M30/M60 Tangential Flow Filtration System

Transcription

1 ProfluxTM M30/M60 Tangential Flow Filtration System For optimum processing flexibility DATA SHEET ProFlux M30 and M60 Tangential Flow filtration Systems provide optimum processing flexibility. The systems and their basic features represent more than thirty years of Millipore experience in ultrafiltration technology. The system control panel displays essential process information and has built-in safety features for manual control of tangential ultrafiltration and microfiltration applications. Selection of the optional level control feature offers additional control and increased efficiency when performing laborious tasks. The systems accommodate spiral-wound cartridges, hollow fiber cartridges or cassette membrane modules. Flexibility in all areas of the design - control panel, system unit and filter combinations - allows easy conversion to meet changing processing requirements. The simplicity and basic safety features of the unit are the key to its outstanding success in the pharmaceutical and biotechnology industry for R&D, pilot or production processes.

2 System Overview The system is composed of three main functional modules: Control panel, pump/power/reservoir unit, membrane filter devices. All process-wetted components are of sanitary design, made of FDA compliant and/or USP Class VI tested materials. The system is suitable for bench-top operation or permanent installation. It can be mounted on a laboratory trolley for mobility, and user convenience when connected to permanently installed process tanks or fermentors in different areas of the plant. It may be operated in cold room conditions. Feed and recirculation flow is provided by a sanitary, low shear, positive displacement lobe pump. The pump is connected to the reservoir and filter devices by a sanitary pipe configuration. Safe filter operation is maintained by constant monitoring of pressures and the ProFlux M control interlocks. A minor process discrepancy is announced by alarms; in case of larger variations, the system shuts down. Process temperature can be maintained by an optional heat exchanger. Components Base The filtration process unit is mounted on a stainless steel base with heightadjustable feet. Feed/Recirculation Pump and Motor The pump is a low shear, sanitary, rotary, lobe pump with mechanical seals. The motor is a TEFC (totally enclosed, fan cooled) type for AC operation. Both pump and motor are mounted on the base. Piping All product contact surfaces are made of 316L stainless steel or FDA compliant and/or USP Class VI tested materials. Flexible hoses with sanitary clamp fittings are provided for connection to the product recovery valve and the permeate manifold. Valves All valves are sanitary, diaphragm type. Reservoir The transparent 27-liter reservoir includes spray ball for CIP (clean in place) with isolation valve and piping, ports for venting, recirculation and filling, spare inlet port and reservoir outlet. Cartridge Mounting Frame A dedicated filter cartridge mounting frame accepts all Millipore filter cartridge configurations as indicated in table on page 6. The unit is supplied with a manifold and cartridge support for one column position. Filter Cartridge Inlet/Outlet Manifold Each system is supplied with a manifold and cartridge support for one cartridge position. Manifold position expansion kits (MEK-2 and MEK-3), described in the options section, provide mounting positions for additional cartridges. Depending on cartridge type and configuration, other components may be required. Please refer to table on page 7. Filter Cartridges and Filter Housings Filter cartridge (and filter housings where required), header kits, interconnector kits and spools are specified by their product numbers in the quotation. These items are not included in the system and must be ordered separately. Control and Power Panel The system controller is mounted in a NEMA 4/ IP65 stainless steel cabinet. The panel is equipped with a mimic membrane keypad, including digital indicators for pressure, on/off pump light and set point alarms which provide the operator with a clear interface for operation. The emergency stop push button and main power switch are located on the front of the panel. An audible alarm is mounted internally. The control panel is mounted on the system base. A variable frequency drive is mounted in the cabinet with control transformer, terminals, fuses and miscellaneous panel hardware including a 30 ma Ground Fault Interrupter (GFI) for operator protection. (NOTE: Lower ma protection should not be applied on the supply line to this type of equipment.) Controls and Alarms The system is manually operated. Required flow rate is achieved by manual adjustment of pump speed via the key pad. Back pressure is adjustable by the manual pressure control valve. Alarm/trip settings are tuned by the operator before starting the system. Correct settings prevent the operator from accidentally damaging the system or cartridges during manual manipulation. The control panel mimic displays a graphic representation of the process flow schematic and process values in addition to the user interface buttons shown in the Control Panel Functions Table.

