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SOP for Tap Density Apparatus


Standard operating procedure of Tap Density Apparatus used to determine the Tapped Density of powders.

1.0  OBJECTIVE

       To describe the operation and calibration procedure of Tap Density Apparatus

2.0  SCOPE

       This SOP is applicable for the operation and calibration procedure of Tap Density Apparatus.

3.0  RESPONSIBILITY

       Officer/ Executive - Quality Control

4.0  ACCOUNTABILITY

       Manager - Quality Control

5.0  PROCEDURE

5.1  Operation

5.1.1  Ensure that working area is clean.
5.1.2  Connect power cord of the instrument to mains and switch ‘ON’.
5.1.3  Instrument starts initialization and display flash and shows the start up screen.

                                              ELECTROLAB ETD-1020
                                              TAP DENSITY TESTER
5.1.4  Set the mode of operation as USP or USER using method key on the front panel.
5.1.4.1  Instrument will stop after every program and validation; report is available at the end of test, in USP mode.
5.1.4.2  Instrument will stop after the set tap value and no validation and result screen will be available, in USER mode.
5.1.5  Press “SET” key to set the test parameter.
5.1.6  Display reads
                                            TAP COUNT 1:    # # # #      ▲▼◄
                                            SET =   EXIT   /   Enter = SCROLL  
5.1.7  Set the TAP COUNT 1.
5.1.8  Enter the Tap count 1 with in 1 to 9999 using the UP/DOWN & DIGIT SCROLL key.
5.1.9  Press ENTER key to go next parameter.
5.1.10  Similarly set TAP COUNT 2 and TAP COUNT 3.
5.1.11  Set the date and time using the UP/DOWN & DIGIT SCROLL KEY.
5.1.12  Select the print option & press ENTER key.
5.1.13  Press the START key to run the test.
5.1.14  Weigh the test sample and enter the weight of test sample.
5.1.15  Press the ENTER key to register the weight.
5.1.16  Fill the test sample into the measuring cylinder.
5.1.17  Level the sample without tapping.
5.1.18  Read the unsettled apparent volume to the nearest graduated unit and enter the volume using the UP/DOWN & DIGIT SCROLL KEY.
5.1.19  Press the ENTER key to register the volume.
5.1.20  Put the measuring cylinder in the holder.
5.1.21  Lock the holder assembly.
5.1.22  Press the START key to run the test.
5.1.23  Display will show the elapsed Taps and Drops per
                                          
                                        ELAPSED TAP: # # #  
                                        Drops / Min.         =        #  #  #
5.1.24  After programmed tap count is over, measure the tapped volume to its nearest graduated unit.
5.1.25  Enter the measured tapped volume using UP / DOWN & DIGIT SCROLL Keys.
5.1.26  Press ENTER key to register the value.
5.1.27  Press the STOP key and instrument displays the results.
5.1.28  After operation enter usage details in instrument usage log book.

5.2  Calibration Procedure

5.2.1  Set the instrument for 100, 250, 750 and 1250 Taps.
5.2.2  Count the tap value & enter observations.

6.0  ABBREVIATIONS

6.1  SOP - Standard Operating Procedure
6.2  USP - United State Pharmacopoeia
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.
Email: .moc.enilediugamrahp@ofni Need Help: Ask Question


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