SOP for Operational Check of Friability Test Apparatus : Pharmaceutical Guidelines

SOP for Operational Check of Friability Test Apparatus

Standard operating procedure to evaluate the performance of friability apparatus.

1.0 OBJECTIVE

To calibrate the equipment for reliable and accurate results.

2.0 SCOPE

This procedure is applicable to calibrate the friability apparatus, installed in quality control laboratory.

3.0 RESPONSIBILITY

3.1 Doing: Technical Assistant
3.2 Checking: Executive /Manager

4.0 ACCOUNTABILITY

Head of the Department

5.0 PROCEDURE

Frequency: Once in a three month
5.1 Operate the instrument as per SOP.
5.2 Set the timer ‘4 min’.
5.2.1 Start the instrument and check the time against a stopwatch.
5.2.2 Enter the results in Annexure-I
5.3.1 Start the instrument and note down the number of revolution per minutes.
5.4 Set the revolution at 100.
5.4.1 Start the instrument and note down the number of revolution.
5.5 Record all results in Annexure-I.
5.6 If results are out of tolerance limit, follow the SOP.

Related: Calibration of Friability Test Apparatus

6.0 ABBREVIATION

6.1 SOP - Standard Operating Procedure

ANNEXURE-I
QUALITY CONTROL LABORATORY
S.O.P.NO.___________
OPERATIONAL CHECK REPORT OF FRIABILITY TEST APPARATUS

 REF.No.         :________________
                                                                 ISSUE DATE : ________________
                                                                ISSUED BY :__________________




OPERATIONAL CHECK DATE

DATE OF LAST OPERATIONAL CHECK DONE
NEXT DUE FOR
OPERATIONAL CHECK




INSTRUMENT DETAILS

INSTRUMENT NAME
INSTRUMENT MAKE
INSTRUMENT
IDENTIFICATION NO.




OBSERVATION
(A)  Set Time : 240 Sec.
       Observed Time :- _____________ (Tolerance : 234 to 246 Sec.)
(B)  Set Time : 1 Min.
Sr. No.
Observed Rotation/Minutes
Limit
01


24 to 26 revolution/Min.
02

03

04


(C)  Set 100 Revolution.

Sr. No.
Observed Rotation
Limit
01


Revolution should be 100
02

03

04


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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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