SOP for Disintegration Tester Apparatus

This document details the procedure for the operation and calibration of the disintegration tester apparatus to the intended users or concerned personnel.       

It is the policy of XYZ Pharmaceuticals Limited that a written procedure shall be followed for the operation and calibration of the disintegration tester apparatus.

This SOP is applicable at the time of the operation and calibration of the disintegration tester apparatus.

RESPONSIBILITY AND ACCOUNTABILITY

Persons along with their responsibilities and accountability are given below:

 Executive  - Corporate Quality Assurance:- To prepare the SOP. Maintain the record as per SOP.

Trainee Analyst/ Jr. Analyst/ Analyst/ Sr. Analyst:- To follow the SOP accordingly

Manager  - Quality Assurance:- To ensure implementation of SOP.

PROCEDURE

GENERAL INSTRUCTION

Clean the instrument with a clean and dry cloth. If required use the wet cloth followed by a dry cloth.

5.1.2 Check the cleanliness of the instrument, disks, and glass beakers.

5.1.3 Connect the instrument with the main power supply (if not connected) heater connector and external probe into their respective sockets provided at the rear side of the instrument.

Fill water in the beakers in such a way that the wire mesh at its highest point is at least 25mm below the surface of the medium, and its lowest point is at least 25mm above the bottom of the beaker.

The instrument shall be calibrated for temperature, number of oscillations per minute, timer, and the highest elevation of the shaft holding the basket assembly.

The frequency of calibration shall be done every quarter and after maintenance (breakdown) of the instrument.

5.2 SYSTEM SETUP AND PRECAUTIONS

5.2.1 Fill the water in the tank up to the marked level (without the beakers) and place the borosil beaker.

5.2.2 Connect the heater wire and external probe (if not connected) in the socket provided at the rear right-hand side.

5.2.3 Connect the main cord to a 230 V A.C. socket.        

5.2.4 Do not put the mains `ON’ if there is no water in the tank up to the marked level or if the tank is empty.           

5.2.5 Ensure that the heater connector is not loosely connected.

While engaging or disengaging the basket assembly, do not apply excessive force.

Disintegration test apparatus uses

Switch “ON” the mains of the instrument and the power switch “ON” the instrument (provided at the rear right-hand side) after ensuring that the instrument set up is OK.

Place two 1000 ml beakers containing the suitable liquid medium in the space provided on the beaker stand.  Adjust the volume of the liquid in the beaker such that the wire mesh of the basket is at the highest point is at least 25 mm below the surface of the liquid.

5.3.3 Place the external probe in the slot provided in any one of the basket assemblies.

5.3.4 Follow this procedure to set the temperature of the water bath:

5.3.4.1 Press the “SET” key: The LED to the right of the key lights up.

5.3.4.2 Press the “TEMP” key: The temperature display shows the previous set temperature and the digit at the extreme right flashes.

5.3.4.3 Press the D  key: With every keypress, the flashing digit can be increased serially.

5.3.4.4 Press Ñ key: With every keypress, the flashing digit can be decreased serially.

5.3.4.5 Press the “DISP SEL” key: With every keypress, the required digit of the display can be selected (which is observed as a flashing digit).

5.3.4.6 Using the D and Ñ keys set the temperature to about 38°C. (This will ensure a temperature of 37°C within the beakers).

5.3.4.7 Press the “ENTER” key: Set LED goes off and the set value is accepted.

[Note: Be sure to press “Enter” to accept the displayed value during the set procedure]

5.3.5 Now the display shows the temperature which is indicated by the LED i.e. BATH or EXT.  By using the “PROBE” key, select the display to indicate SEL either the bath temperature or the beaker temperature.                                              

5.3.6  Press the “TEMP” key to start the temperature controller. The LED above the temperature key will glow.

5.3.7 Follow this procedure to set the timer.  There are two modes of operation  Timer mode and Manual mode.

5.3.7.1 In the Timer mode, the motor will stop automatically after the elapse of the set time and gives an alarm for 10 seconds.

5.3.7.2 In the manual mode, the instrument will not give a time indication and the motor will continue running till it is stopped manually.

5.3.8 Select the required mode by pressing the “TIMER” key.

If the timer LED is `ON’, you are in timer mode.

If the timer LED is `OFF’ and the timer display shows ---- then you are in manual mode.

5.3.9 In the timer mode, two-timer ranges are possible.

The display indicates  ...... mins.  ......  sec.

5.3.10 To change the range of the timer, press the SET key and then press ENTER key. The change in range is indicated by the shifting decimal point.

5.3.11  Now program the set time (i.e. the total duration of the TESTER) as follows:

5.3.11.1 Press the “SET” key: SET LED lights up

5.3.11.2 Press the “TIMER” key: The timer display shows the previous set value and the digit at the extreme right flashes.

