Flexel Pre-designed Solutions for Mixing Intelligent, Powerful and Intuitive Mixing for your cgmp Biomanufacturing

Transcription

1 Flexel Pre-designed Solutions for Mixing, Powerful and Intuitive Mixing for your cgmp Biomanufacturing

2 Flexel Mixer Pre-designed Solutions Table Please click on the headline to go to the selected topic Digital Selection Map Please click on the box that matches your process need Powerful, Intuitive and Mixers from 50 L up to 3000 L. 3 Assurance of Supply for All Fluid-contact Components...4 Formulation Universal ph sensor & Thermowell Thermowell Silicone TuFlux tubing TPE C-Flex tubing Validation and Quality Assurance...5 Universal and Mixing Solutions...6 Pre-designed Solutions for All Process Steps...7 Formulation Universal ph sensor, conductivity sensor & Thermowell Conductivity sensor & Thermowell ph sensor & Thermowell Thermowell Silicone TuFlux tubing TPE C-Flex tubing Formulation...8 Formulation...13 Intermediates...20 Drug Substance Purification...25 Drug Product Formulation...28 Intermediates Flexel for LevMixer with ph sensor and Thermowell Flexel for LevMixer with Thermowell Flexel for Magnetic Mixer with ph sensor and Thermowell Flexel for Magnetic Mixer with Thermowell Standard Hardware for Mixing: The Perfect Fit Standard Palletank for Magnetic Mixer LevMixer...34 Magnetic Mixer Drive Unit...39 LevMixer Drive Unit Accessories...41 Drug Substance Purification Flexel for LevMixer with ph sensor and Thermowell Flexel for LevMixer with Thermowell Design, Application Development and Validation Services Drug Product Formulation Universal ph sensor & Thermowell Silicone TuFlux tubing TPE C-Flex tubing C-Flex is a registered trademark of Saint-Gobain Performance Plastics Corporation.

3 3 Flexel Mixer Pre-designed Solutions Powerful, Intuitive and Mixers from 50 L up to 3000 L Building on 20 years of experience in designing single-use fluid management solutions, we have established Pre-designed Solutions (PDS) for all process steps where either powerful or low shear mixing performances are required. Intermediates to Drug Substances Formulation Drug Product Formulation, Fill and Finish Flexel for Magnetic Mixer 1 offers powerful mixing performances for media and buffer formulation. The strong vertical vortex combined with the baffle effect of the cubical design allows instant downward movement and efficient dissolution of floating powders such as media powders or diatomaceous earth powder used in dynamic body feed filtration applications. In addition, the impeller high torque offers efficient mixing of high concentration or viscous powders such as buffer powders. Flexel for LevMixer 2 for downstream intermediates, drug substances and drug product offers low shear mixing performances for homogenization, viral inactivation and formulation of sensitive drug substances and drug products. The levitated impeller eliminates shear effects that can affect product quality and yield premature fouling of sterilizing grade filters by degrading sensitive proteins and generating particles and aggregates. Formulation Formulation Pre-designed Solutions for media formulation Intermediates Pre-designed Solutions for downstream intermediates When you select a Flexel Mixer PDS, you get assurance of best mixing performance for every specific process step and robust change control with at least 24 months of change notification. Formulation Pre-designed Solutions for buffer formulation Drug Substance Purification Pre-designed Solutions for drug substance purification Drug Product Formulation Pre-designed Solutions for drug product formulation

4 4 Flexel Mixer Pre-designed Solutions Assurance of Supply for All Fluid-contact Components Component Quality and Change Control Critical fluid-contact components used for Flexel for Magnetic Mixer and Flexel for LevMixer PDS are secured by long term contracts and quality agreements to offer the best assurance of supply. Material Qualification Flexel for Magnetic Mixer and Flexel for LevMixer PDS components are evaluated for conformity against the EP and USP standards after reviewing technical documentation and certificates of quality available from our suppliers. Design Qualification Component designs are selected to maximize tubing engagement tensile strength and tightness. Test samples are visually inspected for absence of defect and tested for leak, burst pressure, traction and compression. Using a Flexel for Magnetic Mixer and Flexel for LevMixer Pre-designed Solution in all your process steps provide you with the best quality, change control, business continuity and delivery performances. Our supply contracts and quality agreements ensure at least a 24-month change notification on critical fluidcontact components thus providing robust change control and business continuity. Critical fluid-contact components are also available off-the-shelf to offer the best delivery ability. Additional internal qualification tests are performed to establish extractable profiles, post gamma sterilization shelf life and consistent functional properties. Criteria for Component Selection Biological safety (USP Class VI) TSE-BSE questionnaire Reference USP<87> & USP<88> Compliance with EMA/410/01 and E.P Endotoxin USP<85> or EP Bioburden ISO Sub visible USP<788> or EP particles Others Bisphenol A free, REACH compliance Our core expertise in plastics and polymers enables the selection of the cleanest and most inert materials to minimize chemical interactions with biopharmaceutical fluids, and leacheable substances. Flexel for Magnetic Mixer and Flexel for LevMixer PDS Components Biocompatibility USP <87> or USP<88> Class VI Endotoxin, Sub-visible particulates TSE-BSE EMA/410/01 & REACH Notification period time Flexel bags Yes Yes Yes 24 months Impellers Yes Yes Yes 24 months Top ports Yes Yes Yes 24 months TuFlux tubes Yes Yes Yes 24 months Opta sterile connectors Yes Yes Yes 24 months Fittings Yes Yes Yes 24 months Connectors Yes Yes Yes 24 months Sensors (condutivity, ph, thermowell) Yes Yes Yes 24 months

5 5 Flexel Mixer Pre-designed Solutions Validation and Quality Assurance Flexel for Magnetic Mixer and Flexel for LevMixer PDS are qualified against extensive biological, chemical, physical, extractable and functional testing. Sartorius Stedim Biotech Quality Systems for single-use products follow applicable ISO 9001 and ISO for Medical Devices. Design, manufacture, quality control and sterilization of PDS are conducted under conditions that mirror biopharmaceutical operations and meet cgmp like requirements to ensure they are supplied clean, pure, endotoxin free and sterile. PDS are validated and routinely controlled to provide consistent performance for: Robustness Qualification of the bag manufacturing process capabilities following recommendations from standards (ASTM F-2097, ISO15747) and other publications (PDA,FDA-CBER) Internal standardized methods for connection tests and functional qualification in real process conditions ASTM D882, D1004, F392 for tensile properties, tear resistance and flex durability Gas transmission (Film) ASTM F1927, F1249, F2476: Oxygen, Water Vapor Transmission Rate and Carbon Dioxide. Biocompatibility and chemical compatibility USP<87> and ISO : Biological reactivity tests, in Vitro USP<88>: Biological reactivity tests, in Vivo USP<661> and EP 3.1.5: Containers, physico-chemical tests Plastics ASTM D543-06: resistance of plastic to chemical reagents Purity, extractable and leachable Extractable data TSE/BSE: EMA/410/01 and EP Cleanliness, particles and sterilization USP<788> and EP : Particulate Matter in Injections Endotoxin USP<85> and E.P : Bacterial endotoxins Sterility ISO Sterilization of medical devices Microbiological methods: Bioburden ISO Sterilization by irradiation of Medical Devices: Sterilization of Medical Devices ISO 14644: Cleanroom environmental controls Gamma radiation dose mapping PDS for media, buffer, harvest & downstream intermediates and drug substance process steps are released on the basis of a weekly quality control for bioburden, sub-visible particulates and endotoxin performed on representative samples.,, Intermediates & Drug substance Weekly testing of bioburden, sub-visible particles and endotoxin on representative sample Certificate of Release Statement Monitoring* 100% Batch testing USP Class VI USP<87> and ISO : Biological reactivity tests, in Vitro USP<88>: Biological reactivity tests, in Vivo Physico-chemical testing USP<661> and EP Bioburden ISO * performed weekly on representative samples Endotoxin: USP<85> and E.P Sub-visible Particulates USP<788> and EP Drug Product 1 1 None of the PDS for Drug Product are yet released on the basis of a lot release testing Lot release testing of bioburden, sub-visible particles and endotoxin on actual product sample Gamma radiation Dose Visual inspection Film, bag, seal and packaging Technical Drawing conformity Batch record review

