Dissolution System Drivers Operation Manual 81-200-807 Rev. D Hanson Research Corporation 9810 Variel Avenue Chatsworth, CA 91311 USA (800) 821-8165 (818) 882-7266 FAX (818) 882-9470 www.hansonresearch.com 2012 Hanson Research Corporation. This product is covered under one or more of the following US Patents: 3,572,648 4,108,602 4,274,286 5,198,109 5,296,139 5,639,953 5,639,974 5,682,001 6,006,777 6,076,410 6,422,098 6,821,419 B2 Des.377,152 Des.424,458 & Other Patents Pending.
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Table of Contents Table of Contents... i Revision History... iii 1 Safety Considerations... 1 2 Introduction... 2 2.1 Overview... 2 2.2 Configurations... 3 2.2.1 SR8-Plus/AutoPlus/Agilent Configuration... 3 2.2.2 AutoPlus/Agilent/Non-Hanson Bath Configuration... 3 2.2.3 SR8-Plus/Agilent/Non-Hanson Sampling System Configuration... 4 2.2.4 Vision G2 AutoPlus/Vision G2 Elite 8/Agilent Configuration... 4 2.2.5 Vision G2 AutoPlus/Agilent/Non-Hanson Bath Configuration... 5 2.2.6 Vision G2 Elite 8/Agilent/Non-Hanson Sampling System Configuration... 5 3 Specifications... 6 3.1 Software Requirements... 6 3.2 Hardware Requirements... 6 3.3 Optional Accessories... 7 4 Installation... 8 4.1 Before You Begin... 8 4.2 Hardware Installation... 10 4.2.1 SR8-Plus/AutoPlus/Agilent Configuration... 10 4.2.2 AutoPlus/Agilent/Non-Hanson Bath Configuration... 12 4.2.3 SR8-Plus/Agilent/Non-AutoPlus Sampling System Configuration... 15 4.2.4 Vision G2 AutoPlus/Vision G2 Elite 8/ Agilent Configuration... 16 4.2.5 Vision G2 AutoPlus/Agilent/Non-Hanson Bath Configuration... 18 4.2.6 Vision Elite 8/Agilent/Non-AutoPlus Sampling System Configuration... 21 4.3 Software Installation... 22 4.3.1 Uninstalling Previous Installations of the Hanson Dissolution System Drivers... 22 4.3.2 Installing the Hanson Dissolution Drivers... 25 5 Operation and Programming... 30 5.1 Dissolution Driver... 30 5.1.1 Test Station Tab... 32 5.1.2 Reference Tab... 33 5.1.3 Setup Tab... 34 5.1.4 About Tab... 35 5.2 AutoPlus Driver... 36 Creating a ChemStation Method... 40 5.2.1 Creating an AutoPlus Protocol (Optional)... 40 Table of Contents i
5.2.2 Creating a ChemStation Dissolution Method... 40 5.2.3 Defining the Measurement Cycle... 48 5.2.4 Defining the Control (Optional)... 49 5.2.5 Setting Up the Sampling System... 50 6 Running a Test and Reviewing Data... 52 6.1 Zero the Cells (if done previously, go to Section 6.2)... 52 6.2 Spectrophotometer Reference (Multibath Dissolution Testing Only)... 54 6.3 Load or Run Standards... 55 7 Troubleshooting... 58 8 Maintenance and Calibration... 60 9 Moving and Storage... 61 10 Service Parts... 62 11 Sales and Support... 63 12 General Warranty... 64 Appendix A Dissolution Run Parameters... 65 PreRun Seq.... 65 Dissolution Run... 68 PostRun Seq.... 70 Table of Contents ii
Revision History REVISION DATE DESCRIPTION Operation Manual A 28AUG2006 Initial Release of new operation manual. B 15FEB2007 Updated Revision History. C 10AUG2010 Updated to reflect Vision Tester interface. Updated to reflect Vision Enabled AutoPlus interface. Updated to reflect Chemstation 32 requirements. Miscellaneous contextual adjustments. D 01JUL2012 Updated to reflect Vision G2 Tester Interface Updated to reflect Vision G2 AutoPlus Autosampler interface Updated to reflect Windows 7 compatibility and requirements Dissolution Tester Driver 3.12 28AUG2006 New driver installation menu. Validated with ChemStation v10.01. Improved timing of speed and temperature log feature. Disabled stopping of paddles at start of test for sequential autosamplers. 3.13 21DEC2006 Addressed installation program not installing file xdtpatch.mcx in target computer. 3.14 04JAN2007 Resolved ChemStation not reading the RPM from driver correctly when Regional Settings in Windows switched the use of the comma and the period. 3.15 15FEB2007 Modifed driver to take over control of E-Probes when using a peristaltic pump instead of AutoPlus. 4.00 28JUN2010 Revised driver to work with Vision Elite 8 Dissolution Tester. 5.00 01JUL2012 Revised for Windows 7 compatibility Removed Vision G1 tester compatibility Added Vision G2 tester interface Updated SR8 Plus interface AutoPlus Driver 3.12 28AUG2006 New driver installation menu. Improved Zero Cells functionality for Multibath Mode. Repaired GPF error when more than 21 protocols are used. Added feature to document AutoPlus test parameters at start of test with ability to print automatically or manually. 3.13 21DEC2006 Addressed installation program not installing file apdriver.exe in target computer. Revision History iii
3.14 04JAN2007 Resolved AutoPlus parameters printing at every interval time by printing only at the start of the test. 3.15 15FEB2007 No modification. Version number changed to match SR8-Plus Driver. 4.00 28JUN2010 Revised driver to work with Vision Enabled AutoPlus Autosampler. Fixed an issue where the last blank would be applied properly at every other sampling time. 5.00 01JUL2012 Revised for Windows 7 compatibility Removed Vision Enabled AutoPlus compatibility Added Vision G2 AutoPlus interface Updated legacy AutoPlus interface Revision History iv
1 Safety Considerations No safety considerations are applicable to the Hanson Dissolution System Drivers. Refer to the appropriate operation manuals or other reference materials for the Safety Considerations for each of the individual instruments operating in the system. Section 1 Safety Considerations 1
2 Introduction 2.1 Overview Hanson Dissolution System Drivers were designed by Hanson Research in conjunction with Agilent Technologies specifically to provide a communication tool between the Agilent ChemStation program and select Hanson Research instruments. The drivers provide the mechanism by which the ChemStation can control and retrieve status information from Hanson dissolution instruments such as the SR8-Plus and AutoPlus, and the Vision G2 Elite Dissolution Test Station and Vision G2 AutoPlus automated samplers. This manual refers to the SR8-Plus and AutoPlus as the Legacy instruments and to the Vision G2 Elite Dissolution Test Station and Vision G2 AutoPlus as the Vision instruments. The driver connects as a DDE 1 client to the Agilent ChemStation, establishing a communication channel through which both the ChemStation program and the Hanson drivers can exchange instructions and information. Instructions from the ChemStation are interpreted and implemented by the Hanson drivers through either RS232 via the serial communication port (for Legacy) or TCPI/P network port (for Vision) of the host workstation PC. The Hanson drivers act as a communication tool between the Agilent ChemStation and the Hanson Research instruments. Because the Hanson drivers do not alter the functionality of the ChemStation program, this operation manual does not address the ChemStation program itself, but rather the operation of the Hanson drivers in the ChemStation environment. For information on the ChemStation program, refer to the materials provided with the ChemStation software or contact your Agilent representative. The Hanson Dissolution System Drivers version 5.00 (p/n 81-200-026) are supplied by Hanson Research via CD ROM. These have been validated by Hanson Research with ChemStation Version B.04.02. Hanson Research has not validated version 5.00 drivers with ChemStation Versions lower than B.04.02. 1 DDE stands for Dynamic Data Exchange. DDE is the way that applications running within the Microsoft Windows environment communicate with each other. Section 2 Introduction 2
