Standard Operating Procedure for Inspecting Sealing Quality in Cream Packaging Machines
| Department | Creams |
|---|---|
| SOP No. | SOP/CRM/115/2025 |
| Supersedes | SOP/CRM/115/2022 |
| Page No. | Page 1 of 5 |
| Issue Date | 21/01/2026 |
| Effective Date | 26/01/2026 |
| Review Date | 21/01/2027 |
1. Purpose
The purpose of this SOP is to establish the procedure for inspecting the sealing quality of cream packaging machines to ensure that all sealed containers meet the required standards for integrity, safety, and product protection. This ensures that the final product is free from contamination and properly sealed for storage and transport.
2. Scope
This SOP applies to all cream packaging machines used for sealing containers, including jars, tubes, and bottles. It covers the inspection procedure, criteria for acceptable sealing quality, and corrective actions to be taken if sealing quality is compromised.
3. Responsibilities
- Production Team: Responsible for performing the sealing quality inspection during the packaging process and documenting the results. Ensures that defective seals are promptly addressed.
- Quality Control (QC): Verifies that the sealing process meets GMP standards and conducts random checks on the sealed packages. Ensures compliance with quality standards.
- Maintenance Team: Responsible for maintaining the sealing equipment and performing repairs if the sealing machines are found to be malfunctioning or not meeting the required standards.
4. Accountability
The Production Supervisor is accountable for ensuring that the sealing quality inspections are performed regularly and in accordance with this SOP. The Quality Control Manager is responsible for overseeing the inspection process and ensuring compliance with quality standards.
5. Procedure
5.1 Pre-Inspection Setup
- Ensure that the cream packaging machine is clean and fully operational before starting the sealing process. Perform any necessary pre-operation checks according to the machine’s manual.
- Verify that all required sealing materials (e.g., seals, caps, foil) are available and meet the specified quality standards for the batch being processed.
- Ensure that the packaging material (jars, tubes, bottles) is properly aligned with the sealing machine to avoid misalignment during sealing.
5.2 Performing the Sealing Quality Inspection
- As the cream packaging machine operates, visually inspect the sealed containers for the following criteria:
- Seal Integrity: Ensure that the seal is tight and complete, with no visible gaps, wrinkles, or weak points that could compromise the product’s safety or shelf life.
- Seal Positioning: Ensure that the seal is positioned correctly on the container, with no misalignment or off-center seals.
- Seal Strength: Test a sample of sealed containers by gently pressing on the seal to ensure that it holds firmly without opening. Ensure that the seal does not break under normal handling conditions.
- Inspect the packaging for any other defects, such as damaged containers, cracked lids, or foreign objects within the container.
- Use a sealing quality inspection checklist (Annexure-1) to document the inspection results for each batch, including any defects or deviations from the standard.
5.3 Random Sampling and Testing
- At regular intervals during the production run, randomly select sealed containers for further inspection. Check at least one container every 30 minutes to verify the sealing quality.
- Perform a more detailed inspection on these randomly selected containers, including the application of a seal integrity test (e.g., vacuum test, pressure test) to confirm the seal’s durability.
- Document the results of the random sample testing, including the batch number, the number of containers tested, and any defects found in the Sealing Quality Inspection Log (Annexure-2).
5.4 Corrective Actions for Defective Seals
- If defective seals are identified during the inspection, stop the production line immediately to prevent further defective seals from being produced.
- Identify the cause of the seal defect, which could be due to machine malfunction, incorrect sealing material, or improper machine settings.
- Adjust the machine settings (e.g., temperature, pressure, speed) or replace any faulty parts (e.g., sealing bands, heating elements) to resolve the issue.
- After adjustments are made, conduct a trial run to verify that the machine is now producing acceptable seals. Inspect the seals of the trial run containers before restarting full production.
- Record the defect, cause, and corrective actions taken in the Sealing Quality Inspection Log (Annexure-2) for future reference and tracking.
5.5 Post-Inspection Cleanup
- After the inspection process is completed, ensure that the packaging area is cleaned and free from any packaging debris, especially around the sealing machines and inspection stations.
- Store any unused sealing materials in a clean and dry area to prevent contamination and ensure that they remain in good condition for future use.
5.6 Documentation and Record-Keeping
- Document all sealing quality inspections, including the results of random sampling, defects found, and corrective actions taken, in the Sealing Quality Inspection Log (Annexure-2).
- Ensure that all documentation is reviewed and approved by the Quality Assurance (QA) team for compliance with GMP standards.
- Retain all inspection records for a minimum of two years or as required by regulatory guidelines.
6. Abbreviations
- GMP: Good Manufacturing Practices
- QC: Quality Control
- QA: Quality Assurance
- PPE: Personal Protective Equipment
7. Documents
- Annexure-1: Sealing Quality Inspection Checklist
- Annexure-2: Sealing Quality Inspection Log
8. References
- Good Manufacturing Practices (GMP) Guidelines – 21 CFR Part 211
- International Conference on Harmonisation (ICH) Q7 – Good Manufacturing Practice for Active Pharmaceutical Ingredients
- Packaging Equipment Manufacturer’s Manual
9. SOP Version
Version: 2.0
10. Approval Section
| Prepared By | Checked By | Approved By | |
|---|---|---|---|
| Signature | |||
| Date | |||
| Name | |||
| Designation | |||
| Department |
11. Annexures
Annexure-1: Sealing Quality Inspection Checklist
| Batch Number | Seal Integrity | Seal Position | Seal Strength | Defects Found | Inspector |
|---|---|---|---|---|---|
| 12345 | Pass | Pass | Pass | No defects | John Doe |
Annexure-2: Sealing Quality Inspection Log
| Batch Number | Inspection Date | Defects Found | Corrective Action Taken | Inspector |
|---|---|---|---|---|
| 12345 | 21/01/2026 | None | No action needed | John Doe |
Revision History:
| Revision Date | Revision No. | Revision Details | Reason for Revision | Approved By |
|---|---|---|---|---|
| 01/03/2024 | 1.0 | Initial Version | New SOP Creation | QA Head |
| 01/03/2025 | 2.0 | Format Revision and Updates | Standardization of Document | QA Head |