Pall T Series, Care And Use

Page 1: ...User Guide T Series TFF Cassettes with Omega Membrane Care and Use Procedures For use with Centramate and Centrasette TFF Systems USTR 2433b...

Page 2: ...Pall AT and MT Cassette Holders 14 3 Operating Specifications 17 3 1 Recommended Cross Flow Rates for T Series Cassettes with Omega Membrane 17 3 2 Operating Pressures Temperatures and pH 18 3 3 Hold...

Page 3: ...Feed Retentate Line to Waste 37 5 1 2 Flush the Permeate Line to Waste 38 5 2 Cleaning Cassettes 38 5 2 1 Adding Cleaning Agent to System 38 5 2 2 Recirculate Cleaning Solution 39 5 3 Flush Cleaning...

Page 4: ...ggere le istruzioni per la sicurezza Le istruzioni per la sicurezza in Italiano possono essere richieste a Pall Aviso importante Antes de utilzar consultar instru es de seguran a Instru es de seguran...

Page 5: ...required 5 You should always use pressure gauges or pressure sensing devices in your system so you can monitor the system pressure and differential pressure across the membrane cassette 6 Take suitab...

Page 6: ...omogenates Recovery of products expressed into the media from cell culture Preparation of samples concentrate desalt or buffer exchange before or after column chromatography Caution This guide is desi...

Page 7: ...layed in Figure 1 Preconditioning and post use conditioning are covered in Sections 4 and 5 of this manual Information on product process optimization and processing can be found in other supporting l...

Page 8: ...larger systems to allow feed or retentate flow rate measurement A second flow meter may be used on the permeate Alternatively the permeate receptacle may be placed on a balance The weight of permeate...

Page 9: ...igh side resulting in a low calculated value for water permeability Equation 2 Water Permeability Calculation In applications where the process is controlled by TMP the result may be a low process flu...

Page 10: ...path and add to feed tank You should be able to run the system without drawing air into the pump 6 Position both the retentate and permeate lines to return to the feed tank 7 Adjust the pump to provid...

Page 11: ...er sealing surfaces Inspect the cassettes and gaskets prior to installation for any damage or foreign material which could hamper sealing of the cassettes Figure 4 T Series TFF Cassettes with Omega Me...

Page 12: ...gure 6 Opening Outer Bag 3 Remove cassette still in the inner bag from the outer bag Figure 7 Cassette Package in Inner Bag 4 Turn the cassette so that the seal is turned upright Use scissors to cut t...

Page 13: ...es continue the same gasket cassette gasket pattern ending with a gasket between the last cassette and the end plate Figure 10 Install multiple cassettes with the printed cassette information all faci...

Page 14: ...to be damaged or you repeatedly open and close the holder Figure 10 Example of Multiple Cassette Installation 2 3 How to Torque Pall AT and MT Cassette Holders 1 Install the membrane cassette and gask...

Page 15: ...no more than 1 4 turn at a time For example tighten the first nut 1 4 turn and then tighten the next nut in the sequence 1 4 turn Figure 13 Pall Manual Torque Cassette Holders and Torquing Sequence ww...

Page 16: ...nstalled and compressed in the holder cassettes can be pre conditioned and used in a process A forward flow air integrity test including a system integrity pressure hold test should be performed prior...

Page 17: ...ications 3 1 Recommended Cross Flow Rates for T Series Cassettes with Omega Membrane Table 3 lists recommended cross flow flux CFF rates for operating Pall TFF cassettes with Omega membrane Other para...

Page 18: ...required to prevent air from getting drawn into the pump Tank design significantly affects the minimum volume required to prevent air from getting into the system Permeate Hold up Volume is the total...

Page 19: ...Hold up Volume Procedure 1 Add the volume collected in the graduated cylinder to the feed tank or leave in the graduated cylinder if it was used as a feed tank If the volume collected B was not at le...

Page 20: ...tate and permeate lines in the cylinder and slowly pump out the remaining water in the system allowing air to purge out the lines 2 Carefully remove the permeate line from the graduated cylinder 3 Hol...

Page 21: ...raduated cylinder and slowly pump out the remaining water in the system allowing air to purge out the lines 9 Fill the permeate line with water from the cylinder 10 Record the volume collected in the...

Page 22: ...ates the system temperature to the product temperature Details of each step are presented in the following sections Warning Exceeding the maximum operating pressure for the cassette can permanently da...

Page 23: ...ng agents and conditions are recommended for sanitizing the specific Pall Omega membrane types listed Volume Required 5 L m2 0 5 L ft2 Sanitizing and Depyrogenating Solutions 0 1 to 0 5 N NaOH at 40 t...

Page 24: ...rg 40 psig 6 Adjust the retentate valve to split flow 25 retentate 75 permeate 7 Readjust the pump to give required retentate flow rate 8 Run for 30 minutes The effectiveness of this sanitization proc...

Page 25: ...s to waste 3 Open the retentate and permeate valve 4 Adjust the pump to deliver a flow rate of 5 to 10 L min m2 0 5 to 1 L min ft2 Do not exceed a feed pressure of 2 barg 30 psig 5 Adjust the retentat...

