SOP for Vibro Sifter : Pharmaguideline

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SOP for Vibro Sifter

Standard operating procedure of Vibro Sifter used for sifting of Raw Material in Pharmaceuticals.

1.0 OBJECTIVE

To lay down the procedure for Operation of Vibro Sifter.

2.0 SCOPE

This SOP shall be applicable for Vibro Sifter in Granulation area at Production department.

3.0 RESPONSIBILITY

3.1 Execution: Operator
3.2 Checking: Production Pharmacist & Above

4.0 ACCOUNTABILITY

HOD-Production / Assigned Designee

5.0 PROCEDURE

5.1 Before assembling production person shall ensure the cleanliness of sifter, sieves and gasket & ‘CLEANED’ label on it.
5.2 Check the sieve for its integrity before & after completion of operation, and record in “Sieve Integrity Check Log”.
5.3 Before starting the operation production person get the line clearance from QA person and affix the status label with Product Name, Batch Details to equipment & area.
5.4 Assemble the sifter by putting discharge chute on top of body of sifter then place required sieve. Then keep the position frame and fit the gasket and tight the clamps.
5.5 Tie the poly bag (inside container) properly to the out let of the sifter.
5.6 Load the material around 2 to 3 kg. Through charging port by scoop & then start the sifter by pushing green switch and collect the material in poly bag in labeled bin.
5.7 After completion of operation, tie the poly bag and affix the status label on the container as sifted material.
5.8 Switch of the sifter by pushing “OFF” red bottom after completion of operation.
5.9 Affix “To Be Cleaned” label and fill the “Equipment Log Book”.

Note: The new sieve is procured it will be inspected and given the new I.D.No. (Identification No.), and if Sieve is found torned, with holes or Integrity is not ok in it or unsuitable in any respect for usage, then it is to be replaced immediately and record it in “Sieve/Screen Inward, issuance & Distruction Register”.

6.0 ABBREVIATIONS

6.1 SOP: Standard Operating Procedure
6.2 QA: Quality Assurance
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