Varian dissolution apparatus manual

The system is a two-piece assembly engineered to easily set the shaft length to maintain consistent clearance from the bottom of the vessel. Carryover concerns, typically associated with two-part shafts, are eliminated in the Varian design by having the junction above the liquid level.

So when switching between paddle and basket methods, no height readjustments are required. Refine By Refurbished New 2. Not Specified 9. Listing Type Buy Now 1. Request a Quote Clear Filters. Showing 1 - 24 of 43 Items. Use the lifting straps to lift the dissolution apparatus off of the packing platform. Place the dissolution apparatus on the ground. Warning The electrical connection at the back of the tester is the primary disconnect for the instrument.

The tester should be positioned to allow accessibility to the power cords for easy disconnection. Step 1. Ensure the power switch on the power supply box is in the OFF position. Step 2. Connect the power cord between the receptacle on the side of the dissolution apparatus and an outlet of the appropriate voltage. Turn on the dissolution apparatus. Turn off the dissolution apparatus.

Step 6. Remove the cushioning material between the drive unit and vessel plate. Step 7. Level the instrument by placing the bubble level provided in the accessory kit on the vessel plate. Check for level in the center of the front and rear of the instrument and on the left and right sides of the instrument.

The feet supporting the tester are adjustable. Step 8. Note There is a safety mechanism in the bottom of the left side guide rod which keeps the drive unit from lowering improperly. If the rods do not line up precisely with the holes in the vessel plate, the mechanism engages and the drive unit stops lowering and rises to the home position. The drive unit stops automatically when it reaches the home position. Release the key when the drive unit reaches the desired position.

The drive unit stops automatically when at the lowest position. There is a safety mechanism located in the bottom of the left side guide rod which keeps the drive unit from lowering improperly. Drive Unit Guide Rods guide rod safety mechanism Sliding Back the Drive Unit There are two release levers for the drive unit which keep it from sliding back.

One is located on either side of the drive unit. Ensure the drive unit has been fully raised to the home position. Place both hands on the two release levers and use your index fingers to depress the release levers. Use your thumbs to slide the drive unit back far enough to disengage it from the latching mechanism. Move your hand to the handle at the front of the drive unit and slide the drive unit back until it stops.

This guarantees it is positioned in the correct centering location for operation. Ensure the water bath is positioned under the vessel plate and rests firmly on the base plate. Secure the vessel plate to the frame with three screws. Finger-tighten the screws. Locate the two tubing clamps. The inlet is connected to the water bath outlet and the outlet which is located next to the power switch is connected to the water bath inlet.

Slip a tubing clamp over one end of the short length of tubing that is connected to the underside of the water bath. Slide the clamp toward the end until it is over the inlet port and secure. This ensures a leak-free connection. Caution Do not overtighten the tubing clamps.

Damage to the plastic tubing could result. Slip a tubing clamp over one end of the longer length of tubing that is connected to the back of the water bath. Slide the clamp toward the end until it is over the outlet port and tighten with a screwdriver. Place the end of the temperature probe through the small hole in the back of the vessel plate. Do not fill the water bath at this time. Step 9. Step Locate the accessory kit. Raise the drive unit to its home position and slide it back to allow full access to the vessels.

If applicable, remove one of the vessels and set it aside. Fill the water bath with ultrapure water by pouring the water through the hole in the vessel plate. Fill to the level indicated by the operating water level tag located on the right side of the water bath. Note If possible, preheat the water to speed achievement of the desired bath temperature. Use purified water whenever possible to minimize scale and mineral buildup.

Algaecides may be used to inhibit algae and bacteria growth. Check the label to ensure the formulation is compatible with the plastic materials used in the bath construction. Check all connections for leaks. You may notice bubbles from the water bath inlet as the air in the system is purged. After a few minutes flow into the bath should be smooth and steady. With the unit below the level of the water bath, lift one end and then the other for a minute or two to help air clear from the unit.

Raise the drive unit to its home position and slide it back until it stops. Place the vessel in the hole in the vessel plate. Press down so that the vessel and magnetic ring flanges fit securely in place and are flush with the vessel plate.

Twist the vessel slightly until the magnets in the ring flanges make contact with the magnets in the vessel plate. Repeat steps 2 and 3 for each vessel. The vessels are automatically centered and require no further adjustment. See the current USP for a complete explanation. Raise the drive unit to its home position.