6 6 Flexel Mixer Pre-designed Solutions Universal and Mixing Solutions Universal Easy to Use and Intuitive for All Process Steps The front door and the cubical shape provide convenient installation, deploying and folding of the bag during filling and draining. The front access to sensors and tubing lines facilitates the filling, sampling and draining manipulations. The large 8 diameter top port allows easy and contained powder transfer into the mixing bag. The sided windows allow for visual check of the mixing process. Flexel for Magnetic mixing provides powerful and fast powder dissolution for buffer and media process steps. Flexel for LevMixer offers low shear mixing for downstream intermediates, drug substance and drug product process steps. Front door and cubical shape for an easy bag installation Front access to sensors and tubing for easy manipulation 8 inches top opening for easy powder addition Single-use ph probe and conductivity sensor Weight control Heat exchange jacket and temperature control Mixing for your cgmp Biomanufacturing Mixers are designed for monitoring and controlling all critical mixing parameters required for cgmp processes. In-line control and monitoring of ph, conductivity and temperature are performed with pre-assembled single-use ph probe, conductivity sensor and thermowell. In-line sensors meet the PAT and cgmp requirements, eliminate the risk of contamination present with insertion of re-usabe probes and reduce operator time. Palletank for Mixers are available with weighing functions and heat exchange jacket for integrated control of the volume and temperature. The LevMixer features an automated control of the mixing parameters by reading the real impeller speed, offering mixing recipes and password management. LevMixer Drive unit touchscreen

7 7 Flexel Mixer Pre-designed Solutions Pre-designed Solutions for All Process Steps Top lines ph adjustment lines with CPC Quick coupler or Opta SFT female or when using drain valves on the bottom lines: top addition lines with CPC Quick coupler or Opta SFT female and or sampling line with clave needleless Large 8 diameter Top Port Opened Top Port for powder transfer Closed Top Port for sterile or low bioburden application Single-Use Sensors for in line measurement ph sensor with 2 calibration points Pre-calibrated conductivity sensor Thermowell for temperature measurement Bottom Port Drain valve (2 lines possible) UPS 4 ports allowing 4 lines Mixing Technology Magnetic Mixer for,, Harvest and Intermediates LevMixer for Intermediates, Drug substance and Drug product Bottom Lines Filling line with Tri-Clamp connector or Opta SFT female Draining line with Tri-Clamp connector or Opta SFT male Addition lines with CPC Quick coupler or Opta SFT female Sampling line using clave needleless Inlet and Outlet Connectors Tri-Clamp are used for either sanitary connection or aseptic connection under ISO5 laminar air flow to stainless steel systems CPC quick couplers are used for either sanitary connection or aseptic connection under ISO5 laminar air flow to single-use systems Opta SFT Female enables sterile connections to other single-use systems Clave needleless enables sterile sampling Tubes TuFlux silicone tubing enables safe and fast pumping Clear C-Flex tubing allows for sterile weld connection with BioWelder TC and sterile seal disconnection with BioSealer Sensors Single-use ph sensor: Pre-installed and pre-sterilized single-use ph sensor Large measurement range ph2 ph11 High accuracy after 2 points calibration: ph2 ph9; 10 C 40 C: ±0.1 ph3 ph7; 25 C: ±0.05 Retractable probe: 3 activations validated with maintained sterility Single-use conductivity sensor: Pre-installed and pre-sterilized single-use conductivity sensor Pre-calibrated single-use conductivity sensor and ready to use Large measurement range 100μS/cm up to 200 ms/cm Accuracy: <100 ms/cm: 2% ms/cm: 5% Thermowell: 3.2 mm ID for reusable temperature sensor insertion

8 8 Formulation Formulation Universal ph sensor & Thermowell Thermowell Silicone TuFlux tubing TPE C-Flex tubing PDS for media formulation are designed with a bottom mounted Magnetic Mixer for easy, intuitive and rapid media powder dissolution. An optimized media formulation process involves filling the mixer with water for injection (WFI) up to 60% to 80% of the final volume. WFI can be heated up with the heat exchange jacket to accelerate the dissolution. The mixing drive unit is started and the media powder or a concentrated liquid media is added during mixing. Once the dissolution is complete, WFI is added to adjust to the final volume. Volume adjustment can be automatically performed using weighing control. Temperature and ph can be monitored and adjusted in-line. Process samples are taken off-line for other QC tests. When the formulation is complete, the media is filtered for sterilization and mycoplasma removal and stored before further transfer to the bioreactor. Flexel for Magnetic Mixer PDS for media are available in: version using single-use and integrated sensors for in-line ph and temperature monitoring and adjustment required for your cgmp biomanufacture. Universal version using either reusable sensors via the 8 top opening for in-line controls or sampling in single-use bags for off-line controls. Filling and draining lines are available with Silicone TuFlux, TPE C-Flex tubing and Tri-Clamp 11 sanitary flange. Samples can be taken via an additional Silicone TuFlux line equipped with a clave needleless. The following options are also available: lines for other liquid additions with Silicone TuFlux tubing and quick coupler connector drain valves to prevent powder accumulation in bottom tubing lines

9 9 Formulation Formulation Universal ph sensor & Thermowell Thermowell Silicone TuFlux tubing TPE C-Flex tubing Top lines ph adjustment lines with CPC Quick coupler or when using drain valves on the bottom lines: top addition lines with CPC Quick coupler and or sampling line with clave needleless Single-Use Sensors for in line measurement ph sensor Thermowell for temperature measurement Large 8 diameter Top Port Opened Top Port for powder transfer Mixing Technology Magnetic Mixer Bottom Port Drain valve (2 lines possible) UPS 4 ports allowing 4 lines Bottom Lines Filling line with Tri-Clamp connector Draining line with Tri-Clamp connector Addition lines with CPC Quick coupler Sampling line with clave needleless Flexel for Magnetic Mixer with ph Sensor & Thermowell Bag Volume Part Number Units per box 50 L FMB ½ ID Silicone 100 L FMB l FMB L FMB l FMB L FMB l FMB L FMB l FMB L FMB l FMB Drain Valves Inlet Outlet Sampling Addition ph Adjustment TuFlux 1.5 m (60 ) + ½ ID Silicone TuFlux 1.5 m (60 ) + Clave needleless When a drain valve is used: 1 top line: a ID Silicone TuFlux 0.15 m (6 ) + MPC female + sealing cap When no drain valve is used: 1 bottom line addition: a ID Silicone TuFlux 1.5 m (60 ) + MPC female + sealing cap 2 top lines: TuFlux 0.1 m (4 ) + MPC female + sealing cap

10 10 Formulation Top lines ph adjustment lines with CPC Quick coupler or when using drain valves on the bottom lines: top addition lines with CPC Quick coupler and or sampling line with clave needleless Large 8 diameter Top Port Opened Top Port for powder transfer Formulation Universal ph sensor & Thermowell Thermowell Silicone TuFlux tubing TPE C-Flex tubing Single-Use Sensors for in line measurement ph sensor Thermowell for temperature measurement Mixing Technology Magnetic Mixer Bottom Port Drain valve (2 lines possible) UPS 4 ports allowing 4 lines Bottom Lines Filling line with Tri-Clamp connector Draining line with Tri-Clamp connector Addition lines with CPC Quick coupler Sampling line with clave needleless Flexel for Magnetic Mixer & Thermowell Bag Volume Part Number Units per box 50 L FMB l ½ ID Silicone FMB L FMB l FMB L FMB l FMB L FMB l FMB L FMB l FMB L FMB l FMB Drain Valves Inlet Outlet Sampling Addition ph Adjustment TuFlux 1.5 m (60 ) L FMB ID Silicone 2000 L FMB TuFlux 3 m (119 ) + ½ ID Silicone TuFlux 1.5 m (60 ) + with gasket, 3 ID Silicone TuFlux 3 m (119 ) + Clave needleless Sampling port TuFlux 0.5 m (20 ) + When a drain valve is used: 2 top line: a ID Silicone TuFlux 0.15 m (6 ) + MPC female + sealing cap When no drain valve is used: 1 bottom line: a ID Silicone TuFlux 1.5 m (60 ) + MPC female + sealing cap 1 top line: a ID Silicone TuFlux 0.15 m (6 ) + MPC female + sealing cap 1 bottom line: 3 ID Silicone TuFlux 1.5 m (60 ) + 2 top lines: TuFlux 0.1 m (4 ) + MPC female + Sealing cap 3 Tri-Clamp 3 Tri-Clamp Clave needleless 3 Tri-Clamp

