Aerosol: SOP for Bulk Solution Preparation in Aerosols – V 2.0

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Aerosol: SOP for Bulk Solution Preparation in Aerosols – V 2.0

SOP for Bulk Solution Preparation in Aerosols

Department Aerosol
SOP No. SOP/Aerosol/031/2025
Supersedes SOP/Aerosol/031/2022
Page No. Page 1 of Y
Issue Date 06/02/2025
Effective Date 16/02/2025
Review Date 06/02/2028

1. Purpose

This Standard Operating Procedure (SOP) outlines the process for the preparation of bulk solutions used in aerosol manufacturing. The objective of this SOP is to ensure that bulk solutions are prepared accurately and consistently, maintaining the required specifications for the final aerosol product. This process must be performed under controlled conditions to prevent contamination and ensure that the final product meets quality standards.

2. Scope

This SOP applies to the preparation of all bulk solutions used in aerosol products at [Company Name]. It covers the preparation of both active ingredient solutions and any other formulation components, ensuring that they are mixed, stored, and handled in compliance with GMP standards. This SOP does not cover the preparation of individual aerosol formulations, which is handled in separate procedures.

3. Responsibilities

  • Production Team: Responsible for preparing the bulk solution according to the formulation requirements, ensuring accurate measurement of ingredients and maintaining cleanliness during the preparation process.
  • Quality Control (QC) Team: Responsible for verifying the quality and consistency of the bulk solution, including in-process testing and ensuring that the solution meets the required specifications.
  • Maintenance Team: Responsible for ensuring that the mixing and storage equipment is functioning correctly and is properly cleaned and maintained.
  • Health and Safety Officer: Ensures that safety protocols are followed during the preparation of bulk solutions, particularly when handling hazardous chemicals or propellants.
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4. Accountability

The Manufacturing Manager is accountable for ensuring that this SOP is followed and that bulk solutions are prepared under appropriate conditions. The overall compliance with this SOP is under the supervision of the Quality Assurance (QA) Manager.

5. Procedure

5.1. Preparation of Ingredients

  1. Ensure that all raw materials required for the bulk solution are available and meet the specified quality standards. These materials include active ingredients, excipients, solvents, and any propellants used in the formulation.
  2. Verify the quantities of each ingredient according to the batch formula and ensure that they are measured accurately using calibrated equipment (e.g., scales, volumetric flasks).
  3. Inspect all raw materials for any signs of contamination or damage. If any material appears unsuitable, discard it and report the issue to the Quality Control team.
  4. If necessary, pre-warm any solvents or ingredients that require temperature adjustment to ensure they dissolve or mix properly.

5.2. Mixing Process

  1. Load the ingredients into the appropriate mixing vessel. Ensure that the vessel is clean, dry, and free from any contaminants.
  2. Start the mixing process at a low speed to allow for proper dispersion of the ingredients. Gradually increase the mixing speed as needed to ensure uniformity.
  3. Monitor the mixing process to ensure that the solution is homogeneous and that no undissolved particles remain. If needed, use heating or additional stirring to assist in dissolving or dispersing ingredients.
  4. Periodically check the viscosity, color, and clarity of the solution. If any deviations from the expected appearance are noted, stop the process and investigate the cause.

5.3. In-Process Testing

  1. Perform in-process testing on a sample of the bulk solution to verify that it meets the required specifications, such as:
    • Viscosity
    • pH (if applicable)
    • Uniformity of dispersion
    • Solubility of active ingredients
  2. If the bulk solution does not meet the specifications, stop the process immediately and take corrective actions, which may include re-mixing, adjusting ingredients, or altering processing conditions.
  3. Document all in-process testing results in the In-Process Testing Log (Annexure-1), including any corrective actions taken.
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5.4. Storage of Bulk Solution

  1. Once the bulk solution is prepared and meets the required specifications, transfer it to appropriate storage containers that are clean and sealed to prevent contamination.
  2. Label the storage containers with the following information:
    • Batch number
    • Date of preparation
    • Ingredients used
    • Expiration date (if applicable)
  3. Store the bulk solution in a temperature-controlled environment if necessary, according to the formulation’s requirements (e.g., refrigerated or ambient temperature).
  4. Ensure that the solution is stored away from direct sunlight and sources of contamination, and that it is properly sealed to maintain its integrity.

5.5. Handling Deviations

  1. If any deviations from the process are identified (e.g., improper mixing, incorrect pH, or unexpected color), stop the process and take corrective actions.
  2. Investigate the cause of the deviation and take appropriate corrective and preventive actions to avoid recurrence. Document the deviation and actions taken in the Deviation Log (Annexure-2).
  3. If the deviation cannot be resolved, dispose of the affected bulk solution according to company policies and initiate a rework or re-manufacture as necessary.

5.6. Documentation and Record-Keeping

  1. Document all activities related to bulk solution preparation, including ingredient measurements, mixing conditions, in-process test results, and storage conditions in the Bulk Solution Preparation Log (Annexure-3).
  2. Ensure that the batch records for each bulk solution are complete, accurate, and stored in compliance with the company’s document retention policy.
  3. Maintain all records related to the bulk solution preparation process for future audits, inspections, or quality reviews.
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6. Abbreviations

  • GMP: Good Manufacturing Practice
  • QC: Quality Control
  • CAPA: Corrective and Preventive Actions
  • PPE: Personal Protective Equipment
  • R&D: Research and Development

7. Documents

  1. In-Process Testing Log (Annexure-1)
  2. Deviation Log (Annexure-2)
  3. Bulk Solution Preparation Log (Annexure-3)

8. References

This SOP is based on the following regulatory guidelines and industry standards:

  • Good Manufacturing Practice (GMP) Guidelines
  • FDA Code of Federal Regulations (CFR) Title 21, Part 211
  • ISO 9001:2015 – Quality Management Systems
  • International Pharmacopoeia (Ph. Int.) – Aerosol Delivery

9. SOP Version

Version: 2.0

10. Approval Section

Prepared By Checked By Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: In-Process Testing Log

Test Parameter Test Result Test Date Tested By
Viscosity Pass 06/02/2025 Rajesh Patel

Annexure-2: Deviation Log

Batch No. Deviation Description Corrective Action Operator Name
12345 Incorrect viscosity Re-mixed with additional solvent Rajesh Patel

Annexure-3: Bulk Solution Preparation Log

Batch No. Ingredients Mixing Conditions Operator Name Comments
12345 Active Ingredient, Solvent A, Solvent B Speed: 1000 rpm, Time: 30 mins Rajesh Patel Solution homogeneous

12. Revision History:

Revision Date Revision No. Revision Details Reason for Revision Approved By Page No. Ref. Point No. Details of Revision
01/01/2024 V 1.0 Initial Release First Issue Anjali Sharma Page 1 [Ref Point] First Release
01/01/2025 V 2.0 Updated bulk solution preparation procedure To comply with updated GMP regulations Anjali Sharma Page 1 [Ref Point] Updated procedures
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