AllegroTM Single-Use Mixers

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Eleanor Martin
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US2745c llegrotm Single-Use Mixers igh performance, easy-to-use mixers for manual to fully automated solution preparation Mixing is a critical operation within biopharmaceutical processes for many

The llegro single-use mixers are part of Pall s expanding range of llegro products and services providing integrated process solutions throughout the drug production process.

1 US2745c llegrotm Single-Use Mixers igh performance, easy-to-use mixers for manual to fully automated solution preparation Mixing is a critical operation within biopharmaceutical processes for many applications, ranging from buffer and media preparation, in-process unit operations such as low p viral inactivation, to final formulation. The llegro single-use mixers are part of Pall s expanding range of llegro products and services providing integrated process solutions throughout the drug production process. The llegro mixers combine critical requirements for single-use technologies, such as extreme ease-of-use, with established engineering principles and criteria for robust mixer design to deliver the ultimate in mixing performance. The llegro mixers are available in 200 L, 500 L and 1000 L sizes, in both standard and jacketed stainless steel tote formats, and can incorporate sensors (e.g. p, conductivity and temperature) for on-line monitoring and control. Sensor signals can be handled locally on the mixer, or alternatively, can be fed directly to an existing istributed ontrol System (S) or to an utomated Pall MVP singleuse system. With the added capability of load cell integration, the llegro mixers from Pall can be fully integrated to the llegro MVP automated single-use systems, providing complete automated process monitoring and control solutions for all applications that require mixing (e.g p adjustment for buffers and virus inactivation).

pplications The llegro mixers are designed to provide exceptional mixing performance for a wide range of applications from upstream through the downstream process to formulation and filling.

virus inactivation and buffer preparation } Final formulation mixing n addition to the mixers, Pall also offers a wide range of complimentary technologies within the llegro single-use platform (such

filling. The llegro mixers can be combined with the Pall MVP system to fully automate mixing and filtration processes, including fluid transfer to and from the mixers.

where biologicals sensitive to shear are being mixed.

blade impeller fficient, low shear general purpose mixing over a wide range of applications and shear sensitive soluitons mpeller rotation in clockwise or counter-clockwise direction nflation of the

2 pplications The llegro mixers are designed to provide exceptional mixing performance for a wide range of applications from upstream through the downstream process to formulation and filling. With jacketed and standard totes that can integrate on-line sensor technologies and load cells, potential applications include: } Upstream media preparation for cell culture } ownstream p adjustment, virus inactivation and buffer preparation } Final formulation mixing n addition to the mixers, Pall also offers a wide range of complimentary technologies within the llegro single-use platform (such as filters incorporating state-of-the-art membranes and sterile connection and disconnection devices) providing fully validated, integrated processing solutions from upstream to final formulation and filling. The llegro mixers can be combined with the Pall MVP system to fully automate mixing and filtration processes, including fluid transfer to and from the mixers. The high performance mixer lends itself especially well to difficult mixing applications (mixing dense powders or high viscosities), applications requiring repeatable, fast mixing performance, or where biologicals sensitive to shear are being mixed. Product s and enefits esign principles based on existing llegro 3 tote format for ease-of-use enefit Very easy and quick to install and remove the single-use systems pre and post-use enefit 4 pitch blade impeller fficient, low shear general purpose mixing over a wide range of applications and shear sensitive soluitons mpeller rotation in clockwise or counter-clockwise direction nflation of the mixer bag enefit Provides mixing envelope for consistent performance from L and the ability to have a gas blanket in operation and mix a range of volumes Flexibility to perform both up-flow and down-flow for floating (low density) and settling (high density) fluid or solids Mixer Size 200 L 500 L 1000 L own-flow (anticlockwise rotation) 4-Pitch lade Turbine mpeller Minimum Volume (L)* Maximum Volume (L) * minimum volume also covers on-line sensors 2

enefit enefit acketed Totes Temperature control in

monitoring and control through integration with automated

with high clarity and ultra-low extractables

biocontainer based systems Optional baffles available To

3 enefit enefit acketed Totes Temperature control in appropriate applications Sensor integration llows in-process monitoring and control through integration with automated llegro MVP systems enefit enefit Uses existing llegro film with high clarity and ultra-low extractables Material/validation consistency across all llegro biocontainer based systems Optional baffles available To assist in reducing air entrapment at high rotation speed for sensitive molecules affles 3

Single-Use Mixer esign The llegro single-use mixer design is based on proven engineering principles used to develop efficient and appropriate mixing in a wide range of biopharmaceutical applications.

llegro Mixer iocontainer mpeller over & Powder Port cid/ase ddition Ports nlet Port Plate 4 Pitch lade Turbine mpeller Sensor Port Outlet Port Full ccess oors Powder nlet Gas nlet Gas Return Main

igh Performance Mixing The llegro mixers have been tested on a wide range of applications representing a broad range of biopharmaceutical operations where mixing is required.

