verifying that the cleaning and lubrication processes do not affect the product quality and ensuring that machines are in good condition before production begins.

Health and Safety Officer: Ensures that safety protocols related to cleaning agents, lubricants, and machine handling are followed to prevent accidents or exposure to hazardous materials.

4. Accountability

The Manufacturing Manager is accountable for ensuring that this SOP is followed and that machine parts are cleaned and lubricated according to the prescribed schedule. The overall compliance with this SOP is under the supervision of the Quality Assurance (QA) Manager.

5. Procedure

5.1. Cleaning Machine Parts

1. Before cleaning the machine, turn off the machine and disconnect it from the power source to ensure safety.
2. Follow the manufacturer’s instructions for selecting the appropriate cleaning agents for each machine component. Ensure that cleaning agents are safe for use with the machine materials and are compliant with environmental regulations.
3. Use a clean cloth, brush, or vacuum to remove any debris, dust, or product residue from machine surfaces, including the machine exterior, valves, crimping heads, and any other accessible parts.
4. For machines with sensitive parts such as pressure gauges or sensors, use non-abrasive cleaning methods to prevent damage.
5. If necessary, use a solvent or detergent to clean the machine’s interior parts, such as filling chambers or dispensing nozzles. Ensure that any solvent or detergent used is compatible with the materials being cleaned and that it is applied in the correct concentration.
6. After cleaning, thoroughly rinse any cleaned components with clean water or another suitable solvent to remove any remaining cleaning agents, ensuring no residue remains that could affect machine performance or product quality.
7. Dry cleaned parts using air blowers or clean, lint-free cloths to prevent water or solvent residue from remaining on components.
8. Document all cleaning activities in the Cleaning Log (Annexure-1), including the date, operator name, cleaning agents used, and machine parts cleaned.

5.2. Lubricating Machine Parts

1. Ensure that all machine parts requiring lubrication are properly identified. Refer to the machine’s maintenance manual to determine which parts require lubrication (e.g., moving parts, bearings, gears, and crimping heads).
2. Use only the recommended lubricants for each part, as specified in the machine’s operating manual. Ensure that lubricants meet industry standards for the materials involved.
3. Apply lubricant to the machine parts as specified by the manufacturer. Ensure that the lubricant is evenly distributed and that excess lubricant does not spill onto non-moving parts or the machine surface.
4. For parts with regular movement (e.g., gears or pistons), ensure that lubricant is applied at regular intervals during production to maintain smooth operation and prevent wear and tear.
5. Inspect the lubricated parts to ensure that lubrication does not interfere with the machine’s operation or affect the quality of the product being produced. Excessive lubricant should be wiped off to avoid contamination.
6. Document all lubrication activities in the Lubrication Log (Annexure-2), including the date, operator name, machine parts lubricated, and lubricant used.

5.3. Cleaning and Lubrication Schedule

1. Develop a cleaning and lubrication schedule based on machine usage and the manufacturer’s recommendations. The frequency of cleaning and lubrication will depend on factors such as the machine type, production volume, and operating conditions.
2. Typically, cleaning and lubrication should be performed after each production run, during scheduled downtime, or as needed based on the machine’s performance or any identified issues.
3. Regularly review the cleaning and lubrication schedule and update it as necessary based on machine performance, product quality, or changes to manufacturing processes.
4. Ensure that all team members are aware of the schedule and that they complete the cleaning and lubrication tasks on time to minimize machine downtime and maintain product quality.
5. Record the cleaning and lubrication schedule and completion dates in the Machine Maintenance Schedule Log (Annexure-3).

5.4. Safety and Environmental Considerations

1. Ensure that all cleaning and lubrication activities are performed in compliance with health, safety, and environmental regulations.
2. Wear appropriate personal protective equipment (PPE) such as gloves, safety glasses, and aprons when handling cleaning agents, solvents, or lubricants.
3. Store cleaning agents and lubricants in accordance with the manufacturer’s instructions and ensure that they are disposed of properly to prevent contamination or environmental harm.
4. Ensure that any waste generated during cleaning and lubrication (e.g., used rags, containers, or solvents) is disposed of according to company policies and environmental regulations.

5.5. Documentation and Record-Keeping

1. Ensure that all cleaning and lubrication activities are documented in the appropriate logs (Cleaning Log, Lubrication Log, and Maintenance Schedule Log) to provide a record of the tasks performed and to ensure traceability for quality control purposes.
2. Maintain cleaning and lubrication records in compliance with the company’s document retention policy, ensuring that they are available for audits or regulatory inspections.
3. Review records periodically to identify any trends, such as recurring machine issues, and take corrective actions as needed.

6. Abbreviations

• GMP: Good Manufacturing Practice
• QC: Quality Control
• PPE: Personal Protective Equipment
• SOP: Standard Operating Procedure

7. Documents

1. Cleaning Log (Annexure-1)
2. Lubrication Log (Annexure-2)
3. Machine Maintenance Schedule 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

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 Log

Machine ID	Parts Cleaned	Cleaning Agent Used	Operator Name	Date
F-12345	Filling Chamber	Solvent A	Rajesh Patel	06/02/2025

Annexure-2: Lubrication Log

Machine ID	Parts Lubricated	Lubricant Used	Operator Name	Date
F-12345	Gears	Lubricant X	Rajesh Patel	06/02/2025

Annexure-3: Machine Maintenance Schedule Log

Machine ID	Maintenance Type	Scheduled Date	Completed Date	Operator Name
F-12345	Cleaning and Lubrication	06/02/2025	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 lubrication procedures	To comply with updated GMP regulations	Anjali Sharma	Page 1	[Ref Point]	Updated procedures