SOP for Operational Check of Friability Test 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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