2.2 Configurations The Hanson/Agilent System can be configured in various ways depending on the equipment that will be used on the system. In each case the individual instruments should be installed and connected prior to installing the Hanson Dissolution System Drivers. 2.2.1 SR8-Plus/AutoPlus/Agilent Configuration This configuration includes one, two, or three SR8-Plus Dissolution Test Stations connected to the AutoPlus and the Agilent 8453 Spectrophotometer. This configuration will use both the tester and sampler drivers. See Figure 2-1 for an example setup of this configuration. Figure 2-1 SR8-Plus/AutoPlus/Agilent Configuration 2.2.2 AutoPlus/Agilent/Non-Hanson Bath Configuration This configuration includes one, two, or three Non-Hanson Dissolution Test Stations connected to the AutoPlus and the Agilent 8453 Spectrophotometer. This configuration will use only the sampler driver. Control of the baths will require a driver from the bath vendor or other source, if available. See Figure 2-2 for an example setup of this configuration. Figure 2-2 AutoPlus/Agilent/Non-Hanson Bath Configuration Section 2 Introduction 3
2.2.3 SR8-Plus/Agilent/Non-Hanson Sampling System Configuration This configuration includes one, two, three, or four SR8-Plus Dissolution Test Stations connected to an Agilent 8453 Spectrophotometer with a non-autoplus sampling system such as the Agilent peristaltic pump/valve system. This configuration will use only the tester driver. Control of the sampling system will require a driver from the vendor, if available, for the sampling system or, in the case of the Agilent peri-pump/valve system, the control is incorporated into the Agilent ChemStation software. See Figure 2-3 for an example setup of this configuration. Figure 2-3: SR8-Plus/Agilent/Non-AutoPlus Sampling System Configuration Other accessories and options may be included in a particular system that will change the actual layout of the systems shown. 2.2.4 Vision G2 AutoPlus/Vision G2 Elite 8/Agilent Configuration This configuration includes one, two, or three Vision G2 Elite 8 Dissolution Test Stations connected to the Vision G2 AutoPlus and the Agilent 8453 Spectrophotometer. This configuration will use both the tester and sampler drivers. See Figure 2-4 for an example setup of this configuration. Figure 2-4: Vision G2 AutoPlus/Vision G2 Elite 8 Tester/Agilent Configuration Section 2 Introduction 4
2.2.5 Vision G2 AutoPlus/Agilent/Non-Hanson Bath Configuration This configuration includes one, two, or three Non-Hanson Dissolution Test Stations connected to the Vision G2 AutoPlus and the Agilent 8453 Spectrophotometer. This configuration will use only the sampler driver. Control of the baths will require a driver from the bath vendor or other source, if available. See Figure 2-5 for an example setup of this configuration. Figure 2-5: Vision G2 AutoPlus/Non-Hanson Bath/Agilent Configuration 2.2.6 Vision G2 Elite 8/Agilent/Non-Hanson Sampling System Configuration This configuration includes one, two, three, or four Vision G2 Elite 8 Dissolution Test Stations connected to an Agilent 8453 Spectrophotometer with a non-autoplus sampling system such as the Agilent peristaltic pump/valve system. This configuration will use only the tester driver. Control of the sampling system will require a driver from the vendor, if available, for the sampling system or, in the case of the Agilent peri-pump/valve system, the control is incorporated into the Agilent ChemStation software. See Figure 2-6 for an example setup of this configuration. Figure 2-6: Vision G2 AutoPlus/Non-Hanson Bath/Agilent Configuration Section 2 Introduction 5
3 Specifications 3.1 Software Requirements Hanson Research recommends using the most current, validated version of the software available. Dissolution Testing Software must be installed prior to installing the Hanson Dissolution System Drivers. Agilent ChemStation General Purpose Software, p/n G1115AA Version B.04.02 or higher. Agilent ChemStation Advanced Software, p/n G1116AA. Agilent Dissolution Testing Software, p/n G1118AA Hanson Dissolution System Drivers, p/n 81-200-026 Version 5.00 or higher. 3.2 Hardware Requirements Agilent 8453 Spectrophotometer, with a suitable computer that meets or exceeds the requirements to run the ChemStation program, and has sufficient memory for dissolution systems and a printer. See the Agilent website for current requirements. Agilent 8-Position MultiCell Transport, G1120A (p/n 60-200-031). 8 Flow cells 1mm (p/n 91-215-033), 2mm (p/n 91-215-034), 10mm (p/n 91-215- 035), or other sizes by special order, upon request. Flow cell tubing kit for 8 cells (p/n 60-200-484). Sampling probes, based on system configuration. SR8-Plus Firmware Version 0.98 or higher. 2 AutoPlus Firmware Version 1.01 or higher. 3 Vision G2 Elite 8 Tester Firmware Version 2.10 or higher. 4 2 Order p/n 73-100-722 to upgrade SR8-Plus Firmware. 3 Order p/n 60-200-724 to upgrade AutoPlus Firmware. 4 Consult Hanson Research for the part number of the Vision Tester Firmware upgrade kit. Section 3 Specifications 6
Vision G2 AutoPlus Autosampler Firmware Version 2.11 or higher. 5 3.3 Optional Accessories AutoPlus MultiFill Collector (p/n 60-200-490) for sample collection with Legacy instruments. Vsion AutoFill Collector (p/n 61-201-001) for sample collection with Vision instruments SR8-Plus E-Probe Actuator Kit (p/n 73-105-108) for automatic probe actuation. Vision G2 Elite 8 Tester Magazine (p/n 74-107-010) for automatic probe actuation for 1 liter vessels. Other accessories based on system configuration and intended use. 5 Consult Hanson Research for the part number of the Vision Sampler Firmware upgrade kit. Section 3 Specifications 7