Carefully insert a paddle into each spindle until approximately half of the shaft is above the top of the spindle. Place a 25 mm height sphere in each of the vessels. Gently press down each paddle shaft until the bottom of the paddle blade rests against the height sphere. Place a shaft locking ring on the top of each shaft and slide it down until it rests on the shaft collar. Rotate each shaft locking ring so the drive positioning teeth on both the shaft locking ring and the shaft collar rest against one another, locking the shaft in place.

Remove the height spheres from the vessels. Lower the drive unit until it stops. Installing Basket Shafts Step 1.

Carefully insert a basket shaft into each spindle until approximately half of the shaft is above the top of the spindle. Clip the basket height gauge onto a shaft. Gently press down the basket shaft until the bottom of the gauge rests against the bottom of the vessel. Be careful not to use excessive pressure or the bottom of the vessel may crack. Place a shaft locking ring on the top of the shaft and slide it down until it rests on the shaft collar.

Rotate the shaft locking ring so the drive positioning teeth on both the shaft locking ring and the shaft collar rest against one another, locking the shaft in place.

Remove the height gauge from the basket shaft. Repeat steps 3 - 9 for each of the remaining positions. Installing Rotating Cylinders Note If using rotating cylinders, it is easier to install the evaporation covers prior to installing the rotating cylinders.

Carefully insert a rotating cylinder shaft into the spindle until approximately half of the shaft is above the top of the spindle. Page 32 Setup Step 3. Repeat steps 3 - 7 for each of the remaining positions. Installing the Intrinsic Dissolution Apparatus Step 1. Carefully insert an intrinsic dissolution apparatus shaft into a spindle until approximately half of the shaft is above the top of the spindle. Gently press down the shaft until the desired height is reached.

The intrinsic dissolution apparatus is set at the desired height above the bottom of the vessel. Repeat this procedure as applicable for additional positions. Removing the Dissolution Apparatus To remove paddles, baskets, rotating cylinders or intrinsic dissolution apparatus, complete the following steps: Step 1.

Repeat this step for all positions. Raise the drive unit to its home position and gently remove the shafts taking care not to drop them into the vessels. Locate the centering verification gauge and the EaseAlign centering ring.

EaseAlign Centering Ring Step 2. Slide the centering verification gauge down the shaft until the tapered ends rest in two opposing slots of the EaseAlign centering ring. Rotate the centering verification gauge 90 degrees and slide the gauge down the shaft until the tapered ends rest in the other two opposing slots of the EaseAlign centering ring. The shaft should remain within the confines of the radial cutout of the gauge at both settings.

Repeat steps 2 - 5 for the remaining vessel positions. Installing Cannula Assemblies Step 1. Ensure the sampling and return lines are connected to the sampling and return cannulas of each cannula assembly according to the following order: red 1 , white 2 , blue 3 , purple 4 , yellow 5 , clear 6 , green 7 , and brown 8. Install the cannula assemblies in the appropriate opening in the top cover according to the order listed in step 1. Use the alignment pin and coordinating notch to guide each assembly through the opening in the top cover.

Standard Evaporation Cover opening for cannula assembly opening for DDM tube knobbed evaporation plug in right manual sampling hole evaporation plug in left manual sampling hole Step 2. Align the appropriate openings in the evaporation cover with the plastic DDM tube extending from the bottom of the drive unit and the cannula assembly. Apply gentle upward pressure until the top of the evaporation cover slides over the O-ring on the spindle housing. The evaporation cover floats in place.

Repeat steps 1 - 3 for vessel positions 2 and 3. Repeat steps 2, 3, and 5 for the remaining vessel positions. Both attachments aid the alignment of the evaporation cover on the vessel. The open alignment attachment allows use of the DDM. The solid alignment attachment reduces evaporation and blocks use of the DDM. If using the optional evaporation cover for use with baskets or for low loss, complete the following steps: Step 1.

If using paddles or rotating cylinders, remove the apparatus from vessel position 1. Repeat for each vessel position. If using baskets, place an evaporation cover on the vessel at each vessel position.

Visually align the DDM tube with the DDM alignment attachment and the cannula assembly with the opening in the evaporation cover. Page 38 Setup Step 3. Align the evaporation cover with the cannula assembly and the DDM tube at each vessel position.

