SOP for Operating Procedure of Multi Mill Machine

Learn how to write a standard SOP for operating procedure of multi mill machine in production.

1.0 PURPOSE

To describe the standardized procedure for safe, accurate, and efficient operation, cleaning, and maintenance of the Multi Mill machine, ensuring product quality, consistency, and compliance with GMP guidelines.

2.0 SCOPE

This SOP is applicable for operation, shutdown, cleaning, maintenance, and documentation of the Multi Mill machine used in the Production Department.

Machine Name: Multi Mill Machine

Machine ID:

Capacity:

Manufacturer: Local Manufacturer

3.0 RESPONSIBILITY

3.1 Production Operator: To operate and clean the Multi Mill machine properly.

3.2 Line Supervisor: To supervise operations and ensure line clearance related to the batch.

3.3 Production Manager: To oversee proper implementation of the SOP.

4.0 ACCOUNTABILITY

4.1 Head of Production: To ensure accountability for the entire process.

4.2 Quality Assurance (QA) Manager: To verify and approve adherence to the SOP and documentation.

5.0 REFERENCES / ASSOCIATED DOCUMENTS

5.1 Equipment User Manual

6.0 PRECAUTIONS

6.1 Before operating the machine, ensure that the chamber, screen, beater, etc., are properly locked.

6.2 Do not insert hands, clothing, or tools inside the machine while it is running.

6.3 Do not operate the electric panel with wet hands.

6.4 The machine power must be completely turned off during cleaning.

7.0 TRAINING

7.1 All personnel responsible for operating the Multi Mill machine must be trained according to this SOP, and training records must be maintained.

8.0 PROCEDURE

8.1 Machine Set-up and Operation

8.1.1 Obtain Line Clearance before starting the machine.

8.1.2 Install beater, screen, hopper, etc., as required and ensure locks.

8.1.3 Connect the machine to power and turn on the main switch.

8.1.4 Load the specified quantity of materials into the product hopper.

8.1.5 Set the required RPM and start the machine.

8.1.6 After milling, stop the machine and collect the material.

8.2 Machine Cleaning (Product Changeover / Batch Changeover)

8.2.1 Turn off the main power switch of the machine.

8.2.2 Remove screen, beater, hopper separately.

8.2.3 Perform dry cleaning using brush and vacuum (if applicable).

8.2.4 Perform wet cleaning with the specified detergent.

8.2.5 Rinse with Purified Water.

8.2.6 Dry using compressed air.

8.2.7 Ensure visual cleaning verification by QA.

8.2.8 Enter cleaning records into the Equipment Log Book.

9.0 ABBREVIATIONS / DEFINITIONS

9.1 SOP = Standard Operating Procedure

9.2 GMP = Good Manufacturing Practices

9.3 BMR = Batch Manufacturing Record

9.4 RPM = Revolutions per Minute

10.0 ANNEXURES

10.1 Annexure-1: Daily Operation Log Book