4 Single-Use Mixer esign The llegro single-use mixer design is based on proven engineering principles used to develop efficient and appropriate mixing in a wide range of biopharmaceutical applications. spects of power input, impeller geometry and position, flow characteristics, flow pattern, pumping and shear were all considered as part of the design process. llegro Mixer iocontainer mpeller over & Powder Port cid/ase ddition Ports nlet Port Plate 4 Pitch lade Turbine mpeller Sensor Port Outlet Port Full ccess oors Powder nlet Gas nlet Gas Return Main Fluid nlet Sample Port User ontrol nterface (U) p target of 8.40 to an accuracy of ± 0.06 p units achieved after 36.5 doses in <12 minutes. igh Performance Mixing The llegro mixers have been tested on a wide range of applications representing a broad range of biopharmaceutical operations where mixing is required. The pplications Summary Table summarizes the applications tested and the mixing performance achieved. llegro single-use mixers have been tested to demonstrate capability to mix a wide variety of liquid-liquid, solid-liquid, and high viscosity solutions. For further details on mixing performance, please refer to the pplication note, document reference: US2744. Quality Standards and Validation The llegro single-use mixer biocontainers are 100% leak tested at manufacture. ll llegro biocontainers, including the mixer, are manufactured in a controlled environment (lass 10,000) certified to SO and SO9001. The materials of construction of the llegro mixer biocontainer meet: } USP<88> iological reactivity test n Vivo for lass V - 50 Plastics } USP<87> iological Reactivity Tests n Vitro, ytotoxicity } SO iological valuation of Medical evices } USP<661> Physico-chemical testing for plastics } uropean Pharmacopeia (section 3.1.5) } apanese Pharmacopeia (section 61 Part 1) Mixer iocontainer Motor and Gear ox The mixer totes are manufactured under a Quality Management System ertified to SO 9001 and SO and is in conformity with the requirements of the uropean irective 2004/108/ (lectromagnetic ompatibility) and uropean irective 2006/95/ (Low Voltage Safety). 4

5 pplication Summary Type of Mixing Solution 200 L 500 L (150 rpm) 1000 L (150rpm) Solid Liquid llura Red ye (.05 g/l) 5 seconds (75 rpm) 2 min 5 min MM Media (5.36 g/l) < 7 min (150 rpm) 6 min 11 min PS uffer (9.6 g/l) < 5 min (150 rpm) 4 min 7 min Nal (1 M) (58.44 g/l) < 1 min (150 rpm) 7 min 12 min Liquid Liquid Nal (200 g/l à 10 g/l) < 1 min 4 min 6 min Product Validation s part of our rigorous approach to product validation, Pall has conducted a wide range of tests in addition to the general performance tests to prove the robustness of the llegro mixer. summary of key validation tests are summarized below: } iological safety (USP<87> and <88>) } Physico-chemical tests (USP<661>) } Particulate matter in njections (USP <788>) } USP<85> LL ndotoxin (compared to limit for WF) } xtractables testing (Water and ethanol) } Gamma resistance (Maximum 50 kgy) } Leak tests } rainage/product recovery } Tubing connection robustness Technical Specifications Mixer Tote Part Number Standard Mixer LGRMXTT200L230 LGRMXTT200L120 acketed Mixer LGRMXTT200L230 LGRMXTT200L120 Mixing volume Max (L) Voltage (Vac) urrent () Frequency (z) Motor power (kw) 0.37 mpeller range (rpm) Mixing volume - overing impeller (L) Mixing volume - overing sensors/sample port (L) Gas supply (barg/psig) 4-6 / Gas connections SUPPLY & NT VNT: 10 mm Pneumatic tubing outside diameter G VNT: 12 mm Pneumatic tubing outside diameter Weight - empty (kg) Weight - full (kg) Footprint* (L x W) (mm) 785 x x 615 eight (mm) Materials of onstruction Standard Mixer acketed Mixer 5

