INSTRUMENT OPERATION PROCEDURE DISSOLUTION APPARATUS

1.0. PURPOSE:
To provide a procedure for operating dissolution test apparatus.
2.0. SCOPE:
This covers the procedure for operating dissolution test apparatus
MAKE : ELECTROLAB
MODEL : TDT-08 L
3.0. RESPONSIBILITY:
3.1. Officer-Quality Control
3.2. Executive-Quality Control
4.0. ACCOUNTABILITY:
Manager-Quality Control
5.0. DEFINITION:
Nil
6.0. PROCEDURE:
6.1. Ensure the calibration status is valid and make sure that the instrument is properly placed for use.
6.2. Fill the distilled water in the tank up to the mark level without jars. Place the tank on the base of the instrument such that four screws at the bottom of the tank fits in to the holes on the base plate and heater cable is at the rear side of the instrument.
6.3. Connect the heater plug in the socket provided at the right hand side of the stirrer unit, fill the tank with water up to the level marked without placing any jar in the bath .Add 0.01%cetyl puridinium chloride or sodium benzoate or Bronidiol to prevent fungal growth in the water bath.
6.4. Set the temperature by pressing the SET TEMP and followed by pressing 3,7 and ENTER in number keys, Press START/STOP TEMP start temperature controller will start the controller making the TEMP ON LED glow once the temperature of the water bath has reached to the set value of the temperature, the READY LED will glow on the front panel of the instrument.
6.5. Set the rotation by pressing SET RPM and followed by pressing number keys ex : 50 RPM is required press ‘5’ and ‘0’ then ENTER.
6.6. Set the timer by pressing SET TIMER and followed by pressing number keys ex : i) 30 min is required press 3,0 and ENTER,
ii) 1 hour is required press 1,0,0 and ENTER,
iii) 5 hour is required press 5,0,0 and ENTER.
6.7. Fill the jar with dissolution medium as per the specification and place them in tank and fix the jar holder.
6.8. Fix all the stirrer with paddles or basket carefully.
6.9. Bring the stirrer with using the DOWN KEY.
6.10. Press START/STOP when the READY LED glowing on the front panel. If the water bath temperatures has not reached the set value of the temperature, then temperature display will flash “rd”. In this case press START key again after the READY LED on the front panel is on.
6.11. After end of the timing the buzzer beeps for 10 seconds.
6.12. Draw the sample as per the specification.
6.13. Lift the stirrer using the UP KEY.
6.14. Put ‘OFF’ the instrument after use.
6.15. PRECAUTIONS
6.15.1. Do not start the heater if there is no water in the tank up to the marked level.
6.15.2. The water bath should be filled with RO water only.
6.15.3. To clean the jar and water bath do not use any aggressive material or strong solvent
6.15.4. Do not pull or force the paddle or basket
6.15.5. Do not hold the stirrer while in operation
6.15.6. After every 4 month, put 6 to 8 drops of oil in lifting arrangement for smoother operation (oil parts are provided on the top of the lifting column ).
6.15.7. For lifting up the stirrer, make sure the paddles are stop.
6.15.8. Do not disturb the sensor tube while cleaning the tank.
6.15.9.
6.15.10 External probe should be handled with care.
Replace & clean the water from water bath fortnightly.
7.0. REFERENCES:
Instrument Manual
8.0. ENCLOSURES:
Nil
9.0. ABBREVIATIONS: