from a sample
that has been incubated at a constant temperature for a given period of time. Head Space
technique has some advantages compared to other techniques: quick preparation time
compared to analysis time, possibility to analyse samples that cannot be analysed in liquid or in
solid state, less cross contamination problems and higher sensitivity, as this procedure can be
considered as a pre-concentration step before injection.
System integrity test
The System integrity kit is sold as an option included in the GLP Pack for HT2800T/HT2850T
(see paragraph 1.7.2 Options “). The System integrity test is used to verify the syringe integrity
in Headspace mode.
If this test is enabled, at the beginning of each batch, the system performs a check to verify the
system integrity through a heuristic procedure. This test is carried out using the System integrity
tool (see
Figure
1 and
Figure
1).The septum of this tool should be replaced periodically (see
paragraph 3.6.3 “System integrity tool installation (only for Headspace mode)“).
This check can verify if it is better to replace the syringe (barrel and plunger). Please note that
this check does not replace the necessary periodic validations you have to program for the
instrument qualification. If the test fails, a warning message appears (see paragraph 8.15
System integrity test fail”).
Vial leakage check
This function can only be enabled by the HTA Autosampler Manager (Setup-Options).
If this option is enabled, the pressure inside vials is monitored by a heuristic procedure in order to
check against anomalous values that are indicative of a vial leakage problem.
The Vial leakage test can discriminate samples correctly sealed vs. bad crimping or missing
septa. Each sample is marked with PASS or FAIL information in HTA Autosampler Manager
Windows.

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