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

Transcription

1 Standard Flexel for LevMixer 1 to Fluid Management Systems The Flexel for LevMixer is a new single-use mixing solution using the market leading LevTech levitated impeller and Sartorius Stedim Biotech Flexel 3D Bag. The newly designed cubical mixing tank is based on the proven Palletank technology. Major improvements in bag installation and handling paired with the efficiency and speed of impeller mixing systems make the Flexel for LevMixer the disposable mixing system of choice in the biopharmaceutical industry. Components 1. Palletank for LevMixer is a stainless steel cubical container designed to perfectly fit with the Flexel Bags for LevMixer with its integrated impeller. It includes a railed port for coupling the mobile LevMixer drive unit with the Flexel Bags for LevMixer and a clamp holder to facilitate powder transfer. The hinged door allows easy installation of the bag system whereas the front bottom gate facilitates easy tubing installation and access. Windows on lateral sides enable the user to visually control the mixing process. The cubical shape improves the mixing efficiency and offers scalability from to. 1 LevMixer is a trademark or registered trademark of ATMI, inc in the United States, other countries or both and this product uses ATMI patented LevMixer technology. using ATMI patented mixing technology The Palletank for LevMixer is also available standard either with a heat exchange jacket or with integrated loadcells and weight indicator: The Palletank Jacketed for LevMixer ( to ) is built according to ASME or PED directives. The heat exchange jacket and insulation system allows for efficient chilling, heating, cold or warm storage of biopharmaceutical fluids. - The Palletank Weighing for levmixer ( to ) is configured with built-in load cells linked to the weighing indicator for fast and reliable volume measurement. The CAIS1 Combics 1 indicator allows strain gauge weighing and provides an easy-toread user interface. 2. LevMixer drive unit generates the levitation and rotation of the single-use magnetic impeller without surface contact. This allows the Flexel Palletank for LevMixer to efficiently mix powders, suspensions, solutions or emulsions. The LevMixer drive unit is mobile, cartmounted and designed to interface with Palletank for LevMixer of any types or volumes. 3. Flexel Bags for LevMixer contains an in 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. The patented protection cap provides robustness avoiding contact of the impeller with the film during transport. It also offers a large diameter port for powder transfer. Features and Benefits to Full scalability Flexel for LevMixer Levitated mixing technology Side K-Welds on Flexel Bags for LevMixer PE impeller protection triclamp cap Face bottom port Standard Flexel Bags for LevMixer Hinged door on Palletank for LevMixer Mobile drive unit Rear and lateral windows Full compliance with ISO Ultra clean mixing operation Easy installation, unfolding and walk away filling process Prevents film damage during packaging and transport. Offers large diameter port for powder transfer Easy installation and access to tubing Most designs are available from stock Easy installation Single drive unit can serve multiple mixing Visual check of correct bag installation and mixing process Highest sterility assurance level Clean and sterile mixing operation A patented superconductor technology is utilized to levitate and drive the single-use impeller inside sterile single-use Flexel Bags for LevMixer. The LevMixer drive unit causes the impeller to levitate, lock in position and rotate. Thus it generates no friction or mechanical stress on the bag during mixing and avoids unwanted particle shedding that will affect the purity of the product. SPT2012-e

