SOP for Operational Check of Disintegration Test Apparatus : Pharmaceutical Guidelines

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SOP for Operational Check of Disintegration Test Apparatus

Standard operating procedure to evaluate the performance 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.


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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