Standard Operating Procedure for Capsule Filling Machine

STANDARD OPERATING PROCEDURE (SOP)

OPERATION OF CAPSULE FILLING MACHINE

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1. PURPOSE

The purpose of this Standard Operating Procedure (SOP) is to define the uniform method for the operation, cleaning, and maintenance of the [___________] Capsule Filling Machine to ensure compliance with Good Manufacturing Practices (GMP) and safety regulations.

2. SCOPE

This SOP applies to all personnel authorized to operate, calibrate, or maintain the [] machine within the [] facility.

3. RESPONSIBILITIES

• Operator: Responsible for the correct execution of the filling process and daily sanitation.
• Quality Assurance (QA) Dept: Responsible for verifying process compliance and release of finished batches.
• Maintenance Dept: Responsible for technical repairs and preventative maintenance schedules.

4. PRE-OPERATIONAL REQUIREMENTS

Before initializing the machine, the operator must verify:

1. The machine has been cleaned and marked with a "Cleaned" status tag.
2. The area is free of foreign materials and previous product residue.
3. Personal Protective Equipment (PPE) requirements: [___________].
4. Required raw materials: [] (Batch No: []).

5. OPERATING PROCEDURE

5.1 Preparation

1. Ensure all electrical and pneumatic connections are secured.
2. Verify that the capsule size ([___________]) matches the machine tooling.
3. Load the hopper with the approved powder/pellet formulation.

5.2 Start-Up

1. Turn the Main Power switch to the ON position.
2. Set the machine speed to [___________] RPM.
3. Initiate the cycle by pressing the [START] button on the control panel.
4. Observe the first [___________] capsules for weight accuracy and locking integrity.

5.3 In-Process Monitoring

1. Weight checks shall be performed every [___________] minutes.
2. Any deviation from the weight range of [] mg to [] mg must be reported immediately to the Supervisor.

5.4 Shutdown

1. Empty the hopper of remaining materials.
2. Press the [STOP] button.
3. Switch the Main Power to OFF.
4. Clear all finished product for final quality inspection.

6. CLEANING AND SANITIZATION

• Disassemble the machine parts according to the manufacturer’s manual.
• Clean all contact parts with [___________] (Cleaning Agent).
• Ensure all components are thoroughly dried and documented in the Cleaning Log.

7. SAFETY PRECAUTIONS

• WARNING: Never insert hands into the machine while in operation.
• Emergency Stop (E-Stop) buttons are located at: [___________].
• Lock-Out/Tag-Out (LOTO) procedures must be followed during any maintenance task.

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8. DOCUMENTATION AND APPROVALS

Prepared By: Name: __________________________ Title: __________________________ Signature: ______________________ Date: __________________________

Reviewed By (Quality Assurance): Name: __________________________ Title: __________________________ Signature: ______________________ Date: __________________________

Approved By (Management): Name: __________________________ Title: __________________________ Signature: ______________________ Date: __________________________

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End of Document