pall,颇尔,Allegro 一次性切向流过滤系统,709-10W, 709-13W, 709-10X, 709-13X, 709-13Y, 709-13Z, 709-10Y, 709-14C, 709-14E, 709-14G

产品名称:
Allegro 一次性切向流过滤系统
产品型号:
709-10W, 709-13W, 709-10X, 709-13X, 709-13Y, 709-13Z, 709-10Y, 709-14C, 709-14E, 709-14G
产品描述:

产品介绍

pall,颇尔,Allegro 一次性切向流过滤系统,709-10W, 709-13W, 709-10X, 709-13X, 709-13Y, 709-13Z, 709-10Y, 709-14C, 709-14E, 709-14G
pall,颇尔,Allegro 一次性切向流过滤系统

Allegro 一次性切向流过滤系统

Compact Easy-to-Use and Fully Automated TFF
System, Providing Flexibility in Manufacturing

The Allegro single-use TFF system is designed specifically for the incorporation of single-use components.It is not a disposable version of a traditional TFF system design because new concepts for ease-of-use in single-use processing have been used to achieve this unique design.This includes careful consideration of the layout and installation, allowing full access to components from one side of the system.

Attributes

  • Good engineering design provides reliability, control and ease-of-use
  • Full automation provides control and monitoring of key process parameters
  • Gamma-irradiated manifolds with pre-calibrated sensors ensure quick installation

System Concept

Single use technology is widely accepted in bioprocessing, with key benefits being the elimination of cross contamination and cleaning, and greater system flexibility.
 

Tangential Flow Filtration (TFF) is more complex than many other unit operations for which single-use approaches have been adopted.In TFF, cleaning of the TFF casettes and system is essential to maintain flux and minimize the risk of cross contamination in a multi-product facility.

The Allegro system provides a platform onto which five single-use manifolds are attached.The five manifolds – feed, retentate, permeate, retentate biocontainer and recovery – are provided gamma irradiated and ready to install on the system.

The single-use flowpaths have incorporated single-use sensors where possible.These sensors are manufactured to defined tolerances and minimize downtime in system set up.

 

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Integration of sensors in this system:

  • Allows tracking of key process parameters
  • Provides notification when processing is not within specification
  • Enables automated control of processing to optimum conditions
  • Facilitates fully automated process sequences
Components in the single-use flowpaths have been selected to achieve the performance requirements of the system.Use of components and materials which:
  • Meet the flow and pressure requirements of typical TFF processes
  • Achieve scalability of performance
  • Have full specification and certification
  • Have easy attachment and connectivity

 

System Description

The Allegro single-use TFF system has been designed for ultrafiltration and diafiltration (UF/DF) processes.Typical applications are concentration and diafiltration of proteins, recombinant molecules, potent biological and cytotoxic drugs, and vaccines.

It is fully automated, with a disposable flow path comprising high quality components in five easy to install manifold sets.The 1⁄2 in.ID (internal diameter) system has a recirculation pump capacity of 1000 L/hour, and can typically run 0.5 m²-2.5 m² membrane area with Cadence single-use TFF modules or TFF cassettes (running at a cross flow of 5 L/min/m2).It can be fitted with a 20 L or 100 L retentate biocontainer, and operated in fed batch mode.Cassettes are placed between single-use distribution plates, which are components of the feed and retentate flow paths.The cassette assembly is torqued between two stainless steel plates (non wetted parts), to ensure correct sealing.

Connections can easily be made to Allegro 2D and 3D biocontainers for supply of WFI, diafiltration buffer and process fluid in fed batch operations.Product temperature control, either cooling or heating, is available using a heat exchange plate under the retentate biocontainer.

特点

  • Pressure independent flow provided by a positive displacement diaphragm pump ensures that critical parameters do not vary during the concentration step
  • Fully automated system for control and monitoring of key process parameters
  • Good accessibility for installing flowpaths and daily operation
  • Pre-irradiated manifold sets for feed/retentate/permeate/fed batch/recovery
  • Installation of manifold sets typically takes around 20 minutes
 

Operating Conditions

  • Pressure Range:0 – 4 bar
  • Flow Range:6 – 1000 L/hour
  • Temperature Range:0 – 40 °C
  • Surface Area of Membrane:0.5 – 2.5 m2 (typically)
  • Minimum Working Volume:1 L

Component Specifications

公用设施

  • Power Supply:
    • 230 V 1-phase 50 Hz
    • 120 V 1-phase 60 Hz
  • Compressed Air:Air source at 6 bar for operation of valves
 
Base System 机型 Materials Capacity/ Other
System Frame 1800 x 800 x 1600 mm (L x W x H) 304 stainless steel -
Cassette Holder Centrasette™ SU holder 316 stainless steel 0.5 - 2.0 m2
Recirculation Pump 4 piston diaphragm pump with single-use pump head EPDM elastomers 6 - 1000 L/hour
Pinch Valves Pneumatic actuated   OD range 0.75 in. to 1.0 in.
Flow Meter Single-use turbine with reusable sensor PVDF 0.5 – 20 L/min
Diafiltration Pump Peristaltic   375 升/小时
Control System Fully automated with 颇尔 phase step concept Siemens (Europe), Allen Bradley (US)  
Temperature Control (optional) Heat exchange plate   5 – 50 °C
 

