SOP for Operation of Deduster Cum Metal Detector : Pharmaguideline

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SOP for Operation of Deduster Cum Metal Detector

Standard operating procedure to operate the De-duster Cum Metal Detector used in Tablet manufacturing.

1.0 OBJECTIVE

To lay down the Procedure for Operation of Deduster Cum Metal Detector.

2.0 SCOPE

This SOP shall be applicable for operation of Deduster Cum Metal Detector in the Production area.

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 Check the equipment for cleanliness including the hopper, discharge channels, trolley and dedusting unit.
5.2 Before starting the operation production person get the line clearance from Q.A person by writing the status label with Product Name, Batch Details to equipment & area as per BMR.
5.3 Connect the electrical supply to single phase supply socket.
5.4 Put “ON” the main supply switch. Power “ON” switch inside the panel can be kept always at “ON” position & need not be operated every time ensure that sensitivity control is adjusted between 9th & 10th division.
5.5 Ensure that time control is set between 4th & 5th division.
5.6 Do not disturb the setting of phase control, as it is a permanent adjustment.
5.7 Confirm the rejection mechanism with the help of test pieces.
5.8 Fix the separate poly lined container on rejection discharge chute and other discharge chute attached to the dedusting unit. Keep a container with polythene below the discharge chute of the dedusting unit.
5.9 Ensure that the indication of “LED” bar indicator is at “Nul” position.
5.10 Attach the Metal detector to the Compression machine chute & start the compression machine.
5.11 Adjust feed hopper slowly in such a manner that the Acrylic channel does not get chocked.
5.12 Rejected materials are collected in a duly labeled container and after completion of compression, destroy it by soaking in water in the presence of QA person.
5.13 After the operation is completed. Put “off “main supply & remove the container.
5.14 Affix ‘To be Cleaned ‘label. And fill the “Equipment Log Book”.

6.0 ABBREVIATIONS

6.1 SOP: Standard Operating Procedure
6.2 BMR: Batch Manufacturing Record
6.3 Q.A.: Quality Assurance
6.4 HOD: Head of The Department
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