Standard Operating Procedure for Sieve Integrity Verification in API Manufacturing
| Department | API Manufacturing |
|---|---|
| SOP No. | SOP/API/069/2025 |
| Supersedes | SOP/API/069/2022 |
| Page No. | Page 1 of 10 |
| Issue Date | 13/04/2025 |
| Effective Date | 15/04/2025 |
| Review Date | 13/04/2026 |
1. Purpose
To define the procedure for verifying the physical integrity of sieves used in API manufacturing to ensure that no ruptures, holes, or tears compromise the screening process and to maintain GMP compliance.
2. Scope
This SOP applies to all stainless-steel sieves used for material screening, sifting, or particle size separation in the API production area, including equipment-integrated and standalone sieves.
3. Responsibilities
- Production Operator: Perform sieve integrity checks before and after use and document results.
- Production Supervisor: Review integrity test results and authorize sieve usage.
- QA Department: Ensure verification records are reviewed and maintained.
4. Accountability
The Production Head is accountable for ensuring sieve integrity checks are conducted as per SOP. QA is responsible for verification and compliance review.
5. Procedure
5.1 Types of Sieves
- Hand sieves
- Vibratory sieve deck units
- Inline process sieves (during discharge or milling)
5.2 Frequency of Integrity Checks
- Before every batch use
- After cleaning and before reuse
- Monthly preventive integrity inspection for idle sieves
5.3 Visual Inspection
- Hold sieve against a bright light source or over a dark surface.
- Look for:
- Broken or torn mesh
- Mesh deformation or fraying
- Loose mesh from frame edges
- Check weld joints, rings, and frames for dents or corrosion.
5.4 Physical Testing Using Ball Test (Optional)
- Place glass or rubber balls on the sieve and vibrate for 2–3 minutes.
- Any loose particles falling below indicate a tear or breach.
5.5 Tagging and Documentation
- Attach “Verified” or “Rejected” tag to sieve based on results.
- Record inspection in the “Sieve Integrity Verification Log” (Annexure-1).
- Rejected sieves must be isolated and returned to Engineering for repair or disposal.
5.6 Calibration and Maintenance
- Engineering shall verify mesh size and calibration annually using certified sieve standards or external services.
- Maintain calibration certificates with equipment qualification records.
6. Abbreviations
- SOP: Standard Operating Procedure
- QA: Quality Assurance
- GMP: Good Manufacturing Practices
7. Documents
- Sieve Integrity Verification Log (Annexure-1)
- Equipment Cleaning Log
- Calibration Certificate
8. References
- ICH Q7 – Good Manufacturing Practice for Active Pharmaceutical Ingredients
- US FDA 21 CFR Part 211
- Internal Engineering SOP for Preventive Maintenance
9. SOP Version
Version: 2.0
10. Approval Section
| Prepared By | Checked By | Approved By | |
|---|---|---|---|
| Signature | |||
| Date | |||
| Name | |||
| Designation | |||
| Department |
11. Annexures
Annexure-1: Sieve Integrity Verification Log
| Date | Sieve ID | Mesh Size (µm) | Visual Check | Status | Remarks | Checked By |
|---|---|---|---|---|---|---|
| 13/04/2025 | SV-105 | 250 | OK | Verified | Clean and Intact |
Revision History:
| Revision Date | Revision No. | Details | Reason | Approved By |
|---|---|---|---|---|
| 01/01/2022 | 1.0 | Initial SOP Release | Quality Compliance | QA Head |
| 13/04/2025 | 2.0 | Added Physical Ball Test Option | Process Enhancement | QA Head |