Metrohm 730 Sample Changer User Manual Page 180
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5.6 Validation / GLP
730 Sample Changer, Appendix
177
55.6 .6 Validation / GLP
GLP (Good Laboratory Practice) requirements include the periodic
check of analytical instruments for reproducibility and accuracy
using Standard Operating Procedures (SOP).
Although the instrument in question is not a measuring instrument,
it is recommended to include the 730 Sample Changer in the vali-
dation of an analytical system as a part of it.
If the sample changer is mainly used for titration automation, the
validation of the titration instrument should ideally be done with the
help of the sample changer. In this way, any disturbing factors (for
example, the entrainment of sample or titration solution) which
could influence the measurement results can be included within
the judgment of the entire titration system.
Checking of the electronic and mechanical components of meas-
uring instruments can and should be undertaken by qualified per-
sonnel of the manufacturing company as part of regular servicing.
All Metrohm instruments are provided with start-up test routines
which check that the relevant assemblies are working perfectly
when the instrument is switched on. If no error message is dis-
played, it can be assumed that the instrument is functioning fault-
lessly. Instruments from the Metrohm company are also supplied
with built-in diagnostic programs which enable the user to check
the functioning of certain components in the event of malfunctions
or faulty behavior and to localize the fault. Diagnostic programs
may also be integrated in a validation procedure.
Guidelines for the creation of standard operating procedures for
checking a titration system can be found in the application Bulletin
252/1 ("Validation of Metrohm Titration Instruments according to
GLP/ISO9001"). This can be requested free of charge from
Metrohm.
Furthermore a 3.5" diskette (Application Service Disk, order no.
8.000.8001) is available which contains a work sheet (Format: MS-
Excel, Version 4.0 and 5.0) for the statistical analysis of the vali-
dation.
- 730 Sample Changer 1
- Table of Contents 2
- 1 Overview 4
- 730 Sample Changer, Overview 5
- 1.3 Instrument Description 6
- 1.3.2 Rear View 7
- 1.3.3 Sensors 8
- 11.3.3.5 .5 The Swing Head 9
- 2 Installation 10
- 2.3 Safety Considerations 12
- 2.4.3 Tubing Fixation 15
- 2.4.4 Magnetic Stirrers 15
- 2.4.5 Sample Racks 15
- 2.5 Integration 17
- 2.5.1 Remote Connections 18
- 683 Pump Unit 24
- Cable 6.2135.000 26
- Cable 6.2134.000 26
- 1 2 3 4 5 6 7 8 1 2 3 4 5 6 28
- 3 Introduction 30
- Basic Configuration 31
- >, <1> or <2> 32
- Rack Configuration 33
- The Method 34
- 3.2 Configuration 38
- 3.2.2 Rack Definition 40
- 3.2.3 Dosing Units 42
- 33.2.2.4 .4 RS232 Interface 43
- 3.3 Swing HeadSwing Head 45
- MOVE : sample <ENTER> 49
- MOVE : spec.1 <ENTER> 49
- MOVE : 5 <ENTER> 49
- LIFT : work <ENTER> 50
- LIFT : 150 mm <ENTER> 50
- 3.5 Methods and Sequences 52
- 3.5.3 Process Control 54
- 3.5.4 POWERUP Method 55
- 3.6 User Methods 56
- 4 Detailed Description 62
- 4.2 The Keyboard 63
- 44.2.2.2 .2 Data Entry 81
- 44.2.2.3 .3 Text Entry 82
- <HOME> 84
- 4.3.1 Configuration 85
- >auxiliaries 86
- 4.3.2 Parameters 90
- >manual stop 95
- >start sequence 97
- 1 SAMPLE: = 1 97
- =,+,– 1…999 97
- >sample sequence 104
- 11 WAIT 1 s 104
- 0…1…9999 s 104
- 12 ENDSEQ 104
- 4.5 Sample Racks 107
- 700 Dosino 112
- 4.7.1 Setting up the System 117
- 4.9.3 TriggersTriggers 130
- 4.9.5 Error Messages, Errors 131
- ∗ SAMPLE, STIR, DEF 134
- ∗ CTRL, WAIT, ENDSEQ 134
- Address of stirrer 1…4, ∗ 139
- Address of dosing unit 1…12 139
- Interface selection Rm, RS 140
- ∗, 14 Bit (1,0, or ∗) 144
- ∗ / ENDSEQ> 150
- ∗∗∗∗∗∗∗∗') 152
- 1...4, ∗ 154
- 1.1, 1.2, 1.∗, 2.1, 2.2, 2.∗ 154
- depending on object 156
- 4.11.2 Handshake 158
- Data output 159
- Data input 159
- 4.11.3 Pin Assignment 162
- View of soldered side of plug 163
- 5 AppendixAppendix 164
- 730 Sample Changer, Appendix 165
- 5.2 Technical Specifications 166
- 5.2.2 759 Swing Head 168
- 5.3.1 Servicing 169
- 5.4 Diagnosis 170
- 5.4.3 Working Memory (RAM) 172
- 5.4.4 Display 172
- 55.4.4.5 .5 Keyboard 173
- 5.4.6 Remote Interface 174
- 5.4.8 External Bus Interface 175
- 55.4.4.9 .9 Beeper 176
- 5.5 Initialize data memory 178
- 55.6 .6 Validation / GLP 180
- 5.7.1 Warranty 181
- EU Declaration of Conformity 183
- 759 Swing Head 184
- 5.8 AccessoriesAccessories 186
- Connecting Cables 190
- Sample racks and beakers 190
- Electrodes for Sample Changer 191
- Dosing Instruments 191
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