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

1. Ensure the filtration or centrifugation process is complete and logged.
2. Check that the drying equipment is cleaned, validated, and ready to receive material.
3. Verify line clearance and obtain QA approval before beginning transfer.
4. Confirm batch details, status labels, and cleanliness of transfer containers.

5.2 Transfer of Wet Cake

1. Wear required PPE (gloves, apron, mask, goggles) before handling wet cake.
2. Transfer the wet cake from filter/centrifuge using clean, sanitized SS scoops or transfer devices.
3. Move material to labeled stainless-steel trays or containers designated for drying.
4. Ensure complete transfer; check equipment for residuals and record hold-up weight (if applicable).
5. Label each tray/container with:
   • Product name
   • Batch number
   • Date
   • Weight
   • Dryer ID

5.3 Movement to Drying Area

1. Transport material using designated clean trolleys through approved material movement path.
2. Avoid cross-contamination by ensuring separation from other materials in transit.
3. Place material inside dryer as per defined loading pattern (e.g., from top shelf down).
4. Record time of loading and condition of material in “Wet Cake Transfer Log” (Annexure-1).

5.4 Post-Transfer Activities

1. Clean transfer tools and containers as per equipment cleaning SOP.
2. Record all cleaning activities in the respective logs (Annexure-2).
3. 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

1. Wet Cake Transfer Log (Annexure-1)
2. Cleaning Checklist for Transfer Tools (Annexure-2)
3. 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