4 Installation 4.1 Before You Begin It is important that the software and hardware requirements described in Section 3 (Specifications) are met before beginning the installation. Note: If the Agilent Security Pack (G1813AA) is to be installed, the installation and configuration of the security program must be completed prior to installing the Hanson Research Drivers. Ensure that each of the Hanson Research instruments that will be used in the system are properly installed according to the operation manual for each instrument and considering the final overall setup of the system. Ensure that the Agilent 8453 Spectrophotometer and corresponding PC workstation are properly installed according to the installation manual provided by Agilent, again considering the final overall setup of the system. Refer to Figure 4-1a and 4-1b for suggested placement of the individual instruments on the laboratory bench. Figure 4-1a Suggested Legacy Instrument Placement on Laboratory Bench Section 5 Operation and Programming 8
g 90 60 Vision AutoPlus Elite 8 HP8453 & AutoFill Elite 8 Elite 8 ChemStation 30 0 0 30 60 90 120 150 180 210 240 270 300 330 360 (DISTANCES IN CENTIMETERS) Figure 4-1b Suggested Vision Instrument Placement on Laboratory Bench Note: Placement of individual instruments will vary based on the actual system components used. Section 5 Operation and Programming 9
4.2 Hardware Installation 4.2.1 SR8-Plus/AutoPlus/Agilent Configuration This configuration below includes one, two, or three SR8-Plus Dissolution Test Stations connected to the AutoPlus and the Agilent 8453 Spectrophotometer. Refer to Figure 4-2 for communication connections. B2 B1 B3 Figure 4-2 Communication Connections for SR8-Plus/AutoPlus/Agilent Configuration 1. Connect the communication connector, p/n 47-200-373, to the serial port on the ChemStation PC workstation. Connect the communication cable, p/n 47-200-759, to the communication connector and to Comm Port 1 on the AutoPlus. 2. Connect communication cable, p/n 47-200-759, from Comm Port 2 on the AutoPlus to Comm Port 1 on the SR8-Plus that is Bath 1 (B1). When additional baths are included in the system, verify or make the following connections as appropriate. 3. If a second bath is included in the system, connect Bath 2 by connecting a communication cable, p/n 47-200-759, to Comm Port 2 on Bath 1 and Comm Port 1 on Bath 2. Section 5 Operation and Programming 10
stu j kl v wx abc m no yz () d ef pqr ghi a bc j kl d ef s tu m no ghi v wx pqr yz () stu jkl vwx abc mno yz () def pqr ghi j kl s tu vwx a bc m no y z() def p qr g hi Hanson Dissolution System Drivers Operation Manual 4. If a third bath is included in the system, connect Bath 3 by connecting a communication cable, p/n 47-200-759, to Comm Port 2 on Bath 2 and Comm Port 1 on Bath 3. 5. If not already connected, connect the MultiFill Collector to Comm Port 3 of the AutoPlus. Make or verify the following liquid connections. Refer to Figure 4-3 for liquid connections. BACD SR8-Plus B2 B1 SR8-Plus AutoPlus HP8453 MultiFill B3 SR8-Plus Figure 4-3: Liquid Connections for SR8-Plus/AutoPlus/Agilent Configuration 1. Connect the Source A and B lines to SR8-Plus Bath 1 and Bath 2, as appropriate. 2. Connect the Source C lines to SR8-Plus Bath 3 or media, as appropriate. 3. Connect the AutoPlus D lines to the appropriate lines from the Flow Cell Tubing Kit (p/n 60-200-484), matching color to color for the 8 lines. 4. Connect the remaining lines from the Flow Cell Tubing Kit to the 8 flow cells (color to color). Note: Ensure that the direction of the flow is such that the liquid will be following the correct path into the flow cell as designated by the directional arrow on the flow cell itself. Section 5 Operation and Programming 11
5. Connect the liquid lines coming out of the flow cells to waste or to the input lines on the MultiFill Collector, if included in the system. 6. Position the flow cells in the MultiCell Transport on the Agilent 8453. Note: Hanson Research recommends that the cell in the first position be connected to the tubing with the clear colored fittings and that the sampling probe with the clear colored fitting be placed in blank media. It is also recommended that the cell in the last position be connected to the tubing with the purple colored fitting and that the sampling probe with the purple fitting be placed in the control solution, if applicable. 4.2.2 AutoPlus/Agilent/Non-Hanson Bath Configuration This configuration includes one, two, or three non-hanson Dissolution Test Stations connected to the AutoPlus and the Agilent 8453 Spectrophotometer. See Figure 4-4 for communication connections. Figure 4-4 Communication Connections for AutoPlus/Agilent/Non-Hanson Bath Configuration 1. Connect the communication connector, p/n 47-200-373, to the serial port on the ChemStation PC workstation. Section 5 Operation and Programming 12
2. Connect the communication cable, p/n 47-200-759, to the communication connector and to Port 1 on the AutoPlus. 3. If not already connected, connect the MultiFill Collector to Port 3 of the AutoPlus. Make or verify the following liquid connections. Refer to Figure 4-5 for liquid connections. Figure 4-5 Liquid Connections for AutoPlus/Agilent/Non-Hanson Bath Configuration 4. Connect the Source A and B lines to Bath 1 and Bath 2, as appropriate. 5. Connect the Source C lines to Bath 3 or media, as appropriate. 6. Connect the AutoPlus D lines to the appropriate lines from the Flow Cell Tubing Kit (p/n 60-200-484), matching color to color for the 8 lines, and connecting one cell to each of the 8 D lines from the AutoPlus. Note: Ensure that the direction of the flow is such that the liquid will be following the correct path into the flow cell as designated by the directional arrow on the flow cell itself. Section 5 Operation and Programming 13
7. Connect the remaining lines from the Flow Cell Tubing Kit to the 8 flow cells (color to color). 8. Connect the liquid lines coming out of the flow cells to waste or to the input lines on the MultiFill Collector, if included in the system. 9. Position the flow cells in the MultiCell Transport on the Agilent 8453. Note: Hanson Research recommends that the cell in the first position be connected to the tubing with the clear colored fittings and that the sampling probe with the clear colored fitting be placed in blank media. It is also recommended that the cell in the last position be connected to the tubing with the purple colored fitting and that the sampling probe with the purple fitting be placed in the control solution, if applicable. Section 5 Operation and Programming 14
