SOP of Dissolution Test Apparatus | Electrolab Dissolution Test Apparatus SOP |
- Dissolution Test Apparatus SOP covers below points :
- Precautions while using Dissolution Test Apparatus
- Dissolution Test Apparatus operating procedure
- Dissolution Test Apparatus Protocol setting procedure
- Dissolution Test Apparatus RMP setting procedure
- Dissolution Test Apparatus Temperature setting procedure
- Dissolution Test Apparatus Test preparation procedure
- Dissolution Test Apparatus cleaning procedure
1.0 OBJECTIVE :
- To describe a procedure for operation of Dissolution Test Apparatus.
2.0 SCOPE :
- The SOP is applicable for the operation of Dissolution Test apparatus (ELECTROLAB MAKE APPARATUS (MODEL – INSPIRE 08), used for carrying out Dissolution test of tablet/capsule located in Quality Control Department.
3.0 RESPONSIBILITY :
- Quality control Chemist and above
4.0 ACCOUNTABILITY:
- Quality Control Head
5.0 PROCEDURE :
The apparatus consists of constant temperature water bath made of transparent acrylic. The round bottom glass vessels or acrylic vessels are placed equidistant inside the bath. The jar has acrylic lids which allow passing of stirrer shaft. The shafts are suspended from the top. The stirrers are controlled by microprocessor.
The bath temperature is controlled by microprocessor based controller within + 0.1°C. Additional features of apparatus are microprocessor based digital timer. This is provided with audio alarm which operates as per pre-set time.
For General information on Dissolution Test click below link : Dissolution Test
5.1 PRECAUTIONS :
- Ensure that the power supply to the instrument is switched OFF before cleaning.
- Ensure that the instrument is clean and dried.
- Do not start the heater if the water in the tank is less than the marked level.
- Do not disturb the level of the water tank
- Do not disturb the sensor tube and heater while cleaning the tank.
- Do not pull or force the paddle or basket while removing.
- Do not apply the force while washing baskets.
- Do not hold the stirrer while in operation.
- While moving the stirrer assembly downwards/ upwards, no lids should be present on the vessel.
- Paddle shaft or basket shaft should be fitted properly. Do not over tighten the shaft of (paddle/basket).
- Do not lift the stirrer unit while paddles/baskets are rotating.
- Always cover the dissolution vessel with acrylic lid.
- Handle glass jar carefully.
- Check the water level of instrument and fill the bath with water up to the marked level before placing the test vessels.
5.2 OPERATION :
The Front Panel of Electrolab Dissolution test apparatus shown in figure (c), follow the procedure given below for operation.
- LEDs will glow during respective functions as below,
- TEMP ON. : Red LED will glow when heater is ON.
- READY : Orange LED will glow when both the temperature (bath and vessel) are same as set.
- RUN : Green LED will glow when you start dissolution.
- HALT : Red LED will glow when you stop the process in between dissolution time.
- LIFT UP : Orange LED will blink during platform lift up.
- LIFT DOWN : Green LED will blink during platform lift down.
- Switch on the mains switch.
- Attach Basket/Paddle and ensure all parts are fitted properly.
- Fill all the six merlon jar as per specified media, mentioned in test procedure.
- Switch “ON” the POWER switch.
- After Power On, the instrument will initialize itself; the logo screen will flash for 3 seconds and then Idle screen will be displayed.
- The Idle screen displays the current status of the instrument.
- It indicates the Date, Time, RPM, Bath Temperature, External probe and loaded protocol number.
- Press F1or F2 key from front panel to enter MENU or PREPARE.
- Switch ON heater switch of temperature controller.
- Press ” TEMP” key and then F1 for ON the Heater. press ENTER key.
- Press the key ” Lift ▲” to up the platform.
- Press the key ” Lift ▼” to down the platform.
- After the fixing of Basket/Paddle, set the following parameter as per procedure given,
- PROTOCOL SETTING
- RPM SETTING
- TEMPERATURE SETTING
PROTOCOL SETTING :
- LOAD PROTOCOL
- Press F1 key from front panel to enter menu screen.
- Press 2 to enter protocol menu.
- Press 1 to enter Load Protocol.
- 20 programmable protocols can be loaded
- Protocol No. can be loaded using Up/Down key & to register the No. Enter key needs to be pressed.
- Press F1 to load next protocol.
- Press F2 to load previous Protocols.
- Press F3 to go back to the Protocol screen.
