SOP for Calibration of Disintegration Test Apparatus : Pharmaceutical Guidelines

SOP for Calibration of Disintegration Test Apparatus

Standard operating procedure to calibrate the disintegration test apparatus.

1.0 OBJECTIVE

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

2.0 SCOPE

This procedure is applicable to disintegration test apparatus, installed in the quality control department.

3.0 RESPONSIBILITY

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

4.0 ACCOUNTABILITY

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 the individual beaker with a thermometer and record the results in Annexure- I
5.3 Also record the number of up down cycles per minute. Note down four reading for each bath and record the results in Annexure –I.
5.4 Also measure the oscillation and record the results in Annexure –I.
5.5 If the instrument is out of limit as in Annexure-I, follow the S.O.P.
Note : Each instrument is calibrated with the respective serial number bath. Do not interchange the bath.

6.0 ABBREVIATION

6.1 °C = Degree centigrade
6.2 no. = Number

ANNEXURE-I
QUALITY CONTROL LABORATORY
   OPERATIONAL CHECK REPORT OF DISINTEGRATION TEST APPARATUS
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/minute
                   Remark
01





02

03

04

Limit : 29 to 32 cycles/minute
Measurement of  Oscillation  (Stroke length )
Sr. No
            Oscillation
                   Remark

Arm 1
Arm 2




01


02


03


04


Limit : 55 +/- 2 mm





Ankur Choudhary is India's first professional pharmaceutical blogger, author and founder of Pharmaceutical Guidelines, a widely-read pharmaceutical blog since 2008. Sign-up for the free email updates for your daily dose of pharmaceutical tips.
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