SOP for Milliflex Water Filtration Unit : Pharmaceutical Guidelines

SOP for Milliflex Water Filtration Unit

Standard operating procedure of water filtration unit used to treat the water for analysis.


       To lay down the procedure for operation of Milliflex water filtration unit.

2.0  SCOPE

       It is applicable to Microbiology lab.


       Microbiology personnel


       Head of Department


5.1  Pre operational checks

5.1.1  Check the calibration status of the instrument
5.1.2  Check the status of the sanitation cycle.
5.1.3  Check the status of the monthly calibration.
5.1.4  Ensure the head, funnel and stainless steel grid are autoclaved.
5.1.5  Check the cleaning of the instrument.
5.1.6  Use sterile membrane filter only.
5.1.7  Ensure the printer is attached properly.

5.2  Operation of milliflex

5.2.1  Install the pump head. Switch on the pump by pressing the On/Off button on the key pad the display shows
                       MILLIFLEX PLUS
                       SERIAL NO. 1234
5.2.2  Set the date with arrow key by Up and Down
5.2.3  After setting the date, set time with arrow key by Up and Down
5.2.4  Manual will appear on the screen
5.2.5  Press OK, tare will appear.
5.2.6  Select the sampling option with the help of arrow key
5.2.7  Enabling data export.  In the main menu, use the down arrow to scroll down to export data, press OK, the display shows
                              START  Press OK, display will show
                          OPERATOR  Press up or down keys the display will show
ABCDEFGHIJKLMNOPQRSTUVWXYZ0123456789  Enter the name by pressing the up or down arrow to highlight a character, and then press OK to select it .The selected character is displayed.  Press the up and down arrow to highlight a character selection screen again  Repeat this process for each character. The characters selected so far are displayed when OK is pressed. To delete the last character entered, press C  After entering operator press OK, display will show
                          CASSETTE  Press OK, display will show
                            LOT NO.  Enter the media lot No. as described in point No. 5.7.1 to 5.7.6
                         Increment start 1  Enter the date and time, using the up and down arrows, press OK to confirm the completed entry, in each case. The display show.
Press start  Press START. The settings just entered will be printed

5.3  Set up for manual sampling

5.3.1  In main menu, use the up or down arrows to select sampling and press OK. The display shows.
5.3.2  Press OK. The display shows:
                        VOLUME OFF
5.3.3  Select the ON option by arrow key
                        VOLUME ON
5.3.4  Press OK. The display shows
                       MILLIFLEX 100
5.3.5  Select the milliflex 250 funnel, press the down arrow, the display shows
                       MILLIFLEX 250
5.3.6  Press OK, the display shows:
                       DENSITY (g/ml)
5.3.7  Use the up or down arrows to select the density of the liquid to be tested. Press OK the display shows.
                      MIL 250/1.00

5.4  Set up for auto sampling

5.4.1  In main menu, use the up or down arrows to select sampling and press OK. The display shows.
5.4.2  Press the down arrow the once. The display shows
                  AUTO SAMPLING
5.4.3  Press OK. The display shows the name of the last auto sampling program selected
5.4.4  Use the up or down arrows to move through the list of programs to the required program. Press OK. The display shows
5.4.5  To proceed with the selected program, press OK. The display shows the main program screen for the selected program. For example
                      MF X 100
               MIL 100 / 100 ML
5.5  Use sterile forceps to place the sterile membrane filter on the pump head. Firmly press the sterile funnel onto the pump head.
Note:  Make sure that the base of the funnel is touch with the top of the pump head filter support.
5.6  Pour sample into the funnel, slowly to achieve the required volume
5.7  In Manual mode, if Volume ‘ON’ has been selected, the display will show the volume filled.
5.8  In Auto Sampling mode, the buzzer will sound when the required volume has been reached.
5.9  When the required volume has been reached, stop pouring.
5.10  In Manual mode, press START to start the pump.
5.11  In Auto Sampling mode, filtration starts automatically.
5.12  In Manual mode, operate the pump until the sample has been filtered, then press START to dry out the pump head. Wait for the pump to stop.
5.13  In Auto Sampling mode, when the sample has been filtered, the pump switches automatically to drying. Wait for the pump to stop.
5.14  Remove the funnel from the pump head and remove the membrane with the sterile forceps.
5.15  Place the sterile membrane filter on the pre incubated R2A agar plates. Ensure that there is no air trap inside the filter paper
5.16  Incubates the plates as required.
5.17  Before taking next sample wipe with the head with sporocidal agent and change the SS grid.

