Standard Flexel for Magnetic Mixer 50 L to 2,000 L

1 Standard Flexel for Magnetic Mixer1 50 L to 2,000 L. Components 1. Palletank for Magnetic Mixer is a stainless steel container designed to perfectly fit with the Flexel Bag for Magnetic Mixer with its integrated impeller. It includes a railed port Fluid Management Systems for coupling the mobile Magnetic Mixer drive unit with the Palletank for Magnetic Mixer and a clamp holder to facilitate powder trans- fer. The hinged door allows easy installation of the bag system whereas the front bottom gate facilitates easy tubing and sensors access. From 50 L to 1,000 L: Cubical shape of Palletank for Magnetic Mixer with windows on lateral sides enable the user to visually inspect the mixing process. The cubical shape facilitates the installation and offers scalability from 50 L. to 1,000 L with improved mixing efficiency. The Palletank for Magnetic Mixer is also available Standard either with a heat Description Mixing performances have been proven exchange jacket and | or with integrated The Flexel for Magnetic Mixer is a single-use from 50 L to 2,000 L for buffer and media loadcells and weight indicator: mixing solution using the ATMI patented preparations in single-use Flexel Bag for The Palletank Jacketed for Magnetic Magnetic Mixer Technology, the Sartorius Magnetic Mixer (performance details Mixer is built according to ASME or PED.)

2 Stedim Biotech Flexel Bag for Magnetic available with application notes). directives. The heat exchange jacket Mixer and the proven Palletank technology. Note: Custom 2,500 L and 3,000 L volumes and insulation system allows for efficient can also be offered upon request chilling, heating, cold or warm storage The easy bag installation and handling paired of biopharmaceutical fluids. with the mixing efficiency make the Flexel The Palletank Weighing for Magnetic for Magnetic Mixer the single-use mixing Mixer is configured with built-in load cells system of choice for buffer, media linked to the weighing indicator for fast or feed formulation as well as for large and reliable volume measurement. The v olume mixing. CAIS1 Combics 1 indicator allows strain gauge weighing and provides an easy-to- read user interface. The Palletank Jacketed and Weighing for Magnetic Mixer combines both Palletank.

3 Jacketed and Palletank Weighing specifi- cations. 1 T his product uses ATMI patended Magnetic Mixer technology. SPT2023-e131205 |1. A draining system could also be installed into 2. Magnetic Mixer drive unit generates the Clean and Sterile Mixing Operation the Palletank for Magnetic Mixer to ensure rotation of the single-use Magnetic impeller Flexel for Magnetic Mixer is a compact and complete drainage of the Flexel Bags for coupled to a non-shedding ceramic bearing, non-invasive single-use mixing system with a Magnetic Mixer without bag manipulation by enabling Flexel for Magnetic Mixer to bottom-mounted magnetically-driven impel- the user. The draining system from 50 L to efficiently dissolve and disperse powders, ler capable of providing efficient high-torque 1,000 L is composed by a slope board, a lifting suspensions, solutions or mix emulsions. mixing for all powder-liquid and liquid-liquid device and a tubing positionner.

4 At the end of The interchangeable Magnetic Mixer drive mixing applications. The impeller rotates on a the draining, the lifting device is activated to unit is mobile, cart-mounted and designed low-friction, inert bearing assembly designed drive the liquid toward the bottom line and to interface with any of the Standard to allow high mixing efficiency from 50 L to recover more than of the initial volume. Palletank for Magnetic Mixer . 2,000 L while ensuring low particle shedding (USP <788> compliance after 8 hours of 1,500 L and 2,000 L: 3. Flexel Bag for Magnetic Mixer with rotation at 300 rpm in WFI). Large volume Palletank for Magnetic Mixer pre-assembled Magnetic impeller assembly: is inspired from the well-proven design of Palletank for storage with a geometry to F rom 50 L to 1,000 L: minimize footprint while providing the vor- Flexel Bag for Magnetic Mixer contains an tex required for rapid powder dissolution.

5 In center Magnetic impeller assembly. Its A stainless steel cross mounted on a pulley cubical design simplifies installation and system enables to unfold the Flexel Bag facilitates the unfolding and folding of the for Magnetic Mixer for an easy filling and bag during filling and draining operations. optimized draining. Large volume Palletank The patented protection cap provides for Magnetic Mixer are now available in robustness avoiding contact of the impeller Standard range with heat exchange jacket with the film during transport. It also offers and | or integrated weighing system. a large 8 diameter port for powder transfer. 1,500 L and 2,000 L Flexel Bag for Magnetic Mixer contains a slightly off-centered Magnetic impeller assembly integrated to the well-proven design of Flexel 3D Bag. Powder transfer is facilitated with the 4 . powder addition port that provides direct connection of 15 L or 30 L Powder Transfer Bag hanged on a Powder Bag Holder.

