SOP Guide for Pharma

Capsule: SOP for Coating Capsules with Enteric Coatings – V 2.0

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Capsule: SOP for Coating Capsules with Enteric Coatings – V 2.0

Standard Operating Procedure for Coating Capsules with Enteric Coatings

Department Capsule Manufacturing
SOP No. SOP/CM/092/2025
Supersedes SOP/CM/092/2022
Page No. Page 1 of 7
Issue Date 01/02/2025
Effective Date 05/02/2025
Review Date 01/02/2026

1. Purpose

The purpose of this SOP is to outline the procedure for coating capsules with enteric coatings. Enteric coatings are designed to protect the capsule contents from stomach acid and to ensure that the active ingredients are released in the small intestine. This process must be carried out in compliance with GMP guidelines to ensure the effectiveness, safety, and consistency of the coated capsules.

2. Scope

This SOP applies to the process of coating capsules with enteric coatings in the capsule manufacturing department. It covers the preparation, coating, inspection, and documentation involved in the application of enteric coatings to capsules.

3. Responsibilities

4. Accountability

The Capsule Manufacturing Supervisor is accountable for ensuring that all capsules are coated with the enteric coating according to the SOP. The QA Manager is responsible for reviewing the entire process to confirm that it complies with GMP standards and ensuring the final product’s quality.

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5. Procedure

5.1 Preparing for Capsule Coating

Before applying the enteric coating to the capsules, ensure the following preparations are made:

  1. Review the Coating Recipe
    1. Ensure the correct enteric coating formulation is used. Review the formulation to confirm that the right type of enteric polymer, plasticizer, and solvent are used.
    2. Verify that the quantities of each ingredient are accurate and comply with the formulation specifications.
  2. Prepare Coating Equipment
    1. Check that the coating pan or fluidized bed coater is properly cleaned and calibrated for coating application.
    2. Ensure that all necessary accessories, such as spray guns, air supply, and heating elements, are functioning correctly.
  3. Prepare Coating Solution
    1. Prepare the enteric coating solution as per the formulation guidelines. Ensure that the coating solution is free from lumps and is well-mixed.
    2. Filter the solution if necessary to remove any particulate matter that could affect the coating quality.

5.2 Coating Capsules

Follow the steps below to apply the enteric coating to the capsules:

  1. Loading the Capsules
    1. Load the empty capsules into the coating pan or fluidized bed coater. Ensure that the capsules are uniformly distributed and not overcrowded to allow proper air circulation during coating.
  2. Spraying the Coating Solution
    1. Apply the enteric coating solution to the capsules in a controlled manner, ensuring that each capsule receives an even coating.
    2. Use the spray guns to evenly distribute the solution over the capsules. The solution should be sprayed in thin layers to ensure that the coating is uniform.
    3. Control the air pressure, spray rate, and temperature to optimize the coating application and prevent the capsules from being over-sprayed or under-sprayed.
  3. Drying the Coated Capsules
    1. Allow the coated capsules to dry in the coating pan or fluidized bed. Ensure that the drying temperature is suitable to avoid damaging the coating or the capsule.
    2. Continue the drying process until the coating is uniformly dried and no longer sticky to the touch.
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5.3 Verifying Coating Quality

After the capsules have been coated, verify the coating quality as follows:

  1. Visual Inspection
    1. Inspect the capsules visually to ensure that the coating is uniform, free from cracks, and properly applied to all capsules.
    2. Check that the coating has adhered to the capsule shell and that there is no unevenness in the coating thickness.
  2. Coating Thickness Measurement
    1. Measure the thickness of the enteric coating on a random sample of capsules. Ensure the coating thickness is within the specified limits outlined in the product specifications.
  3. Disintegration Test
    1. Perform a disintegration test on a sample of the coated capsules to confirm that the coating will break down at the desired location in the gastrointestinal tract (small intestine).

5.4 Handling Deviations During Coating

If deviations are observed during the coating process, take the following corrective actions:

  1. Document the Deviation
    1. Document any deviations from the expected coating process in the deviation log. Include the cause, impact, and corrective actions taken.
  2. Investigate the Cause
    1. Investigate possible causes for the deviation, such as incorrect coating solution concentration, improper drying temperature, or equipment malfunction.
  3. Implement Corrective Actions
    1. Take corrective actions, such as adjusting the coating solution, recalibrating equipment, or adjusting the temperature settings.

5.5 Final Approval and Packaging

Once the coating process has been completed and verified, the following steps should be taken:

  1. Final QA Review
    1. The QA team should perform a final review of the coated capsules to ensure they meet the required specifications for appearance, disintegration, and coating thickness.
  2. Approval for Packaging
    1. Once the QA team approves the coated capsules, the batch can be moved to the packaging area for final packaging and labeling.
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6. Abbreviations

7. Documents

  1. Batch Production Record (BPR) (Annexure-1)
  2. Deviation Log (Annexure-2)
  3. Coating Log (Annexure-3)

8. References

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 Coating Date Operator Name Lot Number Approval Status
Batch 001 01/02/2025 John Doe 2025-001-01 Approved

Annexure-2: Deviation Log

Deviation ID Description Corrective Action Taken Operator Name Approval Status
DEV-001 Uneven coating on capsules Adjusted spray pressure and coating speed Jane Smith Approved

Annexure-3: Coating Log

Batch ID Coating Date Operator Name Coating Process Time Approval Status
Batch 001 01/02/2025 John Doe 45 minutes Approved

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 coating and verification process Standardization QA Head
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