4.2.3 SR8-Plus/Agilent/Non-AutoPlus Sampling System Configuration This configuration includes one, two, three, or four SR8-Plus Dissolution Test Stations connected to an Agilent 8453 Spectrophotometer with a non-autoplus sampling system such as the Agilent peri-pump/valve system. Only a single Vision Bath may be connected to non- Hanson samplers. See Figure 4-6 for SR8-Plus communication connections. Hanson Bath Figure 4-6 Communication Connections for SR8-Plus/Agilent/Non-AutoPlus Sampling System Configuration 1. Connect the communication connector, p/n 47-200-373, to the serial port on the ChemStation PC workstation. 2. Connect the communication cable, p/n 47-200-759, to the communication connector and to Port 1 on the SR8-Plus that is Bath 1. When additional SR8-Plus baths are included in the system, verify or make the following connections as appropriate. 3. If a second bath is included in the system, connect Bath 2 by connecting a communication cable, 47-200-759, to Port 2 on Bath 1 and Port 1 on Bath 2. Section 5 Operation and Programming 15
4. If a third bath is included in the system, connect Bath 3 by connecting a communication cable, 47-200-759, to Port 2 on Bath 2 and Port 1 on Bath 3. 5. If a fourth bath is included in the system, connect Bath 4 by connecting a communication cable, 47-200-759, to Port 2 on Bath 3 and Port 1 on Bath 4. 6. Make or verify the liquid connections according to the installation instructions for the sampling system installed. 4.2.4 Vision G2 AutoPlus/Vision G2 Elite 8/ Agilent Configuration This configuration below includes one, two, or three Vision G2 Elite 8 Dissolution Test Stations connected to a Vision G2 AutoPlus and the Agilent 8453 Spectrophotometer. Refer to Figure 4-7 for communication connections. LAN LAN Network Switch LAN LAN LAN Elite 8 Elite 8 Vision HP8453 Elite 8 ChemStation AutoPlus & AutoFill ChemStation Figure 4-7 Communication Connections for Vision G2 AutoPlus/ Vision G2 Elite 8 Testers/Agilent Configuration 1. Connect all dissolution instruments, the HP8453 and the Agilent ChemStation computer to the network switch using network cable p/n 91-211-036. 2. The configuration shown in figure 4-7 is typical but not unique. Depending on preferences or lab requirements, other configurations are acceptable as long as the dissolution instruments are in the local area network of the ChemStation computer. Section 5 Operation and Programming 16
3. If not already connected, connect the Vision AutoFill Collector to the port labeled Collector Port of the Vision G2 AutoPlus using RS232 cable p/n 47-200-759. Make or verify the following liquid connections. Refer to Figure 4-8 for liquid connections. ABCD Elite 8 Elite 8 Vision AutoPlus & AutoFill HP8453 Elite 8 Figure 4-8: Liquid Connections for Vision G2 Elite 8/Vision G2 AutoPlus/ Agilent Configuration 4. Connect the Source A and B lines to Vision Testers 1 and 2, as appropriate. 5. Connect the Source C lines to a third Vision Tester or media, as appropriate. 6. Connect the Vision AutoPlus D lines to the appropriate lines from the Flow Cell Tubing Kit (p/n 60-200-484), matching color to color for the 8 lines. 7. Connect the remaining lines from the Flow Cell Tubing Kit to the 8 flow cells (color to color). Note: Ensure that the direction of the flow is such that the liquid will be following the correct path into the flow cell as designated by the directional arrow on the flow cell itself. Section 5 Operation and Programming 17
8. Connect the liquid lines coming out of the flow cells to waste or to the input lines on the AutoFill Collector, if included in the system. 9. Position the flow cells in the MultiCell Transport on the Agilent 8453. Note: Hanson Research recommends that the cell in the first position be connected to the tubing with the clear colored fittings and that the sampling probe with the clear colored fitting be placed in blank media. It is also recommended that the cell in the last position be connected to the tubing with the purple colored fitting and that the sampling probe with the purple fitting be placed in the control solution, if applicable. 4.2.5 Vision G2 AutoPlus/Agilent/Non-Hanson Bath Configuration This configuration includes one, two, or three non-hanson Dissolution Test Stations connected to the Vision G2 AutoPlus and the Agilent 8453 Spectrophotometer. See Figure 4-9 for communication connections. Network Switch LAN LAN GENERIC BATH GENERIC BATH Vision AutoPlus & AutoFill HP8453 GENERIC BATH ChemStation Figure 4-9 Communication Connections for Vision G2 AutoPlus/Agilent/ Non-Hanson Bath Configuration 1. Connect the Vision G2 AutoPlus Autosampler, the HP8453 and the Agilent ChemStation computer to the network switch using network cable p/n 91-211-036. Section 5 Operation and Programming 18
2. The configuration shown in figure 4-9 is typical but not unique. Depending on preferences or lab requirements, other configurations are acceptable as long as the Vision G2 AutoPlus in the local area network of the ChemStation computer. 3. If not already connected, connect the Vision AutoFill Collector to the port labeled Collector Port of the Vision G2 AutoPlus using RS232 cable p/n 47-200-759. Make or verify the following liquid connections. Refer to Figure 4-10 for liquid connections. ABCD GENERIC BATH GENERIC BATH Vision AutoPlus & AutoFill HP8453 GENERIC BATH Figure 4-10 Liquid Connections for Vision G2 AutoPlus/Agilent/ Non-Hanson Bath Configuration 4. Connect the Source A and B lines to Bath 1 and Bath 2, as appropriate. 5. Connect the Source C lines to Bath 3 or media, as appropriate. 6. Connect the AutoPlus D lines to the appropriate lines from the Flow Cell Tubing Kit (p/n 60-200-484), matching color to color for the 8 lines, and connecting one cell to each of the 8 D lines from the Vision G2 AutoPlus. Section 5 Operation and Programming 19
Note: Ensure that the direction of the flow is such that the liquid will be following the correct path into the flow cell as designated by the directional arrow on the flow cell itself. 7. Connect the remaining lines from the Flow Cell Tubing Kit to the 8 flow cells (color to color). 8. Connect the liquid lines coming out of the flow cells to waste or to the input lines on the AutoFill Collector, if included in the system. 9. Position the flow cells in the MultiCell Transport on the Agilent 8453. Note: Hanson Research recommends that the cell in the first position be connected to the tubing with the clear colored fittings and that the sampling probe with the clear colored fitting be placed in blank media. It is also recommended that the cell in the last position be connected to the tubing with the purple colored fitting and that the sampling probe with the purple fitting be placed in the control solution, if applicable. Section 5 Operation and Programming 20
