1. OBJECTIVE
To lay down the procedure for operation, cleaning and calibration of Dissolution Apparatus
2. SCOPE
This procedure is applicable to Quality Control Department
3. RESPONSIBILITY
• Officer QC
• Manager QC
4. SAFETY INSTRUCTIONS
• Handle the strong acid and base carefully used
• Proper handling the instrument
• Temperature should be carefully adjusted and maintained
5. PROCEDURE
5.1 ASSEMBLY
5.1.1 Ensure that the apparatus consists of following equipment
5.1.1.1 Jars
5.1.1.2 Paddles
5.1.1.3 Baskets
5.1.1.4 pH meter
5.1.2 Place the tank on the base of the instrument such that four screws at the bottom of the tank fit into the holes on the base plate.
5.1.3 Connect the heater plug in the socket.
5.1.4 Fill the tank with water up to the level marked without placing any jar in the bath.
5.1.5 Add 0.01% cetyl pyridinium chloride or sodium benzoate to prevent fungal growth in water bath.
5.2 OPERATION
5.2.1 Switch ‘ON” the power, instrument will initialize.
5.2.2 Press the RPM, TEMP, TIME, keys from the front panel to set the parameters of the test.
5.2.3 Press the ENTER key to register the set parameter in the protocol
5.2.4 Temperature Setting
5.2.4.1 Press the TEMP key from the front panel. Set the temperature from 30.0°C to 40.0°C by using UP / DOWN key.
5.2.4.2 Fix the paddle or basket as per the test requirement. Do not over tighten.
5.2.5 RPM Setting
5.2.5.1 Press the RPM/Time intervals key from front panel.
5.2.5.2 Set RPM/Time Interval from 50/30 to 100/120 by selecting the required protocol
Note: If there are separate keys for RPM and time interval in your instrument then separately put your required date
5.2.6 Add the required volume of the dissolution medium in the jars as specified in the individual specification/ monograph
5.2.7 Bring the stirrer unit down by using button “To Move Down”
5.2.8 Run the apparatus to equibrate dissolution medium in the jars and check the temperature by using a calibrated thermometer.
5.2.9 The inside distance between paddles or basket to the jar should be maintained at 25mm ± 2mm during the test.
5.2.10 Covers the jar containing dissolution medium with the lid provided.
5.2.11 Start the stirrer by pressing the START button.
5.2.12 Sample Withdraw Procedure
5.2.12.1 Collect the sample within +2% of specified time (e.g if time is 30 minutes; sample to be taken within 36 seconds)
5.2.12.2 Withdraw sample from a zone midway between the surface of the dissolution medium and top of rotating basket/paddle, not less than 10 mm from the wall of the vessel and filter the solution
5.2.12.3 Lift the stirrer by using button “To Move UP”
5.2.12.4 Switch off the instrument after completion of testing.
5.2.12.5 Make entry of usage in the instrument usage log book (Annex. I).
5.3 CLEANING
5.3.1 Rinse the motor driven to upper side by Up/Stop/Down switch.
5.3.2 Cleaning procedure for Apparatus:
Frequency: After completion of every dissolution test
5.3.2.1 Switch “OFF” the instrument.
5.3.2.2 Switch “OFF” the mains.
5.3.2.3 Remove the bowls from its place, discard the medium of bowl and wash each bowl properly with purified water then keep inside according to number wise.
5.3.2.4 Remove the basket from basket apparatus and the paddles from the dissolution test apparatus with the help of key.
5.3.2.5 Wash them with purified water, dry with tissue paper and keep at the proper place.
5.3.3 Cleaning procedure for Water Bath of dissolution test apparatus:
Frequency: Once in a week or when necessary.
5.3.3.1 Remove all the bowls from water bath.
5.3.3.2 Remove the lid of water bath and discard the all water from the water bath.
5.3.3.3 Wash the water bath with raw water, detergent solution and with raw water until no foam of detergents remain in the water bath.
5.3.3.4 After complete removal of detergents wash the water bath with purified water.
5.3.3.5 Add 0.01% cetyl pyridinium chloride or sodium benzoate to prevent fungal growth in water bath.
5.3.3.6 Keep the water bath to its place and clean the whole apparatus.
5.3.3.7 Keep the record in Cleaning log book (Annex. II).
5.4 CALIBRATION
5.4.1 No. Of Revolution Check
5.4.1.1 Select any one paddle or basket and check the number of revolutions using a tachometer. Repeat the same procedure for other five paddles/ basket.
5.4.1.2 These procedure is done for 50, 75 and 100 RPM checks
5.4.1.3 Result will be note in calibration report (Annex.III)
5.4.2 Temperature Check
5.4.2.1 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.
5.4.2.2 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.
5.4.2.3 Keep the record in the calibration log book (Annex.III)
5.4.3 Timer Check
5.4.3.1 Adjust the ‘SET TIME’ to 30 minutes, press the start button and simultaneously start the stopwatch. When alarm start, check the time on stopwatch.
5.4.3.2 Follow the procedure for 60, 120minutes as above.
5.4.3.3 Result will be note in calibration report (Annex. III)
6. RELATED DOCUMENTS
Operational Log Book Format – Annex. I
Cleaning Log Book Format – Annex. II
Calibration Report Format – Annex. III
7. DISTRIBUTION INDEX
Original Copy will be retained by Quality Assurance Department.
DISTRIBUTION INDEX
Distributed To Copy No. Received By/Date
Quality Control Department 01
8. ABBREVIATIONS
Q.C Quality Control Department
RPM Revolution per Minute
9. REVISION HISTORY
Revision No Issue Date Supersedes
Reason of Change/ Description
Revision No. Dated
00 25-12-2015 NA NA First Version