Lower the drive unit completely. Setting the Manual Sampling Cannula To sample manually from positions 7 and 8, it is necessary to set the manual sampling cannulas to the correct length. For positions 7 and 8, complete the following steps: Step 1. The Diagnostic Menu screen displays. Do not press down on the adapter. Select the corresponding location on the screen and the appropriate DDM opens. Gentle downward pressure slides the adapter into place.

The adapter prevents the DDM from closing. Attach the cannula part number to the syringe. Manual Sampling through the Top Cover cannula bushing Step 8. Loosen the hex screw on the cannula bushing and slide the bushing up or down the cannula until it is positioned for the correct USP-specified sampling location.

If sampling from a mL volume, remove the bushing. When positioned correctly, tighten the hex screw. Remove the manual sampling cannula and set aside for use during the test. Gently remove the DDM manual override adapter. Does not allow access to the System Setup Menu 1 screen which includes administration and calibration functions.

Does not allow method editor privileges. Passwords are numeric and no longer than eight characters in length. Note If you erase or forget all system administrator passwords, contact the Dissolution Systems Service Department. It is recommended that you immediately change the user identification and password for Administrative control of the VK Dissolution Apparatus once your unit is installed. To set up the user list, complete the following steps: Step 1.

Ensure the dissolution apparatus is turned on. The drive unit moves to the home position and the Login screen displays. The System Setup Menu 1 screen displays. The Administration screen displays. Note To display a letter, hold down the number key until the appropriate letter displays, then release the key.

For example, to display the letter C, press and hold 2. As you hold the number key, the 2 displays and is replaced by an A, then a B and finally a C. If you continue to hold the 2, these characters continue to scroll until you release the number key.

Deleting Preset User Definitions It is recommended that you immediately change the user identification and password for Administrative control of the VK Dissolution Apparatus once your unit is installed. The List and Delete Users screen displays.

Select the preset user identification and password by selecting NEXT until the cursor flashes over the number of the appropriate user identification. Select YES to confirm deletion. Press ESC to return to the Administration screen. Vessel Plate Layout 8 1 7 2 6 5 3 4 Varian, Inc.

After adding the user identifications, passwords, and security, press ESC to return to the System Setup Menu 1 screen. Diagnostics This option is for diagnostic purposes and if applicable, independent operation of the DDMs, cannulas and clutches. This option is applicable only if AutoTemp is installed. If paddle spin is disabled, the paddles do not spin prior to the start of the test. Note: if an initial temperature is taken in the method, the paddles spin regardless of whether paddle spin is enabled or disabled.

If paddle spin is enabled, the paddles spin prior to the start of the test which allows the vessel temperature to equilibrate. This removes the possibility of a temperature gradient—allowing for a more accurate vessel temperature reading. Menu 2 Select MENU 2 to access menus for the setting the clock and communication port functions; entering serial numbers, the number of vessels, and the tester identification number; enabling or disabling all position spin; and to set a delay between the initial temperature measurement and the opening of the DDMs.

This function grants method editor privileges to the administrator and supervisor or all users. If security override is disabled, when the machine is turned on, the Login screen displays and you must log in.

Last User The user identification of the last user and the date and time of last login displays on the screen. Spindle hours are displayed under the screen title. The Calibration Menu screen displays. Enter the difference between the water bath temperature and the vessel temperature. Set Alternate Start Drive Position When performing a staggered start under manual operation with Apparatus 1, you must set the drive unit to an alternate start position.

Bath Vessel Difference Note For this option, if you enter a value outside of the acceptable range, an error message displays indicating appropriate values. To set the bath vessel difference, complete the following steps: Step 1. The acceptable range is 0. The Calibration Menu screen displays with the new bath vessel difference value. Note This value is automatically set when a vessel temperature start is performed. Setting an Alternate Drive Unit Position When performing a staggered start and sampling manually with Apparatus 1, you must set an alternate drive unit start position.

Note Ensure the basket assemblies are installed and the standard evaporation covers are removed prior to beginning this procedure. To set the height to an alternate position, complete the following steps: Step 1. If applicable, remove the cannula assembly. Spindle Housing spindle housing Step 5. Ensure the optional basket evaporation covers are in place. Lower the drive unit to position the baskets just above the evaporation covers.

The drive unit automatically lowers to this position when a staggered start test is started with Apparatus 1 while under manual operation. Cannula Height Calibration Note This section does not apply if you are manually sampling or using staggered baskets or paddles. If it is necessary to adjust the factory-set sampling heights for the cannulas, complete the following steps: Step 1. Ensure the drive unit is in its lowest position. The Set Sampling Depth screen displays with factory-set values for each apparatus.

It refers to the number of steps the cannula motor moves. If you are using paddle over disk or rotating cylinder, select MENU 2 to view these apparatus. Page 52 Administrator Operation Step 6. The number of steps the cannula motor moved to reach that position displays under the selected apparatus and volume.

Note For volumes between mL and mL, the appropriate cannula height is interpolated from the mL and mL settings. For volumes greater than mL, the appropriate cannula height is extrapolated from the mL and mL settings. Press ESC. The cannulas return to the home position and the Calibration Menu screen displays.

The Setup Alarms screen displays the basket and paddle expirations dates and the following options: Option Response PM Expiration Date Use this option to set the preventative maintenance alarm. The cursor flashes. The date displays. Bath Temp. Limit Use this option to set an alarm to sound if the water bath temperature exceeds the set limit. The bath temperature limit displays on the screen.

Entering a value of 0. The Calibration Calendar screen displays. An alarm sounds when an entered date is reached. Select each location and verify the corresponding DDM opens and closes. Select a location and verify the corresponding cannula moves down.

Select the location again and verify the corresponding cannula moves up. Repeat for all cannula positions. Select a location and verify the clutch activates. OFF changes to ON. Select the location again and verify the brake activates. Repeat for all shaft positions. The Bath and Heater Temp screen displays with the bath and heater temperatures. This is the only screen where the heater temperature displays. The System Setup Menu 2 screen displays.

The Comm. Functions screen displays. Note: it is imperative to set the correct number of vessels being used or the instrument will not function properly. When enabled, the paddles or baskets rotate when the drive unit is at any height. This number appears with the dissolution apparatus serial number on the printout. The Clock Functions screen displays. The correct date displays.

The correct time displays. Following is a description of the Comm. To use external control, you must log off the dissolution apparatus. The baud rate must be set to when connected to a VK or Total Solution system. The correct communications port identification number displays. The communications port identification number must be 01 when connected to a VK or single Total Solution system. Note: a leading zero is necessary when entering a communications port identification number between 01 and Setting Serial Numbers To enter the serial numbers of your accessories, complete the following steps: Step 1.

The Enter Serial Numbers screen displays. The corresponding serial number screen displays with numbers 1 through 8 listed down the left side of the screen. The left column is for basket serial numbers and the right column is for shaft serial numbers.

Page 58 Administrator Operation Step 3. As you hold the number key, the 2 displays and is replaced by an A, then a B, and finally a C. Press ENTER to accept an entry and move to the following line until all the serial numbers have been entered. When entering basket and shaft serial numbers, the cursor moves from basket location 1 to shaft location 1 and then to basket location 2 followed by shaft location 2 and so on. Repeat steps 2 - 5 to enter serial numbers for the remaining appropriate accessories.

The Main Menu displays. Note: use this option to heat the bath independent of running a program or performing manual operation. The Manual Operation screen displays. Enter the desired speed in xx format. The acceptable range is 10 to RPM. Enter the desired temperature in xx. The acceptable range is Enter the media volume in xxxx format. The acceptable range is to The Select Apparatus screen displays. Select the apparatus being used.

By default, the sample point alarm is disabled. This selection is necessary only when using Apparatus 1 baskets. The Sample Points screen displays. Enter up to 24 timepoints in hhh:mm:ss format and press ENTER to move to the next timepoint location. The maximum acceptable value is Note Set the sample timepoints far enough apart to allow for the operation of the DDMs and cannulas at least three minutes.

If there is not enough time between sample timepoints, the sample timepoint clock counts negative time. The Manual Sampling screen displays. The cannulas lower and the temperature readings display next to all vessel position numbers at the bottom of the screen. Wait one minute for the readings to stabilize. The temperature reading displays next to the appropriate vessel position number.

