SOP for Operational Check of Disintegration Test Apparatus

1.0 OBJECTIVE :

To check operation of the equipment for reliable and accurate results.

2.0 SCOPE :

This procedure is applicable to disintegration test apparatus installed at quality control department.

3.0 RESPONSIBILITY :

3.1 Doing : Technical Assistant/ Executive
3.2 Checking : Executive /Asst.Manager

4.0 ACCOUNTABILITY :

4.1 Head of the department.

5.0 PROCEDURE :

Frequency : Once in a month
5.1 Operate the instrument as per Standard operating procedure.
5.2 When indicator display 37°C, measure the temperature of individual beaker with thermometer.
5.3 Record the number of up down cycles per minute. Note down four reading & record the result in Annexure-I
5.4 Measure the Osillation and record the result in Annexure-I
5.5 If the instrument out of limit as in Annexure – I, follow the SOP.

Related: Calibration of Disintegration Test Apparatus

6.0 ABBREVIATIONS :

°C = Degree Centigrade

ANNEXURE-I

QUALITY CONTROL LABORATORY

S.O.P.NO.________

OPERATIONAL CHECK REPORT OF DISINTEGRATION TEST APPARATUS

OBSERVATION

Temperature setting :  37°C  

Observed temp. Beaker – 1 ______(Limit : 35.0°C to 39.0°C)

                          Beaker – 2 ______(Limit : 35.0°C to 39.0°C)

Sr. No	Observed Up down cycles/Minutes	Tolerance
01		29 to 32 Cycles/min
02
03
04

Measurement of Oscillation (Stroke length )

Sr. No	Oscillation		Remark
	Arm 1	Arm 2
01
02
03
04

Limit : 55 +/- 2 mm

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