SOP For handling, Operation, maintenance and Calibration of Suppository Tester Apparatus

1. OBJECTIVE:

The purpose of this Standard Operating Procedure (SOP) is to describe the procedure for handling, Operation, maintenance and Calibration of Suppository Tester Apparatus.

2. SCOPE:

This SOP is applicable to Suppository Tester Apparatus (Make: ELECTROLAB, Model No.: ESDT – 3) in Quality Control Department at manufacturing facility of XXX.  

3. RESPONSIBILITY: 

1.   Analyst / Section Head or his Designee shall be responsible for follow the SOP.
2. The Head of Quality Department or his designee shall be responsible and implementation of the SOP.

4. PROCEDURE:

1. PRELIMINARY CHECK AND PRECAUTIONS:

1.   Fill water bath up to marked level.
2. Connect the heater wire and external probe in the socket provided at the rear side of Instrument.
3. Connect the main cord to a 230 V A.C. socket.
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. Ensure that the heater connected is not loosely connected.
6. While engaging or disengaging the basket assembly, do not apply excessive force.
7. Do not slide the Bath on the base plate.
8. Pour the water gently in the bath making it sure that it does not spill outside the bath.
9. Do not use aggressive material or strong solvents to clean the Bath and /or Basket stand.
10. To remove or place the Bath do not pick or place it vertically instead slide the bath on base plate of the Instrument along the guide.
11. Basket stands to be put vertically in the bath aligning the disk such that the stand gets fitted properly.
12. Do not turn the Temperature Knob when in lock position, unlock the Knob and then turn it.
13. Do not use pointed objects to set the parameters.
14. Do not use the Instrument without proper earthing.
15. Replace the fuse with the correct rating whenever required.

4. System Operation :

• Switch on the mains to the instrument and the power switch on the instrument                (provided at rear side of the instrument) after ensuring that the instrument set up is okay.

2.   Switch ON the stirrer Motor switch.
3. The temperature display shows the Bath Temperature.
4. Set the Timer Steps.
5. Set the desired Temperature as mention below:

• Press and Hold the Push Button Switch.
• Unlock the Knob.
• Turn the Knob in clock wise / counter Clock wise Direction to set the desired    Temperature.
• Lock the Knob after the Temperature setting is over.

6. Run the instrument till the Bath Temperature reaches to the Set Value.
7.   Press the RESET Key on the front Panel of the Instrument.

8. Load the Suppositories in the Basket and guide the Basket Stand vertically inside the Bath. Make sure that the disk is positioned such that the basket Stand gets fitted properly.
9. Press the RUN / HALT Key on the front Panel to start the test.
10. Once the test is started, after every Set Period of Time, the Basket Assembly will rotate 180° up to 6 steps.
11. CALIBRATION PROTOCOL:

             Calibration Frequency: Quarterly

1. Record the rotation of the Basket up to each six steps at predefined interval of Time. 

             The acceptance criteria:  After every Set Period of Time the Basket assembly shall rotate 180°.

10. Calibration of timer: Adjust the set time to 5 minutes. Press the start button and   

Simultaneously start the stopwatch. When alarm starts, check the time on the stopwatch.   

Follow the procedure for 10, 15 and 20 minutes as above.

10. Calibration of Heater:.
    1. 10.3.3.1.Set the temperature of the water bath at 36.5°C.
    2. 10.3.3.2.Set the timer at 60 minutes.
    3. 10.3.3.3.Start the apparatus using `RUN / HALT’ key.
    4. 10.3.3.4.Record the temperature of the water inside the Bath at the 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55 and 60 minutes intervals.  

The acceptance criteria:   36°C to 37°C.

10. Sieve Integrity Check :
    1. 10.3.4.1.Check the integrity of the sieve visually against the bright light for following     

parameters.

1. Intactness of the each sieve opening.
2. Any cracks, Abrasion
3. Dents                      

            Acceptance criteria: Visually the integrity must be acceptable with respect to the 

                 above parameters.

   NOTE: If the sieve does not comply for the above parameters, change the Sieve. 

3. Enter the entry of usage of instrument in Usage log book .
4. TRAINING: 

Trainer : Head – Quality Control 

Trainees : Sectional Heads / Analyst / Officers

6. DISTRIBUTION: 

Controlled Copy No.1 :  Head of Department – Quality Assurance

Controlled Copy No.2 :  Head of Department – Quality Control

Original Copy :  Head – Quality Assurance 

7. ANNEXURE: 

Annexure I : Calibration Test Data Sheet

8. REFERENCES: 

Equipment User Manual

9. REVISION HISTORY: 

Sr. No.	Revision No.	Change Control Number	Details of Revision	Reasons(s) for Revision
1	00	———–	New SOP	New SOP