3 ProFlux M Control Panel and Functions KEY FUNCTION 1 Start/Stop key 2 On light (Recirc Pump) 3 Up Arrow key 4 Down Arrow key 5 Recirc/Permeate 6 Inlet Pressure Display 7 Differential/Permeate Pressure Display 8 Outlet Pressure Display 9 Recirc light 10 Pump Select key 11 Permeate light 12 On light (Secondary/ Permeate Pump) 13 Perm light KEY FUNCTION 14 Rev key 15 Cal lights 16 Prime key 17 Lo P light 18 Hi P light 19 Hi D P light 20 Low light 21 Alarm Reset key 22 Interlock Override key 23 Interlock Override 24 Alarm Set key 25 Alarm Set lights 26 Cal Zero key 27 Cal Span key 28 Cal lights SYSTEM OPERATION Operation is simple, safe and consistent. After the cartridges are installed, the operator adjusts the pressure alarm limits to match the specific process requirements or the cartridge operating limitations. The operator then presses the start button, adjusts pump speed and sets the back pressure valve position until the desired pressures are reached. During operation, it may be necessary to fine-tune the pressures if viscosity or temperature cause variations in flow and pressure. The system will shut down if alarm set points are exceeded or the stop button is pressed. After product recovery and rinse cycles, the system can be drained and CIP solution introduced into the tank for cleaning. For all future runs with the same cartridges, the operator only has to fill the reservoir and push the start button, adjust the pump speed and fine-tune the back pressure valve. Systems supplied with the LS/TP (Level Switch and Transfer Pump) option save time when transferring and processing batches from alternative tanks. The system will fill the reservoir automatically to pre-set limit and shut down automatically at end of run. Systems supplied with secondary pump option can be operated in Level Control Mode or in Permeate Control Mode. Level control mode is used for automatic reservoir filling and requires a level switch. Permeate control mode is used for microfiltration and for certain ultrafiltration applications where molecular size of the passing species are close to the size of the membrane s molecular weight cut-off. Permeate control mode is used to enhance the resolution of the filtration process by reducing the gel layer s secondary retention effect. Permeate control requires installation of a secondary pump and a third pressure transducer.

4 Alarms Inlet and differential pressure: The system alarms when the pressure (high) limit alarm setting is exceeded and shuts down when the (high-high) limit is exceeded. Reservoir low level: The system alarms and shuts down at the set point. The reservoir level alarm and trip is only available if the system is connected to the level switch (LS) option. Level Switch Interface All systems have a volt free contact (vfc) interface on the control panel terminal for the level switch. If a level switch (digital vfc) is connected, the system alarms and automatically shuts down when the minimum reservoir level has been reached at the end of the filtration step. This allows unattended operation of the system without the risk of overconcentration or of running the system dry. The level switch also controls continuously fed batch or diafiltration operations with an optional transfer pump. In either case, the system maintains constant reservoir level during the process It automatically alarms and ceases operation when the feed or dialysate supply is depleted. The unit can then be reset for the final concentration phase. OPTIONS The options listed in this section may not be required for your application but are included for full presentation of system capabilities. Heat Exchanger option code: HX The system can be supplied with a tube-in-tube heat exchanger option for product cooling and partial or closed-loop processing. Partial or closed-loop processing is a feature used to minimize final process volume or for handling products with a tendency to foam. The heat exchanger is designed to remove the heat generated by the pump. Cooling water or glycol is required to operate the heat exchanger. A differential temperature (process/coolant) of 10 to 15 degrees C is normally required. The heat-exchanger option contains the complete assembly with temperature indicator (thermometer) fittings, clamps and hand control valves for product and cooling media flow control. Level Switch option code: LS The unit can be supplied with a level switch. This option includes level switch and adjustable mounting bracket for adjustment of the set point. It allows the operator to utilize the automated features described in the Operation section. Level Control with Switch and Transfer Pump option code: LS/TP When used in the level control mode with the optional secondary pump, dialysate or process feed is transferred automatically during processing. The system automatically assures that the tank is continuously topped up with dialysate or feed. When the full batch is transferred, the system shuts down automatically. This option includes: level switch (LS), feed pump with tubing and fittings for connection to the reservoir. Permeate Control option code: PCO This is used mainly for microfiltration (MF) applications, but can also be used for critical ultrafiltration (UF) applications that would otherwise result in variable or poor separation resolution throughout the process run. The permeate pump can be operated from the control panel in Permeate Control mode. In this mode, permeate pressure is indicated on the panel instead of the cartridge differential pressure. The feed pump speed control is operated locally in permeate control mode. This option includes permeate pressure transducer, signal cable, adapter, permeate manifold fittings, permeate pump and tubing for connection to the permeate manifold. Data Acquisition Package For PC option code: DFPC This filtration system can be supplied with a Data Acquisition software package for a PC. This package provides more than real time and historical data chart trending. It gives you the tools to create customized reports for your management and regulatory agencies. The software is specifically developed to assure data integrity so that your process data and alarms are logged correctly. Install the software on your office computer, connect the ProFlux system, then monitor and operate all automated system features from your PC. If your PC is connected to a Local Area Network (LAN), you can monitor or operate from any other PC (Password protected) on the network with the software installed. This is a great advantage for operation of systems installed in cold rooms, to reduce traffic in clean rooms or for remote management supervision. The software package contains the most powerful Supervisory Control And Data Acquisition (SCADA) system on the market. Installed in more than 40,000 machines worldwide, it can provide centralized control of all your

