pH probe calibration and insertion in a Flexel® Bag for LevMixer
Contents
1. 85032 541 21 MENTANA IU113351 Directions for use ziii sartorius biotech pH probe calibration and insertion in a Flexel Bag for LevMixer Magnetic Mixer According to the mixing technology used please refer to the relevant manual Flexel for Magnetic Mixer 50L 100L 200L 400L 650L 1000L Ref 85032 537 50 Flexel Palletank for LevMixer 50L 100L 200L 400L 650L 1000L Ref 85037 541 12 If the Flexel Bag for LevMixer Magnetic Mixer is also equipped with a conductivity device please also refer to the directions for use Conductivity probe used in a Flexel Bag for LevMixer Magnetic Mixer Ref IU 114256 A Warning Please stack horizontally and not more than the required number allowed Before pH probe calibration Good Laboratory Practices GLP recommends to place the pH probe and the standard pH solutions at the process temperature 1 Ona flat surface position the Flexel Bag for LevMixer Magnetic Mixer in such a way that the 8 protective cap is uppermost and the pH probe is in front of you 2 Open the flap on the side of the pH probe by removing the tape Ra Sa 3 Flexel Bag for LevMixer Magnetic Mixer preparation for pH probe calibration 3 1 Flip over the Flexel Bag for LevMixer Magnetic Mixer in such a way that the protective shield red component is uppermost and the pH probe is facing you 3 2 Remove the red protective shi2. ain body until the end 17 Check that the pH probe is fully inserted into Flexel Bag for LevMixer Magnetic Mixer SN End stop open position 18 Set the temperature from the Flexel Bag for LevMixer Magnetic Mixer by inserting a 3 mm OD temperature probe into the 3 mm ID thermowell The temperature acquisition in the pH meter can be performed automatically or manually refer to the User Manual of the pH meter for detailed instructions Z Warning Make sure that the thermowell is fully immersed before fitting the temperature probe Fitting the temperature probe in the thermowell of a dry bag may result in a damage of the thermowell that results in a leak 19 pH probe recalibration 19 1 Hold the pH probe device with both hands One on the pH probe main body static part The other on the pH probe holder mobile part End stop open position Turn anti clockwise and pull the pH probe holder mobile part out of the pH main body r End stop lt J closed position Check that the pH probe is fully in closed position see picture above 19 2 Open the 2 pinch clamps of the silicone tubing and the pinch clamp of the waste bag Open position 19 3 pH probe 2 calibration Z Warning Check that the two pinch clamps on the silicone tubing and the pinch clamp of the waste bag are opened Repeat the above operations 8 to recalibrate the pH probe 19 4 Rinsi
3. andard pH solution If the pH value is not stable gently shake the probe to remove possible residual air bubbles stuck onto the electrode 8 5 Second point calibration Repeat the above operations 8 4 to calibrate the probe with the second standard pH solution 8 6 Calibration evaluation The pH meter automatically evaluates the calibration Refer to the User Manual of the pH meter to check if the calibration evaluation is within the range of the acceptance criteria 9 Rinsing of the pH probe s chamber Rinse the pH probe with a minimum of 120 mL of WHI Water For Injection before insertion of the pH electrode into the Flexel Bag for LevMixer Magnetic Mixer to remove the standard pH solutions 10 Close the 2 pinch clamps of the silicone tubing and the pinch clamp of the waste bag 11 Open the door of the Palletank and check that it is free from particles 12 Flip over the Flexel Bag for LevMixer Magnetic Mixer in order to get the 8 protective cap at the top and the pH probe facing you Possibly Disconnect the pH meter to facilitate the handling of Flexel Bag for LevMixer Magnetic Mixer Z Warning Do not disconnect the waste bag in the case a 2 calibration is further required by an aseptic process Hold the Flexel Bag for LevMixer Magnetic Mixer with both arms in such a way that the waste bag Is supported 13 Insert the Flexel Bag for LevMixer Magnetic Mixer as per
