Operation, Calibration, Cleaning & Maintenance of Bursting Strength Tester

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📦 STANDARD OPERATING PROCEDURE (SOP)

Operation, Calibration, Cleaning & Maintenance of
Bursting Strength Tester

🎯 1. Purpose

To define a controlled and standardized procedure for the operation, calibration, cleaning, and maintenance of the Bursting Strength Tester used for testing pharmaceutical packaging materials, ensuring compliance with GMP, ISO, ASTM, and regulatory guidelines.


📌 2. Scope

  • Quality Control – Packaging Laboratory
  • Incoming raw packaging materials
  • In-process and finished packaging evaluation
  • Research & Development (R&D)

📚 3. Regulatory & Standard References

  • WHO Good Manufacturing Practices (GMP)
  • USFDA – 21 CFR Parts 210 & 211
  • EU-GMP – Chapter 3 & 4
  • Schedule M – Drugs & Cosmetics Rules
  • ISO 2758 / ISO 2759 – Bursting strength of paper & board
  • ASTM D3786 – Bursting strength test method
  • Manufacturer’s approved instrument manual

👥 4. Responsibility

  • QC Analyst: Operation, testing, and routine cleaning
  • QA: SOP compliance, data review, deviation handling
  • Engineering / Calibration Team: Calibration and maintenance

⚠️ 5. Safety & GMP Precautions

  • Verify calibration status before use
  • Do not exceed maximum pressure range
  • Ensure proper clamping of specimen
  • Wear PPE as per laboratory safety guidelines
  • Prevent damage to diaphragm and sealing rings

▶️ 6. Operating Procedure (Step-by-Step)

  1. Verify equipment ID number and calibration validity label.
  2. Ensure the tester is placed on a stable, vibration-free surface.
  3. Switch ON the instrument and allow warm-up (if specified in manual).
  4. Check diaphragm surface for cleanliness and damage.
  5. Prepare the test specimen as per standard size requirement.
  6. Place the specimen centrally over the diaphragm.
  7. Lower the clamping ring and clamp the specimen uniformly.
  8. Ensure no wrinkles or slippage of specimen.
  9. Set pressure application rate as per ASTM / ISO method.
  10. Start the test by activating pressure control.
  11. Allow pressure to increase gradually and uniformly.
  12. Observe and note the pressure at which specimen bursts.
  13. Record bursting strength value (kPa / kg/cm² / psi).
  14. Repeat test for required number of samples.
  15. Calculate average and report results.

📏 7. Calibration Procedure (Using Standard Aluminium Foil / CRM)

Calibration shall be performed using:

  • Certified Standard Aluminium Foil (CRM)
  • Standard Rubber / Synthetic Calibration Sheet (if applicable)
  • Certified pressure calibration device (for gauge verification)
  1. Ensure instrument is clean and in idle condition.
  2. Verify calibration certificate of standard aluminium foil.
  3. Switch ON the tester and allow stabilization.
  4. Place certified aluminium foil centrally on diaphragm.
  5. Clamp foil securely as per normal testing procedure.
  6. Apply pressure gradually at defined rate.
  7. Record pressure at bursting point.
  8. Compare observed value with certified reference value.
  9. Acceptance criteria: ± specified tolerance as per SOP or manual.
  10. Repeat calibration at multiple pressure points.
  11. If results are within limits, label equipment as “CALIBRATED”.
  12. If out of tolerance, inform QA and tag equipment “OUT OF SERVICE”.

Calibration Frequency: As per Calibration Master Plan (typically once per year)


🧼 8. Cleaning Procedure

  • Switch OFF and disconnect power supply
  • Release residual pressure
  • Remove test debris from clamping area
  • Clean diaphragm and plates with approved cleaning agent
  • Wipe dry using lint-free cloth
  • Record cleaning activity if required

🛠️ 9. Preventive Maintenance

  • Inspect diaphragm condition regularly
  • Check pressure gauge/digital sensor accuracy
  • Lubricate moving parts if recommended
  • Replace worn components promptly
  • Maintain maintenance records as per GMP

❌ 10. Deviations & Troubleshooting

  • Inconsistent readings – stop test and notify QA
  • Pressure leakage – equipment to be isolated
  • Foil not bursting uniformly – check clamping

✅ 11. Conclusion

Strict adherence to this SOP ensures accurate bursting strength determination, regulatory compliance, data integrity, and reliable evaluation of pharmaceutical packaging materials.

© 2026 sopnest.blogspot.com. All rights reserved. This content is independently written and intended for educational purposes. References to regulatory guidelines are for compliance guidance only.

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