11 11 Formulation Large 8 diameter Top Port Opened Top Port for powder transfer Formulation Universal ph sensor & Thermowell Thermowell Silicone TuFlux tubing TPE C-Flex tubing Mixing Technology Magnetic Mixer Bottom Port Drain valve (2 lines possible) UPS 4 ports allowing 4 lines Bottom Lines Filling line with Tri-Clamp connector Draining line with Tri-Clamp connector Sampling line with clave needleless Universal Flexel for Magnetic Mixer With Silicone TuFlux Tubing Bag Volume Part Number Units per box 50 L FMB l ½ ID Silicone TuFlux FMB L FMB l FMB L FMB l FMB L FMB l FMB L FMB l FMB L FMB l FMB Drain Valves Inlet Outlet Sampling Addition ph Adjustment 1.5 m (60 ) + with gasket, ½ ID Silicone TuFlux 1.5 m (60 ) + with gasket, TuFlux 0.1 m (4 ) + Clave needleless NA NA

12 12 Formulation Large 8 diameter Top Port Opened Top Port for powder transfer Formulation Universal ph sensor & Thermowell Thermowell Silicone TuFlux tubing TPE C-Flex tubing Mixing Technology Magnetic Mixer Bottom Port UPS 4 ports allowing 4 lines Bottom Lines Filling line with Tri-Clamp connector Draining line with Tri-Clamp connector Addition lines with CPC Quick coupler Sampling line with clave needleless Universal Flexel for Magnetic Mixer With C-Flex TPE Tubing Bag Volume Part Number Units per box 50L FMB NA ½ ID Silicone (Dow 100 L FMB L FMB L FMB L FMB L FMB Drain Valves Inlet Outlet Sampling Addition ph Adjustment Corning) 1 m (40 ) + ½ ID Clear C-Flex 0.5 m (20 ) + ½ ID Silicone (Dow Corning) 1 m (40 ) + ½ ID Clear C-Flex 0.5 m (20 ) + (Dow Corning) 0.15 m (6 ) + 8 ID Clear C-Flex 0.5 m (20 ) + Clave needleless 1 bottom line: ½ ID Silicone (Dow Corning) 1 m (40 ) + ½ ID Clear C-Flex 0.5 m (20 ) + MPX male + sealing cap NA Dow Corning Pharma-50 is a registered trademark of Dow Corning.

13 13 Formulation Formulation Universal ph sensor, conductivity sensor & Thermowell Conductivity sensor & Thermowell ph sensor & Thermowell Thermowell Silicone TuFlux tubing TPE C-Flex tubing PDS for buffer formulation are designed with a bottom mounted Magnetic Mixer impeller for easy, intuitive and rapid buffer powder dissolution. An optimized buffer formulation process involves filling the mixer with water for injection (WFI) up to 60% to 80% of the final volume. WFI can be heated up with the heat exchange jacket to accelerate the dissolution. The mixing drive unit is started and the buffer powder or a concentrated liquid buffer is added during mixing. Once the dissolution is complete, WFI is added to adjust to the final volume. Volume adjustment can be automatically performed using weighing control. Temperature, conductivity, and ph can be monitored and adjusted in-line. Process samples are taken off-line for other QC tests. When the formulation is complete, the buffer is sterile filtered and stored before further use for drug substance purification or final drug product formulation. Flexel for Magnetic Mixer PDS for buffer are available in: version using single-use and integrated sensors for in-line ph, conductivity and temperature monitoring and adjustment required for your cgmp biomanufacture Universal version using either reusable sensors via the 8 top opening for in-line controls or sampling in single-use bags for off-line controls Filling and draining lines are available with Silicone TuFlux, TPE C-Flex tubing and Tri-Clamp 11 sanitary flange. Samples can be taken via Silicone TuFlux line equiped with a clave needleless. The following options are also available: lines for liquid additions with Silicone TuFlux tubing and quick coupler connector drain valves to prevent powder accumulation in bottom mounted tubing

14 14 Formulation ph sensor, conductivity sensor & Thermowell Top lines ph adjustment lines with CPC Quick coupler or when using drain valves on the bottom lines: top addition lines with CPC Quick coupler and or sampling line with clave needleless Large 8 diameter Top Port Opened Top Port for powder transfer Formulation Universal Conductivity sensor & Thermowell ph sensor & Thermowell Thermowell Silicone TuFlux tubing TPE C-Flex tubing Single-Use Sensors for in line measurement ph sensor Conductivity sensor Thermowell for temperature measurement Bottom Port Drain valve (2 lines possible) UPS 4 ports allowing 4 lines Mixing Technology Magnetic Mixer Bottom Lines Filling line with Tri-Clamp connector Draining line with Tri-Clamp connector Sampling line with clave needleless Flexel for Magnetic Mixer with ph sensor, conductivity sensor & Thermowell Bag Volume Part Number Units per box 50 L FMB ½ ID Silicone 100 L FMB l FMB L FMB l FMB L FMB l FMB L FMB l FMB L FMB l FMB Drain Valves Inlet Outlet Sampling Addition ph Adjustment TuFlux 1.5 m (60 ) + ½ ID Silicone TuFlux 1.5 m (60 ) + Clave needleless When no drain valve is used: 2 top lines: a ID Silicone TuFlux 0.15 m (6 ) + MPC female + sealing cap When a drain valve is used: No addition line 2 top lines: MPC female + sealing cap

15 15 Formulation ph sensor, conductivity sensor & Thermowell Top lines when using drain valves on the bottom lines: top addition lines with CPC Quick coupler and or sampling line with clave needleless Large 8 diameter Top Port Opened Top Port for powder transfer Formulation Universal Conductivity sensor & Thermowell ph sensor & Thermowell Thermowell Silicone TuFlux tubing TPE C-Flex tubing Single-Use Sensors for in line measurement Conductivity sensor Thermowell for temperature measurement Bottom Port Drain valve (2 lines possible) UPS 4 ports allowing 4 lines Mixing Technology Magnetic Mixer Bottom Lines Filling line with Tri-Clamp connector Draining line with Tri-Clamp connector Addition lines with CPC Quick coupler Sampling line with clave needleless Flexel for Magnetic Mixer with Conductivity Sensor & Thermowell Bag Volume Part Number Units per box 50 L FMB ½ ID Silicone 100 L FMB l FMB L FMB l FMB L FMB l FMB L FMB l FMB L FMB l FMB Drain Valves Inlet Outlet Sampling Addition ph Adjustment TuFlux 1.5 m (60 ) + ½ ID Silicone TuFlux 1.5 m (60 ) + Clave needleless When a drain valve is used: 1 top line: a ID Silicone TuFlux 0.15 m (6 ) + MPC female + sealing cap When no drain valve is used: 1 bottom line: a ID Silicone TuFlux 1.5 m (60 ) + MPC female + sealing cap NA

16 16 Formulation Formulation Universal ph sensor, conductivity sensor & Thermowell Conductivity sensor & Thermowell ph sensor & Thermowell Thermowell Silicone TuFlux tubing TPE C-Flex tubing Top lines ph adjustment lines with CPC Quick coupler or when using drain valves on the bottom lines: top addition lines with CPC Quick coupler and or sampling line with clave needleless Single-Use Sensors for in line measurement ph sensor Conductivity sensor Thermowell for temperature measurement Bottom Port Drain valve (2 lines possible) UPS 4 ports allowing 4 lines Large 8 diameter Top Port Opened Top Port for powder transfer Mixing Technology Magnetic Mixer Bottom Lines Filling line with Tri-Clamp connector Draining line with Tri-Clamp connector Addition lines with CPC Quick coupler Sampling line with clave needleless Flexel for Magnetic Mixer with ph Sensor & Thermowell Bag Volume Part Number Units per box 50 L FMB ½ ID Silicone 100 L FMB l FMB L FMB l FMB L FMB l FMB L FMB l FMB L FMB l FMB Drain Valves Inlet Outlet Sampling Addition ph Adjustment TuFlux 1.5 m (60 ) + ½ ID Silicone TuFlux 1.5 m (60 ) + Clave needleless When a drain valve is used: 1 top line: a ID Silicone TuFlux 0.15 m (6 ) + MPC female + sealing cap When no drain valve is used: 1 bottom line: a ID Silicone TuFlux 1.5 m (60 ) + MPC female + sealing cap 2 top lines: MPC female + sealing cap

