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PROCEDURE FOR DETERMINATION OF THE FILLED VOLUME OF VIALS.

 DETERMINATION OF THE FILLED VOLUME OF VIALS:

v  Procedure
§  Precautions:
§  Use protective hand gloves.
§  Ensure that the limit of fill weight/volume of the vial is given in the respective BMR.

v  Operation:
v  By weight Method:
§  Keep the weighing balance on the vibration free table.
§  Switch on the weighing balance.
§  Ensure that the pan of weighing balance is completely cleaned.
§  Ensure weighing balance is showing ‘zero’ reading.
§  Ensure that the weighing balance is calibrated.
§  Keep the filled unsealed vial on the pan of weighing balance.
§  Note down the position of the filled vial on the filling Machine.
§  Remove all solution from the vial.
§  Ensure that the solution is completely removed out.
§  Again weigh the empty vial after removing solution.
§  The weight of the solution would be the difference between the weight of the unsealed filled vial and empty vials.
§  The weight of the solution should be within the range.
§  Discard the vial after checking the volume.


v  By Volume Method:
§  Take out the filled vials from the machine conveyor/ rack before sealing and note down the position of vials.
§  Pour all the solution of filled vials in a calibrated measuring cylinder.
§  Check the lower meniscus of the solution and note down in the Batch Manufacturing Record.
§  If it is out of limit, correct immediately.

v  Abbreviations and Definitions
o   SOP   : Standard Operating Procedure; a document where step by step instructions are cited to serve as support for methods or manners of fulfilling a function or functions reliably and consistently.
o   PD      :            Production
o   LAF    :            Laminar Air Flow      
o   BMR   :           Batch Manufacturing Record
o   IPQA   :           In-Process Quality Assurance



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