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In no event shall Distek, Inc. be liable for any loss of profit or any other commercial damage caused or alleged to have been caused directly or indirectly by this document.
Distek Model 2500 Overview W elcome to a new innova tion in Dissolution testing . The Distek Model 2500 Dissolution Test System offers unmatched flexibility and configurability while maintaining the user-friendliness that laboratories around the world have come to expect from the preceding four generations of the 2100 series.
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Accommodates up to 8 vessels ranging in size from 100mL to 4L, allowing the user to run a diverse range of tests. W orks w ith Distek line of Dissolution equipment a nd softw a re. The instrument is compatible with the following equipment/software: Eclipse 5300 EVO 4300 with Firmware Revision 3.01 or higher...
Less than 0.010” (0.254mm) Total Indicator Runout o Manual o Automatic (100 maximum saved Pre-Programmed Methods) Program Modes o Distek EVO 4300, Distek OPT-DISS 405 UV, Agilent UV-Vis 8453, Waters 2695D HPLC User Management Manage up to 50 Users with Multiple Access Level...
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The Material in this document is provided "as is", and is subject to changes without notice in future revisions. Distek disclaims all warranties, either express or implied, with regard to this manual and any information contained herein, including but not limited to the implied warranties of merchantability and fitness for a particular purpose.
Failure to comply with these precautions or warnings elsewhere in this manual violates the safety standard of the design, manufacture and intended use of this instrument. Distek Inc. assumes no liability for the customer or end-user to comply with these requirements.
Introduction 1.5.1 Physical Site Consideration The dimensional requirements specified below are adequate for the installation of the Model 2500 Dissolution System: The minimum bench depth needed (front edge of bench to the back splash or wall) is 22 inches (56cm). However, the minimum recommended bench depth is 25 inches (64cm) for proper ventilation.
Maximum: The Model 2500 Series may add to the humidity of the laboratory during operation. Any vessels filled and left uncovered can raise humidity levels. Water vapor and/or hydrogen chloride vapor from dissolution media can cause serious effects when condensed on electrical components and contacts.
To achieve the full range of controlled operation (20 to 65°C) within specified tolerances, the Model 2500 Series Dissolution System is designed to be installed and operated in laboratories where the maximum operating temperature does not exceed 25°C. The maximum allowable ambient operation temperature is 30°C.
1.6.3 Air Quality Considerations Distek dissolution systems are designed to be operated in a laboratory environment that has no visible dust problem and with organic solvent vapor levels as low as possible. Operation is not recommended in dusty lab environments, or in labs with significant chlorinated or reactive solvent vapor levels.
Environmental Considerations Distek & the WEEE Directive (Waste Electrical & Electronic Equipment) Distek, Inc. is committed to protecting the environment and understands the importance of proper recycling. The “crossed out wheelie bin” symbol on the product or on its packaging indicates that this product must not be disposed of with domestic household waste.
Please take a few moments when unpacking the Distek Model 2500 Dissolution instrument to check for all items indicated on the packing list. Notify Distek or your shipper immediately of any discrepancies or damage to cartons or contents in transit.
With the instrument positioned properly on the bench and leveled, locate the AC power inlet and outlet on the lower left hand side of the instrument. Connect the power cord extension labeled AC Out TCS - for 2500 and 2500 RTD. Connect the supplied main power cord labeled AC In .
Model 2500 Installation TCS Installation To install the TCS for 2500 and 2500RTD, follow the procedure below: Position the thermo-circulator behind the right side of the bath with the TCS fittings facing the right side. Connect the power cord extension to the power port of the TCS and the other end to the main unit.
To install vessels, follow the procedure below: Raise the drive unit. For 2500 and 2500 RTD: Locate the white arrow on the vessel flange then insert a vessel in each position and use the vessel clips on the vessel plate to hold them in place.
Standard Shafts Wireless Sensor Shafts The Model 2500 as a standard comes with standard solid shafts. As an option, RTD wireless sensor shafts were added to monitor individual vessel temperature. If shafts are serialized, follow the Production Final Test report for spindle location.
Installation Vessel Covers There are multiple cover designs you can use with the Model 2500 to minimize evaporation. All Distek vessel covers place the sampling probes at the precise sampling height as per USP, BP, EP and JP standards, the midpoint between the top of the stirring element and the top of the media.
The TempChek is an ultra-high accuracy resolution, hand-held digital thermometer that uses a YSI series precision thermistor. Along with an RS-232 port, it allows temperature data from the TempChek to be sent to the Model 2500 to calibrate the TCS temperature sensors and or the RTD wireless shafts.
The default instrument printer setup is set to USB. Model 2500 local printer connection The Model 2500 can also be connected through a network printer by following the setup below: Log into the instrument as part of the Manager group. The select Setting s | System Setting s | System Setup .
3.3.1 Dedicated Instrument Printer Another option to connect Distek instruments (Models 2500, symphony 7100, sensIR 3200 and Eclipse 5300) is to have a dedicated instrument printer instead of having a local printers for each instruments or connecting the instruments to print through the domain.