17 17 Formulation Formulation Universal ph sensor, conductivity sensor & Thermowell Conductivity sensor & Thermowell ph sensor & Thermowell Thermowell Silicone TuFlux tubing TPE C-Flex tubing Top lines ph adjustment lines with CPC Quick coupler or when using drain valves on the bottom lines: top addition lines with CPC Quick coupler and or sampling line with clave needleless Single-Use Sensors for in line measurement Thermowell for temperature measurement Bottom Port Drain valve (2 lines possible) UPS 4 ports allowing 4 lines Large 8 diameter Top Port Opened Top Port for powder transfer Mixing Technology Magnetic Mixer Bottom Lines Filling line with Tri-Clamp connector Draining line with Tri-Clamp connector Addition lines with CPC Quick coupler Sampling line with clave needleless Flexel for Magnetic Mixer with Thermowell Bag Volume Part Number Units per box 50 L FMB l ½ ID Silicone TuFlux FMB L FMB l FMB L FMB l FMB L FMB l FMB L FMB l FMB L FMB l FMB Drain Valves Inlet Outlet Sampling Addition ph Adjustment 1.5 m (60 ) L FMB ID Silicone 2000 L FMB TuFlux 3 m (119 ) + ½ ID Silicone TuFlux 1.5 m (60 ) + 3 ID Silicone TuFlux 3 m (119 ) + Clave needleless TuFlux 0.5 m (20 ) + When a drain valve is used: 2 top lines: a ID Silicone TuFlux 0.15 m (6 ) + MPC female + sealing cap When no drain valve is used: 1 bottom line: a ID Silicone TuFlux 1.5 m (60 ) + MPC female + sealing cap 1 top line: a ID Silicone TuFlux 0.15 m (6 ) + MPC female + sealing cap 1 bottom line: 3 ID Silicone TuFlux 1.5 m (60 ) + 2 top lines: MPC female + sealing cap 3 Tri-Clamp 3 Tri-Clamp Clave needleless 3 Tri-Clamp

18 18 Formulation ph sensor, conductivity sensor & Thermowell Large 8 diameter Top Port Opened Top Port for powder transfer Formulation Universal Conductivity sensor & Thermowell ph sensor & Thermowell Thermowell Silicone TuFlux tubing TPE C-Flex tubing Bottom Port Drain valve to avoid dead leg volume (2 bottom lines possible) UPS 4 ports allowing 4 bottom lines Mixing Technology Magnetic Mixer Bottom Lines Filling line with Tri-Clamp connector Draining line with Tri-Clamp connector Sampling line with clave needleless Universal Flexel for Magnetic Mixer with Silicone TuFlux Tubing Bag Volume Part Number Units per box 50 L FMB l ½ ID Silicone FMB L FMB l FMB L FMB l FMB L FMB l FMB L FMB l FMB L FMB l FMB Drain Valves Inlet Outlet Sampling Addition ph Adjustment TuFlux 1.5 m (60 ) + ½ ID Silicone TuFlux 1.5 m (60 ) + Clave needleless NA NA

19 19 Formulation ph sensor, conductivity sensor & Thermowell Large 8 diameter Top Port Opened Top Port for powder transfer Formulation Universal Conductivity sensor & Thermowell ph sensor & Thermowell Thermowell Silicone TuFlux tubing TPE C-Flex tubing Bottom Port UPS 4 ports allowing 4 bottom lines Mixing Technology Magnetic Mixer Bottom Lines Filling line with Tri-Clamp connector Draining line with Tri-Clamp connector Addition lines with CPC Quick coupler Sampling line with clave needleless Universal Flexel for Magnetic Mixer with C-Flex TPE Tubing Bag Volume Part Number Units per box 50 L FMB NA ½ ID Silicone (Dow Corning) 1 m (40 ) + ½ ID Clear C-Flex 0.5 m (20 ) L FMB L FMB L FMB L FMB L FMB Drain Valves Inlet Outlet Sampling Addition ph Adjustment ½ ID Silicone (Dow Corning) 1 m (40 ) + ½ ID Clear C-Flex 0.5 m (20 ) + (Dow Corning) 0.15 m (6 ) + 8 ID Clear C-Flex 0.5 m (20 ) + Clave needleless ½ ID Silicone (Dow Corning) 1 m (40 ) + ½ ID Clear C-Flex 0.5 m (20 ) + MPX male + sealing cap NA Dow Corning Pharma-50 is a registered trademark of Dow Corning.

20 20 Intermediates Intermediates Viral inactivation process using 3 single-use mixing bags: Low ph viral inactivation Neutralisation Post filtration Viral inactivation process using 2 single-use mixing bags: Combined Low ph viral inactivation and Neutralisation Post filtration Flexel for LevMixer with ph sensor and Thermowell Flexel for LevMixer with Thermowell Flexel for Magnetic Mixer with ph sensor and Thermowell Flexel for Magnetic Mixer with Thermowell PDS are designed for safe and reliable viral inactivation process steps. They include both Flexel for LevMixer and Magnetic Mixer options and are available with integrated single-use sensors. Low ph viral inactivation of downstream process intermediates consists of 3 steps: The ph of the downstream intermediate is first reduced and maintained at low ph for a validated period of time, usually at ph 3 4 for an hour, until the virus is totally inactivated. The low ph inactivation is followed by a neutralisation step where the ph is increased, usually up to ph 7 8 and a final filtration. All three steps require mixing for inactivation, neutralization and homogenization. To ensure that the entire content of the first mixer is inactivated, including droplets on the mixer wall or dead volume inside tubing, some processes are operated using 3 single-use mixing bags: 1 for low ph viral inactivation 1 for neutralisation 1 for homogenization of the filtered drug substance. Some processes are operated with two single-use mixing bags by combining the 2 mixers for low ph inactivation and neutralisation in one mixer. PDS for Low ph virus inactivation and neutralisation are designed with: Fully closed 8 diameter top port for a safe mixing Integrated single-use ph sensor and thermowell for in-line monitoring and control of the inactivation process Top lines with silicone TuFlux tubing and quick coupler connector for ph adjustment Bottom lines with silicone TuFlux tubing and Tri-Clamp 11 sanitary flange for filling and draining Bottom lines with silicone TuFlux tubing and clave needleless port for sterile sampling The following options are also available: lines for other liquid additions with Silicone TuFlux tubing and quick coupler connector drain valves to avoid hold up volumes into the tubes. PDS for post filtration are designed with: Integrated thermowell for temperature monitoring and control A combined Silicone TuFlux + C-Flex tubing ended by an Opta SFT female to allow sterile connection and disconnection of the adequate filter line A combined Silicone TuFlux + C-Flex tubing ended by a Tri-Clamp 1 ½ sanitary flange for draining Bottom line with silicone TuFlux tubing and clave needleless port for sterile sampling Bottom line with Silicone TuFlux tubing and quick coupler connector for liquid additions Flexel for LevMixer is the preferred mixing technology for all downstream process intermediate purification steps due to its low shear. PDS are also available with the Magnetic Mixer technology for those intermediates substance processes that are not sensitive to shear effects.

21 21 Intermediates Intermediates Flexel for LevMixer with ph sensor and Thermowell Flexel for LevMixer with Thermowell Flexel for Magnetic Mixer with ph sensor and Thermowell Top lines ph adjustment lines with CPC Quick coupler or when using drain valves on the bottom lines: top addition lines with CPC Quick coupler and or sampling line with clave needleless Single-Use Sensors for in line measurement ph sensor Thermowell for temperature measurement Large 8 diameter Top Port Closed Top Port for sterile or low bioburden application Mixing Technology LevMixer Flexel for Magnetic Mixer with Thermowell Bottom Port Drain valve (2 lines possible) UPS 4 ports allowing 4 lines Bottom Lines Filling line with Tri-Clamp connector Draining line with Tri-Clamp connector Addition lines with CPC Quick coupler Sampling line with clave needleless Flexel for LevMixer with with ph sensor and Thermowell for Low ph viral inactivation and Neutralisation Bag Volume Part Number Units per box 50 L FMB ½ ID Silicone 100 L FMB l FMB L FMB l FMB L FMB l FMB L FMB l FMB L FMB l FMB Drain Valves Inlet Outlet Sampling Addition ph Adjustment TuFlux 1.5 m (60 ) + ½ ID Silicone TuFlux 1.5 m (60 ) + Clave needleless When a drain valve is used: 1 top line: a ID Silicone TuFlux 0.15 m (6 ) + MPC female + sealing cap When no drain valve is used: 1 bottom line: a ID Silicone TuFlux 1.5 m (60 ) + MPC female + sealing cap 2 top lines: MPC female + sealing cap