Wait one minute for the reading to stabilize. Select the corresponding location and the appropriate DDM opens. Repeat steps 3 and 4 for vessel position 8. When all parameters listed on the Manual Operation screen have been entered and the DDM manual override adapters are in place for vessel positions 7 and 8, complete the steps listed under the appropriate apparatus on the following pages to start the test immediately. Press RUN. If paddle spin is enabled, press STOP. If paddle spin is disabled, skip this step and continue to step 3.

Pull up the shaft locking ring to lift each paddle out of the medium. Remove the knobbed evaporation plug on the outside of the evaporation cover at vessel position 1, drop the dosage unit and replace the knobbed evaporation plug. Push down the paddle shaft at vessel position 1. The Method Status screen displays and the paddles rotate. At the desired time intervals, manually drop a dosage unit into each additional vessel and push down the corresponding paddle shaft.

For vessel positions 7 and 8, drop a dosage unit into each vessel through the corresponding DDM tube. Continue the dissolution test according to the prescribed method. At the desired time interval, pull samples from each vessel. Two minutes after the final keystroke, the Test in Progress screen displays. For vessel positions 7 and 8, place the long cannula part number into the vessel through the opening in the DDM.

To quit the test from the Test in Progress screen, press ESC once to return to the Method Status screen and a second time to quit the test. To use this setting, continue with the directions indicated below. Install the baskets containing the dosage units. The drive unit lowers to the previously entered alternate start position.

Note If using the standard start height and low-loss evaporation covers, press STOP to stop the drive unit approximately two inches above the vessel plate.

The Method Status screen displays. The Method Status screen displays and the baskets rotate. If using an alternate start height, manually press the basket shafts down so the baskets are lowered into the vessel at the desired time intervals. Lift the evaporation cover at vessel position 1, manually drop the disk assembly into the vessel, and push down the paddle shaft.

Note In order to drop the disk assembly, it may be necessary to raise the drive unit. At the desired time intervals, lift each evaporation cover, manually drop the disk assembly into each vessel and push down the corresponding paddle shaft.

Note For vessel positions 1 - 6, remove the knobbed evaporation plug, pull the sample, and replace the knobbed evaporation plug. Install the patches on the rotating cylinders. The Method Status screen displays and the cylinders rotate. By default, the delayed heating option is disabled. To enable delayed heating, complete the following steps: Step 1. The Delayed Heating screen displays. Pumping functions are not affected by the delay. This feature inhibits the growth of organisms and evaporation by allowing the water bath to be heated only when necessary rather than continuously.

Enter the time in hour format for example, pm is entered as To stop the delayed heating and reset it to the disabled mode, press ESC. Check with other users before proceeding. The Start Method screen displays. Following is a description of the Start Method screen options: Option Response Select Method Use this option to enter a number between 1 and 23 corresponding to the method desired. This is most easily achieved by using List Methods see below. List Methods Use this option to display a list of the methods stored on the VK in order to select a specific method.

The Select Method to Load screen displays. The Start Method screen displays with the new method number and name in place. The printer must be turned on and enabled. Number and Strength. Select the parameter and the cursor flashes on the corresponding line. Enter the appropriate information for each item up to 25 characters. Additional notes and comments up to 30 characters can be entered by selecting NOTE.

Complete each field using any combination of letters or numbers. To display a letter, hold down the number key until the appropriate letter displays, then release the key. When running a method, the text displays on the printout along with the method parameters. Instant Start Use this option to begin the test according to the currently selected method. Use this option to program the test to begin automatically on a specific date and time. Wait External Start Page 75 Operation You can program the test to begin automatically when the dissolution medium reaches a programmed temperature.

The test runs according to the program entered on the VK once the external start command is received. Instant Start Depending upon the apparatus listed in the method and the options installed on your tester, complete the steps listed under the appropriate apparatus on the following pages to start the test immediately.

Manually drop a dosage unit into each vessel. Note For vessel positions 1 - 6, remove the knobbed evaporation plug on the outside of each evaporation cover, drop the dosage unit, and replace the knobbed evaporation plug. Otherwise, skip this step and continue to step 3. Two minutes after either the cannulas return to the home position or the final keystroke, the Test in Progress screen displays. If using the low-loss evaporation covers, replace the covers on the vessels.

If using the standard evaporation covers, the drive unit lowers to the operating position. Note If using the low-loss evaporation covers, press STOP to stop the drive unit approximately two inches above the vessel plate.

Page 80 Operation Step 3. Rotating Cylinder Step 1.