4. eld there is no need to remove its pouch 3 3 Position the centering aligner in the dedicated fitting on the Flexel Bag for LevMixer Magnetic Mixer A Warning Failing to correctly install the centering aligner and magnetic clamp may result in a Flexel Bag for LevMixer Magnetic Mixer damage during filling operations 4 Remove the protective foam from the pH probe 5 Connect the cable of the pH probe DIN plug to the pH meter To connect the cable of the pH probe to a Sartorius portable oH meter PT 10 or PT 15 a DIN to BNC adapter Reference FMA114320 is required Connection of the pH probe DIN Connection to the pH meter BNC 6 Check the functionality of the pH electrode An initial pH value of 6 5 0 3 at room temperature is indicative of a functional electrode If the pH value is not stable gently shake the probe to remove possible residual air bubbles stuck onto the electrode If the pH value is still not correct flush the storage chamber with one calibration solution 7 Verifications before calibration 7 1 Make sure that the 2 pinch clamps of the silicone tubing and the pinch clamp of the waste bag are open neg S Open vA position Note Even if some crystals or liquid appear inside the tubes or in the flush bag the pH sensor remains functionnal if the initial value is 6 5 0 3 at room temperature 7 2 Make sure that the waste bag i
5. ng of the pH probe chamber At the end of calibration process rinse the pH probe with 120 mL of WFI Water For Injection before insertion of the pH electrode into the Flexel Bag for LevMixer Magnetic Mixer 19 5 Close the 2 pinch clamps of the silicone tubing and the pinch clamp of the waste bag 19 6 pH probe re insertion A Warning Check that the two pinch clamps on the silicone tubing and the pinch clamp of the waste bag are closed Repeat the above operations 16 to re insert the pH probe into Flexel Bag for LevMixer Magnetic Mixer 19 7 Check that the pH probe is fully inserted into Flexel Bag for LevMixer Magnetic Mixer A Warning The injected pH probe is designed to enable 3 activations 1 1 insertion 2 withdrawal 3 2 insertion while preserving the sterility into the Flexel Bag for LevMixer Magnetic Mixer Sartorius Stedim Biotech GmbH August Spindler Strasse 11 37079 Goettingen Germany Phone 49 551 308 0 Fax 49 551 308 3289 www sartorius stedim com Specifications subject to change without notice Printed and copyrighted by Sartorius Stedim Biotech GmbH W Publication No S 6017 e13112 Ver 11 2013
6. s supported on a table without sharp edges A Warning Failing to check point 7 1 may result in a leakage of the standard solution into the Flexel bag for LevMixer Magnetic Mixer 8 pH probe calibration 8 1 Set the temperature of the first standard pH solution into the pH meter using a 3 mm OD temperature probe that will be later inserted in the thermowell of the Flexel Bag for LevMixer Magnetic Mixer The temperature acquisition in the pH meter can be performed automatically or manually refer to the User Manual of the pH meter for detailed instructions 8 2 Filla 60 mL Luer syringe with the first standard pH solution Remove any air residual by slightly pressing the syringe oO Dn ME N o Ww impo Sa iin T i Warning Failing to remove air from the syringe may result in the impossibility to flush the electrode aty 8 3 Connect the filled 60 mL Luer syringe to the blue 25 mm diameter Minisart filter inlet of the probe s chamber 8 4 First point calibration refer to the User Manual of the pH meter for detailed instructions A Warning For the first point calibration hold the pH probe in a vertical orientation Minisart filter and inlet of the Flexboy Bag at the top at the rinsing of the 30 first milliliters Air initially trapped into the storage chamber is removed Flush the probe with a minimum of 120 mL of the first St
7. the below picture refer to the User Manual ref 85034 536 18 for detailed instructions 14 Insert the sliding gate Before inserting the pH sensor into the Flexel Bag for LevMixer Magnetic Mixer make sure that the sliding gate is well installed mR emg E OE P E r H 4 A Close the Palletank door Do not insert a temperature probe into the thermowell of a dry bag The thermowell must be fully immersed to fit the temperature probe Z Warning Fitting a temperature probe in the thermowell of a dry Flexel Bag for LevMixer Magnetic Mixer may result in a damage of the thermowell that results in a leak A Warning The absence of sliding gate on a Palletank used with a filled Flexel Bag for LevMixer Magnetic Mixer with pH sensor may result in a bag s exposure with a possible damage of the bag A Warning Check that the waste bag is well supported by the tubing holder 15 Start filling the mixing bag refer to the User Manual ref 85034 536 18 for detailed instructions 16 pH Probe insertion into the Flexel Bag for LevMixer Magnetic Mixer Z Warning Check that the two pinch clamps on the silicone tubing and the pinch clamp of the waste bag are closed Hold the pH probe device with both hands One on the pH probe main body static part The other on the pH probe holder mobile part Turn clockwise and push the pH probe holder mobile part into the pH m
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