Standard Operating Procedure for Use of Vibratory Sifter in API Processing
| Department | API Manufacturing |
|---|---|
| SOP No. | SOP/API/079/2025 |
| Supersedes | SOP/API/079/2022 |
| 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 the operation of vibratory sifters in API manufacturing for ensuring particle uniformity, removal of oversized materials, and compliance with GMP standards.
2. Scope
This SOP applies to the use of vibratory sifters in the screening of Active Pharmaceutical Ingredients (APIs) and intermediates during final processing, blending, or packing.
3. Responsibilities
- Production Operator: Set up and
operate the sifter as per process parameters.
Production Supervisor: Verify sifter calibration, cleanliness, and proper mesh selection.
QA Officer: Perform line clearance and review sifting records and labels.
Engineering Department: Maintain and calibrate vibratory sifters at defined intervals.
4. Accountability
The Production Head is accountable for ensuring correct operation and documentation. QA Head is responsible for verifying GMP compliance and documentation control.
5. Procedure
5.1 Pre-Operation Checks
- Ensure the sifter is clean and labeled “CLEANED”.
- Verify the integrity of the mesh screen for any tears or deformations.
- Check the power supply, earthing, and vibration controls are in proper working condition.
- Record equipment ID, mesh number, and pre-use inspection in the BMR.
5.2 Setup of Vibratory Sifter
- Fix the required sieve mesh (e.g., 40#, 60#) onto the vibrating deck securely.
- Assemble the top cover, clamps, and discharge chute tightly to avoid dusting.
- Align the receiving container beneath the discharge outlet and label appropriately.
- Perform QA line clearance before starting operation using the Sifter Operation Checklist (Annexure-1).
5.3 Sifting Operation
- Transfer the dried or milled API gradually into the feed hopper or charging chute.
- Switch ON the sifter and set RPM/frequency as per equipment operating procedure (e.g., 30–50 Hz).
- Monitor the movement of material and avoid overfeeding to prevent mesh clogging.
- Ensure the operator wears anti-static PPE and avoids hand contact with exposed powder.
- Upon completion, ensure that all material has passed through and no residue remains in the hopper or mesh.
5.4 Post-Operation Procedure
- Turn OFF the sifter and disassemble all contact parts carefully.
- Collect oversized materials (if any) and record their weight in the BMR. Dispose as per SOP.
- Label containers with batch number, quantity, sifter ID, and date.
- Clean equipment as per SOP/API/074/2025 and affix “TO BE CLEANED” label.
6. Abbreviations
- SOP: Standard Operating Procedure
- API: Active Pharmaceutical Ingredient
- QA: Quality Assurance
- BMR: Batch Manufacturing Record
- PPE: Personal Protective Equipment
7. Documents
- Sifter Operation Checklist (Annexure-1)
- Equipment Cleaning Record
- Batch Manufacturing Record
8. References
- ICH Q7 – GMP Guide for APIs
- 21 CFR Part 211 – US FDA GMP Requirements
- Internal Equipment Operating Manual
9. SOP Version
Version: 2.0
10. Approval Section
| Prepared By | Checked By | Approved By | |
|---|---|---|---|
| Signature | |||
| Date | |||
| Name | |||
| Designation | |||
| Department |
11. Annexures
Annexure-1: Sifter Operation Checklist
| Date | Batch No. | Sifter ID | Sieve Mesh | Cleaned Status | QA Clearance | Remarks |
|---|---|---|---|---|---|---|
| 13/04/2025 | API-20250413 | VSFT-02 | 60# | Yes | Yes | Screening approved |
Revision History:
| Revision Date | Revision No. | Details | Reason | Approved By |
|---|---|---|---|---|
| 01/01/2022 | 1.0 | Initial SOP Release | New Equipment Implementation | QA Head |
| 13/04/2025 | 2.0 | Updated safety and RPM controls | GMP Compliance | QA Head |