5.3.11.3 Press the D and Ñ keys to set the desired value.

5.3.11.4 Press the “DISP SEL” key to display the required digit of the timer.

5.3.11.5 Follow steps 3.3.11.3 and 3.3.11.4 until the desired value is set.

5.3.12  Press “ENTER” to accept the set value.

The display shows the present set tone Set LED goes OFF

5.3.13 Check whether the liquid medium in the beakers has attained 37°C.  Place the tablets/capsules in the basket assembly with or without the discs as per the requirement and engage the assembly by gently pressing and hooking it onto the arm.

Start the TESTER using the START / STOP key.

The display shows the time elapsed starting from 00.00 mins.  In the timer mode, the instrument stops after the set time has elapsed.  Alternatively, you can stop the TESTER by pressing START / STOP before completion of the set time.

5.3.14 Pause the TESTER (i.e. time will not be accounted in the timer) by pressing the TIMER key after starting the TESTER.

Operation and Calibration of Disintegration tester Apparatus

The timer LED flashes the time at which you halted. Press the TIMER key again to resume the TESTER.

5.3.15  If the power fails for less than 1 min, then when power resumes the instrument will continue from the last time value.

5.3.16  The instrument will not start the TESTER if the temperature is not reached or if it is above 0.4°C of the set value. It will display ... rd in this condition.

5.3.17  The instrument gives an alarm during the TESTER if the temperature of the bath overshoots above 0.4°C or undershoots below 0.4°C of the set value.

5.3.18  Switch “OFF” the mains of the instrument and main power supply whenever not required

5.3.19  Daily Record shall be maintained as per XYZ/CQA/SOP-055/FR-01, Logbook for Disintegration Tester Apparatus (Appendix I)          

5.4 CLEANING PROCEDURE

5.4.1 Disconnect the instrument from the main power supply before the cleaning of the instrument starts.

5.4.2 Clean the instrument, disks, and basket assembly after the completion of the TESTER firstly with tap water followed by distilled water. If required, use the Isopropyl alcohol and water in a ratio 50: 50 to clean the basket assembly

Ensure that the basket assembly should be properly cleaned.

6.0 Calibration of Disintegration Tester Apparatus

TEMPERATURE CALIBRATION

Set the temperature of 37.5°C of the water tank and allow attaining the set temperature.

Insert the calibrated thermometer in the water bath observe the reading on a display unit and calibrate a thermometer.

Record the observed temperature as per XYZ/CQA/SOP-055/FR-02, Calibration Data Sheet Appendix II 

Acceptance Criteria:

The observed temperature in each beaker should be in the range of 36.5 ˚C to 37.5˚C.

Number of cycle calibration

Operate the equipment and check the number of cycles of up and down of the basket assembly per minute using a calibrated stopwatch.

Repeat step no. 6.2.1 for another basket.

Repeat the same procedure twice for each basket.

Record the observations as per XYZ/CQA/SOP-057/FR-02, Calibration Data Sheet Appendix II (Page No. 2 of 4).

Acceptance Criteria:

The number of cycles per minute should be within the limit of 29 to 32.

Timer Calibration

Set the timer for 1 minute (60 Sec) start the instrument and calibrate the stopwatch simultaneously.

After one minute is over in the stopwatch stop the instrument and stopwatch at once and take the reading of the stopwatch and display unit.

Repeat step no. 6.3.1 and 6.3.2 for 3 minutes (180 Sec) and 5 minutes (300 Sec).

Record the observations as per XYZ/CQA/SOP-055/FR-02, Calibration Data Sheet Appendix II (Page No. 3 of 4).

Acceptance Criteria:

Time should be within 60 ± 02 Sec, 180 ± 05 Sec, 300 ± 05 Sec both the timer and display unit.

Stroke Height Calibration

Place the calibrated scale parallel and vertical to the basket assembly. Operate the instrument manually and check the highest elevation of the shaft manually and record the observation as per XYZ/CQA/SOP-055/FR-02, Calibration Data Sheet Appendix II (Page No. 4 of 4).

Acceptance Criteria:

The stroke height should be 53 to 57mm.

6.5 After the calibration of the instrument, affix the calibration status tag on the instrument and fill in all the required details.

6.6 Summarize all the calibration data as per XYZ/CQA/SOP-055/FR-03, Summary Sheet (Appendix III)

6.7 Report any discrepancy observed during the calibration of the instrument to the Manager of Technical Quality Control or his authorized representative for corrective and preventive action.

6.8 The Manager of Technical Quality Control or his authorized representative will report the same to the manager assurance and notify the defect to Engineering Department service engineer to rectify the defect. Affix the ‘Out of Order’ label on the instrument as per SOP No. XYZ/CQA/SOP-006, Labelling Policy.

7.0  GENERATION OF INSTRUMENT CALIBRATION NUMBER

Generate the instrument calibration number on the calibration data sheet as INSCALXXYYZZZ where INS denotes the instrument, CAL denotes calibration, XX denotes the year, YY denotes the month and ZZZ denotes the sequence number.

>Operation and Calibration of the BOD Incubator 

BANTI SINGH

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