SOP for operation & calibration of Disintegration Test Apparatus

1. OBJECTIVE:

To lay down a procedure for Operation & Calibration of Disintegration test apparatus.

• SCOPE:

This procedure is applicable for procedure for Operation & Calibration of Disintegration test apparatus.

• RESPONSIBILITY:

QC Officer/ QC Executive

• ACCOUNTABILITY:

QC Manager.

• PROCEDURE:
  • Precautions:
    • Do not switch on the mains if water in the tank is not up to the mark.
    • While placing and removing the basket assembly do not apply excessive force.
    • Do not use abrasive materials to clean the instrument.
    • Do not bend the heater while clean the water bath.
  • Operating Procedure
    • Ensure that instrument is clean and free from dust.
    • Ensure that clean purified water / DM Water is filled in the basket till the desired level.
    • Switch ON the main supply and the instrument ON/OFF switch on the instrument.
    • Switch on the heater by pressing “TEMP” Key.
    • Set the temp. by aero key at 37⁰C.
    • Set the time by aero key the desired test t0.
    • ime.
    • Place the capsules to be tested in each of the six cylinders of basket rack assembly after achieved the desired test temperature.
    • Place the disks if mention in the monograph.
    • Press the on key the instrument.
    • Watch the complete disintegration of the capsules and note down in usage log book of disintegration test apparatus.
    • Press stop key to stop the test.
  • Calibration:

• Switch on the mains and switch on the instrument.
• Ensure that the beakers are filled with water the DM water.
• Press the Temp. key for set the temperature at 37⁰C and press enter key.
• Allow the temperature to reach to 37⁰C.When the display shows the temperature 37⁰C, insert the calibrated thermometer into the beaker.
• Note down the reading in calibration record of disintegration test apparatus instrument operate for 2 hours (120 min) and check the temperature after 10 minute with calibrated thermometer and note down the reading.
• Repeat the two more time to confirm the result.
• Results are found satisfactory if the temperature lies between 37⁰C ± 2⁰C.
• For Cycles per minute: Note down the number of cycles in one minute; note down the reading after 10 minutes for 2 hour (120 minute).
• Repeat the test two more times to confirm the results.
• Result are found satisfactory if the cycles per minute 29 to 32.
• For Distance Travelling: Measure the distance travel of basket by calibrated scale.
• Result are found satisfactory if the distance travelling is between 53 mm to 57 mm.Frequency  – one in month.
• TRAINING:

Trainer   : Manager – Quality Control

Trainees : Staff of the QC departments

• DISTRIBUTION:

Master Copy                  :           QA Department

Controlled Copy            :           QC Department

Display Copy                 :           QC Department

• ATTACHMENTS:

Sr. No.	Title	Annexure No.
01.	NA	NA

• REFERENCES:

In-House

1. ABBREVIATIONS:

Abbreviations	Extended Form
SOP	Standard Operating Procedure
NA	Not Applicable
QC	Quality Control
Sr. No.	Serial Number
QA	Quality Assurance
DEPT.	Department

1. REVISION HISTORY OF CHANGE:

Sr. No.	Date	Revision Details	Revision No.