Category Archives: Evolution 6100

Connecting a Distek dissolution system to the Evolution 4300

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).

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Filed under Evolution 4300, Evolution 6100, Evolution 6300, Model 2100C, Model 2500, Symphony 7100

Using the produKEY

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)

Figure 1

 4. Next select Open (see Figure 2) to display the Method Listing screen (Figure 3).

Figure 2

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).

Figure 4

 7. Select the PRODUKEY button on the bottom of the screen (see Figure 5).

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.

Figure 6

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Filed under Evolution 6100, Evolution 6300

Controlling Vessel Temperature Individually on the 6100

One of the core features of the Evolution 6100 that differentiates it from the competition is the ability to run different temperatures in each position simultaneously. In addition the media volume and stirring element can also be varied for each vessel.

The ability to vary key parameters like temperature is important in formulations and R&D. During development n=6 testing is typically not required; therefore the 6100 allows users to increase their throughput by testing their formulations at different temperatures simultaneously on the same unit.

While you may already be aware of this capability, you may be unsure how to program the system to run such parameters.

Below you will find a step by step guide for setting individual temperatures in each position of the Evolution 6100.

Controlling Vessel Temperature Individually on the 6100

1- From the main screen select the MANUAL MODE wizard button.

2- Select INDIV VESSELS. Figure 1 below will then be displayed.

3- Highlight the desired vessel icon and press ENTER. Figure 2 below will now be displayed.

4- Highlight the TEMP field. Using the + and – keys change to the desired test temperature.

5- Highlight the STIR field. Using the + and – keys change to the desired stirring element (PAD for paddles or BAS for baskets).

6- Highlight the VOL field. Using the + and – keys change to the desired test volume.

7- Highlight the RPM field. Using the + and – keys change to the desired test RPM.

8- Highlight the ON/OFF field. Using the + and – keys change to the desired value (on or off).

9- To change setting for other vessels follow one of the two following methods:

a- Highlight the VESSEL # position and using the + and – keys change to the desired vessel number. Follow steps 5-9 to modify the test settings.

b- Highlight the BACK button and press ENTER. Select the vessel to modify from the screen displayed in Figure 3-29. Follow steps 5-9 to modify the test settings.

10- Highlight the BACK button and press ENTER.

11- Highlight the START button on the menu bar and press ENTER

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Filed under Bathless, Evolution 6100

Intrinsic Dissolution

 

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).

Figure 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.

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Filed under Bath-Based, Bathless, Evolution 6100, Evolution 6300, Model 2100C

Cipher Software

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

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Filed under Cipher Software, Evolution 4300, Evolution 6100, Evolution 6300, Model 2100C

Height Adjustment Block

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.

5) Verify.

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Filed under Bath-Based, Bathless, Evolution 6100, Evolution 6300, Model 2100C

VisiChek

The Evolution 6100 is Distek’s flagship dissolution tester, because of the individual vessel heater jackets which allow for rapid and precise media heating.  However, there are unique and valuable features throughout the Evolution 6100 that demand similar attention.  Today we will highlight the Visichek Visual Access system. 

 The Visichek (pictured below) provides optimal visual access to each vessel (Ex. A).  This reflective base provides a unique bottom up perspective and enhances the vantage point for observations.  This is best exemplified in Ex. B as the red arrow shows the actual reflection Visichek provides.

 The bathless system combined with Visichek eliminates obscured vision, often associated with murky bath water, and provides a clear view of the activity in each vessel.  It also eliminates the physical demands of bending down or kneeling to gain optimal perspective.

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Filed under Evolution 6100