1.0 OBJECTIVE:To lay down the procedure for operation and calibration of bulk density apparatus.
2.0 SCOPE:This SOP shall be applicable to Quality Control Dept.
3.0 RESPONSIBILITY:Quality Control Supervisor
4.0 ACCOUNTABILITY:Sr. Manager Quality Assurance
5.1 Operation :5.1.1 Connect the plug to the main switch and switch on the Mains. Home screen will be displayed.
5.1.2 Select “Method” and “Mode” by using Enter and Increment key.
5.1.3 Set Initial taps and final taps in the “User mode” by using Enter key and Increment key.
5.1.4 Enter Batch No., Sample Weight and Unsettled volume.
5.1.5 Fill the measuring cylinder with weighed quantity of powder to be tested.
5.1.6 Place the cylinder by opening the Aluminum metal cap and re-tighten it. Enter to start the strokes.
5.1.7 Strokes shall continue till the set value is attained, which shall be displayed on the digital display.
5.1.8 After the machine stops, observe the staking capacity of the powder in the measuring cylinder.
5.2 Calibration:5.2.1 Clean the Instrument and cylinders.
5.2.2 Adjust the number of strokes to 50, 100 and 200.
5.2.3 After setting the strokes, weigh the sample (Lactose which is passed through 40 mesh sieve) and transfer it to a cylinder.
5.2.4 Fit the cylinder with threading plates and close the cylinder with suitable cover.
5.2.5 After completion of 50, 100 and 200 strokes, record the reading and compare with the standard readings, the difference is to be within tolerable limit.
5.2.6 If any deviations are observed, hang the tag "Out of order" and call the party or service engineer immediately.
6.0 ABBREVIATIONS:6.1 SOP : Standard Operating Procedure
6.2 Dept. : Department
Ankur Choudhary is India's first professional pharmaceutical blogger, author and founder of Pharmaceutical Guidelines, a widely-read pharmaceutical blog since 2008. Sign-up for the free email updates for your daily dose of pharmaceutical tips.
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