22 22 Intermediates Intermediates Flexel for LevMixer with ph sensor and Thermowell Flexel for LevMixer with Thermowell Flexel for Magnetic Mixer with ph sensor and Thermowell Single-Use Sensors for in line measurement Thermowell for temperature measurement Large 8 diameter Top Port Closed Top Port for sterile or low bioburden application Mixing Technology LevMixer Flexel for Magnetic Mixer with Thermowell Bottom Port UPS 4 ports allowing 4 bottom lines Bottom Lines Filling line with Opta SFT female Draining line with Tri-Clamp connector Addition lines with CPC Quick Sampling line with clave needleless Flexel for LevMixer with Thermowell for Post Filtration Bag Volume Part Number Units per box 50 L FMB NA ½ ID Silicone 100 L FMB L FMB L FMB L FMB L FMB Drain Valves Inlet Outlet Sampling Addition ph Adjustment TuFlux 1 m (40 ) + ½ ID Clear C-Flex 0.5 m (20 ) + ½ Opta SFT female ½ ID Silicone TuFlux 1 m (40 ) + ½ ID Clear C-Flex 0.5 m (20 ) + Clave needleless 1 bottom line: a ID Silicone TuFlux 1.5 m (60 ) + MPC female + sealing cap NA

23 23 Intermediates Intermediates Flexel for LevMixer with ph sensor and Thermowell Flexel for LevMixer with Thermowell Flexel for Magnetic Mixer with ph sensor and Thermowell Top lines ph adjustment lines with CPC Quick coupler or when using drain valves on the bottom lines: top addition lines with CPC Quick coupler and or sampling line with clave needleless Single-Use Sensors for in line measurement ph sensor Thermowell for temperature measurement Large 8 diameter Top Port Closed Top Port for sterile or low bioburden application Mixing Technology Magnetic Mixer Flexel for Magnetic Mixer with Thermowell Bottom Port Drain valve (2 lines possible) UPS 4 ports allowing 4 lines Bottom Lines Filling line with Tri-Clamp connector Draining line with Tri-Clamp connector Addition lines with CPC Quick coupler Sampling line with clave needleless Flexel for Magnetic Mixer with ph sensor and Thermowell for Low ph viral inactivation and Neutralisation Bag Volume Part Number Units per box 50 L FMB ½ ID Silicone 100 L FMB l FMB L FMB l FMB L FMB l FMB L FMB l FMB L FMB l FMB Drain Valves Inlet Outlet Sampling Addition ph Adjustment TuFlux 1.5 m (60 ) + ½ ID Silicone TuFlux 1.5 m (60 ) + Clave needleless When a drain valve is used: 1 top line: a ID Silicone TuFlux 0.15 m (6 ) + MPC female + sealing cap When no drain valve is used: 1 bottom line: a ID Silicone TuFlux 1.5 m (60 ) + MPC female + sealing cap 2 top lines: MPC female + sealing cap

24 24 Intermediates Intermediates Flexel for LevMixer with ph sensor and Thermowell Flexel for LevMixer with Thermowell Flexel for Magnetic Mixer with ph sensor and Thermowell Single-Use Sensors for in line measurement Thermowell for temperature measurement Large 8 diameter Top Port Closed Top Port for sterile or low bioburden application Mixing Technology Magnetic Mixer Flexel for Magnetic Mixer with Thermowell Bottom Port UPS 4 ports allowing 4 bottom lines Bottom Lines Filling line with Opta SFT connector Draining line with Tri-Clamp connector Addition lines with CPC Quick coupler Sampling line with clave needleless Flexel for Magnetic Mixer with Thermowell for Post filtration Bag Volume Part Number Units per box 50 L FMB NA ½ ID Silicone 100 L FMB L FMB L FMB L FMB L FMB Drain Valves Inlet Outlet Sampling Addition ph Adjustment TuFlux 1 m (40 ) + ½ ID Clear C-Flex 0.5 m (20 ) + ½ Opta SFT female ½ ID Silicone TuFlux 1 m (40 ) + ½ ID Clear C-Flex 0.5 m (20 ) + Clave needleless 1 bottom line: a ID Silicone TuFlux 1.5 m (60 ) + MPC female + sealing cap NA

25 25 Drug Substance Purification Drug Substance Purification Flexel for LevMixer with ph sensor and Thermowell Flexel for LevMixer with Thermowell PDS are designed for safe and reliable mixing during drug substance purification steps. They feature the Flexel for LevMixer low shear homogenization and integrated single-use ph sensor and thermowell for in-line monitoring and control. Process samples are taken off-line for other QC tests such as product quality attributes and bioburden prior to sterile filtration. The Opta SFT connector or the BioWelder TC are used for respectively sterile connection or sterile weld. Tri-Clamp or quick coupler connectors are used for aseptic connections under ISO laminar air flow. Sterile disconnection is done using the BioSealer. PDS for mixing during drug substance purification are designed for Aseptic filling and draining operations under ISO laminar air flow: bottom lines with silicone TuFlux tubing and Tri-Clamp 1 ½ sanitary flange Sterile filling and draining operations: bottom filling line with a combined Silicone TuFlux + C-Flex tubing ended by an Opta SFT female; bottom draining line with a combined Silicone TuFlux + C-Flex tubing ended by a Tri-Clamp 1 ½ sanitary flange Integrated single-use ph sensor and or thermowell for in-line monitoring and control Top lines with silicone TuFlux tubing and quick coupler connector for ph adjustment Bottom line with silicone TuFlux tubing and clave needleless port for sterile sampling Bottom or top line with Silicone TuFlux tubing and quick coupler connector for liquid additions Fully closed 8 diameter top port for a safe mixing Options with drain valves to avoid hold up volumes into the tubes are also available.

26 26 Drug Substance Purification Intermediates Drug Substance Drug Product Drug Substance Purification Flexel for LevMixer with ph sensor and Thermowell Flexel for LevMixer with Thermowell Top lines ph adjustment lines with CPC Quick coupler or when using drain valves on the bottom lines: top addition lines with CPC Quick coupler and or sampling line with clave needleless Single-Use Sensors for in line measurement ph sensor Thermowell for temperature measurement Bottom Port Drain valve (2 lines possible) UPS 4 ports allowing 4 lines Large 8 diameter Top Port Closed Top Port for sterile or low bioburden application Mixing Technology LevMixer Bottom Lines Filling line with Tri-Clamp connector Draining line with Tri-Clamp connector Addition lines with CPC Quick coupler Sampling line with clave needleless Flexel for LevMixer with ph Sensor and Thermowell Bag Volume Part Number Units per box 50 L FMB ½ ID Silicone 100 L FMB l FMB L FMB l FMB L FMB l FMB L FMB l FMB L FMB l FMB Drain Valves Inlet Outlet Sampling Addition ph Adjustment TuFlux 1.5 m (60 ) + ½ ID Silicone TuFlux 1.5 m (60 ) + Clave needleless When a drain valve is used: 1 top line: a ID Silicone TuFlux 0.15 m (6 ) + MPC female + sealing cap When no drain valve is used: 1 bottom line: a ID Silicone TuFlux 1.5 m (60 ) + MPC female + sealing cap 2 top lines: MPC female + sealing cap

27 27 Drug Substance Purification Intermediates Drug Substance Drug Product Drug Substance Purification Flexel for LevMixer with ph sensor and Thermowell Flexel for LevMixer with Thermowell Single-Use Sensors for in line measurement Thermowell for temperature measurement Large 8 diameter Top Port Closed Top Port for sterile or low bioburden application Mixing Technology LevMixer Bottom Port UPS 4 ports allowing 4 bottom lines Bottom Lines Filling line with Opta SFT female Draining line with Tri-Clamp connector Addition lines with CPC Quick Sampling line with clave needleless Flexel for LevMixer with Thermowell Bag Volume Part Number Units per box 50 L FMB NA ½ ID Silicone 100 L FMB L FMB L FMB L FMB L FMB Drain Valves Inlet Outlet Sampling Addition ph Adjustment TuFlux 1 m (40 ) + ½ ID Clear C-Flex 0.5 m (20 ) + ½ Opta SFT female ½ ID Silicone TuFlux 1 m (40 ) + ½ ID Clear C-Flex 0.5 m (20 ) + Clave needleless 1 bottom line: a ID Silicone TuFlux 1.5 m (60 ) + MPC female + sealing cap NA

