Standard Flexel for LevMixer 50 L to 1,000 L - Sartorius

1 Standard Flexel for LevMixer 1 50 L to 1,000 L. Features and Benefits 50 L to 1,000 L Full scalability Flexel for LevMixer . Levitated mixing Ultra clean mixing Fluid Management Systems technology operation Side K-Welds on Easy installation, Flexel Bags for unfolding and walk LevMixer away filling process PE impeller Prevents film protection damage during pack- triclamp cap aging and transport. Offers large diameter port for powder transfer Face bottom port Easy installation and access to tubing Standard Flexel Bags Most designs are for LevMixer available from stock Description The Palletank for LevMixer is also available Hinged door Easy installation The Flexel for LevMixer is a new single-use Standard either with a heat exchange jacket on Palletank for mixing solution using the market leading or with integrated loadcells and weight LevMixer .

2 LevTech levitated impeller and Sartorius indicator: Stedim Biotech Flexel 3D Bag. The newly The Palletank Jacketed for LevMixer Mobile drive unit Single drive unit can designed cubical mixing tank is based on (50 L to 650 L) is built according to ASME serve multiple mixing the proven Palletank technology. Major or PED directives. The heat exchange jacket Rear and lateral Visual check of correct improvements in bag installation and and insulation system allows for efficient windows bag installation and handling paired with the efficiency and chilling, heating, cold or warm storage of mixing process speed of impeller mixing systems make biopharmaceutical fluids.

3 The Flexel for LevMixer the - The Palletank Weighing for LevMixer Full compliance with Highest sterility disposable mixing system of choice in (50 L to 1,000 L) is configured with built-in ISO 11137 assurance level the biopharmaceutical industry. load cells linked to the weighing indicator for fast and reliable volume measurement. Components The CAIS1 Combics 1 indicator allows strain 1. Palletank for LevMixer is a stainless steel gauge weighing and provides an easy-to- Clean and sterile mixing operation cubical container designed to perfectly fit read user interface. A patented superconductor technology is with the Flexel Bags for LevMixer with its utilized to levitate and drive the single-use integrated impeller.

4 It includes a railed port 2. LevMixer drive unit generates the impeller inside sterile single-use Flexel Bags for coupling the mobile LevMixer drive unit levitation and rotation of the single-use for LevMixer . The LevMixer drive unit causes with the Flexel Bags for LevMixer and a magnetic impeller without surface contact. the impeller to levitate, lock in position clamp holder to facilitate powder transfer. This allows the Flexel Palletank for and rotate. Thus it generates no friction or The hinged door allows easy installation of LevMixer to efficiently mix powders, mechanical stress on the bag during mixing the bag system whereas the front bottom suspensions, solutions or emulsions.

5 The and avoids unwanted particle shedding that gate facilitates easy tubing installation and LevMixer drive unit is mobile, cartmounted will affect the purity of the product. access. Windows on lateral sides enable and designed to interface with Palletank . the user to visually control the mixing for LevMixer of any types or volumes. process. The cubical shape improves the mixing efficiency and offers scalability 3. Flexel Bags for LevMixer contains an in from 50 L to 1,000 L. center magnetic impeller assembly. Its unique sided K-weld design simplifies installation and facilitates the unfolding and folding of the bag during filling and draining operations.

6 The 1 LevMixer is a trademark or registered trademark of ATMI, patented protection cap provides robustness inc in the United States, other countries or both and this avoiding contact of the impeller with the product uses ATMI patented LevMixer technology. film during transport. It also offers a large using ATMI patented mixing technology diameter port for powder transfer. SPT2012-e12027 |1. Applications Quality Assurance 2. Flexel Bags for LevMixer Specifications The LevMixer drive unit delivers strong Sartorius Stedim Biotech Quality Systems for torque for efficient mixing of a wide variety single-use products follow applicable ISO Bag chamber S40 Flexel 3D Bag of solutions from process intermediate to and FDA regulations for Medical Devices.

7 Chamber with multi- final drug product in the biopharmaceutical Design, manufacture and sterilization layer film, including industry. Due to its cubical design the Flexel processes are conducted under conditions EVOH gas barrier layer Bags for LevMixer can ideally be applied that mirror biopharmaceutical operations and PE contact layer for liquid in liquid mixing and solid liquid and meet cGMP requirements. Impeller position Bottom centered mixing operations that require moderate to high mixing intensity such as: Security of Supply Impeller size (126 mm). Buffer & media preparation Sartorius Stedim Biotech has established (50 L - 100 L).

8 Product formulation | reformulation multiple manufacturing sites with consist- Impeller size (161 mm). Hydration | Dissolution of hydrophobic ent industrial processes. The expertise of (200 L to 1,000 L). powders design designing single-use solutions based Bulk intermediate resuspension on collaborative supplier management and Tubing material Silicone, C-Flex . Viral inactivation customer demand planning assures a state- Number of ports 1 top port, 4 front Final formulation of-the-art and robust supply chain that bottom ports can cope with strong market growth. Flexibility Outlet fittings MPC quick connect The LevMixer drive unit operates independ- Specifications coupling, tri-clamp, ently of the Palletank for LevMixer so that a needless sampling port single drive unit can serve multiple Palletank 1.

9 LevMixer drive unit Volumes 50 L, 100 L, 200 L, 400 L, of any types or volumes. Standard Flexel 650 L and 1,000 L. Bags for LevMixer are available from stock. Power They may be readily customized to optimize EU Single Phase 230 V, Nominal filling Minimum2 Maximum the integration into specific processes. Expert 50 | 60 Hz volume volume design service is available on-site through USA Japan Single Phase 110 V, 50 L 30 L 60 L. Sartorius Stedim Biotech application engi- 60 Hz 100 L 40 L 120 L. neers on a worldwide basis. Single Phase 230 V, 200 L 60 L 230 L. Transformer (110 V 400 L 120 L 420 L. Validation Input), 50 | 60 Hz 650 L 160 L 720 L.

10 Flexel Bags for LevMixer have been qualified 1,000 L 250 L 1,060 L. Input wattage < 350 Watts applying the most stringent and innovative Hold-up volume < 2 L (typical). test regimes. Biological, chemical and Footprint 94 cm + 41 cm physical tests combined with extensive 37 inch + 16 inch Process 0 50 C. extractable testing provide users of Flexel temperatures Weight 47 kg (103 lb). Bags for LevMixer with data representing the Sterilization: by Gamma irradiation widest range of process fluids in a variety of Temperature Ambient 4 to 30 C. processing conditions. Full compliance with Ambient humidity Less than 75%. ISO11137 allows for a validated claim of 2.