that the banding process complies with GMP standards and internal quality guidelines, reviewing the setup procedure and approving the final capsules for packaging.

Maintenance Team: Ensures that the capsule banding equipment is well-maintained and free from any mechanical issues that could affect the banding process.

4. Accountability

The Capsule Manufacturing Supervisor is accountable for ensuring that the capsule banding equipment is properly set up and maintained according to this SOP. The QA Manager is responsible for ensuring that the capsules meet the required quality standards and that the banding process complies with regulatory requirements.

5. Procedure

5.1 Preparation for Capsule Banding

Before setting up the capsule banding equipment, complete the following preparatory steps:

1. Check Capsule Type and Banding Requirements
   1. Verify the type of capsules being used (e.g., size, material) and ensure that the correct banding material is selected for the batch.
   2. Ensure that the banding requirements, such as color, width, and material, are defined based on the formulation and batch specifications.
2. Inspect Banding Equipment
   1. Inspect the capsule banding equipment for cleanliness and ensure that no residues or blockages are present in the system.
   2. Check the condition of the banding rollers, banding material feed, and any other parts that interact with the capsules during the process.
3. Verify Capsule Feed Mechanism
   1. Ensure that the capsule feed system is functioning correctly and that capsules are being fed smoothly into the banding machine.
   2. Check that the capsule orientation is correct to ensure proper band placement.

5.2 Setting Up the Banding Equipment

Once preparations are complete, follow these steps to set up the banding equipment:

1. Load Banding Material
   1. Load the banding material into the appropriate feeder of the capsule banding machine. Ensure the material is free of wrinkles or folds that could cause uneven band application.
   2. Ensure that the material is compatible with the capsule type and that it meets the batch-specific requirements for size and material type.
2. Set Banding Width and Thickness
   1. Adjust the banding material width and thickness settings on the machine according to the batch specifications.
   2. Ensure that the settings allow for a smooth and even application of the band around the capsule’s seams without causing damage to the capsule.
3. Adjust Banding Speed
   1. Set the banding machine speed according to the recommended settings for the specific capsule size and formulation.
   2. Ensure that the speed is set to allow the banding material to be applied uniformly across all capsules without compromising the banding quality.

5.3 Running a Test Batch

After setting up the machine, run a test batch to verify that the banding parameters are correct:

1. Start the Test Batch
   1. Start the banding machine with a small test batch of capsules. Ensure that the capsules are aligned properly and that the banding material is applied uniformly.
2. Inspect Banding Quality
   1. Inspect the test capsules for proper band placement, uniformity, and adherence. Ensure that the band is applied smoothly around the capsule without causing damage or deformation.
   2. Check the quality of the banding, including color consistency and coverage.
3. Adjust Settings if Necessary
   1. If any issues are detected, adjust the settings on the banding machine, such as pressure, temperature, or speed, and rerun the test batch.

5.4 Production Run

Once the test batch has passed inspection, proceed with the full production run:

1. Load Capsules for Banding
   1. Load the full batch of capsules into the machine, ensuring that they are properly oriented and fed into the banding system.
2. Start Production Run
   1. Start the full production run and monitor the capsules during banding to ensure that the banding process is proceeding smoothly and without defects.
   2. Monitor the capsule feed rate, banding speed, and material application throughout the production process to ensure consistency and quality.

5.5 Quality Control During Production

During the banding process, continuously monitor the following parameters to ensure consistent quality:

1. Capsule Alignment and Feed Rate
   1. Monitor the alignment of the capsules as they move through the banding equipment to ensure that they are properly aligned for uniform band application.
2. Banding Material Application
   1. Check the application of the banding material regularly to ensure that it is being applied evenly and that the band is securely attached to the capsule.
3. Monitor Seals
   1. Inspect the seals to ensure that the band is properly sealed around the capsule without gaps or excess material that could cause defects in the final product.

5.6 Post-Banding Actions

Once the banding process is complete, perform the following steps:

1. Capsule Inspection
   1. Inspect the final batch of capsules to ensure that the banding is applied correctly, with no deformed capsules or material defects.
2. Document the Process
   1. Document the machine settings, adjustments made, and the results of the quality checks in the batch production record (BPR).
3. Transfer to Packaging
   1. Once the banding process is complete and the capsules pass inspection, transfer them to the packaging area for further processing and final packaging.

5.7 Equipment Maintenance and Cleaning

After completing the banding process, perform the following maintenance and cleaning actions:

1. Clean Banding Machine
   1. Clean the banding machine thoroughly to remove any residual banding material, dust, or other contaminants.
2. Inspect Banding Equipment
   1. Inspect the machine for any signs of wear, particularly on rollers, sealing surfaces, and feeding mechanisms. Replace any worn or damaged components.
3. Lubricate Moving Parts
   1. Lubricate moving parts as per the equipment manual to prevent wear and ensure smooth operation in future production runs.

6. Abbreviations

• SOP: Standard Operating Procedure
• GMP: Good Manufacturing Practice
• QC: Quality Control
• QA: Quality Assurance
• BPR: Batch Production Record

7. Documents

1. Batch Production Record (BPR) (Annexure-1)
2. Capsule Banding Quality Control Log (Annexure-2)
3. Equipment Maintenance Log (Annexure-3)

8. References

• USP <1163> – Pharmaceutical Dosage Forms: Capsules
• FDA Guidelines for Capsule Manufacturing
• International Conference on Harmonization (ICH) Guidelines for Pharmaceutical Manufacturing

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Batch Production Record (BPR)

Batch ID	Production Date	Banding Parameters	Operator Name
Batch 001	01/02/2025	Material: Gelatin, Band Width: 5mm, Speed: 25 capsules/min	John Doe

Annexure-2: Capsule Banding Quality Control Log

Sample ID	Band Quality	Defects	Inspector Name
Sample 001	Pass	No defects	Jane Smith

Annexure-3: Equipment Maintenance Log

Machine ID	Maintenance Date	Tasks Performed	Technician Name
Banding Machine 1	01/02/2025	Checked rollers, replaced worn components	Jane Smith

Revision History:

Revision Date	Revision No.	Revision Details	Reason for Revision	Approved By
01/01/2024	1.0	Initial Version	New SOP Creation	QA Head
01/02/2025	2.0	Updated banding parameters	Standardization	QA Head