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