Cipher instrument control software is a Windows based application designed and developed by Distek to remotely access and control the dissolution equipment. Cipher can be installed locally or networked to provide full access to any Distek dissolution bath and autosampler from any appropriately connected PC running the application. Cipher allows the user to create and run methods, monitor instrument status, generate reports, and control users and manager logins.
RS-232 port (COM port) to configure either single or multiple baths connected to the PC serial ports. This has been made possible due to the capability of the RS-232 port in Distek Model 2500 Dissolution Systems (a NULL RS-232 cable is required).
Model 2500 Graphic User Interface (GUI) 2500 Dashboard This is the main display screen of the Model 2500 instrument. It gives you access to available menus. Below is a brief description of the function of each item. 2500 Dashboard Screen Title Bar: Shows the Distek logo, current time and date.
Below is a brief description of the function of each item. 2500 RTD Dashboard Screen Title Bar: Shows the Distek logo, current time and date. Menu Tabs: Used to navigate throughout the software. User Login Name: Displays who is logged in to the instrument.
Below is a brief description of the function of each item. 2500 RTD Dashboard Screen Title Bar: Shows the Distek logo, current time and date. Menu Tabs: Used to navigate throughout the software. Method Name (or Manual): Shows the selected Method when running; otherwise, shows a manual run.
System Settings: Perform instrument system setup, shaft calibration, service upgrades and instrument validation. Help: Information regarding on how to use the instrument and how to contact Distek if you encounter any issues with the instrument. Help also contains the instrument serial numbers, identification and firmware revisions.
Modified Paddles Intrinsic The apparatus height is set and configured for baskets and paddles purchased at Distek, and should not have to be changed unless the height is out of specification. For better height adjustment reproducibility, it is recommended to keep vessels in the same position after emptying and washing.
Manual Run 5.4.1 2500 with Standard Shafts This section describes how to use the Model 2500 instrument in Manual Run. From the Dashboard, set the temperature by selecting temperature display. Enter the desired temperature using the on-screen keypad. Start heating by selecting the Pla y button.
Operation 5.4.2 2500 RTD This section describes how to use the Model 2500 with Wireless Sensors in Manual Run. From the Dashboard, set the temperature by selecting temperature display. Enter the desired temperature using the on-screen keypad. Start heating by selecting the Pla y button.
5.4.3 2500 Select This section describes how to use the Model 2500 with Wireless Sensors in Manual Run. Every time a method is started, the instrument will verify that each shaft were not moved or replaced. If there are changes, the application will alert the operator that changes were made.
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Ba sket, M odified Pa ddles, Intrinsic. Temperature range is from 20.0°C to 65.0°C . Volume range is from 500mL to 1000mL. Enable which vessels will be used (available only to 2500 RTD and Select). RPM range is from 30 to 300 RPM.
Simultaneous Drop Using Baskets 5.7.3.1 2500 with Standard Shafts This section describes how to run the Model 2500 using baskets for simultaneous sampling. Choose M ethods tab. The Select Method screen displays the method listing. Select the desired method you want to run.
Operation 5.7.3.2 2500 RTD-Select This section describes how to run the Model 2500 with Wireless Sensors using baskets for simultaneous sampling. Choose M ethods tab. The Select Method screen displays the method listing. Select the desired method you want to run.
Simultaneous Drop Using Paddles 5.7.4.1 2500 with Standard Shafts This section describes how to run the Model 2500 using paddles for simultaneous sampling. Choose M ethods tab. The Select Method screen displays the method listing. Select the desired method you want to run.
Operation 5.7.4.2 2500 RTD-Select This section describes how to run the Model 2500 with Wireless Sensors using paddles for simultaneous sampling. Choose M ethods tab. The Select Method screen displays the method listing. Select the desired method you want to run.
Staggered Drop Using Baskets 5.7.5.1 2500 with Standard Shafts This section describes how to run staggered sampling with the Model 2500 using baskets. Choose M ethods tab. The Select Method screen displays the method listing. Select the desired method you want to run.
Operation 5.7.5.2 2500 RTD-Select This section describes how to run staggered sampling with the Model 2500 with Wireless Sensors using baskets. Choose M ethods tab. The Select Method screen displays the method listing. Select the desired method you want to run.
Staggered Drop Using Paddles 5.7.6.1 2500 with Standard Shafts This section describes how to run the Model 2500 using paddles using staggered sampling. Choose M ethods tab. The Select Method screen displays the method listing. Select the desired method you want to run.
Operation 5.7.6.2 2500 RTD-Select This section describes how to run staggered sampling with the Model 2500 with Wireless Sensors using baskets. Choose M ethods tab. The Select Method screen displays the method listing. Select the desired method you want to run.
TCS Schedule is a way to turn on or turn off the circulator heat and motor pump at a given scheduled time to save electricity when the instrument is not in use. The sample screen shots below are ONLY for Model 2500 and 2500RTD. The Model 2500 Select does not have TCS.
Accurate calibration of the bath temperature sensor is essential for proper operation of the Model 2500 instrument. Factory calibration provides accuracy within ±0.1 °C. Care must be taken when re-calibrating the instrument, in order to realize the full accuracy and proper sensing temperature range.
