Standard Operating Procedure for sieving of powders or granules.
1.0 Purpose
The purpose of this SOP is to establish a standard procedure for sieving of powders or granules for tablets, capsules,dry powder suspension manufacturing.
2.0 Scope
This SOP is implemented for the procedure used for the process of sieving in the oral solid dosage form area.
3.0 Responsibility
3.1 The Granulation Operator is responsible for the sieving process.
3.2 The production officer is responsible for the implementation of this SOP.
3.3 The HOD of production is responsible for ensuring the implementation of this SOP.
3.4 Quality assurance Officer monitors the compliance of this SOP.
4.0 Procedure
4.1 Equipment Sieving
4.1.1 Take line clearance before starting the sieving process.
4.1.2 Check in BMR, which equipment is to be used for the sieving of powders or granules.
4.1.3 Take the required sieve mentioned in BMR & install it in an oscillating granulator or Russell sifter.
4.1.4 Weigh the quantity of powders or granules to be sieved, as mentioned in BMR.
4.1.5 Add the required materials to the hopper of equipment and press the start button to collect the sieved powders or granules.
4.1.6 Collect the sieved material in the container and process it for further stages.
4.1.7 Remove the sieve from the equipment and wash it as per sieve cleaning SOP.
4.1.8 Record the activity in the logbook.
4.2 Manual Sieving
4.2.1 For manual cleaning take the required sieve mentioned in BMR.
4.2.2 Add powders or granules to be sieved with the help of a scoop.
4.2.3 Rub gently with gloved hands and collect the sieved material in a polythene bag placed below the mesh.
4.2.4 After completion of the sieving process, record the activity in the logbook.
5.0 Abbreviations
5.1 SOP: Standard Operating Procedure
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