Operation and Calibration of Bursting Strength Tester

  1. Objective

To lay down a procedure for operation and calibration of Bursting Strength Tester. It is used to determine the Bursting Strength of C-box, Carton etc.

  • Scope

This SOP is applicable for operation and calibration of Bursting Strength Tester (Make: LINUX, Model:  DH-826)  in Quality Control.

  • Responsibility

QC Chemist / Officer : To follow the procedure and maintain record as applicable.           

  • Accountability

Head Quality Control  :  For System Compliance

  • Procedure:  
    • Operation:
      • Ensure that equipment is clean.
      • Check the calibration due date.
      • Switch on the mains.
      • To ON the machine turn the indicator switch to ON position. The indicator will glow.
      • Select the head for testing by turning the selector switch either on gaze 1 (for measuring the BS of c-box) or gaze 2 (for measuring the BS of carton, label, paper etc.).
      • Turn the clamping wheel in anticlock wise direction.
      • Take sample to be tested and place it over the diaphragm plate. Clamp the sample by applying adequate pressure by clockwise turn of wheel.
      • Bring the lazy hand (red knob of the gauze) to zero position.
      • Press the “Push for Burst” button and keep it pressed till the sample bursts.
      • Read the value from the gauze in kg/cm2 and record.
      • Bring the lazy hand (red knob of the gauze) to zero position.
      • Enter the details in Instrument log.
      • Replacement of Diaphragm:
        • Switch the mains ‘ON’. Select the Head through the selector switch. The piston retracts back to its starting position if not already there.
        • Turn the clamping wheel to have equivalent clamping pressure from triclamp to the diaphragm plate.
        • Loosen the diaphragm nut by anti clockwise rotation with clamp spanner supplied with this machine.
        • Remove the clamp pressure by raising the triclamp. Remove the diaphragm nut, diaphragm plate and the rubber diaphragm from its seating.
        • Remove the diaphragm nut, diaphragm plate and the rubber diaphragm from its seating.
        • Check the level of the fluid. Fill if less to form a slight meniscus. Place the flat side of the diaphragm on the seat by sliding movement covering the liquid to prevent any air trap inside the system.
        • Place the diaphragm plate carefully without displacing the diaphragm; Hold finder tight the diaphragm nut over the diaphragm plate.
        • Place the diaphragm plate carefully without displacing the diaphragm.
        • Hold finger tight the diaphragm nut over the diaphragm plate.
        • Lower the tripod to clamp the diaphragm plate.
        • Turn the diaphragm nut and then apply further pressure from the tripod.
        • Tighten the nut further.
        • Repeat this procedure till optimum tightening of the nut and the plate is achieved.
        • Make a few burst on paper / board to relieve the surface tension of the diaphragm.
        • Replace the diaphragm after approx. 1000 testing or damage.
      • In case any problem observed inform to service engineer.
    • Calibration:
      • Operate the equipment as per point no. 5.1.
      • Measure the bursting strength of calibration aluminium foil Board Type 11.8 kg/cm2 on Gauge 1 and record the value on annexure I.
      • Measure the bursting strength of calibration aluminium foil paper Type 3.2 kg/cm2 on Gauge 2 and record the value on annexure I.
      • Acceptance criteria:
S. No. Standard Sample Standard Bursting Strength Limit
1. Calibration aluminum foil Broad Type 11.8 kg/cm2 for Gauge 1 11.8 kg/cm2 ± 0.3 kg/cm2
2. Calibration aluminum foil paper Type 3.2 kg/cm2 for Gauge 2 3.2 kg/cm2 ± 0.2 kg/cm2
  • Enter the details in Annexure I.
    • Prepare the calibration tag and affix it on the equipment.
    • Enclose the old calibration tag with the record and don’t throw it.
    • If the variation is not within the specified tolerance limits:
      • Label the equipment with a tag, “OUT OF CALIBRATION”.
      • Inform the Department Head.
      • Do not use equipment until all errors are rectified. After rectification, again calibrate the equipment & record the observation.
    • Frequency: 6 Months ± 3 days.
  • Annexure (S)

NA

  • Reference (S)

Manufacturer manual

  • Glossary

SOP                 :           Standard Operating Procedure

QA                   :           Quality Assurance

QC                  :           Quality Control

Kg                    :           Kilogram

cm                   :           Centimeter

  • Revision History
Rev. No. Details of changes Reason for change

Bhanu Pratap Singh

BHANU PRATAP SINGH IS EXPERIENCED IN PHARMACEUTICAL, AUTHOR AND FOUNDER OF PHARMACEUTICAL GUIDESLINE (WWW.PHARMAGUIDESLINE.COM), A WIDELY READ PHARMACEUTICAL BLOG SINCE 2019. EMAIL:- INFO@PHARMAGUIDESLINE.COM

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