- 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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