Standard Operating Procedure for In-Line Filtration of Creams before Packing
| Department | Creams |
|---|---|
| SOP No. | SOP/CRM/051/2025 |
| Supersedes | SOP/CRM/051/2022 |
| Page No. | Page 1 of 6 |
| Issue Date | 07/11/2025 |
| Effective Date | 12/11/2025 |
| Review Date | 07/11/2026 |
1. Purpose
The purpose of this Standard Operating Procedure (SOP) is to define the process for in-line filtration of creams before packing. In-line filtration ensures that the cream is free from any particulate matter, undissolved ingredients, or contaminants that may have been introduced during the manufacturing process. This step is crucial to maintain the quality, consistency, and safety of the final product before it is packed and distributed.
2. Scope
This SOP applies to the in-line filtration process of all cream formulations in the Creams Department. It covers the procedures for filtering cream before the packing process to ensure that the final product meets the required quality standards.
3. Responsibilities
- Production Team: Responsible for performing the in-line filtration process according to the SOP. They must ensure that the filtration equipment is properly set up, and the filtration process is carried out without interruption.
- Quality Control (QC): Responsible for monitoring the filtration process and performing tests on the filtered cream to ensure it meets the specified quality standards, including particle size and clarity.
- Quality Assurance (QA): Ensures compliance with this SOP and verifies that the filtration process is correctly documented and that the cream is free from particulate contamination before it proceeds to packing.
- Maintenance Team: Responsible for ensuring that the filtration equipment is properly maintained, cleaned, and calibrated to function effectively during the in-line filtration process.
4. Accountability
The Head of Creams Manufacturing is responsible for ensuring that the in-line filtration process is executed in compliance with this SOP. The QA Manager is accountable for verifying that the cream is free of particulates and meets the required quality specifications before packaging.
5. Procedure
5.1 Preparation for In-Line Filtration
- Ensure that all equipment required for filtration, such as filtration units, filters, and containers, are clean and ready for use.
- Verify that the filter media (e.g., mesh filters, cartridge filters) are suitable for the cream formulation and are within their expiration date.
- Inspect the production line to ensure that there is no residual cream or contaminant from the previous batch, which may affect the filtration process.
- Confirm that the required raw materials are available and ready for the next batch, and that the MFR for the cream specifies the filtration method and filter size.
5.2 Setting up the Filtration System
- Install the appropriate filters in the filtration system, ensuring they are correctly fitted to prevent leaks or bypass.
- Ensure that the filtration system is correctly connected to the production line, including ensuring the flow rate is properly set and the filter is able to handle the volume of cream.
- Verify that the filtration unit is free from any blockages or damage, and ensure that it is capable of maintaining the required flow rate for the entire batch.
5.3 In-Line Filtration Process
- Begin the filtration process by starting the flow of cream through the filtration system. Monitor the flow rate to ensure that it is consistent and within the specified parameters.
- Continuously check for any visible blockages or signs of excessive resistance, which could indicate an issue with the filter or a clogging of the system.
- Maintain an appropriate flow rate throughout the filtration process to prevent overloading the filter or causing incomplete filtration.
- If the system becomes clogged or if the flow rate decreases significantly, stop the process and inspect the filter for any blockages. Replace the filter if necessary.
5.4 Sampling and Testing during Filtration
- During the filtration process, take periodic samples of the cream from the filtration line to monitor the clarity and absence of particulates.
- Perform visual inspections and, if necessary, use a microscope or particle counter to check for any remaining particulates.
- If any particulates are found in the sample, stop the filtration process and investigate the issue, which may involve replacing the filter or adjusting the filtration settings.
- Continue filtering until the cream meets the required quality standards, as specified in the MFR. Ensure that all tests and checks are documented.
5.5 Post-Filtration Checks and Final Inspection
- Once the filtration process is complete, conduct a final visual inspection of the cream to ensure it is clear and free from visible particles.
- If necessary, conduct additional tests such as particle size analysis or filtration efficiency tests to ensure the cream meets the required specifications.
- Ensure that the cream is at the correct temperature and viscosity before proceeding to the next stage of production or packaging.
5.6 Cleaning and Maintenance after Filtration
- After the filtration process is completed, clean the filtration system thoroughly to prevent any residue from the previous batch from contaminating the next batch.
- Follow the cleaning SOP for the filtration equipment, ensuring that all parts are sanitized and that no residual cream is left in the system.
- Inspect the filtration system and replace any parts (e.g., filters) that show signs of wear or damage. Document any maintenance performed on the system.
5.7 Documentation and Reporting
- Record all aspects of the in-line filtration process in the batch record, including the time, date, filter specifications, flow rate, and any issues encountered during the process.
- Document the results of the filtration tests, including sample observations, particle count, and any corrective actions taken.
- Ensure that the batch record is submitted for final review and approval by the QA team before proceeding with the next step of production or packaging.
5.8 Final Approval and Packaging
- Once the cream passes the filtration and testing processes, the cream is ready for the final steps in the production process, including packaging and labeling.
- Ensure that all documentation is complete and approved before the product moves to the packaging stage.
6. Abbreviations
- QC: Quality Control
- QA: Quality Assurance
- GMP: Good Manufacturing Practices
- API: Active Pharmaceutical Ingredient
- MFR: Master Formula Record
7. Documents
- Filtration Log (Annexure-1)
- Batch Record (Annexure-2)
- Filtration Efficiency Test Report (Annexure-3)
8. References
- Good Manufacturing Practices (GMP) Guidelines – 21 CFR Part 211
- International Conference on Harmonisation (ICH) Q7 – Good Manufacturing Practice for Active Pharmaceutical Ingredients
- FDA Guidelines for Cosmetics Manufacturing
9. SOP Version
Version: 2.0
10. Approval Section
| Prepared By | Checked By | Approved By | |
|---|---|---|---|
| Signature | |||
| Date | |||
| Name | |||
| Designation | |||
| Department |
11. Annexures
Annexure-1: Filtration Log
| Batch Number | Filtration Start Time | Filtration End Time | Filter Type | Flow Rate | Remarks |
|---|---|---|---|---|---|
| 12345 | 08:30 AM | 09:00 AM | Mesh Filter 10 μm | 5 L/min | No issues |
Annexure-2: Batch Record
| Batch Number | Process Step | Time | Operator |
|---|---|---|---|
| 12345 | In-Line Filtration | 08:30 AM | John Doe |
Annexure-3: Filtration Efficiency Test Report
| Test Parameter | Result | Specification | Remarks |
|---|---|---|---|
| Particulate Count | 0 | Less than 10 particles/100 mL | Pass |
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 |