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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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