- Objective
- 1 To describe the procedure for preventive maintenance of Tablet Dissolution Apparatus
- 2.0 Responsibility
- Executive – Quality Control – To perform the preventive maintenance activity
- Head – Quality Control — To ensure compliance against established schedule
- 3.0 PROCEDURE
- 3.1 Precautions:
- 3.2 Ensure that the power supply to the instrument is switched “off” before starting the preventive maintenance.
- 3.3 Clean the instrument with a clean dry cloth every day.
- 3.4 Performance checks shall be done for the following parameters as per SOP no. QC070 before performing preventive maintenance.
- Vessel temperature
- RPM
- Paddle/Basket Height
- Timer
- Wobbling of paddle/basket
- Eccentricity
- 3.5 Enter the values in standard maintenance card as per SOP preventive maintenance procedure for laboratory instruments
- 3.6 The following components of the dissolution shall be subjected for preventive maintenance on the schedule date.
- 3.7 DISSOLUTION BATH:
- Remove the heater connections from the control panel
- Check for leaks/cracks outside the bath after filling with fresh purified water.
- Jar holder connections shall be verified, replace in case of any damages.
- Remove the water from the bath and clean the heater with smooth dry cloth, replace in case of any scratches found on heater.
- Temperature sensor shall be cleaned with smooth polished cloth.
- Heater connects shall be verified.
- 3.8 SYSTEM CONTROLLER:
- Remove the cover of the system controller, clean inside portion with a smooth nylon brush.
- Check the spindle belts and carrier bearings, replace new belts or bearings in case of any discrepancies.
- Spindle stepper motor shall be verified and cleaned with smooth brush.
- Check electronic circuit with a multimeter and repair the respective affected circuits.
- Circuit-cooling fan shall be verified for properly functioning.
- Clean the motor with smooth brush.
- Spindle bearings shall be verified for any corrosion, replace when any bearing got corrosion.
- 3.9 BODY OF THE DISSOLUTION APPARATUS:
- Check for any abnormal sound is observed at lifting bearings
- Apply the grease to lifting bearings.
- Apply engine oil to lift road at backside.
- Lift motor condition shall be checked and repaired.
Frequency of the Preventive maintenance for Dissolution Apparatus is once in 3 months.
- 4.0 ABBREVIATIONS
- SOP – Standard operating procedure
- PM – Preventive maintenance
- QC- Quality Control
- 5.0 REFERENCE
- Sop – calibration of dissolution apparatus
- Sop preventive maintenance procedure for laboratory instruments
- 6.0 ANNEXURES
Nil
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