6 Mixer Tote Part Number Mixer tote Mixer biocontainer (original) Mixer biocontainer (sensor biocontainer) LGRMXTT200L230 LGRMXTT200L SS LGRMXTT200L230 LGRMXTT200L120 iocontainer film; outlet port; inlet manifold & top hat: Low ensity Polyethylene (LP); mpeller: Polysulfone (PS); Flush outlet port valve (½ in.): Polysulfone (PS); Shaft: Stainless Steel SS; O-rings: Silicone; Mechanical seals: Low ensity Polyethylene (LP) iocontainer film; inlet ports; top hat; hose barb outlet port: Low ensity Polyethylene (LP); mpeller: Polysulfone (PS); Shaft: Stainless Steel SS; O-ring: Silicone; Mechanical seals: Low ensity Polyethylene (LP) *Leg centre distances Mixer Tote Part Number Standard Mixer LGRMXTT500L230 LGRMXTT500L120 acketed Mixer LGRMXTT500L230 LGRMXTT500L120 Mixing volume Max (L) Voltage (Vac) urrent () Frequency (z) Motor power (kw) 0.37 mpeller range (rpm) Mixing volume - overing impeller (L) Mixing volume - overing sensors/sample port (L) Gas supply (barg/psig) 4-6 / Gas connections SUPPLY & NT VNT: 10 mm Pneumatic tubing outside diameter G VNT: 12 mm Pneumatic tubing outside diameter Weight - empty (kg) Weight - full (kg) Footprint* (L x W) (mm) 1170 x x 815 eight (mm) Materials of onstruction Mixer tote Mixer biocontainer (sensor biocontainer) 304 SS iocontainer film; inlet ports; top hat; hose barb outlet port: Low ensity Polyethylene (LP); mpeller: Polysulfone (PS); Shaft: Stainless Steel SS; O-ring: Silicone; Mechanical seals: Low ensity Polyethylene (LP) *Leg centre distances 6

7 Mixer Tote Part Number Standard Mixer LGRMXTT1000L230 LGRMXTT1000L120 acketed Mixer LGRMXTT200L230 LGRMXTT200L120 Mixing volume Max (L) Voltage (Vac) urrent () Frequency (z) Motor power (kw) 0.37 mpeller range (rpm) Mixing volume - overing impeller (L) Mixing volume - overing sensors/sample port (L) Gas supply (barg/psig) 4-6 / Gas connections SUPPLY & NT VNT: 10 mm Pneumatic tubing outside diameter G VNT: 12 mm Pneumatic tubing outside diameter Weight - empty (kg) Weight - full (kg) Footprint* (L x W) (mm) 1360 x x 1084 eight (mm) Materials of onstruction Mixer tote Mixer biocontainer (sensor biocontainer) 304 SS iocontainer film; inlet ports; top hat; hose barb outlet port: Low ensity Polyethylene (LP); mpeller: Polysulfone (PS); Shaft: Stainless Steel SS; O-ring: Silicone; Mechanical seals: Low ensity Polyethylene (LP) *Leg centre distances 7

