SOP for Crimping Machine Operation and Maintenance
Department | Aerosol |
---|---|
SOP No. | SOP/Aerosol/042/2025 |
Supersedes | SOP/Aerosol/042/2022 |
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 correct operation and maintenance procedures for crimping machines used in the aerosol packaging process. The purpose of this SOP is to ensure that the crimping machines are properly operated and maintained, to guarantee consistent and high-quality seals on aerosol cans, and to reduce the risk of defects such as leakage or improper sealing.
2. Scope
This SOP applies to all crimping machines used for sealing aerosol cans at [Company Name]. It includes procedures for the operation, maintenance, and troubleshooting of crimping machines. This SOP does not cover the detailed maintenance of individual machine components, which are handled by separate procedures.
3. Responsibilities
- Production Team: Responsible for operating the crimping machine during the production process, ensuring that cans are sealed properly and within the required specifications.
- Maintenance Team: Responsible for performing routine and preventive maintenance on the crimping machine to ensure its proper functioning, including cleaning, lubrication, and parts replacement as needed.
- Quality Control (QC) Team: Responsible for verifying that the crimping operation produces seals that meet quality standards, including checking for leaks
4. Accountability
The Manufacturing Manager is accountable for ensuring that this SOP is followed, and that the crimping machine operates effectively and efficiently. The overall compliance with this SOP is under the supervision of the Quality Assurance (QA) Manager.
5. Procedure
5.1. Pre-Operation Checks
- Before operating the crimping machine, verify that all components are clean and free from any debris, product residues, or foreign material.
- Ensure that the machine is properly calibrated and set to the correct specifications for the aerosol can being processed (e.g., crimping pressure, speed, and positioning).
- Check the pressure settings on the crimping machine and ensure that the machine is receiving the proper air supply to function effectively.
- Inspect the crimping die for signs of wear or damage and ensure it is clean and aligned correctly. Verify that the sealing ring is in place and functioning properly.
- Ensure that all safety guards and covers are in place, and that the emergency stop button is functional.
- Check that the can alignment system is properly adjusted to ensure that cans are positioned correctly during crimping.
- Record the results of the pre-operation check in the Crimping Machine Pre-Operation Log (Annexure-1).
5.2. Operating the Crimping Machine
- Start the machine by activating the power supply and pressing the “Start” button. The machine should enter the “Standby” mode first, and then automatically move into the “Active” mode when production begins.
- Place the filled aerosol cans into the crimping machine’s loading system, ensuring that the cans are correctly positioned under the crimping head.
- As the machine operates, the crimping head should press the valve onto the can and create a secure seal. Observe the machine’s operation to ensure that the sealing is consistent and that no cans are misaligned or improperly crimped.
- Monitor the machine’s cycle time and ensure that it remains consistent with the desired production speed. Any irregularities should be documented and investigated.
- If a malfunction occurs during operation, immediately stop the machine using the emergency stop button and troubleshoot the issue according to the manufacturer’s instructions.
- Record the production data (batch number, start time, operator name, and number of cans processed) in the Batch Production Log (Annexure-2).
5.3. Post-Operation Checks
- Once the production run is complete, turn off the machine’s power supply and ensure that all components are in the “Safe” position.
- Inspect the finished cans for proper sealing. Check for any signs of leakage, improper crimping, or damaged valves. Reject any cans that do not meet quality standards.
- Remove any unused materials, such as crimping rings or labels, and clean the machine to remove any product residue or debris from the crimping process.
- Record the number of acceptable and rejected cans in the Post-Operation Report (Annexure-3), along with any corrective actions taken during the operation.
5.4. Routine Maintenance
- Perform daily maintenance tasks as per the machine’s maintenance schedule, which may include lubricating moving parts, cleaning crimping dies, and inspecting the air pressure system.
- Check the alignment and calibration of the crimping machine regularly to ensure consistent and accurate crimping. Recalibrate if necessary.
- Inspect the crimping machine for any signs of wear or damage, particularly the crimping die, and replace any worn parts before the machine is used for production.
- Log all maintenance activities, including repairs, parts replacement, and inspections, in the Crimping Machine Maintenance Log (Annexure-4).
5.5. Troubleshooting
- If the crimping machine produces defective seals, check the following:
- Ensure that the crimping die is properly aligned and free from debris.
- Verify that the sealing pressure and speed are within the correct parameters.
- Check the machine for signs of wear on the crimping components.
- Inspect the aerosol cans for deformities or misalignments.
- If the machine stops unexpectedly, check the power supply, air pressure, and machine settings. Investigate any error codes displayed on the control panel and refer to the troubleshooting guide in the machine manual.
- Document any issues and corrective actions taken in the Troubleshooting Log (Annexure-5).
5.6. Documentation and Record-Keeping
- Ensure that all logs related to machine operation, maintenance, and troubleshooting are accurately completed and stored according to the company’s document retention policy.
- These records should be available for internal and external audits, as well as for regulatory inspections.
6. Abbreviations
- GMP: Good Manufacturing Practice
- QC: Quality Control
- PPE: Personal Protective Equipment
- SOP: Standard Operating Procedure
7. Documents
- Crimping Machine Pre-Operation Log (Annexure-1)
- Batch Production Log (Annexure-2)
- Post-Operation Report (Annexure-3)
- Crimping Machine Maintenance Log (Annexure-4)
- Troubleshooting Log (Annexure-5)
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
9. SOP Version
Version: 2.0
10. Approval Section
Prepared By | Checked By | Approved By | |
---|---|---|---|
Signature | |||
Date | |||
Name | |||
Designation | |||
Department |
11. Annexures
Annexure-1: Crimping Machine Pre-Operation Log
Machine ID | Check Description | Operator Name | Date & Time | Remarks |
---|---|---|---|---|
CM-001 | Checked crimping die alignment | Rajesh Patel | 06/02/2025 | No issues |
Annexure-2: Batch Production Log
Batch No. | Start Time | Operator Name | Seals Produced | Test Results |
---|---|---|---|---|
12345 | 06/02/2025 | Rajesh Patel | 5000 | Pass |
Annexure-3: Post-Operation Report
Batch No. | Stop Time | Operator Name | Issues Encountered | Corrective Actions |
---|---|---|---|---|
12345 | 06/02/2025 | Rajesh Patel | None | None |
Annexure-4: Crimping Machine Maintenance Log
Maintenance Type | Details | Performed By | Date |
---|---|---|---|
Lubrication | Lubricated crimping die | Rajesh Patel | 06/02/2025 |
Annexure-5: Troubleshooting Log
Batch No. | Issue | Action Taken | Operator Name |
---|---|---|---|
12345 | Crimping misalignment | Adjusted die alignment | 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 operation and maintenance procedures | To comply with updated GMP regulations | Anjali Sharma | Page 1 | [Ref Point] | Updated procedures |