2 Applications The LevMixer drive unit delivers strong torque for efficient mixing of a wide variety of solutions from process intermediate to final drug product in the biopharmaceutical industry. Due to its cubical design the Flexel Bags for LevMixer can ideally be applied for liquid in liquid mixing and solid liquid mixing operations that require moderate to high mixing intensity such as: Buffer & media preparation Product formulation reformulation Hydration Dissolution of hydrophobic powders Bulk intermediate resuspension Viral inactivation Final formulation Flexibility The LevMixer drive unit operates independently of the Palletank for LevMixer so that a single drive unit can serve multiple Palletank of any types or volumes. Standard Flexel Bags for LevMixer are available from stock. They may be readily customized to optimize the integration into specific processes. Expert design service is available on-site through Sartorius Stedim Biotech application engineers on a worldwide basis. Validation Flexel Bags for LevMixer have been qualified applying the most stringent and innovative test regimes. Biological, chemical and physical tests combined with extensive extractable testing provide users of Flexel Bags for LevMixer with data representing the widest range of process fluids in a variety of processing conditions. Full compliance with ISO11137 allows for a validated claim of sterility on all Sartorius Stedim Biotech Single-Use Products with a sterility assurance level of 10-6 over the shelf life. Flexel Bags for LevMixer are tested for compliance to: USP <87>: Biological reactivity tests, in Vitro USP <88>: Biological reactivity tests, in Vivo USP <661>: Containers-Physicochemical tests Plastics USP <788> Particulate matter in injections Large-volume injections and E.P : Particulate contamination-sub-visible particles 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 for Medical Devices. 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 design designing single-use solutions based on collaborative supplier management and customer demand planning assures a stateof-the-art and robust supply chain that can cope with strong market growth. Specifications 1. LevMixer drive unit Power EU USA Japan Input wattage Footprint Single Phase 230 V, Hz Single Phase 110 V, 60 Hz Single Phase 230 V, Transformer (110 V Input), Hz < 350 Watts 94 cm + 41 cm 37 inch + 16 inch 47 kg (103 lb) Weight Temperature Ambient 4 to 30 C Ambient humidity Less than 75% Mounted on stainless cart with four clean room wheels and push handles IP rating Impeller speed Initial set-up time Vessel changeover time CE mark Material for external surfaces IP RPM 45 Minutes < 7 Minutes Compliant Stainless Steel #316L 2. Flexel Bags for LevMixer Specifications Bag chamber S40 Flexel 3D Bag chamber with multilayer film, including EVOH gas barrier layer and PE contact layer Impeller position Bottom centered Impeller size 4.95 (126 mm) ( - ) Impeller size 6.35 (161 mm) ( to ) Tubing material Silicone, C-Flex Number of ports 1 top port, 4 front bottom ports Outlet fittings MPC quick connect coupling, tri-clamp, needless sampling port,,,, and Nominal filling volume Hold-up volume Process temperatures Sterilization: Minimum 2 Maximum volume 30 L 60 L 40 L 120 L 60 L 230 L 120 L 420 L 160 L 720 L 2 1,060 L < 2 L (typical) 0 50 C by Gamma irradiation 2 Minimum volume under aseptic conditions with closed bag. Mentioned minimum volumes are lowered with open bags. LevMixer drive unit 2 SPT2012-e12027

3 3. Palletank for LevMixer 3.1 Palletank for LevMixer w/o weighing and w/o jacket Main construction materials Surface finish 304L stainless Steel Windows made of PC and EPDM sealing Glass bead blasted and passivated Door to : Front hinged door and PC windows Port Railed port for drive unit coupling Bag tubing gate Front port and bottom port for bag lines sensor access ( to ) Dimensions (Approx.) Mounted on stainless cart with four clean room wheels and push handles,,,, and W + D + H mm ( in) ,090 mm ( in) ,190 mm ( in) ,342 mm ( in) 1, ,452 mm ( in) 1, , ,652 mm ( in) Weight (approx.) 42 kg (93 lb) 53 kg (117 lb) 68 kg (150 lb) 99 kg (218 lb) 126 kg (278 lb) 210 kg (463 lb) 3.2 Palletank for LevMixer Jacketed PED version (for Europe, Asia and NEMEA) 3 Main construction materials Surface finish 304L Stainless Steel Perlit balls (Insulation) Glass bead blasted and passivated Door Front insulated hinged door (except and, no door) Port Railed port for drive unit coupling Bag tubing gate PTFE front bottom gate for bag lines sensor access Mounted on stainless cart with four clean room wheels and push handles Operating 0 50 C (32 F 122 F) temperature Working pressure -1 to 6 bars (-14 to 87 psi) Test pressure 9 bars (131 psi) PED Compliant Insulated On all sides, the bottom and the lid Jacketed 4 sides and bottom ( and ) 3 sides and bottom ( to ) Heat Transfer Fluid Inlet Outlet Heat Transfer fluid Volume in the jacket (Approx.) Dimensions (Approx.) Weight (approx.) Manual ¾ Ball valve and ¾ Tri-Clamp connection 4 L 5 L 7 L 10 L 13 L,,, and W + D + H ,096 mm ( in) ,201 mm ( in) ,301 mm ( in) 1, , ,451 mm ( in) 1, , ,561 mm ( in) 115 kg (254 lb) 142 kg (313 lb) 210 kg (463 lb) 305 kg (673 lb) 386 kg (851 lb) 3 The above specifications are applicable to FXC116199, FXC116200, FXC116201, FXC and FXC Palletank for LevMixer Palletank for LevMixer Jacketed SPT2012-e

