Monday , September 25 2023

SOP on cleaning and operating procedure of bursting strength tester

  • Objective:
    • To lay down the cleaning & operating procedure of bursting strength tester.
  • Scope:
    • This SOP is applicable for the cleaning & operating procedure of bursting strength tester in quality control laboratory.
  • Responsibilities:
    • Chemist or above of QC laboratory in Packaging material Quality Control section is responsible for carrying out the cleaning & analysis as per the procedure & interpretation of the results obtained.
  • Accountability:
    • Head – Quality control.
  • Procedure:
    • Cleaning procedure:
      • Switch off power supply of the equipment before cleaning. Clean the equipment with a dry cloth every day.
      • If necessary wet cloth shall be used for effective cleaning it shall be dried immediately using a dry cloth.
      • Do not use any solvent or strong cleaner to clean the equipment.
      • Maintain a cleaning record.
    • Operating Procedure:
      • Test should be carried out at room temperature i.e. at 25 ± 2 ºc.Sample should not be less than 152 mm wide and of sufficient length to permit a total of 20 bursts.
      • Place the sample to be tested over the diaphragm.
      • Switch on the mains, and then switch on the red mains switch located on the control panel.The red switch will be glow up.
      • Rotate the clamping wheel anti-clockwise.
      • Insert the sample specimen between the fixed plate and the claming plate.
      • Rotate the clamping wheel clockwise.
      • The clamps should be tight enough to avoid slippage of sample during testing but at the same time should not crush the entire flute structure.
      • Select the dial gauge with the help of direction valve as per requirement of capacity for specimen to be tested.
      • Rotate the zero knob provided on the centre of the dial gauge antilockwise.This will bring the red pointer very close to the black pointer.
      • Press (and hold) the green start button so that the diaphragm will raise because of the hydraulic pressure.
      • As soon as the sample bursts, release the green / start button to stop the machine.
      • Now press (and hold) the Red / Reverse button till the black needle almost reaches 0 on the dial. Release the red / reverse button to stop.
      • The black pointer has come down with the pressure but the red pointer is still indicating maximum pressure at burst point.
      • Note down the gauge reading in analytical test report as bursting strength which is indicated by the red pointer ( Maximum pressure at burst point ).
      • Remove the tested sample by rotating the clamp wheel in anti-clock wise direction and then fix a new sample.
      • Test all sample in the above manner.
      • Note down the reading, and calculate the maximum ,minimum and average value of Bursting Strength.
      • Then take the dial indicator at zero position and switch off the mains.
  • List of Annexures / Formats
    • ‘Not Applicable’ 
  • References (if any).
  • In- house.
  • Reason for Revision
  •  ‘Not Applicable’


About Pharmaceutical Guidanace

Ms. Abha Maurya is the Author and founder of pharmaceutical guidance, he is a pharmaceutical Professional from India having more than 18 years of rich experience in pharmaceutical field. During his career, he work in quality assurance department with multinational company’s i.e Zydus Cadila Ltd, Unichem Laboratories Ltd, Indoco remedies Ltd, Panacea Biotec Ltd, Nectar life Science Ltd. During his experience, he face may regulatory Audit i.e. USFDA, MHRA, ANVISA, MCC, TGA, EU –GMP, WHO –Geneva, ISO 9001-2008 and many ROW Regularities Audit i.e.Uganda,Kenya, Tanzania, Zimbabwe. He is currently leading a regulatory pharmaceutical company as a head Quality. You can join him by Email, Facebook, Google+, Twitter and YouTube

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