28 28 Drug Product Formulation Intermediates Drug Substance Drug Product Drug Product Formulation Universal ph sensor & Thermowell Silicone TuFlux tubing TPE C-Flex tubing PDS are designed for safe and reliable drug product formulation. They feature the Flexel for LevMixer low shear homogenization and integrated single-use ph sensor and thermowell for in-line monitoring and control. The drug product formulation involves a mixing step where the product is formulated before final filtration, fill and finish in its final container. During this step, the drug substance is mixed with other buffers and excipents to obtain the final drug product concentration and composition. ph is monitored and or adjusted in-line and samples are taken off-line for other QC tests such as product quality attributes and bioburden prior to sterile filtration. Flexel for LevMixer PDS for final formulation are available in: version using single-use and integrated sensors for in-line ph and temperature monitoring and adjustment required for your cgmp biomanufacture Universal version where sterile samples are taken for off-line controls PDS are designed for either sterile or aseptic connections and sterile disconnections. The Opta SFT connector or the BioWelder TC are used for respectively sterile connection or sterile weld. Tri-Clamp or quick coupler connectors are used for aseptic connections under ISO laminar air flow. Sterile disconnection is done using the BioSealer. PDS for final formulation are designed with: Bottom lines with a combined Silicone TuFlux + C-Flex tubing ended by an Opta SFT connector to allow pumping and sterile weld and or seal Integrated single-use ph sensor and thermowell for in-line monitoring and control Top lines with silicone TuFlux tubing and Opta SFT connector for sterile ph adjustment Bottom line with silicone TuFlux tubing and clave needleless port for sterile sampling Bottom or top line with Silicone TuFlux tubing and Opta SFT connector for sterile liquid additions Fully closed 8 diameter top port for a safe mixing Universal PDS for final formulation are designed for: Aseptic operations under ISO laminar air flow: filling and draining lines with silicone TuFlux tubing and Tri-Clamp 1 ½ sanitary flange additions and ph adjustment lines with Silicone TuFlux tubing and quick coupler connector sampling line with TuFlux tubing and clave needleless port For sterile operations: filling and draining lines with a combined Silicone + C-Flex tubing ended by an Opta SFT connector or ended by a Tri-Clamp 1 ½ sanitary flange ph adjustement top lines with Silicone TuFlux tubing ended by Opta SFT connector sampling line with a clave needleless port liquid addition lines either with a combined Silicone + C-Flex tubing ended by a quick coupler connector or with Silicone TuFlux tubing ended by Opta SFT connector The large 8 diameter top port is either opened or fully closed for sterile mixing applications. Options with drain valves to avoid hold up volumes into the tubes are also available.

29 29 Drug Product Formulation Intermediates Drug Substance Drug Product Drug Product Formulation Universal ph sensor & Thermowell Silicone TuFlux tubing TPE C-Flex tubing Top lines ph adjustment lines with Opta SFT female or when using drain valves on the bottom lines: top addition lines with Opta SFT female and or sampling line with clave needleless Single-Use Sensors for in line measurement ph sensor Thermowell for temperature measurement Large 8 diameter Top Port Closed Top Port for sterile or low bioburden application Mixing Technology LevMixer Bottom Port Drain valve (2 lines possible) UPS 4 ports allowing 4 lines Bottom Lines Filling line with Opta SFT female Draining line with Opta SFT male Addition lines with Opta SFT female Sampling line with clave needleless Flexel for LevMixer with ph sensor & Thermowell Bag Volume Part Number Units per box 50 L FMB ½ ID Silicone 100 L FMB l FMB L FMB l FMB Drain Valves Inlet Outlet Sampling Addition ph Adjustment TuFlux 1 m (40 ) + ½ ID Clear C-Flex 0.5 m (20 ) + ½ Opta SFT female ½ ID Silicone TuFlux 1 m (40 ) + ½ ID Clear C-Flex 0.5 m (20 ) + ½ Opta SFT male Clave needleless When a drain valve is used: 1 top line: a ID Silicone TuFlux 0.15 m (6 ) + a Opta SFT female When no drain valve is used: 1 bottom line: a ID Silicone TuFlux 1.5 m (60 ) + a Opta SFT female 2 top lines: 4 Opta SFT female All information on patents can be found at Pall.com/patents.

30 30 Drug Product Formulation Intermediates Drug Substance Drug Product Top lines ph adjustment lines with CPC Quick coupler top addition lines with CPC Quick coupler Large 8 diameter Top Port Opened Top Port for powder transfer Drug Product Formulation Universal ph sensor & Thermowell Silicone TuFlux tubing TPE C-Flex tubing Mixing Technology LevMixer Bottom Port Drain valve (2 lines possible) Bottom Lines Filling line with Tri-Clamp connector Draining line with Tri-Clamp connector Sampling line with clave needleless Universal Flexel for LevMixer for Drug Product Formulation with Silicone TuFlux Tubing Bag Volume Part Number Units per box 50 L FMB l ½ ID Silicone TuFlux 100 L FMB L FMB Drain Valves Inlet Outlet Sampling Addition ph Adjustment 1.5 m (60 ) + ½ ID Silicone TuFlux 1.5 m (60 ) + Clave needleless 2 top lines: a ID Silicone TuFlux 0.15 m (6 ) + MPC female + sealing cap 2 top lines: MPC female + sealing cap All information on patents can be found at Pall.com/patents.

31 31 Drug Product Formulation Intermediates Drug Substance Drug Product Drug Product Formulation Universal ph sensor & Thermowell Silicone TuFlux tubing TPE C-Flex tubing Top lines ph adjustment lines with Opta SFT female or when using drain valves on the bottom lines: top addition lines with Opta SFT female Large 8 diameter Top Port Opened Top Port for powder transfer Closed Top Port for sterile or low bioburden application Mixing Technology LevMixer Bottom Port Drain valve (2 lines possible) UPS 4 ports allowing 4 bottom lines Bottom Lines Filling line with Tri-Clamp connector or Opta SFT female Draining line with Tri-Clamp connector or Opta SFT male Addition lines with CPC Quick coupler Sampling line with clave needleless Universal Flexel for LevMixer for Drug Product Formulation with TPE C-Flex tubing Bag Volume Part Number Units per box Aseptic connections under ISO laminar air flow 50 L FXB NA ½ ID Silicone (Dow 100 L FXB L FXB Drain Valves Inlet Outlet Sampling Addition ph Adjustment Corning ) 1 m (40 ) + ½ ID Clear C-Flex 0.5 m (20 ) + ½ ID Silicone (Dow Corning ) 1 m (40 ) + ½ ID Clear C-Flex 0.5 m (20 ) + (Dow Corning ) 0.15 m (6 ) + 8 ID Clear C-Flex 0.5 m (20 ) + 1 bottom line: ½ ID Silicone (Dow Corning ) 1 m (40 ) +½ ID Clear C-Flex 0.5 m (20 ) + MPX male + sealing cap NA Sterile connections 50 L FMB l ½ ID Silicone 100 L FMB L FMB TuFlux 1 m (40 ) + ½ ID Clear C-Flex 0.5 m (20 ) + ½ Opta SFT female ½ ID Silicone TuFlux 1 m (40 ) + ½ ID Clear C-Flex 0.5 m (20 ) + ½ Opta SFT male Clave needleless Clave needleless 2 top lines: a ID Silicone TuFlux 0.15 m (6 ) + a Opta SFT female 2 top lines: TuFlux 0.1 m (4 ) + 4 Opta SFT female All information on patents can be found at Pall.com/patents. Dow Corning Pharma-50 is a registered trademark of Dow Corning.