4 ASME version (for North America and Canada) 4 Main construction materials Surface finish Door Port Bag tubing gate Operating temperature Working pressure Test pressure Heat exchanger Piping to from heat exchanger Insulated 304L Stainless Steel Foamglass and ceramic fiber Glass bead blasted and passivated Front insulated hinged door (except and, no door) Railed port for drive unit coupling UHMW front bottom gate for bag lines sensor access Mounted on stainless cart with four clean room wheels and push handles 0 50 C (32 F 122 F) 10 bars (150 psi) 13 bars (196 psi) ASME certified and stamped per Section 8, division 1 Designed and built under the ASME code for pressure piping, B31 On all sides, the bottom and the lid Jacketed 4 sides and bottom ( and ) 3 sides and bottom ( to ) Heat transfer fluid Male NPT connection Inlet Outlet Heat transfer fluid volume in the jacket (Approx.) Dimensions (Approx.) Weight (approx.) 4 L 5 L 7 L 10 L 13 L,,, and W + D + H ,070 mm (30 1 / / / 8 in) ,175 mm (32 3 / / / 4 in) ,271 mm (35 1 / / / 16 in) 1, , ,368 mm (42 15 / / / 8 ) 1, , ,478 mm (47 1 / / / 16 ) 144 kg (317 lb) 191 kg (422 lb) 254 kg (560 lb) 336 kg (740 lb) 437 kg (964 lb) 4 The above specifications are applicable to FXC117445, FXC117446, FXC117447, FXC and FXC Palletank for LevMixer Weighing Main construction materials Surface finish Door 304L Stainless Steel Windows made of PC and EPDM sealing Glass Bead Blasted and passivated Front hinged door and PC windows Port Railed port for drive unit coupling Bag tubing gate Front bottom gate for bag lines sensor access Mounted on stainless cart with four clean room wheels and push handles Integrated Combics 1 CAIS1 Scale Indicator Material of construction Stainless steel Max. readability 31,250 digits IP protection rate IP69K Operating 10 C to 40 C (14 F to 104 F) temperature range Integrated Loadcells PR 6211 IP protection rate IP68 (depth of 1.5 m for 10,000 hrs.), IP69K High overload protection Material Stainless steel Vibration resistance Acc. to IEC Fc; 20 g, 100 h, Hz Design Low installation height Integrated lift-off protection Dimensions 5 (Approx.) Weight (approx.) Maximum load capacity 100 kg (220 lb) 150 kg (330 lb) 300 kg (660 lb) 500 kg (1,100 lb) 900 kg (1,980 lb) 1,500 kg (3,300 lb) Resolution in g 50 g (1.7 oz) 50 g (1.7 oz) 100 g (3.5 oz) 200 g (7,0 oz) 200 g (7.0 oz) 500 g (17.6 oz),,,, and W + D + H mm ( in) ,090 mm ( in) ,190 mm ( in) ,342 mm ( in) 1, ,452 mm ( in) 1, , ,652 mm ( in) 55 kg (121 lb) 63 kg (139 lb) 80 kg (176 lb) 110 kg (242 lb) 135 kg (298 lb) 220 kg (485 lb) 5 The given dimensions are the footprint dimensions. Please refer to the technical drawings for detailed dimensions including scale indicator holder. 4 SPT2012-e12027

