SOP for Operating Procedure of Communiting Mill

OBJECTIVE

To lay down a procedure for the operation of the Communiting mill.

SCOPE

This procedure applies to the production department in the Pharmaceutical Manufacturing Facilities Formulation division.

RESPONSIBILITY

The production operator is responsible for the implementation of the process.

The production In-Charge is responsible for the execution and compliance of the procedure.

PROCEDURE

Pre-checks

• Availability of trained operating personnel wearing clean uniforms, gloves and nose masks.
• Availability of power supply.
• Availability of clean SS containers to collect milled material.
• Ensure the cleanliness of the area and machine with proper labeling and line clearance.

Machine Assembling

• Assemble the screen, screen plate, and Discharge port.
• Fix the perforated screen as per the product requirement along with the base plate.
• Check whether the gaskets are in good condition and are placed properly.
• Clamp Feed-Discharge port and slide plate.

Operation

• Switch ‘ON’ the mains.
• Set the speed of the blade as mentioned in BMR.
• Run the Communiting mill empty for a few seconds and observe for any abnormal sounds. If noticed then switch OFF the mains and reassemble the parts.
• Arrange an SS container lined with a double polybag; tie the polybag to the discharge hopper to avoid dust.
• Switch ‘ON’ the mains. Charge the material into the feed hopper with the help of a clean SS scoop.
• Open the slide plate slowly and control the flow of the inlet material.
• Optimum output can be obtained by maintaining a constant rate of feeding.
• Do not overload the Blade; otherwise, the Motor or Belt will be damaged
• While Operating the Machine, ensure that guards & blades are properly closed otherwise it will cause major physical injury to the operating personnel.
• All the operation details shall be entered in the equipment usage log book.

ABBREVIATION

Q.A - Quality Assurance

BL - Beta-Lactam

SOP - Standard Operating Procedure

No. - Number

P.D - Production

ANNEXURE

Nil

REVISION HISTORY

Nil

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