32 32 Flexel Mixer Pre-designed Solutions Standard Hardware for Mixing: The Perfect Fit Powder Transfer Bag System 15 L & 30 L powder bags for easy contained powder addition. LevMixer Drive Unit l Contact-free impeller l RPM l Impeller speed reading l Remote control l Recipe Management Palletank for Mixing Palletank for Mixing from 50 L to 3,000 L available with both heat exchange-jacket and integrated weighing functions. Weighing functions Heat exchange jacket Palletank for Large Volume Mixing (up to 3,000 L): Utilizing the wellproven design of Palletank for storage geometry to minimize footprint while providing the vortex required for rapid powder dissolution. Opened Top Port for powder transfer Palletank for Mixing from 50 L to 1,000 L: Cubical shape of Palletank for Mixing with side windows enables the user to visually inspect the mixing process. Draining System from 50 L to 3,000 L to ensure complete drainage without bag manipulation by the user. Closed Top port for sterile application Mobile drive unit: One drive unit can serve multiple mixing tanks of different volumes. Magnetic Mixer Drive Unit l Strong Magnetic coupling l RPM l High Torque l No shaft through l No dynamic seal Side windows Draining System from 50 L to 3,000 L

33 33 Hardware Standard Palletank for Magnetic Mixer LevMixer Palletank for Magnetic Mixer LevMixer w o Weighing w o Jacket Jacketed Weighing Jacketed & Weighing Palletank without Weighing and without Jacket Description Technical Specifications Main construction materials 304 L Stainless Steel Windows made of PC and EPDM sealing (50 L to 1,000 L) Surface finish Glass bead blasted and passivated Door 50 L to 1,000 L Front hinged door and PC windows 1,500 L and 2,000 L Front and lateral hinged doors. Port Railed port for drive unit coupling Bag tubing gate Front bottom port for bag lines sensor access Mobility 50 L to 1,000 L Mounted on stainless cart with four clean room wheels and push handles Volumes 50 L, 100 L, 200 L, 400 L, 650 L, 1,000 L, 1,500 L and 2,000 L Minimum door height 1,500 L and 2,000 L 1,550 mm (61 in) Minimum ceiling height 1,500 L 2,800 mm (110 in) 2,000 L 3,300 mm (130 in) Volume Dimensions (approx.) W D H Weight Part Number 50 L mm ( in) 42 kg (93 lb) FXC L ,090 mm ( in) 53 kg (117 lb) FXC L ,190 mm ( in) 68 kg (150 lb) FXC L ,342 mm ( in) 99 kg (218 lb) FXC L 1, ,452 mm ( in) 126 kg (278 lb) FXC ,000 L 1,301 1,113 1,652 mm ( in) 210 kg (463 lb) FXC ,500 L 1,340 1,125 2,240 mm ( in) 380 kg (836 lb) FXC ,000 L 1,340 1,135 2,740 mm ( in) 453 kg (996 lb) FXC117340

34 34 Hardware Standard Palletank for Magnetic Mixer LevMixer Palletank for Magnetic Mixer LevMixer w o Weighing w o Jacket Jacketed Weighing Jacketed & Weighing Palletank Jacketed Description Technical Specifications PED version (for Europe, Asia and NEMEA) ASME version (for North America and Canada) Main construction materials 304L Stainless Steel Perlit balls (Insulation) 304L Stainless Steel Foamglass and ceramic fiber Surface finish Glass bead blasted and passivated Door Front insulated hinged doors (except 50 L and 100 L, no door) Lateral insulated hinged doors for 1,500 L and 2,000 L Port Railed port for drive unit coupling Bag lines sensor gate PTFE front bottom gate UHMW front bottom gate Mobility (50 L to 1,000 L) Mounted on stainless cart with four clean room wheels and push handles Operating temperature 0 50 C ( F) Working pressure 1 to 6 bars ( 14 to 87 psi) 10 bars (150 psi) Test pressure 9 bars (131 psi) 13 bars (196 psi) Compliance PED Compliant Heat exchanger: ASME certified and stamped per Section 8, division 1 Piping to from heat exchanger: Designed and built under the ASME code for pressure piping, B31 Insulated On all sides, the bottom and the lid Jacketed 4 sides and bottom (50 L and 100 L) 3 sides and bottom (200 L to 1000 L) 3 sides and bottom for 1500 L base, module and top module insulated only Inlet Outlet of heat transfer fluid Manual ¾ Ball valve and ¾ Tri-clamp connection Male NPT connection

35 35 Hardware Standard Palletank for Magnetic Mixer LevMixer Palletank for Magnetic Mixer LevMixer w o Weighing w o Jacket Jacketed Weighing Jacketed & Weighing Palletank Jacketed Volumes Technical Specifications PED version (for Europe, Asia and NEMEA) Dimensions (approx.) W D H 50 L ,096 mm ( in) 100 L ,201 mm ( in) 200 L ,301 mm ( in) 400 L 1,098 1,153 1,451 mm ( in) 650 L 1,235 1,287 1,561 mm ( in) 1,000 L 1,337 1,374 1,761 mm ( in) 1,500 L 1,500 1,650 2,400 mm ( in) 2,000 L 1,500 1,650 2,900 mm ( in) * 17 L for ASME Weight Part Number Dimensions (approx.) W D H ASME version (for North America and Canada) 115 kg (254 lb) FXC ,070 mm (30 ½ in) 142 kg (313 lb) FXC ,175 mm (32 i ¼ in) 210 kg (463 lb) FXC ,271 mm (35 ½ 35 b 50 1 / 16 in) 305 kg (673 lb) FXC ,091 1,078 1,368 mm (42 42 e 53 c ) 386 kg (851 lb) FXC ,207 1,212 1,478 mm (47 ½ 47 ¾ 58 i ) 496 kg (1,094 lb) FXC ,337 1,433 1,750 mm ( a 68 c in) 680 kg (1,500 lb) FXC ,500 1,650 2,415 mm ( in) 895 kg (1,970 lb) FXC ,500 1,650 2,895 mm ( in) Weight Part Number Heat transfer fluid volume in the jacket (approx.) 144 kg (317 lb) FXC L 191 kg (422 lb) FXC L 254 kg (560 lb) FXC L 336 kg (740 lb) FXC L 437 kg (964 lb) FXC L 601 kg (1,326 lb) FXC L* 680 kg (1,500 lb) FXC L* 895 kg (1,970 lb) FXC L

36 36 Hardware Standard Palletank for Magnetic Mixer LevMixer Palletank for Magnetic Mixer LevMixer w o Weighing w o Jacket Jacketed Weighing Jacketed & Weighing Palletank with Weighing Description Technical Specifications Integrated Combics 1 CAIS1 Scale Indicator Material of construction Stainless Steel Max. readability digits IP protection rate IP69K Operating temperature range 10 C to 40 C (14 F to 104 F) Integrated Loadcells PR 6211 IP protection rate IP68 (depth of 1.5 m for 10,000 hrs.), IP69K Overload High overload protection Material Stainless steel Vibration resistance Acc. to IEC Fc; 20 g, 100 h, Hz Design Low installation height Lift-off Integrated lift-off protection Volumes Max net weighing Resolution in g Accuracy in g capacity in kg 50 L L L L L ,000 L 1, ,000 1,500 L 2, ,000 2,000 L 2,400 1,000 2,000 Dimensions (approx.) Volumes W D H Weight Part Number Palletank with Weighing (No Jacket) 50 L mm ( in) 55 kg (121 lb) FXC L ,090 mm ( in) 63 kg (139 lb) FXC L ,190 mm ( in) 80 kg (176 lb) FXC L ,342 mm ( in) 110 kg (242 lb) FXC L 1, ,452 mm ( in) 135 kg (298 lb) FXC ,000 L 1,301 1,113 1,652 mm ( in) 220 kg (485 lb) FXC ,500 L 1,340 1,125 2,240 mm ( in) 510 kg (1,125 lb) FXC ,000 L 1,340 1,125 2,740 mm ( in) 590 kg (1,300 lb) FXC122375

37 37 Hardware Standard Palletank for Magnetic Mixer LevMixer Palletank for Magnetic Mixer LevMixer w o Weighing w o Jacket Jacketed Weighing Jacketed & Weighing Palletank with Jacket and Weighing Same specifications apply for the Weighing like page 36 and for the Jacket like pages 34 and 35. Dimensions (approx.) Volumes W D H Weight Part Number Palletank Jacketed and Weighing PED version 50 L 1, ,100 mm ( in) 142 kg (313 lb) FXC L 1, ,200 mm ( in) 180 kg (397 lb) FXC L 1, ,300 mm ( in) 240 kg (529 lb) FXC L 1,490 1,050 1,450 mm ( in) 395 kg (871 lb) FXC L 1,600 1,260 1,560 mm ( in) 495 kg (1,091 lb) FXC ,000 L 1,745 1,370 1,760 mm ( in) 633 kg (1,396 lb) FXC ,500 L 1,500 1,650 2,400 mm ( in) 496 kg (1,094 lb) FXC ,000 L 1,500 1,650 2,900 mm ( in) 680 kg (1,500 lb) FXC Dimensions (approx.) Volumes W D H Weight Part Number Palletank Jacketed and Weighing ASME version 50 L 1, ,100 mm ( in) 160 kg (354 lb) FXC L 1, ,200 mm ( in) 225 kg (497 lb) FXC L 1, ,300 mm ( in) 335 kg (740 lb) FXC L 1,490 1,050 1,450 mm ( in) 430 kg (950 lb) FXC L 1,600 1,260 1,560 mm ( in) 530 kg (1,171 lb) FXC ,000 L 1,745 1,370 1,760 mm ( in) 700 kg (1,547 lb) FXC ,500 L 1,500 1,650 2,400 mm ( in) 780 kg (1,719 lb) FXC ,000 L 1,500 1,650 2,900 mm ( in) 895 kg (1,973 lb) FXC122361