5 Ordering information 1. Flexel Bags for LevMixer Tubing Bottom Port 1 Bottom Port 2 Bottom Port 3 Bottom Port 4 Qty/Box FXB STD Flexel Silicone + Clear 1/2 + 3/ m (60 ) 1/2 + 3/ m (60 ) 1/8 + 1/ m (23.6 ) 1/2 + 3/ m (60 ) 2 Bag + sealing cap sampling port FXB STD Flexel Silicone + Clear 1/2 + 3/ m (60 ) 1/2 + 3/ m (60 ) 1/8 + 1/ m (23.6 ) 1/2 + 3/ m (60 ) 2 Bag + sealing cap sampling port FXB STD Flexel Silicone + Clear 1/2 + 3/ m (60 ) 1/2 + 3/ m (60 ) 1/8 + 1/ m (23.6 ) 1/2 + 3/ m (60 ) 2 Bag + sealing cap sampling port FXB STD Flexel Silicone + Clear 1/2 + 3/ m (60 ) 1/2 + 3/ m (60 ) 1/8 + 1/ m (23.6 ) 1/2 + 3/ m (60 ) 2 Bag + sealing cap sampling port FXB STD Flexel Silicone + Clear 1/2 + 3/ m (60 ) 1/2 + 3/ m (60 ) 1/8 + 1/ m (23.6 ) 1/2 + 3/ m (60 ) 2 Bag + sealing cap sampling port FXB STD Flexel Silicone + Clear 1/2 + 3/ m (60 ) 1/2 + 3/ m (60 ) 1/8 + 1/ m (23.6 ) 1/2 + 3/ m (60 ) 2 Bag + sealing cap sampling port SPT2012-e

6 2. Palletank for LevMixer 2.1 Palletank for LevMixer w/o weighing and w/o jacket FXC FXC FXC FXC FXC FXC STD Palletank Cubical Mix 50L (Impeller) incl. Adaptation Set and STD Palletank Cubical Mix 100L (Impeller) incl. Adaptation Set and STD Palletank Cubical Mix 200L (Impeller) incl. Adaptation Set and STD Palletank Cubical Mix 400L (Impeller) incl. Adaptation Set and STD Palletank Cubical Mix 650L (Impeller) incl. Adaptation Set and STD Palletank Cubical Mix 1000L (Impeller) incl. Adaptation Set and 2.2 Palletank for LevMixer Jacketed PED Version (for Europe, Asia and NEMEA) FXC FXC FXC FXC FXC STD Palletank Cubical Jacketed-Mix 50L (Impeller PED) incl. Adaptation Set STD Palletank Cubical Jacketed-Mix 100L (Impeller PED) incl. Adaptation Set STD Palletank Cubical Jacketed-Mix 200L (Impeller PED) incl. Adaptation Set STD Palletank Cubical Jacketed-Mix 400L (Impeller PED) incl. Adaptation Set STD Palletank Cubical Jacketed-Mix 650L (Impeller PED) incl. Adaptation Set ASME Version (for North America and Canada) FXC FXC FXC FXC FXC STD Palletank Cubical Jacketed-Mix 50L (Impeller ASME) incl. Adaptation Set STD Palletank Cubical Jacketed-Mix 100L (Impeller ASME) incl. Adaptation Set STD Palletank Cubical Jacketed-Mix 200L (Impeller ASME) incl. Adaptation Set STD Palletank Cubical Jacketed-Mix 400L (Impeller ASME) incl. Adaptation Set STD Palletank Cubical Jacketed-Mix 650L (Impeller ASME) incl. Adaptation Set 6 SPT2012-e12027

