sealing process records and approves capsules for packaging.

Maintenance Team: Responsible for ensuring that the capsule sealing machine is well-maintained and free of any mechanical issues that could affect sealing quality.

4. Accountability

The Capsule Manufacturing Supervisor is accountable for ensuring that the capsule sealing machine parameters are adjusted correctly. The QA Manager is responsible for ensuring that the sealing process complies with regulatory standards and that the capsules meet quality specifications.

5. Procedure

5.1 Preparation for Sealing Machine Adjustment

Before adjusting the capsule sealing machine parameters, ensure the following preparations are completed:

1. Verify Capsule Type and Sealing Requirements
   1. Ensure that the capsule type (e.g., size, gelatin type) and sealing requirements (e.g., hardness, tightness) are defined based on the formulation and batch requirements.
2. Inspect Sealing Machine
   1. Inspect the sealing machine for cleanliness and ensure that there are no residues, debris, or blockages that may interfere with the sealing process.
   2. Check the sealing surfaces, rollers, and pneumatic systems to ensure they are functioning properly and do not have any damage or wear.
3. Ensure Proper Capsule Feed
   1. Ensure that the capsule feed mechanism is working correctly. Check that capsules are properly aligned in the machine and will be directed to the sealing heads without obstruction or misalignment.

5.2 Adjusting Sealing Machine Parameters

Follow these steps to adjust the machine parameters for optimal sealing:

1. Adjust Sealing Temperature
   1. Set the sealing temperature according to the type of capsule being used and the formulation requirements. Typical sealing temperatures range from 80°C to 120°C depending on the capsule material and fill.
   2. Ensure that the temperature is set evenly across the sealing heads to avoid uneven or incomplete seals.
2. Set Sealing Pressure
   1. Adjust the sealing pressure based on the capsule size and material. Too high a pressure can cause capsule deformation, while too low a pressure can result in poor seals.
   2. Ensure that the pressure is evenly distributed across the capsule seams to ensure a strong and consistent seal.
3. Set Sealing Time
   1. Adjust the sealing time based on the machine type and capsule material. Typical sealing times are between 1-3 seconds per capsule.
   2. Ensure that the sealing time is sufficient for the sealing material to bond without overexposing the capsules to heat or pressure, which could damage them.
4. Check Sealing Head Alignment
   1. Check that the sealing heads are properly aligned with the capsule seams. Misalignment can result in improper seals or cracked capsules.
   2. Adjust the alignment as necessary to ensure the sealing heads are in direct contact with the capsule shell.

5.3 Testing Sealing Quality

Once the machine parameters are adjusted, test the sealing quality by performing the following checks:

1. Visual Inspection
   1. Visually inspect a sample of sealed capsules to check for visible defects, such as incomplete seals, cracks, or signs of leakage.
   2. Ensure that the seal is uniform, with no gaps or irregularities at the seam.
2. Pressure Test
   1. Perform a pressure test by applying gentle pressure to the sealed capsules. Capsules should not show any signs of leakage or breakage under moderate pressure.
   2. Any capsules showing signs of failure should be discarded and the sealing parameters adjusted accordingly.
3. Seal Integrity Test
   1. Conduct a seal integrity test using a seal tester to check that the capsules meet the required specifications for seal strength.
   2. Any capsules that fail the integrity test should be rejected, and the sealing machine parameters should be re-evaluated and adjusted as necessary.

5.4 Monitoring During Sealing Process

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

1. Monitor Sealing Temperature
   1. Monitor the temperature during the sealing process to ensure it remains within the optimal range. Adjust the temperature if fluctuations are detected.
2. Monitor Capsule Feed Rate
   1. Ensure that the feed rate of capsules into the machine is consistent and that no capsules are skipping or jamming the machine.
3. Monitor Sealing Pressure and Time
   1. Periodically check the sealing pressure and time to ensure they are within the set parameters, adjusting as necessary if capsules are not sealing properly.

5.5 Post-Sealing Actions

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

1. Capsule Inspection
   1. Perform a final visual inspection of the sealed capsules to ensure the seals are intact and there are no defects in the finished product.
   2. Segregate any defective capsules and document the issue in the deviation log for further investigation.
2. Document the Process
   1. Record the machine settings, adjustments made, and the outcome of the seal quality tests in the batch production record (BPR).
   2. Ensure that any deviations from the standard sealing process are documented and reviewed by the QA team for corrective actions.
3. Transfer to Packaging
   1. Once the sealed capsules have passed inspection and quality control checks, transfer them to the packaging area for further processing.

5.6 Equipment Maintenance and Cleaning

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

1. Clean Sealing Machine
   1. Clean the sealing machine after every batch to remove any residue or ink left on the sealing surfaces or rollers.
   2. Use appropriate cleaning agents and follow the manufacturer’s guidelines for cleaning and disinfecting the machine.
2. Inspect for Wear and Tear
   1. Inspect the sealing machine for signs of wear, particularly on sealing heads and rollers. Replace any worn or damaged components.
3. Lubricate Moving Parts
   1. Lubricate moving parts of the sealing machine to ensure smooth operation and prevent wear.

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. Sealing Machine Maintenance Log (Annexure-2)
3. Capsule Sealing Quality Control 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	Sealing Date	Capsule Type	Sealing Parameters	Operator Name
Batch 001	01/02/2025	Soft Gelatin, Size 00	Temperature: 100°C, Pressure: 8 bar, Time: 2 seconds	John Doe

Annexure-2: Sealing Machine Maintenance Log

Machine ID	Maintenance Date	Tasks Performed	Technician Name
Sealing Machine 1	01/02/2025	Calibrated temperature and pressure settings	Jane Smith

Annexure-3: Capsule Sealing Quality Control Log

Sample ID	Seal Quality	Capsule Condition	Operator Name
Sample 001	Pass	No defects	John Doe

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 sealing process parameters	Standardization	QA Head