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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