SOP for Cleaning and Sanitization Between Stages
| Department | Aerosol |
|---|---|
| SOP No. | SOP/Aerosol/032/2025 |
| Supersedes | SOP/Aerosol/032/2022 |
| 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) defines the cleaning and sanitization processes required between manufacturing stages of aerosol products. The purpose of this SOP is to ensure that all equipment, utensils, and manufacturing areas are properly cleaned and sanitized to prevent cross-contamination and to maintain compliance with GMP standards. This is essential to ensure the quality and safety of aerosol products during each stage of production.
2. Scope
This SOP applies to all aerosol manufacturing processes at [Company Name] and covers cleaning and sanitization between stages such as formulation preparation, filling, and packaging. It includes cleaning of all equipment, surfaces, and utensils that come into contact with the product. This SOP does not cover the general cleaning of production facilities, which is handled by other procedures.
3. Responsibilities
- Production Team: Responsible for performing the cleaning and sanitization procedures between stages, ensuring all equipment and surfaces are properly cleaned and sanitized before transitioning to the next stage.
- Quality Control (QC) Team: Responsible for verifying the effectiveness of the cleaning and sanitization process through sampling, visual inspection, and other validation methods as required.
- Maintenance Team: Responsible for ensuring that cleaning equipment (e.g., washing machines, sanitization systems) is properly maintained and in working condition to support the cleaning process.
- Health and Safety Officer: Ensures that proper safety protocols are followed during the cleaning and sanitization process, particularly when handling chemicals and cleaning agents.
4. Accountability
The Manufacturing Manager is accountable for ensuring that this SOP is followed during the cleaning and sanitization process. The overall compliance with this SOP is under the supervision of the Quality Assurance (QA) Manager.
5. Procedure
5.1. Preparation for Cleaning and Sanitization
- Before starting the cleaning process, ensure that all equipment, utensils, and surfaces that require cleaning are properly identified and labeled. Remove any product residues from the previous stage.
- Ensure that the correct cleaning and sanitizing agents are available. Verify that the agents are approved for use in the production of aerosol products and are suitable for the materials being cleaned.
- Ensure that all operators are wearing appropriate PPE, including gloves, face shields, and lab coats, to protect against chemicals and to maintain the cleanliness of the environment.
- Ensure that cleaning and sanitizing equipment (e.g., cleaning machines, hand-held cleaning tools) are in good working condition and calibrated if necessary.
5.2. Cleaning Process Between Stages
- Begin the cleaning process by thoroughly washing all surfaces and equipment that came into contact with the product. Use the specified cleaning agents and follow the manufacturer’s instructions for their use.
- Clean all equipment parts that come into contact with the product, such as mixing vessels, filling machines, valves, nozzles, and packaging equipment. Pay special attention to areas where product residue may accumulate, such as seams and joints.
- Ensure that all surfaces are scrubbed and cleaned to remove any product residues, dirt, or other contaminants.
- Rinse the cleaned equipment thoroughly to remove any residual cleaning agents. Ensure that no cleaning agent residues remain on the equipment that could affect product quality.
5.3. Sanitization Process Between Stages
- After cleaning, apply the appropriate sanitizing agent to all surfaces, ensuring that it is applied uniformly and thoroughly. The sanitizing agent should be suitable for the type of equipment being sanitized and effective against any microbial contamination.
- Allow the sanitizing agent to sit for the recommended contact time as per the manufacturer’s guidelines. Do not remove or rinse the agent prematurely.
- Ensure that all equipment is dried properly after sanitization to prevent the growth of microbes or mold during the next phase of production.
- Ensure that sanitized equipment is stored in a clean and protected area, where it will not become contaminated before it is used in the next manufacturing stage.
5.4. In-Process Testing and Validation
- Perform regular sampling of equipment surfaces after cleaning and sanitization to verify the effectiveness of the process. Swab testing or rinse sampling may be used, depending on the type of equipment and the requirements of the product being manufactured.
- Conduct microbiological testing on surface samples to ensure that no harmful microorganisms are present after sanitization. If any microbial contamination is detected, re-clean and re-sanitize the equipment.
- Document all in-process validation results, including microbiological testing, in the Cleaning and Sanitization Log (Annexure-1).
5.5. Handling Deviations
- If any equipment or surfaces fail to meet cleanliness or sanitation standards during testing, stop the process and repeat the cleaning and sanitization steps. Investigate the cause of failure and take corrective actions as necessary.
- Record any deviations from the cleaning process in the Deviation Log (Annexure-2), including the batch number, the issue encountered, and the corrective actions taken.
- If necessary, consult with the maintenance team to ensure that the cleaning equipment is functioning properly or that the appropriate cleaning agents are being used.
5.6. Documentation and Record-Keeping
- Complete the Cleaning and Sanitization Log (Annexure-1) with all details, including equipment cleaned, cleaning agents used, sanitizers applied, and the operator’s name and signature.
- Document all microbiological testing results and any corrective actions in the Cleaning Validation Log (Annexure-2).
- Ensure that all records are stored according to the company’s document retention policy and are available for future audits or inspections.
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
- Cleaning and Sanitization Log (Annexure-1)
- Cleaning Validation Log (Annexure-2)
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: Cleaning and Sanitization Log
| Equipment | Cleaning Agent Used | Sanitizer Applied | Cleaning Date | Operator Name |
|---|---|---|---|---|
| Filling Machine | Detergent A | Sanitizer B | 06/02/2025 | Rajesh Patel |
Annexure-2: Cleaning Validation Log
| Batch No. | Test Parameter | Test Result | Test Date | Operator Name |
|---|---|---|---|---|
| 12345 | Microbial Test | Pass | 06/02/2025 | Rajesh Patel |
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 cleaning and sanitization procedures | To comply with updated GMP regulations | Anjali Sharma | Page 1 | [Ref Point] | Updated procedures |