8 eat xchange rea stimation for acketed Mixer Totes: Mixer apacity (L) ssumed Minimum Working Volume (L) rea vailable for eat Min. Working Volume (m 2 ) alculated Maximum Working Volume (L) llegro Mixer Standard Single-Use Systems Ordering nformation Scale Part Number escription 200 L LGRMXTT200L230 Standard Mixer Tote 230 Volts 200 L LGRMXTT200L230 acketed Mixer Tote 230 Volts 200 L LGRMXTT200L120 Standard Mixer Tote 120 Volts 200 L LGRMXTT200L120 acketed Mixer Tote 120 Volts rea vailable for eat Max. Working Volume (m 2 ) 200 L LGRMX Standard Mixer Tote 230 Volts + Mettler Toledo (p &/or ond) Transmitter 200 Lt LGRMX acketed Mixer Tote 230 Volts + Mettler Toledo (p &/or ond) Transmitter 200 L LGRMX Standard Mixer Tote 120 Volts + Mettler Toledo (p &/or ond) Transmitter 200 L LGRMX acketed Mixer Tote 120 Volts + Mettler Toledo (p &/or ond) Transmitter 200 L LGRMX acketed Mixer Tote 230 Volts + Status Temp Transmitter & PT100 Sensor 200 L LGRMX acketed Mixer Tote 120 Volts + Status Temp Transmitter & PT100 Sensor 200 L LGRMXTT200L-FT FT for Mixer Tote 120 or 230 Volts 200 L LGRMXW200 Standard tote weighing platform 200 L LGRMXW200 acketed tote weighing platform 200 L LGRMX200LQOQ Q/OQ ocumentation for 200 L Mixer 500 L LGRMXTT500L230 Standard Mixer Tote 230 Volts 500 L LGRMXTT500L230 acketed Mixer Tote 230 Volts 500 L LGRMXTT500L120 Standard Mixer Tote 120 Volts 500 L LGRMXTT500L120 acketed Mixer Tote 120 Volts 500 L LGRMX Standard Mixer Tote 230 Volts + Mettler Toledo (p &/or ond) Transmitter 500 L LGRMX acketed Mixer Tote 230 Volts + Mettler Toledo (p &/or ond) Transmitter 500 L LGRMX Standard Mixer Tote 120 Volts + Mettler Toledo (p &/or ond) Transmitter 500 L LGRMX acketed Mixer Tote 120 Volts + Mettler Toledo (p &/or ond) Transmitter 500 L LGRMX acketed Mixer Tote 230 Volts + Status Temp Transmitter & PT100 Sensor 500 L LGRMX acketed Mixer Tote 120 Volts + Status Temp Transmitter & PT100 Sensor 500 L LGRMXTT500L-FT FT for Mixer Tote 120 or 230 Volts 500 L LGRMXW500 Standard tote weighing platform 500 L LGRMXW500 acketed tote weighing platform 500 L LGRMX500LQOQ Q/OQ ocumentation for 500 L Mixer 1000 L LGRMXTT1000L230 Standard Mixer Tote 230 Volts 1000 L LGRMXTT1000L230 acketed Mixer Tote 230 Volts 8

9 Scale Part Number escription 1000 L LGRMXTT1000L120 Standard Mixer Tote 120 Volts 1000 L LGRMXTT1000L120 acketed Mixer Tote 120 Volts 1000 L LGRMX Standard Mixer Tote 230 Volts + Mettler Toledo (p &/or ond) Transmitter 1000 L LGRMX acketed Mixer Tote 230 Volts + Mettler Toledo (p &/or ond) Transmitter 1000 L LGRMX Standard Mixer Tote 120 Volts + Mettler Toledo (p &/or ond) Transmitter 1000 L LGRMX acketed Mixer Tote 120 Volts + Mettler Toledo (p &/or ond) Transmitter 1000 L LGRMX acketed Mixer Tote 230 Volts + Status Temp Transmitter & PT100 Sensor 1000 L LGRMX acketed Mixer Tote 120 Volts + Status Temp Transmitter & PT100 Sensor 1000 L LGRMXTT1000L-FT FT for Mixer Tote 120 or 230 Volts 1000 L LGRMXW1000 Standard tote weighing platform 1000 L LGRMXW1000 acketed tote weighing platform 1000 L LGRMX1000LQOQ Q/OQ ocumentation for 1000 L Mixer Single-Use Mixer Systems The following irradiated system exists as off-the-shelf designs for different mixing applications. Further standard designs are available. ontact Pall for full details. Single-use mixer systems can also be designed according to specific application requirements. For a customized design, please contact your Pall representative with your specific application details. Mixer System esign Number Port L asic irradiated design for fluid and powder addition ¼ in. Thermo-elastomer tubing, welded end 3 in. lanked sanitary powder port ½ in. Thermo-elastomer tubing (0.2 m), female MPX and plug ½ in. Thermo-elastomer tubing (0.2 m), female MPX and plug 3 in. lanked sanitary powder port Top face Gas inflation port, ¼ in. (from U) Gas exhaust port, ½ in. (to U) Main fluid in port, ½ in. Powder addition port Flush outlet port, ½ in. (bottom face) 9

Mixer System esign Number Port F G 609-80L 200 L asic design allows for acid/base adjustment and sampling for off-line analytics/q (using customers own sensors) ¼ in.