5 Data acquisition package For PC MONITOR: Alarms Events Trends networked process systems. It offers seamless operation between Millipore s chromatography and tangential flow filtration systems equipped with the required interface. The DFPC option includes a comprehensive software package as described above, RS-232/422 converter and 10m (33 feet) cable to connect the ProFlux M system to your PC. Excel macros are included for customization and transfer of its reporting capabilities. Compatible PC (Minimum 486/ 66 with 16 MB RAM), Microsoft Windows software and Microsoft Excel supplied by others. Installation of this option requires on site staff with ability to connect the RS232/422 converter, connect the cable and install the software. Customized use of this option requires basic PC skills and knowledge of Microsoft Excel. Basic use of this option requires minimum PC operating skills. Filter Cartridge Manifold Expansion kits option code: MEK-2 and MEK-3 The standard system with one column can be configured to accept up to 3 parallel columns of filter cartridges. The manifold expansion kit MEK-2 provides one additional position to the base unit. Total with kit installed is 2 columns. The manifold expansion kit MEK-3 adds a third position; total with MEK-2 and MEK-3 kits installed is three columns. The package includes inlet/outlet and permeate manifold fittings, attachments and gaskets for the cartridge configurations listed in the System capacity table on page 6. Extended Sanitary Hose option code: ESH Required when operating with type H53 Hollow Fiber cartridges. Please refer to table 6. Series Reducer Spool option code: SRS Required when operating with only one spiral S10 cartridge in series. Please refer to table on page 7. DOCUMENTATION and SUPPORT Operating Manual and Validation Guide Each system is supplied with a comprehensive Operating Manual and Validation Guide in two copies. The Validation Guide contains equipment installation qualification and operating qualification, specific to the system. It lists test procedures and expected results. Set-up and Installation Units are shipped assembled. All systems have been pre-assembled, calibrated and tested at the factory. Cartridges and housings require installation on site regardless of system size.

6 M30/M60 Cartridge Adapter Kits Hollow Fibers H5, H10 Integral with cartridge - no adapter required. H30, H53 Product No: W includes: 2 Polysulfone adapters - 3" 2 Clamps, gaskets - 3" 1 Blanking cap, gasket, clamp - 1½ 1 Hose adapter, gasket, clamp - 1½ 2 Reducers - 1-1½ Spirals S10 Header Kit Product No: includes: Inlet and outlet caps with fittings, 2 sanitary clamp connectors and gaskets (1 kit required per spiral column) S10 Series Connector Kit Product No: To connect 2 spirals in series. includes: 1 clamp, gasket and permeate inter-connector. (For three in series order 2 kits) SPECIFICATIONS M30 M60 PHYSICAL Dimensions (L x W x H) 84 x 54 x 150cm (33 x 21 x 59in) Weight (base unit) 127 Kg (280lbs) 130 Kg (286lbs) CARTRIDGE AND MEMBRANE AREA CAPACITY Spiral cartridges Up to 30 ft 2 (2.8 m 2 ) Up to 60 ft 2 (5.7m 2 ) Hollow fiber cartridges Up to 53 ft 2 (5.0 m 2 ) Up to 106 ft 2 (10.0 m 2 ) PUMP CAPACITY Recirculation pump Lobe positive displacement Maximum 4.2 bar (60psi) 40 L/min 61 L/min MINIMUM PROCESS VOLUME 3 S10 spirals in series with HX/Loop 2L MATERIALS (process wetted) FDA compliant and/or USP Class VI tested RESERVOIR CAPACITY CONNECTIONS Product Recovery Permeate. Vent, Fill, Cartridge. yes 27L 3/4 Sanitary clamp 1/2 Sanitary clamp 1 Sanitary clamp CONTROL PANEL Integrated control panel Splash proof NEMA4/IP 65 Pressure indicators Digital; indication in BAR/PSI Pump Speed Digital; indication in %max Push buttons Tactile response ELECTRICAL 200/240VAC Phase-Phase 18 amps 28 amps 200/240VAC 1-Phase 18 amps 28 amps 200/230VAC 3-Phase 15 amps 18 amps 380/460VAC 3-Phase 12 amps 15 amps Pressure transducers Sanitary (titanium) Interface auxiliary pump Volt-free contact ENVIRONMENTAL CONDITIONS 0-40 C (non condensing) M30/M60 Typical System Cartridge Capacity (at 1cp) Note: Pellicon cassette holders are currently being integrated to fit this system. Adapter kits will be available shortly. Please contact your local sales representive for the latest information. Model Cartridge type (1) H5 H10 H30/53 S10 M30 Quantity Membrane area ft /53 30 m /5 2.8m M60 Quantity Membrane area ft /53 60 m /5 5.6 (1) Adapter kit required for spiral cartridge and H30/53 cartridge use

