1.0 OBJECTIVE
To lay down the procedure for operation of Cad mill.2.0 SCOPE
This SOP shall be applicable for the Cad Mill in Granulation Area at Production department.3.0 RESPONSIBILITY
3.1 Execution: Operator3.2 Checking: Production Pharmacist & Above
4.0 ACCOUNTABILITY
HOD-Production / Assigned Designee5.0 PROCEDURE
5.1 Production person shall ensure the cleanliness of the machine & area and ‘CLEANED’ label on it.5.2 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.
5.3 Check the integrity of screen before & after completion of operation & record the observation “Screen integrity check Log”.
5.4 Insert the beater assembly knife forward / Impact forward, depending on the requirement and tighten by means of four wing nuts and set the required speed by changing the V-belt and close the belt cover then tight the two wing nuts.
5.5 Insert the screen of the required size.
5.6 Affix throat and secure by means of further four wing nuts.
5.7 Place the feed tray in position & set the container below discharge point of cad mill. Container lined with poly bag. One end of poly bag attached with discharge point of cad mill and other ends inside container.
5.8 Switch “ON” the mains and then press green button to start the cad mill.
5.9 Start the mill and feed the material through feed tray slowly.
5.10 Switch “OFF” the mains after completion of operation and remove the container, tighten the poly bags and affix status label (milled).
5.11 Affix “To Be Cleaned” label on the Cad mill & fill “Equipment Log Book”.
6.0 ABBREVIATIONS
6.1 SOP: Standard Operating Procedure6.2 QA: Quality Assurance
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