10 Mixer System esign Number Port F G L 200 L asic design allows for acid/base adjustment and sampling for off-line analytics/q (using customers own sensors) ¼ in. Platinum cured silicone, plugged ½ in. Platinum cured silicone, plugged ¾ in. Platinum cured silicone with sanitary fittings ¼ in. Platinum cured silicone with swabable Luer fittings losed losed losed ¾ in. Platinum cured silicone with sanitary fittings ¼ in. Platinum cured silicone with MP male connector and cap ¼ in. Platinum cured silicone with MP male connector and cap 3 in. Powder port with gasket, blank and clamp Powder addition port Top face Gas inflation port, ¾ in. (from U) L L ¼ in. cid/base addition port ¼ in. cid/base addition port Outlet port, ¾ in. (bottom face) Gas exhaust port, ½ in. (to U) Main fluid in port, ¾ in. Front face G F G ½ in. sensor port F ¾ in. sensor port ¾ in. sensor port ¼ in. sample port Mixer System esign Number Port F G M 200 L esign allows for 1 non-sterile sensor attachment (p or onductivity). Sampling for off-line analytics/q and acid and base adjustment. ¼ in. Platinum cured silicone, plugged ½ in. Platinum cured silicone, plugged ¾ in. Platinum cured silicone with sanitary fittings ¼ in. Platinum cured silicone with swabable Luer fittings ¾ in. Platinum cured silicone with sensor screw fitting losed losed ¾ in. Platinum cured silicone with sanitary fittings ¼ in. Platinum cured silicone with MP male connector and cap ¼ in. Platinum cured silicone with MP male connector and cap 3 in. Powder port with gasket, blank and clamp 10

11 609-80M L G F Single-use mixer systems can also be designed according to specific application requirements. ppropriate filters (sterilizing grade/ bioburden/mycoplasma reduction) and leenpak sterile connectors for sterile fluid addition can be incorporated into system designs. For a customized design, please contact your Pall representative with your specific application details. Mixer System esign Number Port F G R 500 L; Q 1000 L asic esign: Sample line; cid/ase addition lines; Main fluid in/out with sanitary ports ¼ in. Platinum ured Silicone, Plugged ½ in. Platinum ured Silicone, Plugged 1 in. Platinum ured Silicone + Sanitary fittings ¼ in. Platinum ured Silicone + Swabable Luer Fittings ¾ in. losed ¾ in. losed ½ in. losed 1 in. Platinum ured Silicone + Sanitary fittings ¼ in. Platinum ured Silicone + MP Male onnector and ap ¼ in. Platinum ured Silicone + MP Male onnector and ap 3 in. Powder Port with Gasket, lank and lamp R L Q L G F 11

12 Mixer System esign Number Port F G P 500 L, Y 1000 L esign allows for 2 non-sterile sensor attachment (p and/or onductivity). Sampling for off-line analytics/q and acid and base adjustment ¼ in. Platinum ured Silicone, Plugged ½ in. Platinum ured Silicone, Plugged 1 in. Platinum ured Silicone + Sanitary fittings ¼ in. Platinum ured Silicone + Swabable Luer Fittings ¾ in. Platinum ured Silicone + Sensor Port/Plug (non-aseptic) ¾ in. Platinum ured Silicone + Sensor Port/Plug (non-aseptic) ½ in. losed 1 in. Platinum ured Silicone + Sanitary fittings ¼ in. Platinum ured Silicone + MP Male onnector and ap ¼ in. Platinum ured Silicone + MP Male onnector and ap 3 in. Powder Port with Gasket, lank and lamp P L Y L G F orporate eadquarters Port Washington, NY, US toll free (US) phone biopharm@pall.com uropean eadquarters Fribourg, Switzerland +41 (0) phone LifeSciences.U@pall.com sia-pacific eadquarters Singapore phone sgcustomerservice@pall.com Visit us on the Web at -mail us at allegro@pall.com nternational Offices Pall orporation has offices and plants throughout the world in locations such as: rgentina, ustralia, ustria, elgium, razil, anada, hina, France, Germany, ndia, ndonesia, reland, taly, apan, orea, Malaysia, Mexico, the Netherlands, New Zealand, Norway, Poland, Puerto Rico, Russia, Singapore, South frica, Spain, Sweden, Switzerland, Taiwan, Thailand, the United ingdom, the United States, and Venezuela. istributors in all major industrial areas of the world. To locate the Pall office or distributor nearest you, visit The information provided in this literature was reviewed for accuracy at the time of publication. Product data may be subject to change without notice. For current information consult your local Pall distributor or contact Pall directly. 2015, Pall orporation. Pall,, llegro and the llegro design are trademarks of Pall orporation. indicates a trademark registered in the US and TM indicates a common law trademark. Filtration.Separation.Solution.SM is a service mark of Pall orporation. -Flex is a trademark of Saint-Gobain Perfromance Plastics. 2/15, PF, GN US2745c

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