To lay down the procedure for operation of semi auto induction cap sealing machine.
This SOP shall be applicable for operation of Semi Auto Induction Cap Sealing machine in Packing Area in 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 Semi Auto Induction Cap Sealing Machine, its parts, area and “CLEANED” label on it.
5.1.1 Before starting the operation production person get the line clearance from Q.A. person and affix the status label with Product Name, Batch details to Equipment and area.
5.1.2 Adjust the height of the machine for a gap of about 2 mm between the container/cap and sealing head.
5.1.3 Adjust trigger switch position to operate when the container/cap is in the place under the center of the sealing.
5.1.4 On the front panel select the heating time (approx. 3.5 sec) by pressing p or q button, for proper sealing.
5.1.5 Insert container to trigger and allow to complete sealing cycle / time.
5.1.6 Once set for a particular container, the unit shall automatically start when the container is in place.
5.1.7 During the operation of Induction Cap Sealing at every half hour interval Pharmacist shall conduct random check of sealed bottles and counter check for:
· Sealing quality.
· Filled Quantity of tablets.
5.1.8 After completion of operation. Put “OFF” the mains.
5.1.9 Affix “To be cleaned” status label and fill the “Equipment Log Book”.
· Sufficient trail run should be taken with empty bottles to ensure satisfactory sealing before starting actual Induction sealing operation.
· Written line clearance should be obtained from Q.A. person before commencing Induction sealing and also prior to change over to another batch of same product or to a new product.
· After completion of trail with empty bottles, discard these bottles. It should not send out with filled and sealed bottles.
6.1 SOP: Standard Operating Procedure
6.2 BPR: Batch Packing Record
6.3 Q.A.: Quality Assurance
6.4 HOD: Head of The Department
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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