4.2.6 Vision Elite 8/Agilent/Non-AutoPlus Sampling System Configuration This configuration includes one, two, three, or four Vision G2 Elite 8 Dissolution Test Stations connected to an Agilent 8453 Spectrophotometer with a non-autoplus sampling system such as the Agilent peri-pump/valve system. See Figure 4-11 for communication connections. LAN LAN Network Switch LAN LAN LAN Elite 8 Elite 8 ChemStation HP8453 Elite 8 Hanson Elite Bath 8 GENERIC SAMPLER Figure 4-11 Communication Connions for Vision G2 Elite 8 Tester/ Agilent/Non-AutoPlus Sampling System Configuration 1. Connect all dissolution testers, the HP8453 and the Agilent ChemStation computer to the network switch using network cable p/n 91-211-036. 2. The configuration shown in figure 4-11 is typical but not unique. Depending on preferences or lab requirements, other configurations are acceptable as long as the dissolution instruments are in the local area network of the ChemStation computer. 3. Make or verify the liquid connections according to the installation instructions for the sampling system installed. Section 5 Operation and Programming 21
4.3 Software Installation The Hanson Dissolution System Drivers CD (p/n 81-200-026) contains two drivers one for the SR8-Plus and Vision G2 Elite 8 Dissolution Test Stations and another for the Legacy AutoPlus and the Vision G2 AutoPlus Autosampler. If your system contains an AutoPlus sampler and one or more Hanson baths, both drivers will be installed and will work together with the ChemStation. If your system contains only Hanson baths, then the bath driver alone will be installed and work in conjunction with your peristaltic pump and valve systems or other sampling system. The bath driver will work independently of drivers for autosampler systems other than the Agilent peristaltic pump and valve system. If your system contains an AutoPlus and non-hanson baths, the AutoPlus driver will be installed and work independently of the other manufacturer s bath driver. 4.3.1 Uninstalling Previous Installations of the Hanson Dissolution System Drivers If the Hanson Dissolution System Drivers have been previously installed on the ChemStation computer, make sure that you uninstall any previous installation (even of the same revision) of the dissolution drivers before attempting an installation. To uninstall a previously installed version of the Hanson Dissolution System Drivers: 1. Open the ChemStation program and switch to Dissolution Testing Mode (ModeDissolution Testing Mode). 2. If necessary, select the On-line Hanson AutoPlus from the Sampling menu (InstrumentSelect Sampling SystemOn-line Hanson AutoPlus) to activate the AutoPlus icon. Section 5 Operation and Programming 22
3. Click on the AutoPlus icon and select the Options menu. The following dialog box will appear. 4. Click on the Remove AutoPlus Driver button. This will remove the AutoPlus driver from the ChemStation configuration register. 5. Click Yes at Do you really want to remove the AutoPlus Driver? prompt and OK at the You must restart ChemStation for changes to apply. 6. Click OK to close the Hanson AutoPlus Options window. 7. Exit ChemStation. 8. Click on the Windows Start button and select Programs Hanson Research Uninstall. Section 5 Operation and Programming 23
This will uninstall the Hanson Research Drivers from the system. 9. Restart ChemStation and verify that the AutoPlus is removed from the list of available sampling systems. Section 5 Operation and Programming 24
10. Additionally, verify that when Dissolution Bath Status is selected from the Instrument menu, no Dissolution Bath Status window opens. 4.3.2 Installing the Hanson Dissolution Drivers Before beginning the driver installation verify that the AutoPlus and SR8-Plus or Vision Dissolution Test Stations have their power turned on and that they are properly connected as described in Section 4.2 (Hardware Installation). 1. The Hanson Dissolution Drivers are provided on a CD ROM. Begin the installation by inserting the disc and selecting Install Drivers from the CD menu. Section 5 Operation and Programming 25
3. The following splash screen is displayed once the installation process initializes, click on the Next button to continue. 4. Follow the on-screen instructions from the InstallShield Wizard. Enter a user name or department name in the Name Field. Enter the company name in the Company Field. Enter the serial number from the serial number label on the CD ROM case in the Serial Field. 5. Select the path to the ChemStation directory as the Destination Directory. Typically, the path will be C:\hpchem if upgrading from a previous version of ChemStation, or Section 5 Operation and Programming 26
C:\Chem32 for a new installation. These are the default ChemStation directories. If necessary, use the Change button to modify the path. 6. Choose Next to create and add program icons to the Hanson Research program folder. The InstallShield Wizard will continue the installation and configure the drivers required by your system configuration. Section 5 Operation and Programming 27
7. Once the setup program is finished copying the required files to the proper locations, Restart the computer in order for Windows to load the new files properly. 8. Run the ChemStation program and select the Dissolution Testing Mode. Once you select the Dissolution Testing mode, the setup program will configure the ChemStation to recognize the new drivers added. Section 5 Operation and Programming 28
9. If your system contains legacy instruments and they are connected properly and powered, the configuration editor will detect your configuration automatically. A window similar to the one below is displayed depending on your configuration: 10. If your system contains Vision instruments which require a static I.P address (usually obtained from the I.T. department of the lab), you need to select the type of instrument and enter its UNIQUE address. 11. Click on the Test Settings button and wait until the green checkmarks are displayed, if not check the configuration settings and connections and click on Test Settings again. 12. Once you have green check marks on all the instruments selected, click Save and Exit and Restart ChemStation in order for the changes to take effect. Section 5 Operation and Programming 29
5 Operation and Programming This section will discuss only those operation and programming features that may differ from the operation and programming features defined by Agilent and discussed in the manuals provided with the ChemStation software. 5.1 Dissolution Driver Start the ChemStation and select either Dissolution Testing Mode or Multibath Dissolution Testing Mode, as desired. The ChemStation will load the dissolution bath driver automatically. The driver can be used to view the status of a Bath 1 in Dissolution Testing Mode or of each configured bath in Multibath Dissolution Testing Mode, as follows. To view the status of Bath 1 in Dissolution Testing Mode, select Dissolution Bath Status from the Instrument menu. To view the status of any configured bath in Multibath Dissolution Testing Mode, first select the desired bath from the available baths. Section 5 Operation and Programming 30
