Capsule: SOP for Preparing Gelatin Solution for Capsule Shells – V 2.0

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Capsule: SOP for Preparing Gelatin Solution for Capsule Shells – V 2.0

Standard Operating Procedure for Preparing Gelatin Solution for Capsule Shells

Department Capsule Manufacturing
SOP No. SOP/CM/051/2025
Supersedes SOP/CM/051/2022
Page No. Page 1 of 6
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 preparing a gelatin solution used in the formulation of capsule shells. This procedure ensures the proper concentration, consistency, and quality of the gelatin solution, which is crucial for the shell formation process.

2. Scope

This SOP applies to the preparation of gelatin solutions for capsule shells in the manufacturing of hard gelatin capsules. It covers the selection of materials, preparation steps, and quality checks to ensure that the gelatin solution meets the required specifications.

3. Responsibilities

  • Formulation Development Team: Responsible for selecting the appropriate gelatin and excipients for capsule shell formulation and providing the necessary formulation specifications.
  • Manufacturing Team: Responsible for preparing the gelatin solution according to this SOP and ensuring that the solution is of the correct consistency and quality for capsule shell formation.
  • Quality Control (QC) Team: Responsible for testing the gelatin solution to ensure it meets quality standards, such as viscosity, concentration, and gel strength.
  • Quality Assurance (QA) Team: Ensures that the gelatin solution preparation process is conducted in compliance with GMP and regulatory requirements, and reviews the batch records for completeness and accuracy.

4. Accountability

The Capsule Manufacturing Supervisor is accountable for ensuring that the gelatin solution preparation process is executed in compliance with this SOP. The QA Manager is responsible for ensuring that the process complies with GMP and regulatory standards.

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5. Procedure

5.1 Gelatin Selection

Before preparing the gelatin solution, ensure that the correct type of gelatin is selected:

  1. Gelatin Type

    1. Select pharmaceutical-grade gelatin with the appropriate bloom strength and viscosity for capsule shell formation. Bloom strength typically ranges from 150 to 250.
    2. Ensure the gelatin is sourced from reputable suppliers and is free from contaminants.
  2. Excipients (Optional)

    1. If necessary, select appropriate excipients, such as plasticizers (e.g., glycerin, sorbitol) to modify the flexibility and texture of the gelatin shell.

5.2 Preparation of Gelatin Solution

The following steps should be followed for preparing the gelatin solution:

  1. Weighing Gelatin

    1. Weigh the required amount of gelatin based on the formulation. Ensure that the weight is accurate to avoid variations in the final product.
  2. Preparing Solvent

    1. Prepare the solvent (typically purified water) by heating it to a temperature of 60°C to 70°C. Ensure that the water temperature is controlled to prevent premature gelling.
  3. Adding Gelatin to Water

    1. Slowly add the weighed gelatin to the heated water while continuously stirring to avoid clumping. Use a low-speed mixer to gently combine the gelatin with the solvent.
    2. Allow the mixture to hydrate for 30 to 60 minutes, depending on the gelatin type, before proceeding to the next step.
  4. Stirring and Dissolving

    1. Stir the gelatin solution using a mechanical stirrer or homogenizer to dissolve the gelatin completely. Maintain a consistent stirring speed to prevent air incorporation, which can cause bubbles in the solution.
  5. Adding Plasticizers

    1. If plasticizers are used, add them after the gelatin is completely dissolved to improve flexibility and prevent cracking of the capsules.
  6. Adjusting Viscosity

    1. Check the viscosity of the gelatin solution using a viscometer. Adjust the viscosity by controlling the temperature or adding more solvent if necessary. The target viscosity should be suitable for capsule shell formation.
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5.3 Quality Control and Testing

After preparing the gelatin solution, perform the following quality control tests to ensure it meets the required specifications:

  1. Viscosity Test

    1. Use a viscometer to measure the viscosity of the gelatin solution. The viscosity should be within the range required for the specific capsule formulation.
  2. Gel Strength Test

    1. Perform a gel strength test to ensure the gelatin solution has the appropriate bloom strength. This can be measured using a Bloom gel strength tester.
  3. Appearance Check

    1. Visually inspect the gelatin solution to ensure it is clear, free from lumps, and homogeneous. Any presence of foreign particles or inconsistencies should be addressed before proceeding.
  4. pH Test

    1. Measure the pH of the gelatin solution to ensure it is within the desired range (usually between 4.5 and 5.5). If necessary, adjust the pH using suitable acid or base.

5.4 Storage of Gelatin Solution

Once the gelatin solution has been prepared and tested, it should be stored under appropriate conditions:

  1. Temperature Control

    1. Store the gelatin solution at a temperature between 20°C and 25°C to maintain its viscosity and prevent premature gelling.
  2. Storage Containers

    1. Store the solution in clean, airtight containers to prevent contamination and moisture loss. Label the containers with the date of preparation and batch number for traceability.
  3. Use Within Specified Timeframe

    1. Use the gelatin solution within the specified timeframe (usually within 24-48 hours) to ensure its effectiveness in capsule shell formation. If the solution is stored for longer periods, verify that it meets the required viscosity and gel strength before use.
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5.5 Documentation and Record-Keeping

Ensure that all steps of the gelatin solution preparation process are properly documented:

  1. Batch Records

    1. Maintain a batch record that includes the recipe, the amount of gelatin used, the temperature and time of processing, and the test results for viscosity, gel strength, and pH.
  2. Quality Control Reports

    1. Document all quality control tests performed on the gelatin solution, including results of viscosity, gel strength, appearance, and pH testing.

6. Abbreviations

  • SOP: Standard Operating Procedure
  • QA: Quality Assurance
  • QC: Quality Control
  • API: Active Pharmaceutical Ingredient
  • GMP: Good Manufacturing Practice

7. Documents

  1. Gelatin Solution Batch Record (Annexure-1)
  2. Quality Control Testing Report (Annexure-2)
  3. Gelatin Solution Storage Log (Annexure-3)

8. References

  • USP <871> – Gelatin Testing
  • FDA Guidance for Industry: Good Manufacturing Practices
  • 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: Gelatin Solution Batch Record

Batch ID Gelatin Type Water Volume Plasticizer Added Preparation Date
Batch 001 Gelatin 150 Bloom 1 L Glycerin 01/02/2025

Annexure-2: Quality Control Testing Report

Test Type Result Specification Remarks
Viscosity 250 cps 200-300 cps Pass

Annexure-3: Gelatin Solution Storage Log

Storage Date Storage Temperature Storage Container Storage Duration
01/02/2025 25°C Sealed Plastic Drum 48 Hours

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 viscosity and storage guidelines Standardization QA Head
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