D-811

Creating Instrument Method Files using Chromeleon Series 7.X Series Software

Section D — Laboratory Operations and Specifications 4 pages

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1.0 Purpose 
 
 The purpose of this procedure is to provide general guidelines for creating a new HPLC
 instrument method file. 
 
 2.0 Scope 
 
 This procedure applies to instrument method files created, stored or altered on lab computer(s)
 dedicated to Dionex HPLC system(s). This procedure applies specifically to the Chromeleon
 
 Series 7.X software. This procedure is limited to the use of the Instrument Method Wizard for
 
 use in creating instrument method files. See Chromeleon Series 7.X electronic Help for details
 on creating program files manually. 
 
 3.0 Responsibility 
 
 ad It is the responsibility of QC and Analytical Chemists to follow this procedure.
 
 3.2 It is the responsibility of QC Laboratory Management to implement this procedure and
 
 to ensure that the procedure is being followed. 
 
 3.3. ‘It is the responsibility of QC Laboratory Management to keep the SOP current with the
 
 latest Ion Labs practices. 
 
 4.0 Definitions 
 
 4.1 QC — Quality Control 
 
 4.2 3-D-— Three Dimensional 
 
 43 AD-—Analytical Development 
 
 
 

[SOP D-811 | Page 2 of 4]

 Standard Operating Procedure SOP No | Rev 
 Creating Instrument Method Files using Chromeleon | 0-811 4 | Page 2 of 4 
 Series 7.X Software 
 
 44 D-XXX- Designation for the SOP with which the instrument method is associated
 
 5.0 References 
 
 5.1 Chromeleon Series 7.Xelectronic Help 
 
 6.0 Procedure 
 
 6.1 Instrument method files contain the operating instructions for each piece of the HPLC
 
 system which include the pumps, auto-sampler, column compartment and detector(s).
 
 6.2 Common Program Parameters: 
 
 6.2.1 Detector signal to be recorded and parameters of the signal.
 
 6.2.2 Flow rate and solvent composition (gradients will have multiple timed steps).
 
 6.2.3 Injection command 
 
 6.2.4 Column oven temperature 
 
 6.2.5 Start / End of data acquisition 
 
 6.2.6 End of the program 
 
 6.3 The Create Instrument Method Wizard 
 
 6.3.1 The options listed here are starting points, if the method calls for different
 setting, they override the conditions labeled below. 
 
 6.3.2 From within the Chromeleon Console, select Instrument Method from the
 Create pull-down menu. 
 
 6.3.3 The Instrument Method wizard opens and displays the available instruments.
 Select the instrument where the method will be run, then select Next >.
 
 
 

[SOP D-811 | Page 3 of 4]

 Standard Operating Procedure SOP No Rev 
 Creating Instrument Method Files using Chromeleon | 0-811 4 | Page 3 of4 
 Series 7.X Software 
 
 6.3.4 This next page lists the general settings for the system. Enter the method run
 time. Deselect diagnostic channels 1 (ColumnOven_Temp) and 3 
 
 (Temp _Lamphouse). Keep diagnostic channel 2 (Pump Pressure) checked,
 then click Next >. 
 
 6.3.5 This next page displays the general pump settings. Name the solvents used.
 Accept the default pressure limits and flow acceleration / deceleration
 
 conditions and click Next >. Set the flow gradient and flow rate.
 
 6.3.6 This next page displays general settings for the autosampler. Accept the default
 
 settings for all parameters except the draw speed. Using the method injection
 
 volume, set the draw speed such that the draw time is equal to 10 seconds. (e.g.
 use a draw speed of 2ul/sec for a 20pl injection volume.) Click Next >.
 
 6.3.7 This next page provides additional auto-sampler settings. Select partial loop for
 the inject mode unless using the maximum setting (FullLoop). Accept the
 
 remaining default settings and click Next >. Alternatively, select Normal from
 
 the Inject Mode drop-down menu, accept the remaining default settings and
 click Next >. Some autosamplers are equipped to control sample vial
 
 temperature. If so equipped and required, check the Use Temperature Control
 box and set the Temperature. Accept the default settings for the remaining
 
 parameters and click Next >. 
 
 6.3.8 This next page sets the column oven temperature. If temperature control is
 
 required, check the Use Temperature Control box and enter the temperature.
 
 Accept the remaining default settings and click Next >. 
 
 6.3.9 This next page sets channel settings for the UV detector. Enter the desired
 
 wavelength(s) and check the channel boxes to enable acquisition. If 3D spectral
 data is to be collected, keep the corresponding box checked, enter the
 
 wavelength range, accept the remaining default values and click Next >. (Note:
 
 It is also possible to edit acquisition times for individual lamp channels. If
 required, check the Edit acquisition times box and enter the desired time
 
 
 

[SOP D-811 | Page 4 of 4]

 Standard Operating Procedure SOP No Rev 
 Creating Instrument Method Files using Chromeleon D-811 Page 4 of 4 
 Series 7.X Software 
 
 intervals.) Click the electronic Help button for specific details on programming
 collection of 3-D spectra. 
 
 6.3.10 The final page provides space for a comment as well as a description. The
 comment should be descriptive and include the analyte(s) analyzed. The
 
 description is optional and can be used to capture helpful information related to
 the content and intended use of the method. 
 
 6.3.11 The file name is generated in the following format: 
 
 6.3.11.1 D-XXX __analyte(s). 
 
 6.3.12 Click Finish to open the instrument method in the Chromatography Studio.
 
 Review the method components for accuracy and completeness. 
 
 6.3.13 At this time, shutdown or standby parameters may optionally be set.
 
 7.0 Revision History 

| Rev | Date | Description of Changes | CCR # | By |
|-----|----------|------------------------|-------|----|
| 0 | 08/02/11 | New - - | - | - |
| 1 | 02/26/13 | Reformatted SOP. | 13-123 | B. Johns |
| 2 | 02/19/15 | Biennial review. Reformatted SOP. | 15-0174 | B. Johns |
| 3 | 07/25/17 | Biennial review. Revised to reflect software upgrade. | 17-0828 | C. Perry |
| 4 | 02/02/21 | Scheduled Review — Fixed a few typos, Added some clarification CC- | 21-0032 | J. Maignan |