With the desired bath selected, select Dissolution Bath Status from the Instrument menu. In Dissolution Testing Mode a window will open for Bath 1. In Multbath Dissolution Testing Mode a window will open for the selected bath. Section 5 Operation and Programming 31
5.1.1 Test Station Tab Status Resembles the SR8-Plus display and allows the user to monitor the test station status of the selected bath. Bath Parameters Allows the user to manually control the stirrer and temperature control of the bath and to verify that ChemStation is communicating with the bath. E-Probes Allows the user to control the SR8-Plus E-Probes, Auto-Probes (for the Vision G2 Elite 8 Auto-Mag), or other automated sampling probes. Note: The E-Probes frame will be grayed out if this feature is not available or is disabled in your system. Handling of Bath Parameters Allows the user to specify whether or not bath parameters are implemented immediately upon loading the method. Normally you would want Change stirrer settings immediately unchecked and Change heater settings immediately checked so that when you load a method, the motor does not start but the bath starts to heat to the target temperature. Section 5 Operation and Programming 32
Hide Details Allows the user to hide all of the details of the bath driver window and show only the status display. The display floats above all other windows to allow constant bath monitoring. Print Allows the user to print the bath status information to the ChemStation printer. 5.1.2 Reference Tab Reference Serial Numbers Allows the user to keep track of the vessel, paddle, basket, and basket shaft serial numbers used with the test station. Hide Details Allows the user to hide all of the details of the bath driver window and show only the status display. The display floats above all other windows to allow constant bath monitoring. Print Allows the user to print the reference information to the ChemStation printer. Section 5 Operation and Programming 33
5.1.3 Setup Tab Note: Typically, the settings in this tab will not be changed. Contact Hanson Research before making changes to these settings. Tester Model Either SR8-Plus or Vision G2 Dissolution Testers. IP Address or RS232 Serial Port The serial port where the tester is connected or the static I.P. address of the Vision tester. Instrument Identification Edit the identification string that the bath uses to respond to remote commands. Log Level Creates a communications log to aid in troubleshooting. Test Setup The serial port where the tester is connected or the static I.P. address of the Vision tester. Hide Details Hide extra details of status window and show only the status display. The display floats above all other windows to allow constant bath monitoring. Print Allows the user to print the setup information to the ChemStation printer. Section 5 Operation and Programming 34
5.1.4 About Tab The about tab contains important information about the dissolution bath driver such as the part number, revision, company, user, and serial number. Note: Always have the information displayed on the About Tab ready when contacting Hanson Technical Support. Print Allows the user to print the setup information to the ChemStation printer. Close Hide status window completely. Section 5 Operation and Programming 35
5.2 AutoPlus Driver To access the functions of the Hanson AutoPlus (or Vision-Enabled AutoPlus) Driver, click on the AutoPlus icon (which looks like a light blue circle with a syringe in front). The functions available to the user are described in this section. Transfer The action of moving a volume of fluid from a source to a target location. This function operates like the Transfer function in the AutoPlus Automatic Syringe Control. To use this function, enter the desired transfer volume and select a Source (A-D) and a Target (A-D). Click the Transfer button to perform the transfer. Whenever the Blank, Standard, or Sample spectrophotometer functions are selected, the driver will instruct the AutoPlus to pump liquid through the flow cells at the volume selected in the Transfer function. To disable this action, disable Auto Rinse/Wait as indicated in the Auto Rinse/Wait description on the next page. Wash The action of clearing out the liquid from the sampling line using blank or wash media. This function operates like the Wash function in the AutoPlus Automatic Syringe Control. Section 5 Operation and Programming 36
To use this function enter the desired wash volume and select a Source (A-D) and a Target (A-D or All). Click the Wash button to perform the wash. Use this feature as dictated by your prerun or postrun requirements. Prime The action of purging air from the sampling line with fluid. This function operates like the Prime function in the AutoPlus Automatic Syringe Control. To use this function, enter a prime volume and select a Source (A-D or All) and a Target (A-D or All). Click the Prime button to perform the prime. Use this feature as dictated by your prerun or postrun requirements. Note: The user must ensure that the media replace line is primed or purged of air before starting a sampling procedure that requires media replacement. Auto Rinse/Wait Clicking on this menu item either enables (checked) or disables (unchecked) this option. If this option is enabled, the driver will instruct the AutoPlus to pump the volume specified in the Transfer function whenever the user chooses to measure a blank, standard, or sample from the buttons in ChemStation or the corresponding buttons on the 8453. When using these functions, the AutoPlus will not pump if this option is disabled. Section 5 Operation and Programming 37
Test Parameters Allows the user to rinse the flow cells with a certain volume before each measurement, or to select an AutoPlus protocol (Legacy by number, Vision by Name) whenever the ChemStation initiates a sampling event (measurement cycle). Select a wait time that allows the flow cell to be full and stable before the ChemStation starts reading the flow cells. The AutoPlus Test Parameters can also be accessed from the Instrument menu by selecting Setup Sampling System (which brings up the Setup MultiCell Transport dialog box) and clicking the Parameters button. Options Opens the following window of options. Typically, the Position cell changer option will be selected (checked). With this option selected, the cell changer will automatically move to the cell position that is designated as the blank in the Measure Cycle Definition when the blank is measured manually; when the standard is measured manually, the cell changer will automatically move to the position designated as the control in the Measure Cycle Definition. When this option is not selected (unchecked), the cell changer will remain in its current position when the blank and standard are measured manually. Section 5 Operation and Programming 38
Clicking the Remove AutoPlus Driver button will remove the AutoPlus driver from the ChemStation registry. Removal of the AutoPlus Driver cannot be undone. If the AutoPlus Driver is removed from the ChemStation registry, the Hanson Dissolution Drivers must be completely uninstalled as per Section 4.3.1 and reinstalled as per Section 4.4. Log Level Creates a communications log to aid in troubleshooting. Help Gives the user access to the AutoPlus Driver Help system. About The About screen contains important information about the dissolution bath driver such as the part number, revision, company, user, and serial number. Note: Always have the information displayed on the About screen ready when contacting Hanson Technical Support. Section 5 Operation and Programming 39
Creating a ChemStation Method 5.2.1 Creating an AutoPlus Protocol (Optional) If the AutoPlus is used on the system, you have the option of having the ChemStation program instruct the AutoPlus to run an AutoPlus protocol at each sampling time point. This option is required when using AutoPlus Collect and Detect methods and when using the Retrieval Reservoir. At a minimum, the AutoPlus protocol must be set up to rinse and detect. Additional options can be programmed for collection and retrieval as needed. Refer to the AutoPlus Operation Manual (for Legacy p/n 60-200-802, for Vision p/n 61-108-010 ) for protocol programming. For the Legacy AutoPlus, only one sampling point is required as the AutoPlus protocol will be run at each sampling point. For the Vision G2 AutoPlus, no sampling points are required. 5.2.2 Creating a ChemStation Dissolution Method 1. Open the Edit Method window by clicking the Setup button in the Dissolution window. 2. Choose Product/Bath, or... Section 5 Operation and Programming 40
... choose Edit Product Info and Bath Parameter from the Method menu. This will open the Product, Bath and Info Method Parameters window. 3. Complete the information on the Product tab screen according to your method needs and the requirements for the ChemStation system. 4. Complete the information on the Bath tab screen according to your method needs and the requirements for the ChemStation system. Section 5 Operation and Programming 41
5. Click on the Advanced button to setup the interval at which the speed and temperature status data is logged. If so equiped, choices appear to actuate the automatic E-Probe control, to set the default stroke length which controls the travel of the e-probe or magazine and the pill dropper use. 6. Complete the information on the Options & Info tab screen according to your method needs and the requirements for the ChemStation system. 7. If the Hanson Research SR8-Plus or Vision Driver is installed, the bath parameters are to be controlled by the ChemStation. Place a check in the Bath Parameters are controlled by ChemStation box by clicking in the box. This will allow the ChemStation Section 5 Operation and Programming 42
program to control the start and stop of the stirrers, the stir speed, and the bath temperature. Note: When a new method is created, the ChemStation defaults to Bath Parameters are controlled by ChemStation unchecked! 8. From the Edit Method window click Evaluation, or...... choose Edit Evaluation Parameter from the Method menu to open the Evaluation Method Parameters window. Section 5 Operation and Programming 43
9. Complete the information on the Analysis tab screen according to your method needs and the requirements for the ChemStation system. 10. Complete the information on the Calculation tab screen according to your method needs and the requirements for the ChemStation system. Section 5 Operation and Programming 44
11. Complete the information on the QC Limits tab screen according to your method needs and the requirements for the ChemStation system. 12. From the Edit Method window click Diss.-Run, or...... choose Edit Dissolution Run Parameter from the Method menu to open the Dissolution Run Method Parameters window. Section 5 Operation and Programming 45
13. Complete the information on the PreRun Seq. tab screen according to your method needs and the requirements for the ChemStation system. Refer to Appendix A for details on the Actions and Parameters that are available when utilizing the Hanson Research Drivers. 14. Complete the information on the Dissolution Run tab screen according to your method needs and the requirements for the ChemStation system. Refer to Appendix A for details on the Actions and Parameters that are available when utilizing the Hanson Research Drivers. Section 5 Operation and Programming 46
15. Complete the information on the PostRun Seq. tab screen according to your method needs and the requirements for the ChemStation system. Refer to Appendix A for details on the Actions and Parameters that are available when utilizing the Hanson Research Drivers. Section 5 Operation and Programming 47
5.2.3 Defining the Measurement Cycle When running dissolution tests utilizing the Hanson AutoPlus and the Agilent MultiCell Transport for the 8453, it is necessary to identify the intended contents of each UV cell in the MultiCell Transport (i.e. Blank, Sample, Control, or Not Used). To define the measurement cycle,: 1. Choose Define Measurement Cycle from the Method menu to open the Measure Cycle Definition window. The Total Steps per Measure Cycle is always 8 when using the 8-position MultiCell Transport, regardless of how many cells will actually be used. 2. Using the drop down menu for each cell position (Meas. No), set the Measure As to Blank, Sample, Control, or Not Used, as appropriate for the test method. Section 5 Operation and Programming 48
Note: Agilent and Hanson Research recommend that the first cell (Meas. No 1) always be set to Blank. Hanson Research recommends that the AutoPlus tubing from the AutoPlus syringe position number 7 (clear) be directed to this cell and that the sample probe be directed to a container of blank media. 3. Enter the appropriate drawn Volume and added Volume as required by your method to automatically calculate the volume change corrections. 5.2.4 Defining the Control (Optional) 1. If a control is being used, choose Define Control for Measurement Cycle from the Method menu to open the Control for Measurement Cycle Definition window. 2. Enter the Analyte Name, Concentration, Unit, and Dev. Limit % as appropriate for the test method. Section 5 Operation and Programming 49
5.2.5 Setting Up the Sampling System 1. With the On-line Hanson AutoPlus selected as the sampling system, click the Setup button in the Sampling window, or...... choose Setup Sampling System from the Instrument menu to open the Setup Multicell Transport window. 2. Enter the Cell Path Length for each cell as appropriate for the test method. Section 5 Operation and Programming 50
