OPERATION OF DISINTEGRATION TEST APPARATUS (MAKE – ELECTRO LAB)

• OBJECTIVE:

• To lay down the procedure for operation of Disintegration test apparatus (Make – Electro Lab and Model: ED-2AL).

• SCOPE:

This SOP is applicable to procedure for operation of Disintegration test apparatus (Make – Electro Lab and Model: ED-2AL) at {Company Name} {Location}.

• RESPONSIBILITY:
• Officer/Executive/Designee Quality Control – Shall be responsible for operation as per SOP.
• Head/Designee Quality Control – Shall be responsible for ensuring compliance as per SOP.
• ACCOUNTABILITY:

             QA Head shall be Accountable for implementation of SOP.

• PROCEDURE:

• Ensure that the power supply to the apparatus is switched OFF before removing water from the bath. Use mild detergents for cleaning the bath. Replace the water from the bath weekly or whenever required.
  • Ensure the water level in the bath is up to the mark.
  • Ensure the Mains supply, Heater connector and External probe connected to the instrument, provided at the rear right-hand side of the instrument.
  • Place the beakers, filled with media on the beaker stand inside the bath.
  • Switch on the instrument.
  • Press the “SET” key.
  • Press ‘TEMP” key and set the required temperature by using “▲or▼” keys.
  • Press ‘ENTER” key to store desired temperature and the temperature controller starts and a red-light glow indicating the heater is ON.
  • When the set temperature of bath is attained, check the temperature in the Jar’s with external probe provided.
  • Select the Timer 1 & Timer 2 key in MIN: SEC range by pressing the key SET, ENTER simultaneously. In case of HRS: MIN the display shows a “-” before.
  • Press “SET “key.
  • Press “TIMER” key and set the required time by using “▲or▼” keys.
  • Press “ENTER” key to set timer.
  • “START/STOP” key is toggle key for the timer.
  • Select the bath temperature indicator using PROBE/SEL key. Once the bath temperature achieves the set value the instrument is ready to use.
  • Place on tablet/capsule in each of the tube and insert a disc in each of the tube.
  • Start the apparatus and note the time taken by the last tablet/capsule for complete disintegration.
  • Switch OFF the apparatus and power supply after the test is over, clean the basket, discs and beaker.
  • Enter the details of usage in user logbook.
• REFERENCES:

Not Applicable

• ANNEXURES: 

         ENCLOSURES: SOP Training Record.

•  DISTRIBUTION:

• Controlled Copy No. 01  :          Head Quality Assurance
• Controlled Copy No. 02  :         Head Quality Control
• Master Copy                    :          Quality Assurance Department
• ABBREVIATIONS:

• REVISION HISTORY:             

CHANGE HISTORY LOG

Annexure-I
Disintegration tester user logbook