When connecting a Distek dissolution system to the Evolution 4300 syringe-pump dissolution autosampler, you will need to connect an RS-485 cable between the two systems to allow for electronic control of the dissolution unit from the autosampler.
Depending on the type of dissolution system that is being utilized with the Evolution 4300 autosampler, the specific RS-485 cable needed will be different (the connecting ends are different).
If you have our new symphony 7100 or Model 2500, you will need part number 2700-0162 (RS-485 Cable for 4300 Sampler to 7100 and 2500).
If you are using an Evolution 6100, Evolution 6300 or 2100C, you will need part number 2400-0004 (RS-485 Cable for 4300 Sampler to 2100C, 6100, and 6300).
The Evolution Dissolution System comes standard with a data access key referred to as the produKEY. This key allows methods to be easily copied and transferred to multiple units without having to reprogram the method settings, saving time, and improving your laboratory’s efficiency. There is also a calibration produKEY to store and easily retrieve calibration data in case of a failure. Additional produKEYs are available from Distek. Each produKEY is capable of storing up to five methods.
Saving a Method to the produKEY:
Note: The operator logged in to the system must be part of the Manager group to save a method to the produKEY.
1. Insert the produKEY into the slot to the right of the control keypad. Turn the key clockwise ¼ turn. The unit will produce an audible beep.
2. Return to the Main screen.
3. Open the method to be saved to the produKEY: From the Main screen select the Auto Mode Wizard (see Figure 1)
4. Next select Open (see Figure 2) to display the Method Listing screen (Figure 3).
5. Highlight the method to open, select ENTER and then OPEN from the menu bar.
6. Select the MORE OPTIONS button on the bottom of the screen (see Figure 4).
7. Select the PRODUKEY button on the bottom of the screen (see Figure 5).
8. Select YES from the message window to store the information to the produKEY. A long beep confirms the action.
9. Rotate the produKEY counterclockwise a ¼ turn then clockwise a ¼ turn.
10. The screen shown in Figure 6 will be displayed showing the methods stored on the produKEY.
The intrinsic dissolution rate is defined as the dissolution rate of pure substances under the condition of constant surface area, agitation-stirring speed, pH and ionic-strength of the dissolution medium.
The knowledge of intrinsic dissolution rate is vital in screening new drug candidates as it can help optimize the physiological effectiveness of new dosage forms. Distek has improved the performance and reliability of the rotating cylinder or “wood apparatus” with the paddle over stationary disk intrinsic apparatus. This is available in two configurations; standard for use with 1L vessel and mini for use with 100/200 ml vessels. The Distek design avoids the formation of air bubbles on the surface of the product and eliminates the potential of product “slippage” as can be the case with the wood apparatus.
The Distek standard and mini intrinsic apparatus consists of steel punch, die, and base plate (fig. A).
Test material is placed in the 0.8 cm diameter die cavity (optional cavity sizes are available) and the punch is inserted. The punch, die and press plate are placed in a laboratory press and kept under 2000 psi for 4-5 minutes. The press plate is disconnected from the die to expose a compact pellet of .5 cm2 surface area.
A Viton gasket is placed around the threaded shoulder of the die and a polypropylene plastic cap is screwed onto the threads. The assembly is then immersed, pellet side up, in the bottom of a flat dissolution vessel containing 900ml of dissolution medium at 37C. The paddle blade is positioned 6mm above the surface of the pellet and rotated at 50 rpm.
See USP 30-NF 25 General Chapter <1087> page 531 for more details.
The embedded temperature sensor inside each of the hollow stirring shafts allow the EVOLUTION Series to continuously control, monitor, and record the temperatures of each individual vessel throughout the entire Dissolution test. Located inside and at the bottom most position of the shaft (red arrow below), the temperature sensors are able to continuously monitor the temperature of the media. Without the use of an external thermometer it eliminates any associated hydrodynamic effects. The EVO 6100 and EVO 6300 are the only dissolution systems on the market with this capability.
The shafts of the EVO 6100 and EVO 6300 are designed for 100% assurance that the medium temperature is maintained throughout the entire test. Also, it eliminates the need to remove the shaft when changing between apparatus 1 (baskets) and apparatus 2 (paddles) thanks to the use of detachable stirring elements and the height adjustment block.
Cipher instrument control software is a Windows based application designed and developed by Distek to remotely access and control our dissolution equipment.*
Cipher can be installed locally or networked providing 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. Cipher also offers the flexibility to set the level of security appropriate for your laboratory. When enabling all the security features and combined with the appropriate internally developed policies, Cipher will meet 21 CFR part 11 compliance.
* Cipher currently controls the Model 2100C, EVO 6100, 6300, and 4300
Procedure for priming your TCS 0200C Thermocirculator. Failure to properly prime the TCS will result in damage to the heater and/or pump.
1. Fill bath midway between the top of the bath inlet fitting and the lower outlet fitting, (dotted line in figure 2).
2. Attach a 3ft (1m) long x 5/8″ (16mm) ID drain tubing to drain valve.
3. Raise drain tubing to the vertical position (figure 1). The drain valve should be tilted up.
4. Open the drain valve to allow pump inlet tubing to fill with water for 5-10 seconds.
5. Slowly lower drain tubing to allow the tubing to fill with water (figure 2). Fill the tubing with as much water as possible.
6. Close the drain valve.
7. Lift drain tubing vertically and open the drain valve allowing the water to flow through the pump. Water should be observed exiting the TCS through the bath water inlet tubing and port.
8. Repeat steps 4-7 as necessary.
9. Close the drain valve.
10. Remove and empty the priming tubing from the drain valve.
11. Turn on the TCS power.
12. If water does not immediately begin to circulate turn off the TCS power and repeat the priming procedure.
Setting your Distek Dissolution tester apparatus 1 and 2 to the proper USP defined height using Distek’s height adjustment block increases efficiency. It allows for a rapid change between apparatus 1 and 2 without having to remove the shaft and reset the proper height. The height block is located on the side of your Evolution 6100, 6300 and Model 2100C labeled paddles or baskets (red arrow).
To set the proper height follow these steps:
1) Raise the drive head of the unit to the highest position.
2) Loosen the shaft collar (blue arrow) with an allen wrench and raise the shaft half way.
3) Turn the height adjustment block (red arrow) to the horizontal or neutral position. At that point, you will not be able to read the text (paddles or baskets) from the front of the unit.
4) Lower the drive head until it sits firmly on the horizontal height adjustment block.
5) With paddle blades installed on all the shafts, lower the drive head until the paddle blades touch the bottom of the vessels.
6) Tighten the shaft collars with an allen wrench.
7) Raise the drive head.
8) Turn the height adjustment block to paddles and lower the drive head until it sits on the height adjustment block.
9) The height is now set to the appropriate height per USP, 25mm +/- 1mm.
10) The height can verified using the Distek height-chek tool.
To use baskets:
1) Raise the drive head of the unit.
2) Replace the paddles with basket adapters when using detachable shafts and stirring elements.
3) Turn the height adjustment block (red arrow) to baskets.
4) Lower the drive head until it sits on the height adjustment block.