- EDIT PROTOCOL
- Press 2 to enter Edit Protocol.
- Select the protocol which needs to be edited using Up/Down arrow and press ‘Enter’ key.
- The respective protocol details such as Drug Name, Media Name, pH Value, Temperature, Media Vol, Power fail, Apparatus, Time Table, Sampling info details need to be entered.
- Note: Valid media volume selection for 1 liter vessel will be from 500 ml to 1000 ml. Fixed manifold configuration is required if media volume selection is less than 500 ml.
- The protocol details can be edited using alphanumeric keypad.
- The next parameters can be selected for editing before saving the previous parameter by pressing F3 key from front panel.
- To select different apparatus press Enter key and select the desired apparatus using numeric keys.
- To edit Time Table parameter press Enter key. The sampling time interval, action & total number of samples (1 to 24) can be set as per user requirement using shift & alphanumeric keys.
- For single time point, action table will have only one sampling option. Infinity (min) can be selected after last sample.
- For Multiple time point, action table will have only two options media change and sample. Infinity (min.) can be selected after last sample.
- Press F3 to save & go back to main menu screen.
RPM SETTING :
- Press RPM key from front panel.
- Press numeric key to register the rpm range from 20 to 300 RPM.
- Press F1 key to Turn-On the motor & F2 key to Turn-off.
- If RPM is out of range an error screen will be displayed.
TEMPERATURE SETTING :
- Press Temp key from front panel.
- Press numeric key to register the temperature range from 20° to 40ºC.
- Press F1 or F3 to Turn On/Off heater.
- If temp is out of range an error screen will flash for 3 secs.
TO PREPARE THE TEST :
- Load the appropriate protocol no. & Press F2 key to start preparing the test.
- Batch Number & A.R. Number will be displayed.
- Using down arrow and enter key, the Batch no. & A.R. no. up to ten digits can be added. Press Enter key to register the Numbers.
- After the connection between the instruments is done, sample collector will initialize & ‘Lift Not Park’ indication will be displayed (if lift is not parked).
- ‘Wait for Temperature’ indication will be displayed till the set temperature is achieved. User can also access MENU to check Jar Temperature.
- Ready Indication will glow on front panel when jar temperature reach to set point & Start indication will be displayed.
- Press START key from front panel to start the test.
- Current status of the test and sample timing are displayed throughout the test.
- After the completion of specified run time, the instrument will give short beep sound indicating that the test is completed, then proceed the further as per specified method for analysis.
- At the time interval specified in individual monograph, withdraw a sample from a zone midway between the surface of the dissolution medium and the top of rotating basket/ paddle not less than 1 cm from the glass vessels wall.
- Take the platform up by pressing “▲ Lift UP” key.
- Clean all the vessels and stirrer after completion of the analysis and switch OFF the instrument.
CLEANING :
- Cleaning of Paddles: After completion of the test, lift up the stirring unit and remove the paddles. Wash the paddles thoroughly with tap water and then rinse with distilled water and dry them properly.
- Cleaning of Baskets: After completion of the test, remove the baskets carefully. Wash the baskets thoroughly with the tap water. Clean the baskets by sonication if required and finally rinse with distilled water and dry them properly.
- Cleaning of Jars: After completion of the test, clean the jars with tap water and then rinse with distilled water and dry. Do not use any aggressive materials or solvents to clean the jars.
- Cleaning of acrylic water tank: Frequency: once in a fortnight.
- To clean the water tank first lift up the stirring unit and disconnect the plug of main switch. Remove the paddles/baskets and jars. Then remove the water from the tank by siphoning. Clean the jars thoroughly with distilled water, remove it by siphoning and then fill the tank with fresh distilled water up to the mark.
For Calibration Procedure for Dissolution Test Apparatus click below link : Calibration of Dissolution Test Apparatus SOP
6.0 ABBREVIATIONS:
| Abbreviation | Expanded form |
| mm | Millimeter |
| cm | Centimeter |
| 0C | Degree Celsius |
| % | Percentage |
| RPM | Rotation Per Minutes |
| ml | Milliliter |
| no. | Number |
| Min | Minutes |
| nm | Nanometer |
| mbar | Millibar |
| SAMP | Sampling |
| INTV | Interval |
| TEMP | Temperature |
7.0 ANNEXURES:
NIL
8.0 SOP REFERENCES
- Manual of Disintegration Test Apparatus
END OF THE SOP