1.0 Purpose

To define the procedure for operation, cleaning, and maintenance of the Vibro Sifter used in production to ensure efficient sieving of raw materials and granules as per cGMP requirements.

2.0 Scope

This SOP applies to the Vibro Sifter installed in the production area of [Company Name], used for particle separation, de-lumping, and sieving.

3.0 Responsibility

• Production Operator: To operate and clean the Vibro Sifter.

• Production Supervisor: To verify usage, cleaning, and ensure compliance.

• Engineering: To carry out preventive maintenance and repairs.

• Quality Assurance (QA): To verify line clearance and cleaning status.

4.0 Definitions

• Vibro Sifter: A mechanical sieving machine with vibratory motion that separates particles based on size using wire mesh sieves/screens.

5.0 Procedure

5.1 Operation

1. Ensure equipment is labeled “Cleaned” and free from previous product residues.

2. Assemble the sifter with the required mesh screen as per the BMR.

3. Fix clamps properly and ensure no leakage points.

4. Place labeled container(s) at the discharge port.

5. Switch ON the power supply and set vibration amplitude as required.

6. Feed material gradually into the charging port.

7. Collect sifted material (undersize) and retained material (oversize) separately.

8. After completion, switch OFF power supply.

9. Record usage details in the equipment logbook.

5.2 Cleaning

Type A – Batch-to-Batch Cleaning

1. Disconnect power supply.

2. Dismantle charging port, screen, and discharge components.

3. Remove adhering powder using a nylon brush.

4. Wash contact parts with 1% detergent solution.

5. Rinse thoroughly with purified water.

6. Dry with lint-free cloth or hot air.

7. Reassemble and affix “Cleaned” label.

Type B – Product Changeover Cleaning

1. Perform all steps of Type A cleaning.

2. Wipe non-contact parts and external surfaces with 70% IPA.

3. QA to verify cleanliness before next product run.

Type C – Weekly / Periodic Cleaning

1. Clean motor housing, clamps, and external frame.

2. Inspect mesh screens for damage or blockage.

5.3 Maintenance

1. Preventive maintenance to be carried out as per engineering schedule.

2. Inspect vibration motor, springs, and clamps for wear or looseness.

3. Replace damaged or worn mesh screens.

4. Record maintenance activities in the equipment history card.

6.0 Safety Precautions

• Do not operate without properly fixed clamps.

• Never use damaged or torn mesh screens.

• Avoid overloading to prevent motor strain.

• Always switch OFF power before dismantling or cleaning.

• Use gloves, mask, and goggles during operation and cleaning.

7.0 Documentation

• Equipment usage logbook

• Cleaning record

• Preventive maintenance record

8.0 References

• Manufacturer’s operating manual

• cGMP guidelines

• Batch Manufacturing Record (BMR)

9.0 Abbreviations

• SOP: Standard Operating Procedure

• BMR: Batch Manufacturing Record

• cGMP: Current Good Manufacturing Practices

• IPA: Isopropyl Alcohol

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

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