Preventive Maintenance of Dissolution Test Apparatus


  1. Objective
  1. 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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