Page 26: ...rate of 5 L min m2 0 5 L min ft2 5 Adjust the retentate valve to split flow 25 retentate 75 permeate 6 Readjust pump to give required retentate flow rate 7 Recirculate for 30 minutes 8 Direct retentat...

Page 27: ...ectively the membrane was cleaned back to its original state This procedure must be performed with all new cassettes after steps 4 2 through 4 4 are completed Water quality should be Water for Injecti...

Page 28: ...to deliver the recommended cross flow flux Refer to Table 3 i If required set the pump flow rate to the required retentate flow rate ii Adjust the permeate valve till retentate and permeate flow rate...

Page 29: ...e 3 points measured 9 Draw a straight line from the origin that best fits the data points plotted 10 From the graph determine the water permeate flux rate at the transmembrane pressure in Table 10 11...

Page 30: ...Determine the initial normalized water permeability NWP20 C Figure 21 Determining Membrane Water Permeability Table 11 Temperature Correction Factors TCF for Normalizing Water Permeability Temperature...

Page 31: ...should be performed before performing the integrity test If the system temperature will be altered from the current value it is recommended that buffer conditioning and temperature stabilization Secti...

Page 32: ...ath Note The feed retentate flow path must be drained of liquid before performing the system or membrane cassette integrity test The procedure for draining the feed retentate flow path will depend on...

Page 33: ...air diffuses through the membrane to pressurize the permeate side If there is still airflow 5 sccm after the permeate and feed retentate pressures are equal a leak is indicated 5 Once the system press...

Page 34: ...deformed install new gaskets Reinstall the cassettes in the holder 4 Repeat the Membrane Cassette Integrity Test Section 4 6 3 If the cassette still fails an integrity test contact your local Pall rep...

Page 35: ...reached For example if the hardware surface temperature is 20 to 25 C and fluid is introduced at 4 C the torque on a full stack of cassettes may drop 20 to 40 due to contraction of the polymeric eleme...

Page 36: ...ate to maintain a feed pressure of 1 to 2 barg 15 to 30 psig for UF membranes 7 Recirculate fluid for 10 to 15 minutes if conditioning for pH and ionic stability at ambient temperature For equilibrati...

Page 37: ...reuse compared to discarding cassettes after a single use 5 1 Flushing Cassettes after Use Following a TFF process the product if in the concentrate would have likely been recovered by displacement wi...

Page 38: ...L m2 0 5 L ft2 minimum Recommended cleaning agents for Pall membranes see Section 6 2 Membrane Types Omega Cleaning Solutions 0 1 to 0 5 N NaOH at 25 to 45 C 0 1 to 0 5 N NaOH 200 to 400 ppm NaOCl at...

Page 39: ...tion Follow steps 5 1 1 and 5 1 2 to flush with water through the retentate then the permeate Add fresh cleaning solution to the feed tank and follow the steps in Section 5 2 1 5 3 Flush Cleaning Agen...

Page 40: ...valve 3 Adjust the pump to deliver a flow rate of 5 L min m2 0 5 L min ft2 or until the feed pressure equals 2 barg 30 psig 4 Open the retentate valve until the retentate flow rate is 5 to 10 of the...

Page 41: ...te from the effluent at end of flush and assay If the pH TOC and extractable levels are not acceptable repeat steps 2 to 10 until acceptable levels have been obtained 5 4 Determine Membrane Recovery f...

Page 42: ...vel in the feed tank and refill if necessary 2 Open the permeate and retentate valve completely 3 Adjust the pump speed to deliver the recommended cross flow flux Refer to Table 3 4 Close the retentat...

Page 43: ...water permeate flux rate vs TMP for the 3 points measured 9 Draw a straight line from the origin that best fits the data points plotted Note The plot should be linear for UF membranes If the points do...

Page 44: ...especially if cleaning is done at an elevated temperature and the system cannot maintain temperature of the cleaning fluid Studies altering conditions cycle time temperature or reagent concentration s...

Page 45: ...the storage solution be tested to determine if it is sufficiently caustic Cassettes may be flushed with fresh storage solution at this time Table 14 Recommended Storage Temperatures for Used Cassettes...

Page 46: ...fied pressure range 4 Run for 3 to 5 minutes 5 Stop the pump 5 6 4 Cassette Storage Procedure for Storage in the Holder 1 Close the feed retentate and permeate valves The holder and cassettes remain f...

Page 47: ...ristics Table 15 illustrates the compatibility of different Omega membrane cassettes at 20 C unless otherwise noted with respect to physical characteristics The table should only be used as a guide Ca...

Page 48: ...1 Long term storage 7 days in Phosphoric Acid H3PO4 may cause slight yellowing of the cassette s polyurethane encapsulant Table 18 Alkalies and Oxidizers Type Foulant Condition Sodium Hydroxide NaOH P...

Page 49: ...ties organic or inorganic in the product or from other sources like water buffers etc Hold up Volume The total volume contained within the feed retentate flow path Most of this volume is recoverable M...

Page 50: ...tentate The liquid that flows through the feed retentate channels of the cassette returning from the cassette retentate port back to the feed tank sccm Standard Cubic Centimeters per Minute SIP Steam...

Page 51: ...484 5400 phone 516 801 9548 fax biopharm pall com E mail International Offices Pall Corporation has offices and plants throughout the world in locations such as Argentina Australia Austria Belgium Bra...