Dissolution Test Apparatus

SOP FOR CALIBRATION, OPERATION AND CLEANING

1.purpose : Cleaning, Calibration and operational procedure of 6- Station Dissolution Apparatus.

2.Scope : This procedure is applicable to clean, calibrate and operate 6- Station Dissolution Apparatus.

Instrument:Dissolution Apparatus

Make: Electrolab

3.Reference / Attachments :

3.1 Reference

3.1.1 None

3.2 Attachments

3.2.1
Attachment – I : Instrument Usage Log
Attachment – II : Calibration Label
Attachment – III : Monthly calibration log for pH meter
Attachment – IV : History Card
Attachment – V : periodic Cleaning


4.Responsibility
4.1 Quality Head location
4.1.1 To review, audit and approval of SOP
4.1.2 Implementation of system as per SOP.
4.1.3 Training to the concern before implementation of SOP.
4.1.4 To ensure the operation, calibration and maintenance of the instrument is as per recommended Procedure.
4.2 Head Quality control
4.2.1 To ensure proper documentation as per SOP
4.2.2 To initiate the maintenance activity while breakdown.
4.3 Quality control officer / chemist
4.3.1 Operation of the instrument.
4.3.2 Calibration of the instrument.
4.3.3 Recording all document related to calibration and maintenance.

5.Calibration frenquency :
Calibrate the instrument once in 3 months or immediate after any maintenance.

6. Distribution
6.1 Quality control
6.2 Quality Assurance
6. Procedure
6.1 Clean the 6-Station Dissolution Apparatus and surroundings
6.2 Ensure that the Apparatus consists of following equipment.
6.2.1 Jars
6.2.2 Paddles
6.2.3 Baskets
6.2.4 pH meter
6.3 Place the tank on the base of the instrument such that four screws at the bottom of the tank fits into the holes on the base plate and
      heater cable is at the rear side of the instrument.
6.4 Connect the heater plug in the socket provided at the rear right hand side of the stirrer unit. Fill the tank with water upto the level marked
      without placing any jar in the bath. Add 0.01% cetyl pyridinium chloride or sodium benzoate or bronidiol to prevent fungal growth in water
      bath.
6.5 Plug in the mains chord a 230 V/ A. C./15 Amp. Power supply socket. Switch on the power switch and heater switch provided at the
     back side of the stirrer unit.
6.6 Press set temperature push button and adjust the set temperature knob till the digital reading shows 37 degree Celcious. Lock the knob
      after setting.
6.8 Make entry of the usage in the instrument log Register.
6.9 Always keep the lifting switch situated at the instrument in center when not in use.

7. Operation Procedure:
7.1 Ensure, that the instrument is calibrated.
7.2 Fix the paddle or basket as per the test requirement. Do not overtighten.
7.3 Start the stirrer by pressing the RUN switch.
7.4 Set thr RPM by turning RPM knob clockwise to increase the RPM and anti-clockwise to decrease the RPM. After setting the RPM, lock
      the knob and stop the stirrer by pressing the reset switch. Do not turn the knob when it is in LOCK position always unlock the knob and
      turn.
7.5 Set the time as specified in individual specification/monograph by using thumb wheel switch.
7.6 Select the manual mode using the auto manual switch. This switch illuminates in auto mode. In auto mode the instrument will give an
      alarm after every set interval and the stirrer will keep on running.
7.7 Add the required volume of the deaerated dissolution medium in the jars as specified in the individual specification / monograph.
7.8 Bring the stirrer unit down by using up – stop – down switch. Run the apparatus to equibrate dissolution medium in the jars and check
      the temperature with a calibrated theromometer.
7.9 If baskets are used, lift the stirrer unit, down by using up – stop – down switch. If paddle is used, place one tablet / capsule in the jar.
     Care to be taken : The inside distance between paddle or basket to the jars should be maintained at 25mm +2mm, during the test.
7.10 Cover the jars containing dissolution medium with the lids provided.
7.11 Start the stirrer by pressing the start switch. Run the apparatus for the set time.
7.12 Collect the sample within +2% of specified time. [ For eg If time is 30 mts., sample to be taken within 36 seconds.]
7.13 Withdraw sample from a zone midway between the surface of the dissolution medium and the top of the rotating basket or blade, not
       less than 1cm. From the vessel wall and filter the solution.
7.14 Lift the stirrer by using the up – stop – down switch at the end of the set time.
7.15. Switch off the Instrument.

8. Calibration Procedure:
8.1 At start set the Revolutions per minute to 50 and Start the instrument and check the initial RPM. At the end of 1 hour stop the 
     instrument and check for number of revolutions per minute. Continue for another 1 hour and check for the number of revolutions per
     minute. Like wise the procedure is to be repeated for 100 RPM. The limit for the revolutions is ± 2% of the set value.
8.2 At start set the temperature to 37° C and start instrument and check the initial temperature. At the end of 1 hour stop the instrument and
     note the temperature of the medium. Continue for another 1 hour and check the temperature of the medium. The limit of the temperature
     should be between 36.5°C to 37.5°C. Check the temperature of the dissolution medium by a calibrated thermometer.
8.3 The wobbling of each shaft is measured by placing the Wobblometer at the center of the shaft of the paddle/Basket and note the value
     observed in the guage of the wobblometer keeping the instrument on 50 RPM.

9. Cleaning Procedure:
9.1 After use clean the jars(Test Vessels) with water and rinse with distilled water.
9.2 To clean the marlon jars and water bath do not use any abrasive material
9.3 Clean the tank at least once in a week. Add 0.01% cetyl pyridinium chloride or sodium benzoate or bronidiol to prevent fungal growth in
      water bath.
9.4 Do not disturb the sensor tube while cleaning the tank.

9. Cleaning Procedure:
9.1 After use clean the jars(Test Vessels) with water and rinse with distilled water.
9.2 To clean the marlon jars and water bath do not use any abrasive material
9.3 Clean the tank at least once in a week. Add 0.01% cetyl pyridinium chloride or sodium benzoate or bronidiol to prevent fungal growth in
      water bath.
9.4 Do not disturb the sensor tube while cleaning the tank.