3. Click the Parameter button to open the Hanson AutoPlus Test Parameters window. 4. Choose Rinse flowcells with or Run AutoPlus protocol #. When Rinse flowcells with is selected, ChemStation will instruct the AutoPlus to pump the specified volume from the source dissolution bath through the flow cells at each sampling time point. The Wait before reading flowcells for time automatically defaults to 10 seconds of wait per 1 ml of volume pumped. This is the recommended setting. When Run AutoPlus protocol is selected, it is necessary to choose the appropriate AutoPlus protocol from the drop-down list. The protocol is selected by number (1-25) for the Legacy AutoPlus and by name for the Vision G2 AutoSampler (as shown below). The ChemStation will instruct the AutoPlus to run the selected protocol at each sampling time point. This option is required for Collect and Detect methods and whenever the Retrieval Reservoir is used. 5. Click the Print button (if desired) in the Hanson AutoPlus Test Parameters window to print the AutoPlus test parameters that will be used with the ChemStation. Section 5 Operation and Programming 51
6 Running a Test and Reviewing Data The information in this section is intended to be a general overview on running a dissolution test. For more complete information, refer to the ChemStation reference materials and Section 5 (Operation and Programming) of this operation manual. 1. Power on the 8453, the SR8-Plus or Vision Dissolution Test Station(s), the AutoPlus, and the MultiFill collector, if used. 2. Launch the ChemStation program and turn on the appropriate lamp(s) (InstrumentLamps). 3. Choose Dissolution Testing Mode (single bath) or Multibath Dissolution Testing Mode as appropriate for the configuration of the system. 6.1 Zero the Cells (if done previously, go to Section 6.2) Note: Zeroing the cells is only required if the cells are moved from their positions or replaced AFTER zero cells is performed. It does not need to be repeated otherwise. When using the MultiCell Transport, it is appropriate to match the cells by using the Zero Cells option. Agilent recommends that the cells be filled with purified water to zero the cells. During the zeroing process, the cell in Position 1 will be set to zero at all wavelengths. Each subsequent cell is evaluated against the first cell, and values are obtained and stored in the zero cells registry to correct for the cell variations at each wavelength. The cells should be zeroed whenever the cells are moved from their positions in the MultiCell Transport or if the cells are changed. If, when attempting to run a ChemStation method, a message appears indicating that there are no zero cell values, it is recommended that the cells be zeroed before continuing with the test. Section 6 Running a Test and Reviewing Data 52
1. In Dissolution Testing mode (single bath mode), fill the cells with water by using the Prime function described in Section 5 (Operation and Programming) or by using the AutoPlus syringe controls. 2. Choose Zero Cells from the Hanson menu. 3. Run and save the zero cells data. 4. In Multibath Dissolution Testing mode, fill the cells with water by using the Prime function described in Section 5 (Operation and Programming) or by using the AutoPlus syringe controls. 5. Choose Spectrophotometer Reference from the Measure menu. The MultiCell Transport will move to the reference position and the measurement will be made. 6. Choose Zero Cells from the Measure menu. 7. Run and save the zero cells data. Section 6 Running a Test and Reviewing Data 53
6.2 Spectrophotometer Reference (Multibath Dissolution Testing Only) In order to operate the system in Mutibath mode, it is necessary to perform the spectrophotometer reference prior to running blanks, standards, or samples. This reference must be measured each time the ChemStation program is opened and after switching back to the Multibath mode from any other mode. To measure the reference: 1. Choose Spectrophotometer Reference from the Measure menu. The MultiCell Transport will move to the reference position and the measurement will be made. 2. Load or Create the ChemStation method. Note: To create a new method, follow the steps in Section 5 (Operation and Programming) in this manual and the appropriate ChemStation reference information. 3. To load an existing method, choose Load Method from the File menu. An existing ChemStation method will contain the dissolution setup, the definitions of the measurement cycle and control, and the sampling system setup. Section 6 Running a Test and Reviewing Data 54
The existing method will be loaded and the method name will be displayed in the Method field. Note: When running in Multibath Dissolution Testing mode, a method must be loaded or created for each bath that will be operated. 6.3 Load or Run Standards In order to analyze the data and calculate dissolution results, standard information must be available. Standard data may be available in the ChemStation method, if the method was saved with standard data. Additionally, standard data may be saved in a standard file that can be loaded. To load standards from a file: 1. Choose Load Standards from the File menu. Section 6 Running a Test and Reviewing Data 55
2. To run new standards prior to beginning the dissolution test, fill the appropriate cell with standard by using the Transfer function described in Section 5 (Operation and Programming), by using the AutoPlus syringe controls, or by allowing the AutoPlus to pump (Auto Rinse/Wait on) with the appropriate volume programmed in the AutoPlus Transfer feature within ChemStation (see Section 5 [Operation and Programming]). 3. Click the Standard button to initiate the measurement of the standard(s). Section 6 Running a Test and Reviewing Data 56
Note: It is possible to run standards as part of the Pre-Run Seq. in the Dissolution Setup; however, this requires pumping from the AutoPlus through all eight sampling lines and will require additional pre-run preparation. Refer to the ChemStation reference materials and Appendix A of this operation manual for additional information. 4. With the appropriate ChemStation method(s), standards, and other necessary items loaded for each bath, initiate the dissolution test by clicking the Run Dissolution button. The test will run according to the parameters programmed in the ChemStation method. 5. At the conclusion of each test, clean up each instrument according to its individual clean up instructions. Note: For additional information, refer to the ChemStation reference materials and the operation manual(s) or user guide(s) for the Vision, SR8-Plus, AutoPlus, and Retrieval Reservoir, as necessary. Section 6 Running a Test and Reviewing Data 57