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
For More Pharma Updates Visit –https://pharmaguidances.com