7 Cartridge Configurator

8 SCALE UP WITH MILLIPORE PROFLUX SYSYTEMS ProFlux: A series of highly flexible filtration systems with increasing levels of automation Sizes for processing of less than one liter to thousands Choice of automation level and custom-designed features Interchangeable use of different filter cartridges Meeting special requirements of biopharmaceutical production Larger Systems Up to 100 times the capacity of M30/ M60 Assured future scale-up and flexibility Engineered to a base line master plan for expandable configurations and functionality Long Experience Millipore offers over 30 years experience in ultrafiltration. Hundreds of Millipore systems installed worldwide and continuous component testing are Millipore s basis for design and component selection. ProFlux systems cannot be compared with filtration systems assembled from individual catalogue items or by assembly firms specializing in stainless steel plumbing and fittings ProFlux minimizes your risk of project delays or revalidation due to unawareness of critical factors ProFlux systems, incorporating latest technology, build on our long experience with popular DC and SP filtration systems Assured Quality Each Millipore system manufactured at our ISO 9001 facility is fully calibrated and tested before shipment. It must pass system-specific Installation and Operating Qualification Choosing a Millipore system assures easy installation and start-up Safety and Automation Manual to fully automated processing Outstanding process safety and repeatability Integrated Separation Processes Automated ProFlux systems allow full process control integration with Millipore s chromatography systems. A great advantage in all phases from process design, documentation, validation, operation to maintenance. International Support When international transfer or duplication of your process is required - in your organization or to licensees around the world, Millipore can facilitate this process. Millipore systems are available through our worldwide locations, providing regional support - wherever you may need it even if unforeseeable during pilot studies or process planning. To Place an Order or Receive Technical Assistance For additional information call the nearest number listed below: In the U.S. and Canada Call toll-free MILLIPORE ( ) Millipore Worldwide AUSTRALIA A C N Tel. Toll Free (008) In Sydney Area (02) CHINA, PEOPLE S REPUBLIC OF Beijing: (86-1) Guangzhou: (86-20) Shanghai: (86-21) INDIA Bangalore: Tel. (812) ITALY Milano: (02) Roma: (06) SINGAPORE Tel. (65) SPAIN Madrid: Barcelona: In the U.S. FAX Orders (617) In CANADA FAX Orders (613) Millipore and Amicon are registered trademarks of Millipore Corporation or an affiliated company. Proflux is a trademark of Millipore Corporation or an affiliated company. Lit. No. P712Q Rev 1.3 Printed in U.S.A. 6/97 Copyright 1997Millipore Corporation or an affiliated company, Bedford, MA Printed on recycled paper. AUSTRIA, CENTRAL EUROPE, C.I.S., AFRICA, MIDDLE-EAST AND GULF In Austria Tel BALTIC REPUBLICS In Finland Tel BELGIUM AND LUXEMBOURG Tel. (02) FAX (02) BRAZIL Tel. (011) CANADA Tel. (416) CZECH REPUBLIC Tel DENMARK Tel FINLAND Tel. (90) FRANCE Tel. (1) GERMANY Tel. (06196) HONG KONG Tel. (852) HUNGARY Tel. (1) JAPAN Tel. (03) KOREA Tel. (82-2) MALAYSIA Tel. (60) MEXICO Tel. (525) THE NETHERLANDS Tel. (01608) NORWAY Tel POLAND Tel /32 PUERTO RICO Tel. (809) SWEDEN Sundbyberg: SWITZERLAND Tel. (01) TAIWAN Tel. (886-2) U.K. and IRELAND Tel. (01923) U.S.A. Tel. Toll Free 800-MILLIPORE ( ) In Puerto Rico In All Other Countries Millipore Intertech (U.S.A.) Tel. +1 (617)