Standard Operating Procedure for Inspecting and Cleaning Filters in Cream Production Lines
| Department | Creams |
|---|---|
| SOP No. | SOP/CRM/105/2025 |
| Supersedes | SOP/CRM/105/2022 |
| 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 a procedure for inspecting and cleaning filters used in cream production lines. Proper inspection and cleaning of filters are essential to prevent contamination and ensure the quality of the final cream product.
2. Scope
This SOP applies to all filters used in the cream production lines. It includes procedures for regular inspection, cleaning, and maintenance of filters to ensure they function effectively and do not compromise product quality.
3. Responsibilities
- Production Team: Responsible for following the SOP for inspecting and cleaning the filters during routine production processes.
- Maintenance Team: Responsible for inspecting the filters, performing deep cleaning if needed, and replacing damaged or worn-out filters.
- Quality Control (QC): Ensures that the filters meet the necessary cleanliness standards and that no contaminants are present in the cream product.
4. Accountability
The Production Supervisor is accountable for ensuring that the filters are inspected and cleaned in accordance with this SOP. The Maintenance Manager is responsible for overseeing the maintenance and repair of the filters to ensure their proper functioning.
5. Procedure
5.1 Pre-Operation Setup
- Before starting the production run, ensure that all filters are properly installed and positioned within the production line equipment. Check that the equipment is clean and free of any obstructions that could affect filter performance.
- Verify that the filter elements are the correct type and size for the cream production line. Replace any worn or damaged filters before starting production.
- Check for any visible signs of damage or wear on the filter housing, seals, or fittings. Replace any faulty components as necessary.
5.2 Inspecting the Filters
- Perform a visual inspection of the filters regularly, ideally at the start of each production shift. Look for signs of clogging, damage, or product buildup on the filters.
- If the filter is clogged or shows signs of excessive buildup, it should be removed for cleaning or replacement.
- Check the filter housing for leaks or signs of wear. If any leaks are found, seal them promptly to avoid contamination.
- Ensure that filter seals are intact and that they create an airtight fit, preventing bypass of contaminants.
5.3 Cleaning the Filters
- To clean the filters, first, stop the production line and isolate the filter from the system. Follow all safety procedures when handling the filters, including wearing appropriate Personal Protective Equipment (PPE).
- For reusable filters, follow the manufacturer’s guidelines on the appropriate cleaning method. Generally, this may involve washing the filter with warm water and a suitable detergent to remove any product residues.
- For particularly dirty filters, additional cleaning methods, such as ultrasonic cleaning or high-pressure water rinsing, may be necessary to ensure that all contaminants are removed.
- After cleaning, inspect the filters once more to ensure that all residues have been removed and that the filter is in proper condition.
- If the filter is damaged or the cleaning process does not restore its performance, replace the filter with a new one.
5.4 Reinstalling the Filters
- Once cleaned or replaced, reinstall the filter into the production line, ensuring that it is securely positioned and properly sealed.
- Verify that all connections to the filter are tight and that no leaks are present.
- Check that the filter is aligned correctly with the flow direction, as indicated by the manufacturer’s instructions.
- Ensure that the filter is securely fastened in place to avoid any issues during production.
5.5 Post-Operation Inspection
- At the end of each production run, inspect the filters to ensure they have performed effectively during the process. Check for any signs of clogging or excessive product residue.
- If filters were cleaned during the run, ensure that the post-operation inspection confirms that they are still in good condition for future use. Record the inspection results in the Filter Maintenance Log (Annexure-1).
5.6 Documentation
- Record all filter inspections, cleanings, and replacements in the Filter Maintenance Log (Annexure-1). Include the date of inspection, the condition of the filter, and any corrective actions taken.
- Ensure that the maintenance log is reviewed and approved by the Quality Assurance (QA) team to verify that all cleaning and maintenance tasks have been completed according to standard procedures.
6. Abbreviations
- GMP: Good Manufacturing Practices
- QC: Quality Control
- QA: Quality Assurance
- PPE: Personal Protective Equipment
7. Documents
- Annexure-1: Filter Maintenance 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
- Manufacturer’s Manual for Filters
9. SOP Version
Version: 2.0
10. Approval Section
| Prepared By | Checked By | Approved By | |
|---|---|---|---|
| Signature | |||
| Date | |||
| Name | |||
| Designation | |||
| Department |
11. Annexures
Annexure-1: Filter Maintenance Log
| Filter ID | Inspection Date | Condition | Action Taken | Operator |
|---|---|---|---|---|
| FLT-001 | 21/01/2026 | Good | Cleaned and reinstalled | 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 |