SOP for Calibration of Disintegration Apparatus (Make: Electrolab)

OBJECTIVE

To lay down the procedure for calibration of the Disintegration Test Apparatus for better and error-free use.

SCOPE

This procedure is applicable for the Disintegration Test Apparatus (MAKE: ELECTROLAB, installed in the Quality Control Department.

RESPONSIBILITY

• It is the responsibility of QC Executives to perform the calibration of the apparatus to follow the procedure fully.
• It is the responsibility of the QC Manager to ensure that the procedure is properly followed.

PROCEDURE

Frequency: 

Calibration should be conducted once every six months and after repairs/maintenance.

• Start the apparatus as per the current version of SOP for operation.
• Place 1000mL of water in the 1000mL beaker and check the following.

Temperature Setting:

• When the indicator displays 25°C, measure the temperature of the individual beaker with a thermometer and record the results as per Attachment-I
• Repeat the same procedure for measuring the temperature at 37°C and record the results as per Attachment-I.

ALSO READ: Operational Qualification of Disintegration Tester

Strokes / Minute:

• Record the number of up-down cycles per minute. Note down four readings for each bath and record the results as per Attachment-I.

Oscillations:

• Measure the oscillations for Basket A and Basket B four times and calculate the mean value. Using a metric ruler, measure the distance the basket travels between the highest and lowest point of the bottom of the basket through the beaker. Record the results as per Attachment-I.

ATTACHMENT

Attachment – I: Calibration Record of Disintegration Tester

ABBREVIATIONS

SOP: Standard Operating Procedure

QC: Quality Control

REVISION HISTORY

Nil

ALSO READ: SOP for Calibration of Electrolab Dissolution Apparatus