38 38 Hardware Magnetic Mixer Drive Unit Magnetic Mixer Drive Unit Drive Units Magnetic Mixer LevMixer Description Power EU USA Japan Input Wattage Footprint Drive Unit height to top of handle Weight 25 kg (55 lb) Ambient Temperature 4 to 30 C Max. Humidity Technical Specifications Single Phase 230 V, Hz Single Phase 110 V, 60 Hz Single Phase 230 V, Transformer (110 V Input), Hz < 150 Watts cm (33 in 16 in) 104 cm (41 in) 85 % (non-condensing), * avoid condensation, * for indoor use Mobility Mounted on stainless cart with four clean room wheels and push handle IP rating NEMA 4X, IP 65 Impeller speed RPM Initial set-up time Not applicable Vessel changeover < 5 Minutes CE mark Compliant Material for external surfaces Stainless Steel #316L Noise Level 57.1 dba Part Number LT-DU-005-US LT-DU-006-EU LT-DU006-UK LT-DU006-SW LT-DU006-AU LT-DU006-JA Description Magnetic Mixer Drive Unit, 110 V, US Power Cord Magnetic Mixer Drive Unit, 230 V, EU Power Cord Magnetic Mixer Drive Unit, 230 V, UK Power Cord Magnetic Mixer Drive Unit, 230 V, Swiss Power Cord Magnetic Mixer Drive Unit, 230 V, Australian Power Cord Magnetic Mixer Drive Unit, 230 V, Japanese Power Cord and Transformer

39 39 Hardware LevMixer Drive Unit LevMixer Drive Unit Drive Units Part Number LT-DBTL300 LT-SVSP402 LT-SVSP403 Magnetic Mixer LevMixer Description Superconducting drive machine on cart with universal latch for 8, 15 and 23 ports. Control panel ( V) and lifting mechanism on handle and welded body. 304 L Stainless Steel with 35 μin. Ra 0.89 μm Ra surface finish. Includes tool box with accessories. Remote control cable Analog I O Cable, 6 m (20 ft.) Remote control cable Digital I O Cable, 6 m (20 ft.) Description Footprint in mm (inches) W L H Weight Control box, cart & mixer enclosure material Control box, cart & mixer enclosure surface finish Control box ingress rating IP 65 Enclosure ingress rating IP 23 Voltage Input Wattage Amperage Technical Specifications Collapsed configuration: 407 1, mm ( in.) Expanded configuration: 407 1, mm ( in.) 123 lbs (56 kg) 304 L Stainless Steel At least 35 µin. Ra 0.89 µm Ra VAC, Hz Less than 350 W Voltage fluctuation +/ 10% Altitude rating Max humidity Ambient temperature 4 40 C Motor horsepower Power cord length E-stop (present, yes no, location) Min and Max impeller speed Connections for remote output control Functions available from remote control panel Signal type(s) for remote output control Mixer charge time Operator interface type Method for RPM measurement Noise level at operator position Mobility Wheel material Recipe storage Password protection CE Mark UL 100 V 3.0 A; 110 V 2.5 A; 230 V 1.5 A 1,000 m (3,280 ft) 85%, avoid condensation 1/8hp 6 m (20 ft) Yes, face of control box 20 to 210 RPM TURCK RSFPV61, RSFPV579 Motor start, stop Speed adjustment, indication Alarm indication Mode of control (remote local) indication Impeller speed out 4 20 ma, motor control in 0 10 VDC, discrete I O signals relay contact type 35 minutes Touchscreen PLC Direct measurement of impeller speed via non-contact magnetic sensor 67 db Mounted on stainless cart with four clean room wheels and push Handles 2X swivel (front), 2X stationary (rear) Polyurethane Up to 10 recipes can be stored Operator, Supervisor, Maintenance levels Compliant Compliant

40 40 Hardware Accessories Draining System Accessories Draining System Powder Transfer System Description Main construction materials Surface finish Volumes Activation of the lifting device Technical Specifications 304L Stainless Steel EPDM PVC Glass bead blasted and passivated 50 L, 100 L, 200 L, 400 L, 650 L and 1,000 L < 15 kg (max allowed weight) Volumes Dimensions Slope board (approx.) Part Number 50 L mm ( in) FXA L mm ( in) FXA L mm ( in) FXA L mm ( in) FXA L mm ( in) FXA ,000 L 1,045 1, mm ( in) FXA ,500 L 3,000 L Lifting System upgrade draining kit for Palletank 1,500 L to 3,000 L FXA122382

41 41 Hardware Accessories Powder Bag Holders Accessories Draining System Powder Transfer System Two vertical positions for 15 L and 30 L Powder Transfer Bags Description Powder holder accessory for Palletank LevMixer Magnetic Mixer L Powder holder accessory for Palletank LevMixer Magnetic Mixer L Powder holder accessory for Palletank LevMixer Magnetic Mixer 1000 L Construction Material 304L Stainless Steel and Nylon Surface Finishing Glass Bead Blasted Weight (approx.) 8 kg 9 kg 9 kg 9 kg Overall dimensions (approx.) W D H Height above Palletank with 15 L Powder Transfer Bag with 30 L Powder Transfer Bag Additional features ,080 mm in. 726 mm 28.6 in. 986 mm 38.8 in ,080 mm in. Two vertical positions for 15 L and 30 L Powder Transfer Bags. Rotary powder holder for easy access to the hook ,080 mm in. Powder holder accessory for Palletank LevMixer Magnetic Mixer 1500 L 3000 L ,080 mm in. Part Number FXA FXA FXA FXA FXA FXA FXA FXA FXA Description STD Palletank Cubical Accessory Powder Holder 50 L 100 L Only non-jacketed STD Palletank Cubical Accessory Powder Holder 200 L 400 L 650 L Only non-jacketed STD Palletank Cubical Accessory Powder Holder 1,000 L Only non-jacketed STD Palletank Cubical Accessory Powder Holder with winch 1,500 L Suitable for Jacketed and non Jacketed STD Palletank Cubical Accessory Powder Holder with winch 2,000 L Suitable for Jacketed and non Jacketed STD Palletank Cubical Jacketed-Mix Accessory Powder Holder 50 L 100 L only jacketed STD Palletank Cubical Jacketed-Mix Accessory Powder Holder 200 L 400 L 650 L only jacketed STD Palletank Cubical Jacketed-Mix Accessory Powder Holder 1,000 L only jacketed STD Palletank accessory hook for powder bag holder upgrade

42 42 Hardware Accessories Powder Transfer Bags Accessories Draining System Powder Transfer System Description Bag Chamber Fittings Accessory Volumes Number of Port Irradiation Technical Specifications Multiple layer film construction, including Permanently Static Dissipative (PSD) LDPE contact layer 4-inch triclamp Pinch clamp 15 L and 30 L 1 port kgy Triclamp Reducer Description Triclamp Reducer Material of Construction Sterility Technical Specifications 8-inch to 4-inch triclamp reducer with a 4-inch triclamp plug, 4-inch triclamp gasket and 4-inch triclamp union Reducer: polyethylene, Plug: polyethylene, Gasket: platinum cured silicone, 4-inch triclamp union: glass reinforced polyamide Non sterile Cap Gasket Union Description Cap Gasket Union Material of Construction Sterility Technical Specifications 4-inch triclamp plug, 4-inch triclamp gasket, 4-inch triclamp union Plug: polyethylene, Gasket: platinum cured silicone, 4-inch triclamp union: glass reinforced polyamide Non sterile Part Number Description Bag Port 1 Qty. Box FMA STD Powder Bag 15 L (PWD Port) with pinch clamp 4-inch triclamp 5 FMA STD Powder Bag 30 L (PWD Port)with pinch clamp 4-inch triclamp 5 FMA inch to 4-inch triclamp reducer NA 1 FMA Component Plug Gasket Union for TC4 NA 5