SOP on operation and cleaning of analytical balance used in aseptic area (Sartorious).

SOP on operation and cleaning of analytical balance used in aseptic area (Sartorious)

  • Objective:
  • To lay down a procedure for operation and cleaning of analytical balance used in the aseptic area (Make: Sartorious).
  • Scope
  • The SOP describes the procedure for operation and cleaning of analytical balance used in the aseptic area (Make: Sartorious).
  • Responsibility
  • Officers or above – Production.
  • Accountability
  • Production Head.
  • Procedure
  • Operation
  • Close all the side doors properly and check the level of weighing balance, center the position of spirit level.
  • If the balance is not leveled, turn the leveling screws clock wise or anti clock wise direction to get the air bubble exactly in the middle.
  • To switch on the instrument press on/off botton on the front panel.
  • To start the printer switch on the main power supply .Attach one end of the connecting port to the printer and the other to the input supply of the weight balance.
  • Press calibration switch on the front panel and wait for the instrument to complete the internal calibration.
  • Press Tare on the front panel. Ensure the reading “0.0000” appears on the display.
  • Complete the calibration activity as per the procedure described in SOP for daily calibration and monthly verification of analytical weight balance. (Make: Sartorious).
  • Proceed for weighing operation
  • Open one of side door and put the SS bowl on the Pan.
  • Close the side doors properly and press tare. Ensure the reading “0.0000” appears on the display.
  • Again open the side door and transfer the power from filled vial to the SS bowl.
  • The reading shown on the display is of the net weight of the powder filled. Press print on the front panel of the balance.
  • Repeat the above steps  for the net weight of the other filled units.
  • Weight checking is to be done on hourly basis by production in-charge and on two hourly bases by the IPQA incharge for all the 24 heads of the filling machine
  • Note the filled weights in the Batch Manufacturing record and attach the printouts alongwith.
  • Cleaning procedure.
  • Cleaning of the analytical balance is to be done daily after days activities are over.
  • Clean the entire balance surface with dry mope.
  • Clean the entire balance with lint free mope soaked in 70% IPA.
  • Remove the weighing pan with the screw driver and clean the pan and the surface below pan with 70% IPA.
  • Fix the pan to balance with screw driver.
  • Operation conditions
  • Keep the scale in dust free atmosphere
  • Keep the scale away from heavy wind and free from vibration to get a stable reading.
  • Avoid spilling of product and other liquids on scale.
  • Ensure the scale is operated in the normal temperature range.
  • Remove the SS bowl from the weighing pan as soon as weighing is completed.
  • Do not put the object on to the scale with great force.
  • Do not exceed the operating range.
  • Forms and Records (Annexures)
  • Not Applicable
  • Distribution
  • Master copy –  Quality Assurance
  • Controlled copies- Quality Assurance, Production, Quality Control
  • History
    Date Revision Number
    Reason for Revision
    00 New SOP

 

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