Standard Operating Procedure for Filtering Through Stainless Steel Screens in Elixir Manufacturing
| Department | Elixir Department |
|---|---|
| SOP No. | SOP/ELX/096/2025 |
| Supersedes | SOP/ELX/096/2022 |
| Page No. | Page 1 of 8 |
| Issue Date | 11/04/2025 |
| Effective Date | 15/04/2025 |
| Review Date | 11/04/2026 |
1. Purpose
To lay down the procedure for filtering elixir formulations through stainless steel screens to remove undissolved particles, fibers, and foreign matter prior to storage, filtration, or packing.
2. Scope
This SOP is applicable to all batches of elixir manufactured in the Elixir Department that require filtration through stainless steel mesh screens as part of the process workflow.
3. Responsibilities
- Production Operator:
- Install screens, conduct filtration, and record the operation as per SOP.
- Production Supervisor:
- Ensure screen mesh size is as per the BMR and integrity is verified before use.
- QA Officer:
- Verify filtration records and approve product for further processing.
4. Accountability
The Head of Production is accountable for ensuring that the filtration process through stainless steel screens is performed using clean and undamaged mesh, and that filtration is documented and traceable.
5. Procedure
5.1 Preparation Before Filtration
- Ensure the stainless steel mesh screen is cleaned, sanitized, and visually free from damage, rust, or blockage.
- Select the correct mesh size as specified in the BMR (e.g., 100#, 200#, etc.).
- Assemble the screen with proper sealing and secure it on the filtration tank or receiving container.
5.2 Filtration Process
- Transfer the elixir solution from the mixing vessel to the holding tank or storage container via gravity or low-pressure pump through the mesh screen.
- Avoid excessive pressure or force which may cause rupture or dislodging of the screen.
- Monitor the flow and ensure no backflow or leakage occurs during transfer.
- If clogging occurs, pause filtration and replace the screen after cleaning.
5.3 Post-Filtration Handling
- Upon completion, dismantle the screen and wash thoroughly with purified water followed by cleaning with detergent and disinfectant solution.
- Dry the screen and inspect for integrity before storing in designated area.
- Record filtration details in the Stainless Steel Screen Log (Annexure-1).
5.4 Precautions
- Do not use damaged, bent, or corroded screens.
- Do not interchange mesh sizes without QA approval.
- Ensure screens are dedicated to specific product categories if required.
6. Abbreviations
- SOP: Standard Operating Procedure
- BMR: Batch Manufacturing Record
- QA: Quality Assurance
7. Documents
- Stainless Steel Screen Log (Annexure-1)
- Batch Manufacturing Record (BMR)
8. References
- WHO TRS 986 – Good Manufacturing Practices for Pharmaceutical Products
- 21 CFR Part 211.65 – Equipment Construction
9. SOP Version
Version: 2.0
10. Approval Section
| Prepared By | Checked By | Approved By | |
|---|---|---|---|
| Signature | |||
| Date | |||
| Name | |||
| Designation | |||
| Department |
11. Annexures
Annexure-1: Stainless Steel Screen Log
| Date | Batch No. | Mesh Size | Used For | Operator | Cleaned & Inspected By | Remarks |
|---|---|---|---|---|---|---|
| 11/04/2025 | ELX-1035 | 200# | Pre-holding filtration | Rajesh Kumar | Sunita Reddy | Filter clean and intact |
Revision History:
| Revision Date | Revision No. | Revision Details | Reason for Revision | Approved By |
|---|---|---|---|---|
| 01/01/2024 | 1.0 | Initial SOP Release | New SOP | QA Head |
| 11/04/2025 | 2.0 | Enhanced filtration precautions and documentation format | Compliance Update | QA Head |