To lay down the procedure for Operation of Multimill.
This SOP shall be applicable for Multimill in all Granulation area at Production department.
3.1 Execution : Operator
3.2 Checking : Production Pharmacist & Above
HOD-Production / Assigned Designee
5.1 Production person shall ensure the cleanliness of the machine & area and ‘CLEANED’ label on it.
5.2 Check the integrity of screen before and after the operation and record the observation in “Screen 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 Fix the beater assembly.
5.5 Fit the screen of required size and the hopper properly.
5.6 Set the Multimill in required direction (Knife forward / Impact forward) by moving the lever/ knob. Then adjust the required speed by changing the position of V- belt.
5.7 Tie the poly bag to the discharge chute of Multimill by food grade rubber & keep the poly bag in S.S. In process container and then place container below the discharge port.
5.8 Put “ON” the mains, then press green button and load the material, adjust the chute plate so that material will feed slowly and checks for smooth functioning of the machine.
5.9 Control the flow with stopper plate & ensure that the hopper is not charged heavily otherwise the Multimill can get blocked.
5.10 Put “OFF” the mains after completion of the operation.
5.11 Affix “To Be Cleaned” label on Multimill & fill the “Equipment Log Book”.
The new screen is procured it will be inspected and given the new I.D.No. (Identification No.), and if Screen 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 & Destruction Register”.
6.1 SOP: Standard Operating Procedure
6.2 HOD: Head of The Department
6.3 S.S.: Stainless Steel
Ankur Choudhary is India's first professional pharmaceutical blogger, author and founder of Pharmaceutical Guidelines, a widely-read pharmaceutical blog since 2008. Sign-up for the free email updates for your daily dose of pharmaceutical tips.
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