- To lay down a procedure for Calibration of Friability Test Apparatus to give accurate and reproducible data.
- This Standard Operating Procedure (SOP) is applicable to In process samples.
- IPQA / Production Executive / Officer
- Head–Quality Assurance
- 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
- Master copy – Quality Assurance
- Controlled copies- Quality Assurance, Production, Quality Control.engineering
Date Revision Number Reason for Revision – 00 New SOP
Instrument calibration Format: Friability Test Apparatus
|SOP No.||Issue Date|
|S.No.||Set Time (Min)||Actual No. Of Revolutions||Limit|
25±1 Revolutions / Minute
|S.No.||Set Revolutions||Actual No. Of Revolutions||Limit|
Calibrated By: Checked By:
Next Calibration Due On: QA Manager:
For More Pharma Updates Visit –http://pharmaguidances.com