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 Disintegration Test Apparatus (MAKE: ELECTROLAB, installed in 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 QC Asst. Manager to ensure that the procedure is properly followed.
FREQUENCY
Calibration should be conducted once in every six months and after repairs/maintenance.
- Start the apparatus as per current version of SOP for operation.
- Place 1000mL of water in the 1000mL beaker and check the following.
Temperature Setting:
- When indicator display 25°C, measure the temperature of individual beaker with thermometer and record the results as per Attachment-I
- Repeat the same procedure for measuring temperature at 37°C and record the results as per Attachment-I
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
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ABBREVIATIONS
SOP : Standard Operating Procedure
REVISION HISTORY
Nil
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