7 2.3 Palletank for LevMixer Weighing FXC FXC FXC FXC FXC FXC STD Palletank Cubical Mix 50L (Impeller Weighing) incl. Adaptation Set STD Palletank Cubical Mix 100L (Impeller Weighing) incl. Adaptation Set STD Palletank Cubical Mix 200L (Impeller Weighing) incl. Adaptation Set STD Palletank Cubical Mix 400L (Impeller Weighing) incl. Adaptation Set STD Palletank Cubical Mix 650L (Impeller Weighing) incl. Adaptation Set STD Palletank Cubical Mix 1000L (Impeller Weighing) incl. Adaptation Set 3. Drive units For Flexel Palletank for LevMixer w/ and w/o weighing and for Flexel Palletank for LevMixer Jacketed LT-DBTL002 LevMixer drive machine for US and Canada on cart with two latches for 8 and 15 ports. Control panel (110 V) US and lifting mechanism on handle and welded body. Includes tool kit with accessories. LT-DBTL003 LevMixer drive machine with European certification on cart with two latches for 8 and 15 ports. Control panel (220 V) Europe and lifting mechanism on handle and welded body. Includes tool kit with accessories. LT-DBTL004 LevMixer drive machine with European certification on cart with two latches for 8 and 15 ports. Control panel (220 V) Japan and lifting mechanism on handle and welded body. Includes tool kit with accessories. Includes Japanese transformer. LT-DBTL005 LevMixer drive machine with European certification on cart with UK-Plug and two latches for 8 and 15 ports. UK Control panel (220V) and lifting mechanism on handle and welded body. Includes tool kit with accessories. LT-DBTL010 LevMixer drive machine with European certification on cart with Australian plug and two latches for 8 and 15 ports. Australia Control panel (220V) and lifting mechanism on handle and welded body. Includes tool kit with accessories. For Flexel Palletank for LevMixer (all ranges) LT-DBTL006 LevMixer drive machine for US and Canada on cart with three latches for 8, 15 and 20 ports. Control panel (110 V) US and lifting mechanism on handle and welded body. Includes tool kit with accessories. LT-DBTL007 LevMixer drive machine with European certification on cart with three latches for 8, 15 and 20 ports. Control panel (220 V) Europe and lifting mechanism on handle and welded body. Includes tool kit with accessories. LT-DBTL008 LevMixer drive machine with European certification on cart with three latches for 8, 15 and 20 ports. Control panel (220 V) Japan and lifting mechanism on handle and welded body. Includes tool kit with accessories. Includes Japanese transformer. LT-DBTL009 LevMixer drive machine with European certification on cart with UK-Plug and three latches for 8, 15 and 20 ports. UK Control panel (220 V) and lifting mechanism on handle and welded body. Includes tool kit with accessories. LT-DBTL011 LevMixer drive machine with European certification on cart with Australian plug and three latches for 8, 15 and 20 ports. Australia Control panel (220 V) and lifting mechanism on handle and welded body. Includes tool kit with accessories. SPT2012-e

8 4. Spare Parts 4.1 Spare Parts for Palletank for LevMixer FXA FXA FXA FXA FXA FXA FXA STD Palletank Spare Part Adaption Set STD Palletank Cubical Spare Part 50L STD Palletank Cubical Spare Part 100L STD Palletank Cubical Spare Part 200L STD Palletank Cubical Spare Part 400L STD Palletank Cubical Spare Part 650L STD Palletank Cubical Spare Part 1000L 4.2 Spare Parts for Drive Units LT-DBCI001 Magnetic charger with bearing for use with 6-magnet oriented impellers (4.95 ) LT-DBCI005 Magnetic charger with bearing for use with 4-magnet oriented impellers (6.35 ) LT-DBCI002 Replacement bearing for magnetic charger LT-DBCI001 LT-DBAK004 Testing Impeller for use with 6-magnet oriented impellers (4.95 ) LT-DBAK007 Testing Impeller for use with 4-magnet oriented impellers (6.35 ) LT-DBBI007 Magnetic Clamp to hold Locking Dish in place LT-SPP003 Spare Parts Pouch for LevMixer Drive Units LT-SPP004 Spare Parts Pouch for Japanese LevMixer Drive Units Sartorius Stedim Biotech GmbH August-Spindler-Strasse Goettingen, Germany Phone Fax USA Toll-Free UK France Italy Spain Japan Specifications subject to change without notice. Printed and copyrighted by Sartorius Stedim Biotech GmbH W Publication No.: SPT2012-e12027 Order No.: Ver