Standard Operating Procedure for Transfer of Wet Cake for Drying in API Manufacturing
| Department | API Manufacturing |
|---|---|
| SOP No. | SOP/API/029/2025 |
| Supersedes | SOP/API/029/2022 |
| 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 standard procedure for transferring wet cake obtained after filtration or centrifugation to the designated drying equipment in a manner that prevents contamination, ensures traceability, and maintains product integrity.
2. Scope
This SOP applies to all wet cake transfer operations conducted in the API manufacturing area, irrespective of batch size or drying equipment type (e.g., Tray Dryer, RVD, FBD).
3. Responsibilities
- Production Operator: Execute the transfer procedure as per BMR.
- Production Supervisor: Ensure cleanliness of containers and equipment before use.
- QA Personnel: Perform line clearance and verify proper labeling and documentation.
- Engineering Personnel: Ensure dryers and transfer tools are available and in validated condition.
4. Accountability
The Production Head is accountable for compliance and implementation of this SOP, while the QA Head is responsible for overall verification.
5. Procedure
5.1 Pre-Transfer Checks
- Ensure the filtration or centrifugation process is complete and logged.
- Check that the drying equipment is cleaned, validated, and ready to receive material.
- Verify line clearance and obtain QA approval before beginning transfer.
- Confirm batch details, status labels, and cleanliness of transfer containers.
5.2 Transfer of Wet Cake
- Wear required PPE (gloves, apron, mask, goggles) before handling wet cake.
- Transfer the wet cake from filter/centrifuge using clean, sanitized SS scoops or transfer devices.
- Move material to labeled stainless-steel trays or containers designated for drying.
- Ensure complete transfer; check equipment for residuals and record hold-up weight (if applicable).
- Label each tray/container with:
- Product name
- Batch number
- Date
- Weight
- Dryer ID
5.3 Movement to Drying Area
- Transport material using designated clean trolleys through approved material movement path.
- Avoid cross-contamination by ensuring separation from other materials in transit.
- Place material inside dryer as per defined loading pattern (e.g., from top shelf down).
- Record time of loading and condition of material in “Wet Cake Transfer Log” (Annexure-1).
5.4 Post-Transfer Activities
- Clean transfer tools and containers as per equipment cleaning SOP.
- Record all cleaning activities in the respective logs (Annexure-2).
- Ensure wet cake storage area is cleaned and ready for the next batch.
6. Abbreviations
- SOP: Standard Operating Procedure
- QA: Quality Assurance
- RVD: Rotary Vacuum Dryer
- FBD: Fluidized Bed Dryer
- BMR: Batch Manufacturing Record
7. Documents
- Wet Cake Transfer Log (Annexure-1)
- Cleaning Checklist for Transfer Tools (Annexure-2)
- Label Verification Sheet (Annexure-3)
8. References
- ICH Q7 – GMP for Active Pharmaceutical Ingredients
- 21 CFR Part 211 – Good Manufacturing Practice for Finished Pharmaceuticals
- Internal Plant Material Handling SOPs
9. SOP Version
Version: 2.0
10. Approval Section
| Prepared By | Checked By | Approved By | |
|---|---|---|---|
| Signature | |||
| Date | |||
| Name | |||
| Designation | |||
| Department |
11. Annexures
Annexure-1: Wet Cake Transfer Log
| Date | Batch No. | Source Equipment | Tray ID | Weight (kg) | Transferred By | Dryer ID |
|---|---|---|---|---|---|---|
| 13/04/2025 | API-202504 | CF-102 | TR-015 | 22.6 | TD-01 |
Annexure-2: Cleaning Checklist for Transfer Tools
| Item | Cleaned (Yes/No) | Cleaned By | Verified By | Remarks |
|---|---|---|---|---|
| SS Scoop | Yes | Dry and No Residue |
Annexure-3: Label Verification Sheet
| Container ID | Label Details Checked | Verified By (QA) | Date |
|---|---|---|---|
| TR-015 | Batch No., Product, Weight | 13/04/2025 |
Revision History:
| Revision Date | Revision No. | Details | Reason | Approved By |
|---|---|---|---|---|
| 01/01/2022 | 1.0 | Initial Issue | New SOP | QA Head |
| 13/04/2025 | 2.0 | Added Label Verification and Tray Details | Audit Recommendation | QA Head |