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Calibration procedure for friability test apparatus. Quality assurance

  • OBJECTIVE
  • To lay down a procedure for Calibration of Friability Test Apparatus to give accurate and reproducible data.
  • SCOPE
  • This Standard Operating Procedure (SOP) is applicable to In process samples.
  • RESPONSIBILITY
  • IPQA / Production Executive / Officer 
  • ACCOUNTABILITY
  • Head–Quality Assurance
  • PROCEDURE
  • Operate the Friability test apparatus as per SOP No.  BA(II)QA202
  • Set display to 30 revolutions.
  • Press [RUN/HALT] key to start.
  • Count the number of revolutions in 1 minute and record it in Annexure -I.
  • Repeat 5.2 to 5.4 with number of revolutions set at 60 and 110 and check the number of revolutions in 2 and 4 minutes respectively.
  • If number of revolutions observed in specified time is within 25±1 revolution/minute, the apparatus is ok.
  • Now set the display to 25 revolutions and Press [RUN/HALT] key to start.
  • Count the number of revolutions and record it in Annexure –I
  •  Repeat 5.7 to 5.8 with number of revolutions set at 50 and 100 and count the number of revolutions.
  • If number of revolutions is 25±1,50±2 and 100±4 respectively the apparatus is ok
  • Fill the details in calibration status label pasted on the Instrument / Apparatus.
  • Report any discrepancy observed during calibration to QA Head and notify the defect to engineering department or Service Engineer of the instrument.
  • Affix an Under Maintenance label on the
  • Frequency of calibration
  • Calibrate the apparatus once in a month and after each maintenance job.
  • Forms and Records (Annexures)
  • Instrument calibration Format: Friability Test Apparatus – Annexure-1
  • Distribution
  • Master copy –  Quality Assurance
  • Controlled copies- Quality Assurance, Production, Quality Control.engineering
  • History
    Date Revision Number Reason for Revision
    00 New SOP

 

Annexure-1

Instrument calibration Format: Friability Test Apparatus

Location   Instrument ID  
Make   Model  
SOP No.   Issue Date  

 

S.No. Set Time (Min) Actual No. Of Revolutions Limit
1 1    

 

25±1 Revolutions / Minute

2 2  
3 4  

 

S.No. Set Revolutions Actual No. Of Revolutions Limit
1 25   25±1
2 50   50±2
3 100   100±4

   Calibrated By:                                                                                          Checked By:

   Date                                                                                                           Date

 

    Next Calibration Due On:                                                                         QA Manager:

                                                                                                                        Date            

 

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