🧱 Operation and Calibration of Sieve Shaker

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The sieve shaker is an essential instrument in pharmaceutical laboratories for particle size analysis of powders and granules. Accurate operation, proper calibration, and regular maintenance are critical for reproducible results, regulatory compliance, and GMP adherence. This SOP provides a detailed, step-by-step guide for operating, calibrating, and maintaining a sieve shaker in QC, R&D, and in-process testing laboratories.

1. Purpose

To establish a standardized procedure for the operation, calibration, and maintenance of the Sieve Shaker used for particle size distribution analysis of powders and granules in pharmaceutical laboratories, ensuring accuracy, reproducibility, and compliance with GMP and pharmacopeial requirements.

2. Scope

• Quality Control laboratories
• Research and Development laboratories
• In-process and finished product testing
• Any department performing sieve analysis

3. Definitions

• Sieve Shaker: Mechanical device that agitates a stack of test sieves to separate particles by size.
• Test Sieve: Standardized sieve with defined mesh aperture.
• Sieve Analysis: Method to determine particle size distribution.
• Mesh Size: Number of openings per inch of sieve screen.
• Retention: Quantity of material retained on each sieve.

4. Precautions

• Operate the sieve shaker only by trained personnel.
• Ensure sieves are clean, dry, and free from damage.
• Do not overload sieves beyond recommended sample quantity.
• Secure the sieve stack firmly before operation.
• Place the instrument on a stable, vibration-free surface.
• Use appropriate PPE during operation.

5. Responsibilities

Role	Responsibility
Analyst	Conduct sieve analysis, cleaning, and documentation
QC Supervisor	Review results and records
Quality Assurance	Ensure compliance and manage deviations
Engineering / Calibration	Calibration and preventive maintenance

6. Equipment & Materials

• Sieve Shaker (electromagnetic / mechanical)
• Standard test sieves (IP / USP / ASTM)
• Sieve pan and lid
• Calibrated weighing balance
• Stopwatch / built-in timer
• Cleaning brush and lint-free cloth
• Authorized logbooks

7. Operation Procedure

7.1 Preparation

• Ensure the sieve shaker is clean, calibrated, and labeled with valid calibration status.
• Select appropriate sieves as per test specification.
• Arrange sieves in descending order of mesh size (coarsest on top, finest at bottom).
• Place sieve pan at the bottom and lid on the top sieve.

7.2 Sample Loading

• Accurately weigh the required quantity of sample.
• Transfer the sample gently onto the top sieve.
• Avoid spillage and uneven distribution.

7.3 Sieving Operation

• Secure the sieve stack on the shaker using the clamping mechanism.
• Set the sieving time as per method (e.g., 5–10 minutes).
• Set vibration or amplitude if applicable.
• Start the sieve shaker.
• Allow the operation to complete without interruption.

7.4 Post-Sieving

• After completion, stop the instrument.
• Carefully remove the sieve stack.
• Collect and weigh the material retained on each sieve.
• Record the weights.

7.5 Calculations

• Calculate % retained on each sieve.
• Calculate cumulative % retained and % passing.
• Verify compliance with specification.

7.6 Documentation

• Record sieve numbers, sample weight, sieving time, and results.
• Enter usage details in the instrument logbook.

8. Calibration Procedure

8.1 Frequency

• Once every 6 or 12 months
• After relocation or major maintenance

8.2 Timer Verification

• Set the timer for a defined duration (e.g., 5 minutes).
• Verify actual time using a calibrated stopwatch.
• Record set time vs observed time.

8.3 Vibration / Amplitude Check

• Verify shaker vibration or amplitude as per manufacturer specification.
• Ensure uniform motion during operation.

8.4 Sieve Integrity Verification

• Inspect sieves for mesh damage or deformation.
• Verify sieve identification and certification.

8.5 Acceptance Criteria

• Timer deviation: ±5% of set time
• Uniform vibration without abnormal noise

8.6 Post-Calibration

• Affix calibration status label with due date.
• Document calibration records.
• If out of limits, label instrument as OUT OF CALIBRATION and inform QA.

9. Cleaning & Maintenance

• Clean sieves after each use using soft brush.
• Do not damage sieve mesh during cleaning.
• Remove powder residues from shaker platform.
• Perform preventive maintenance as per manufacturer instructions.

10. References

• USP <786> Particle Size Distribution Estimation by Analytical Sieving
• IP / Ph. Eur. – Sieve Analysis
• ICH Q7 – GMP Guidelines
• WHO Technical Report Series – GMP
• Manufacturer’s Instruction Manual – Sieve Shaker

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