1.0 PURPOSE:
2.0 SCOPE:
The SOP for Calibration of Friability Test Apparatus covers the Calibration of Friability test apparatus at Quality assurance, Quality control and production department of (Company name).
3.0 DEFINITIONS:
4.0 RESPONSIBILITY:
4.1 Officer (QA, QC & Production) to calibrate Friability tester as per the SOP of the instrument.
4.2 Head of the Department (or) His designee is responsible for ensuring compliance to SOP.
5.0 PROCEDURE:
5.1 Performance Calibration:
5.1.1 Timer Calibration:
5.1.1.1 Verify the timer for the times 1:00 minutes, 4:00 minutes and 5:00 minutes by using a calibrated stop watch and record the results in Calibration record as per Annexure-I.
5.1.1.2 Acceptance Criteria: Observed time in the stop watch should not deviate more than ±10% of each set value.
5.1.2 Calibration of RPM:
5.1.2.1 Set the Instrument RPM 25, time 1:00 minute and run the instrument as per friability tester operation SOP without sample and check the RPM with a calibrated Tachometer and record the observation in Calibration record as per Annexure-I.
5.1.2.2 Perform the RPM Calibration for 50 RPM as per point 5.1.2.1.
5.1.2.3 Acceptance Criteria: RPM should not deviate more than ±1 from the set point.
5.1.3 Calibration of Counts:
5.1.3.1 Set the Instrument RPM 25, count 100 and run the instrument as per friability tester operation SOP without sample. Record the observation in Calibration record as per Annexure-I.
5.1.3.2 Acceptance Criteria: No Deviation permitted from set point.
5.1.3.3 Performance Calibration Schedule: Once in a month and after any major maintenance job.
6.0 ABBREVIATIONS:
6.1 SOP – Standard Operating Procedure.
6.2 QA – Quality Assurance
6.3 CAL – Calibration.
6.4 RPM – Rotation for minute.
6.5 QC – Quality control
7.0 REFERENCES:
SOP for operating and cleaning Friability test apparatus
8.0 LIST OF ANNEXURS:
Annexure-I: Template for Calibration of Friability test apparatus.
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