Selecting the System Settings For Model 2500, select TCS Ca libra tion or Tem pera ture Ca libra tion for wireless sensors. A popup window message prompts user to enter a password to access the temperature calibration mode. Select OK and enter the appropriate password using the on-screen keypad.
If equipped with wireless sensors, perform Lo-Cal first of shafts with bath temperature between 20-23°C. The sample screenshots below are similar for Model 2500 with or without the wireless sensor option. Place the TempChek probe as close as possible next to the external probe inside the bath.
If equipped with wireless sensors, perform Lo-Cal of shafts first with bath temperature between 20-23°C. The sample screen shots below are similar for Model 2500 with or without the wireless sensor option. Place the TempChek probe as close as possible next to the external probe inside the bath.
Fill the vessels with at least 900mL DI water with temperature between 20°C to 23°C. Follow the steps below to calibrate the RTD shafts using the Distek TempChek. From the TCS Calibration screen, select Sha ft Ca libra tion as shown.
Operation 5.10.6 Battery Monitor Available only for 2500RTD and 2500 Select, the Battery Monitor screen continuously captures and transmits each wireless shaft sensor battery capacity for operators to see. It alerts the operators in real-time as to when the battery will need changing.
Lubrication Belt Tension This section gives a very brief overview of how to properly maintain the Model 2500 Series Dissolution Instrument. To ensure consistent performance, a Preventive Maintenance and Operational Qualification should be performed periodically. Distek recommends these to be performed at least twice a year.
To ensure consistent performance, follow the recommended steps below: Apply a small amount of multipurpose light oil (Distek recommends 3 in 1 Oil) on the whole length of the drive guide rods using a clean rag or paper towel.
Mechanical This chapter gives an overview of the different types of problems that you might encounter while operating the Model 2500 Dissolution System. To ensure consistent performance, follow the recommended solutions given for a specific problem. Improper servicing or adjustment practices can cause further instrument failure or serious physical injuries.
Troubleshooting 7.1.1 General Messages This section gives an overview samples of the different types of general messages encountered while operating the Model 2500 Dissolution System. Follow the recommended response given for a specific message. M essa g e Description Confirms to the user to abort the test.
Error Messages This section gives an overview samples of the different types of error messages encountered while operating the Model 2500 Dissolution System. To ensure consistent performance, follow the recommended response given for a specific message. M essa g e Description Informs the user about the maximum test time.
Troubleshooting 7.1.3 Warning Messages This section gives an overview samples of the different types of warning messages encountered while operating the Model 2500 Dissolution System. Follow the recommended response given for a specific message. M essa g e Description Warns the user about sampling time requirements.
Troubleshooting 7.1.4 Service Messages This section gives an overview sample of the different types of service messages encountered while operating the Model 2500 Dissolution Bath. To ensure consistent performance, follow the recommended response given to a specific message. Message Description USB flash drive is not available or cannot be accessed.
LCD Display This section gives an overview of possible issues which may be encountered with the instrument LCD display while operating the Model 2500 Dissolution System. To ensure consistent performance, follow the recommended solutions given for a specific problem. Problem...
Power Supply This section gives an overview of possible issues which may be encountered with the instrument power supply while operating the Model 2500 Dissolution System. To ensure consistent performance, follow the recommended possible solutions given for a specific problem.
Troubleshooting Heating This section gives an overview of possible issues regarding the heating of the vessels while operating the Model 2500 Dissolution System. To ensure consistent performance, follow the recommended possible solutions given for a specific problem. Problem Possible Solution...
Model 2500 Troubleshooting Stirring This section gives an overview of possible issues regarding the stirring function while operating the Model 2500 Dissolution System. To ensure consistent performance, follow the recommended possible solutions given for a specific problem. Problem Possible Solution...
Model 2500 Troubleshooting I/O Communication This section gives an overview of possible issues regarding the (input/output) I/O Communication of the Model 2500 Dissolution System. Follow the recommended possible solutions given for a specific problem. Problem Possible Solution N o printout Printer Check Distek for a printer compatibility list.
Temperature Calibration Using TempChek This section gives an overview of possible issues when calibrating the shaft sensors using a Distek TempChek on the Model 2500 Dissolution System. To ensure consistent performance, follow the recommended possible solutions given for a specific problem.
Model 2500 Troubleshooting Mechanical This section gives an overview of possible mechanical problems encountered while operating the Model 2500 Dissolution System. To ensure consistent performance, follow the recommended possible solutions given for a specific problem. Problem Possible Solution By using a bubble level or digital level, level the instrument from...
UPS may be needed. Although the Distek Model 2500 is designed with internal surge protection, failure to follow these recommendations may compromise the operation of the system and, should the system be damaged by power surges, lightning or other significant power fluctuations, such system damage is not covered by Distek’s warranty.
Model 2500 Appendix C: Sample Printouts Appendix C: Sample Printouts This section presents some example printouts which were generated by the Model 2500 Series instrument (InstaPrint, Saved Report, Method Printout and User List). InstaPrint printout generated during a method test:...