5.18  Calibration

5.18.1  Enter the configuration menu as described in the configuration section. Press the down arrow until the display shows validation.
5.18.2  Press OK. The display shows
5.18.3  Press OK. The display shows
              ENTER CODE OR
                       PRESS C
5.18.4  Enter the security code (press start three times) and then press OK
5.18.5  When the security code has been entered, the display shows
               CALIBRATION DATE
                      DD MM YY
5.18.6  Press the UP or down arrows to enter the calibration date, and then press OK the display shows
                 REMOVE HEAD
                  PRESS START
5.18.7  Remove the pump head and press START, the display shows
                 MEASURING . . .
                 PLEASE WAIT . . .
5.18.8  After a few seconds the display shows
                    PUT HEAD
                 PRESS START
5.18.9  Reinnstall the pump head and press START the display shows,
                    PUT 50 G
             PRESS START 0, 0
5.18.10  Place the 50 g calibration weight on the pump head and press start
5.18.11  The pump calibrates with the 50 g weight . Next the display prompts the user for the 100 g weight and then for the 200 g weight. Follow the prompts as they are displayed. After calibration with the three weights, the display shows,
                  CANCEL: C
5.18.12  To proceed, and confirm the calibration, press OK. The displays,
                 PRESS OK
5.18.13  Follow the prompts displayed to verify the new calibration. After each weight measurement, the display shows the measured value. Press START to confirm the displayed value and proceed to the next step.
5.18.14  When the verification procedure is completed, The display shows
              PRINT PRESS START
                  CONTINUE: OK
5.18.15  Press START, the printer prints the calibration data while the display shows
5.18.16  When printing has finished, the display returns to

Frequency of calibration: Monthly

5.19  Sanitizing

5.19.1  Sanitize the pump interior, using the automated procedure described in the Sanitization section.
Sanitizing agents: Disinfectant available for the day of use.
5.19.2  At the main program screen press OK to enter the main menu the display shows.
5.19.3  Press the down arrow until the display shows
5.19.4  Press OK the display shows.
               PUT EXPANDABLE
                   PRESS START
5.19.5  Place the sterile membrane filter and a milliflex funnel, on the pump head and press START. The display shows
           FILL 100 ML OF AGENT
                   PRESS START
5.19.6  Fill the funnel with 100 ml of sanitizing agent and press START. The display shows
5.19.7  The pump pulls through 50 ml of agent, pause for ten minutes, and then pulls through the remaining 50 ml A bar graph at the bottom of the display shows the progress of the operation.
5.19.8  After the pump has emptied the funnel, its runs a drying cycle and then display shows
           FILL 4 X 100 ML OF WATER, PRESS START
5.19.9  Fill the funnel with 100 ml of sterile water and press START. The display shows
5.19.10  The pump empties the funnel and runs a drying cycle then the display shows
            FILL 100 ML OF WATER
                   PRESS START
5.19.11  Fill the funnel with 100 ml of sterile water and press START. The rinsing cycle is performed as before. Then the display prompts for the funnel to be filled again, for each rinse, for a total of four rinses when the fourth rinse has been completed, the display shows
                    PRESS START
5.19.12  Press START, remove the funnel and discard it, the display shows
5.19.13  Press C to go back to the main program screen

Frequency of sanitization: Weekly

5.20  Cleaning

5.20.1  Clean the exterior of pump with a lint free mop with 70 % filtered v/v isopropyl alcohol.
Frequency: Before and after every use.

5.21  Tare procedure

Note: The tare procedure adjusts the measurement system in the pump for the weight of the installed pump head. The tare procedure shall be performed whenever the pump head is changed, and whenever the display does not show ’O’, with an empty funnel on the head.
5.21.1  When the display shows tare, press OK. The displays show
                     PRESS START
5.21.2  Remove anything on the pump head and press START. The display shows
                   MEASURING . . .
                   PLEASE WAIT . . .
5.21.3  After a few seconds, the display returns to the main program screen for the previously selected program.
5.22  Autoclave the pump head, SS grit before first use.


6.1  SOP - Standard Operating Procedure
6.2  G - Gram
6.3  Ml - Milli litre
6.4  % - Percentage

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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