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

- SCOPE:
This SOP is applicable to Suppository Tester Apparatus (Make: ELECTROLAB, Model No.: ESDT – 3) in Quality Control Department at manufacturing facility of XXX.
- RESPONSIBILITY:
- Analyst / Section Head or his Designee shall be responsible for follow the SOP.
- The Head of Quality Department or his designee shall be responsible and implementation of the SOP.
- PROCEDURE:
- PRELIMINARY CHECK AND PRECAUTIONS:
- Fill water bath up to marked level.
- Connect the heater wire and external probe in the socket provided at the rear side of Instrument.
- Connect the main cord to a 230 V A.C. socket.
- 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.
- Ensure that the heater connected is not loosely connected.
- While engaging or disengaging the basket assembly, do not apply excessive force.
- Do not slide the Bath on the base plate.
- Pour the water gently in the bath making it sure that it does not spill outside the bath.
- Do not use aggressive material or strong solvents to clean the Bath and /or Basket stand.
- 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.
- Basket stands to be put vertically in the bath aligning the disk such that the stand gets fitted properly.
- Do not turn the Temperature Knob when in lock position, unlock the Knob and then turn it.
- Do not use pointed objects to set the parameters.
- Do not use the Instrument without proper earthing.
- Replace the fuse with the correct rating whenever required.
- 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.
- Switch ON the stirrer Motor switch.
- The temperature display shows the Bath Temperature.
- Set the Timer Steps.
- 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.
- Run the instrument till the Bath Temperature reaches to the Set Value.
- Press the RESET Key on the front Panel of the Instrument.
- 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.
- Press the RUN / HALT Key on the front Panel to start the test.
- Once the test is started, after every Set Period of Time, the Basket Assembly will rotate 180° up to 6 steps.
- CALIBRATION PROTOCOL:
Calibration Frequency: Quarterly
- 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°.
- 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.
- Calibration of Heater:.
- 10.3.3.1.Set the temperature of the water bath at 36.5°C.
- 10.3.3.2.Set the timer at 60 minutes.
- 10.3.3.3.Start the apparatus using `RUN / HALT’ key.
- 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.
- Sieve Integrity Check :
- 10.3.4.1.Check the integrity of the sieve visually against the bright light for following
parameters.
- Intactness of the each sieve opening.
- Any cracks, Abrasion
- 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.
- Enter the entry of usage of instrument in Usage log book .
- TRAINING:
Trainer : Head – Quality Control
Trainees : Sectional Heads / Analyst / Officers
- DISTRIBUTION:
Controlled Copy No.1 : Head of Department – Quality Assurance
Controlled Copy No.2 : Head of Department – Quality Control
Original Copy : Head – Quality Assurance
- ANNEXURE:
Annexure I : Calibration Test Data Sheet
- REFERENCES:
Equipment User Manual
- REVISION HISTORY:
Sr. No. | Revision No. | Change Control Number | Details of Revision | Reasons(s) for Revision |
1 | 00 | ———– | New SOP | New SOP |