Standard Operating Procedure (SOP)

Here is a complete Standard Operating Procedure (SOP) for an Automatic Capsule Filling Machine, typically used in pharmaceutical manufacturing for precise and efficient encapsulation.

1. Purpose

To define the procedure for the operation and handling of the Automatic Capsule Filling Machine to ensure consistent product quality, operator safety, and compliance with GMP standards.

2. Scope

This SOP applies to all production operators involved in capsule filling at [Facility Name].

3. Responsibilities

• Machine Operator: Operate the capsule filling machine as per SOP and maintain records.

• Supervisor: Verify adherence to SOP and perform in-process checks.

• Quality Assurance: Perform line clearance and batch quality review.

4. Safety and Hygiene Precautions

• Wear prescribed PPE (gloves, cap, mask, gown, shoe cover).

• Ensure machine area is clean and free from prior product residue.

• Verify that only approved materials are present in the area.

• Ensure all safety guards and interlocks are functioning.

• Never touch moving parts during operation.

5. Materials and Equipment

• Automatic Capsule Filling Machine (e.g., Bosch, Fette, Sejong, etc.)

• Empty hard gelatin or HPMC capsules

• Blended powder or granules (approved batch)

• Capsule polishing equipment (if used)

• Batch Manufacturing Record (BMR)

• Capsule weight checker (optional)

6. Procedure

6.1 Pre-Operation Checks

1. Ensure the machine is clean and labeled as “Cleaned.”

2. Verify the product, capsule size, and batch details.

3. Obtain line clearance from QA before batch start.

4. Set up the machine with correct parts (dosing disc, segment, capsule hopper, powder hopper).

6.2 Machine Setup

1. Load empty capsules into the capsule hopper.

2. Load powder/granules into the powder hopper.

3. Set machine parameters:

   • Capsule size

   • Dosage weight

   • Filling speed

   • Vacuum pressure

4. Run empty trial to check alignment and functionality.

5. Adjust parameters as needed to achieve proper separation, filling, and locking.

6.3 Operation

1. Start machine and monitor:

   • Capsule separation

   • Dosing uniformity

   • Locking mechanism

2. Collect filled capsules in a clean labeled container.

3. Periodically check capsule weight and locking integrity.

4. Record in-process checks as per BMR.

6.4 Completion

1. Stop the machine after completing the batch.

2. Remove remaining capsules and powders from hoppers.

3. Clean the machine as per cleaning SOP.

4. Record all data and observations in the BMR.

5. Label machine status as “To Be Cleaned.”

7. Cleaning and Maintenance

• Follow equipment cleaning SOP after every batch.

• Inspect and maintain parts like vacuum pumps, dosing discs, and filters.

• Report any mechanical issues immediately.

8. Documentation

• Batch Manufacturing Record (BMR)

• Equipment Cleaning Log

• In-process Check Sheet

• Capsule Weight Check Log

• Line Clearance Checklist

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