 

 
Product Control Material 机型 Materials Capacity/Other
Flowpath Tubing ½ in. internal diameter Platinum cured silicone -
Recirculation Pump Single-use pump head EPDM elastomers  -
Pressure Monitoring Single-use pressure sensor 聚砜 -0.48 to 5.2 bar
Pressure Control Pneumatic actuated single-use diaphragm valve 聚丙烯  -
Cassette Distribution Plate Plastic manifold plates around cassettes 聚丙烯  -
Flow Meter Single-use turbine with reusable sensor PVDF  -
Tubing Connectors Quick connectors Polysulfone, Silicone  -
Connectors for Distribution Plate Triclamp-hosebarb Triclamp gasket Polypropylene Silicone  -
生物容器 Allegro 2D and 3D biocontainers LDPE 5 L, 10 L, 20 L, 100 L
电导率 Single-use flow cell 聚丙烯 1 μS/cm to 200 mS/cm
 
 
 

Designed for Ease-of-Use

Single-use technology brings many benefits in bioprocessing and can make unit operations simpler to carry out.The fully automated single-use TFF system makes UF/DF a straightforward process with full control over the key parameters.
  • Actuated valves
  • Fully automated TMP and retentate flow control
  • Pressure and flow sensors for monitoring
  • ½ in.ID high pressure silicone tubing
  • Optional conductivity sensors on retentate and permeate
  • Positive displacement diaphragm pump
  • Fed batch and diafiltration buffer feed control
  • User-configurable phases and recipes
  • Can be run in automatic or manual mode All process signals and component status are shown on the main screen
  • 颇尔 analytical tool supplied for trending and calculation
  • Data logging and batch reporting

CAD image showing manifolds, valves, and pumps


 

CAD image showing feed, retentate, and permeate manifolds


 

Performance of Allegro single-use TFF system using Omegat™ T-series cassettes with 10 kd membrane (0.5 m2 for 20 L, 1.5 m2 for 100 L).

 

Concentration of 20 L batch 10g/L IgG and 100 L of 10 g/L BSA in 1m NaCl


 

电导率


 

结果

  • Both batches achieved target concentration factors while maintaining a linear decrease in flux on a semi-log curve.This linear relationship is expected and is comparable to a conventional TFF system
  • The system design allows sufficient mixing:the conductivity wash out profiles for each was comparable to the theoretical wash out curve

 

Quality Standards

颇尔 maintains a very stringent approach to quality of purchased and manufactured components.The system is designed and built to well recognize industry standards, including but not limited to:
  • EMC 89/336/EEC
  • Good Automated Manufacturing Practice (GAMP) current version
  • Software meets CFR 21 Part 11 for electronic records, signatures and audit trail
  • The rules governing medicinal products in the European Community, Volume IV, Good Manufacturing practice for medicinal products, Annex 11, computerized systems

The single-use flowpaths:

  • Are assembled in a dedicated Class 10000 Clean Room, to ISO standards 9001:2008 and 14001:2004 using validated assembly methods
  • Have components which have been tested for biocompatibility and certified to USP <88> Biological Reactivity Tests, in vivo, for Class VI plastics
  • Components are certified TSE/BSE free
  • Are supplied double bagged and irradiated at 30 - 50 KGy

Feed Manifold

 
Part Number PT01 TT01 连接器
  Pressure Temperature  
709-10W X X MPX
709-13W X - MPX
 

Retentate Manifold

 
Part Number PT02 PT04 FT01 AT01 连接器
  Pressure Flow Flow Condcutivity  
709-10X X X X X MPX
709-13X X X X - MPX
709--13Y X X - X MPX
709-13Z X X - - MPX
 

Permeate Manifold

 
Part Number PT03 FT02 AT02 连接器
  Pressure Flow Condcutivity  
709-10Y X X X MPX
709-14C X X - MPX
709--14E X - X MPX
709-14G X - - MPX
 

硬件

 
Part Number 描述
LGRTFFCS120AEU 1⁄2 in. single-use TFF system with Q1200 feed pump, 230 V 50 Hz 1-Phase
LGRTFFCS120AU 1⁄2 in. single-use TFF system with Q1200 feed pump, 120 V, 60 Hz 1-Phase
 

Retentate Biocontainer

 
Part Number Biocontainer Size
709-12A 5 L
709-12B 10 L
709-12A 20 L
709-14K 100 L
 

Product Recovery Biocontainer

 
Part Number Biocontainer Size
709-11E 5 L
709-14H 10 L
709-14J 20 L
709-14K 100 L
 

 


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