Standard Operating Procedure (SOP)

1. Purpose

To define the standard procedure for the safe and hygienic transfer of lubricated granules from the storage bunker to the compression machine, ensuring product quality and compliance with GMP standards.

2. Scope

This SOP applies to all production staff involved in the compression stage of tablet manufacturing using lubricated granules stored in bunkers.

3. Responsibilities

• Operator: Carry out the transfer as per SOP and document the process.

• Supervisor: Verify the process and ensure compliance.

• Quality Assurance: Monitor and approve process as per GMP.

4. Safety and Hygiene Precautions

• Wear prescribed PPE: gown, gloves, mask, hairnet, and shoe covers.

• Ensure equipment is clean and verified.

• Avoid contamination by maintaining a closed system or covered transfer path.

• Confirm equipment status (cleaned, ID-tagged, and calibrated).

5. Materials and Equipment

• Lubricated granules (ready for compression)

• Cleaned and labeled bunker

• Compression machine (cleaned, ready for use)

• Transfer hose or chute (if applicable)

• Material transfer logbook

• Cleaning checklist

6. Procedure

6.1 Pre-Transfer Checks

• Verify the status label on the lubricated granules (Batch No., status: Approved).

• Ensure the bunker and compression machine are cleaned and labeled appropriately.

• Check the availability of the batch manufacturing record (BMR).

6.2 Transfer Process

1. Align the bunker outlet with the compression machine hopper inlet or connect the transfer hose.

2. Open the valve of the bunker slowly to begin the transfer.

3. Monitor the flow rate to avoid bridging or overfeeding.

4. Gently tap if needed to facilitate flow (do not force).

5. Once transfer is complete, close the valve and disconnect any hoses if used.

6.3 Post-Transfer

• Record the transfer in the BMR and material transfer logbook.

• Clean any spilled material immediately.

• Ensure the hopper is not overfilled.

• Inform QA for line clearance if required.

7. Documentation

• Batch Manufacturing Record (BMR)

• Material Transfer Log

• Equipment Cleaning Record

• Line Clearance Checklist

8. Precautions

• Do not mix batches during transfer.

• Prevent exposure of granules to open air to avoid contamination.

• Ensure traceability through documentation.

🎓 Discover one of the best Pharmaceutical Production courses available — click below to explore the course that’s shaping future Production skills.

https://trcjw.on-app.in/app/oc/338669/trcjw