6 2| SPT2023-e131205. Features & Benefits 50 L to 2,000 L Flexel for Magnetic Mixing Complete volume range: Full scalability with proven performances 50 L, 100 L, 200 L, 400 L, 650 L, 1,000 L, 1,500 L, 2,000 L (application notes available on demand). (2,500 and 3,000 L available as custom products). Low-friction, inert bearing assembly Low particle shedding (USP <788> compliance after 8 hours of rotation in WFI). Strong Magnetic coupling High-torque, high rotation speed for rapid powders dissolution Face bottom port(s) Easy installation and access to tubing and sensors Standard designs of Flexel Bag for Magnetic Mixer Save on development, engineering costs and leadtime Mobile Magnetic Mixer drive unit Single drive unit can serve multiple mixing Palletank of different volumes Full compatibility from 50 L to 2,000 L. Full compliance with ISO 11137 Highest sterility assurance level 50 L to 1,000 L Flexel for Magnetic Mixing Cubical shape Easy installation, filling and draining with a single operator 8'' PE top powder port with cap (sanitary fitting) Prevents film damage during packaging and transport Offers large diameter port for powder transfer Provides connection to Powder Bag (with a reducer).

7 Enables mixing until complete bag's drainage Lateral windows Visual check of correct bag installation and mixing process Draining system > recovery Hinged door on Palletank for Magnetic Mixer Facilitates installation 1,500 L, 2,000 L Flexel for Magnetic Mixing Rectangular shape and system for bag's unfolding prior Easy installation, filling and draining with a single operator to filling Provides limited footprint Enables impeller rotation with minimum volume of 100 L. 4'' PE powder port with cap (sanitary fitting) held in Provides direct connection to Powder Transfer Bag stainless steel clamp holder Modular Palletank with separate modules Facilitates fitting through doors in existing facilities Front and lateral doors on Palletank for Magnetic Mixer Facilitates bag installation Pulley system on Palletank for hoisting the bag Easy filling > recovery and for optimized draining SPT2023-e131205 |3.

8 Validation Applications Flexel Bags for Magnetic Mixer have been qualified applying the The Magnetic Mixer drive unit delivers strong torque and high rotation most stringent and innovative test regimes. Biological, chemical and speed for efficient mixing in a wide variety of biopharmaceutical physical tests combined with extensive extractable testing provide applications. With its efficient high-torque impeller, Flexel Bags for users of Flexel Bags for Magnetic Mixer with data representing the Magnetic Mixer can ideally be applied for powder-liquid and liquid- widest range of process fluids in a variety of processing conditions. liquid mixing applications, requiring powerful mixing such as: Full compliance with ISO11137 allows for a validated claim of sterility on all Sartorius Stedim Biotech Single-Use Products with a sterility Buffer preparation assurance level of 10-6 over the shelf life.

9 Media preparation . Flexel Bags for Magnetic Mixer are tested for compliance to: Feed subtsrate preparation USP <87>: Biological reactivity tests, in Vitro Hydration and dissolution of hydrophobic powders USP <88>: Biological reactivity tests, in Vivo Large volume bulk intermediate resuspension and homogenization USP <661>: Containers-Physicochemical tests Plastics Large volume product formulation USP <788> Particulate matter in injections Large-volume injec- tions and : Particulate contamination-sub-visible particles Ask for the following Sartorius Stedim Biotech application notes to access details of mixing performances. USP<85> and EP : Bacterial endotoxins test ISO 11737: Microbiological methods-Determination of a population of microorganisms on products ISO 11137: Sterilization of Health care products-Radiation Quality Assurance Sartorius Stedim Biotech Quality Systems for single-use products follow applicable ISO and FDA regulations.

10 Design, manufacture and sterilization processes are conducted under conditions that mirror biopharmaceutical operations and meet cGMP requirements. Security of Supply Sartorius Stedim Biotech has established multiple manufacturing sites with consistent industrial processes. The expertise of designing single-use solutions based on collaborative supplier management and customer demand planning assures a state-of-the-art and robust supply chain that can cope with strong market growth. 4| SPT2023-e131205. Specifications 1. Magnetic Mixer Drive Unit 2. Flexel Bag for Magnetic Mixer Power Bag chamber S40 Flexel 3D Bag Chamber with EU Single Phase 230 V, 50|60 Hz Multi- Layer Film, including EVOH gas USA Single Phase 110 V, 60 Hz barrier layer and PE contact layer Japan Single Phase 230 V, Impeller position: Transformer (110 V Input), 50|60 Hz 50 L to 1,000 L Bottom centered Input Wattage < 150 Watts 1,500 L and 2,000 L Bottom off-centered Footprint 84 + 41 cm (33 in + 16 in) Impeller size 161 mm ( ).