pall,颇尔,XRS 20 生物反应器系统,XRS20BR, XRS20IQOQ, XRS20REGTREE, 609-40A

产品名称:
XRS 20 生物反应器系统
产品型号:
XRS20BR, XRS20IQOQ, XRS20REGTREE, 609-40A
产品描述:

产品介绍

pall,颇尔,XRS 20 生物反应器系统,XRS20BR, XRS20IQOQ, XRS20REGTREE, 609-40A
pall,颇尔,XRS 20 生物反应器系统

XRS 20 生物反应器系统

Unique agitation improves cell culture performance

The XRS 20 Bioreactor System is a new single-use bioreactor system with unique agitation and control properties designed for the cultivation of mammalian cells in suspension culture under controlled conditions and suitable for applications ranging from general life sciences research to seed train operations and full GMP production at the 2 to 20 liter scale.

Comprised of three components (XRS 20 Platform, XRS 20 Controller, and Allegro™ XRS 20 Biocontainers), the XRS System produces superior performance (as measured by higher density, better cell viability, and higher expression levels) compared to competitor rocker systems because its unique Bi-Axial agitation produces shorter mixing times and higher mass transfer properties.

The XRS 20 Bioreactor System incorporates a number of other features to ensure easy operation, robust performance, and suitability for GMP operations:
 

See the XRS 20 Bioreactor System IN ACTION
 
特点 优势
XRS 20 Platform
Bi-axial agitation (rocking motion on two horizontal axes at 90 degrees separation) Improved agitation properties:shorter mixing times and higher mass transfer rates
Fully enclosed platform with safety interlock Improved operator safety, suitable for production environments, protects light sensitive culture media
Allegro XRS 20 Biocontainer
3 dimensional biocontainer design Superior mixing (with bi-axial platform), robust in operation
Biocontainer with integrated optical sensors, integrated filters, pre-assembled tubing sets True single use system, ease of installation, minimal turn-around time
Gas inlet and exhaust filters are integrity testable, sterilizing grade 0.2 μm Improved suitability for GMP operations
Integrated bottom drain with rotary lift valve Improved suitability for GMP operations, minimal hold up volume, ease of use
Multiple liquid addition ports:
  • Main liquid addition line with female CPC
  • Reagent line 1 with female luer
  • Reagent line 2 with female luer
  • Accessory port with female luer
Improved ease of use, easily handles fed batch operations, acid/base pH
control feeds
Integrated single use pH and Dissolved Oxygen (DO) sensors Ease of use and reduced probability of contamination
Integrated sampling port Ease of use - Very low hold up volume (less than 5 mL), capable of sampling without stopping agitation
Single-use biocontainer built with Allegro film Assurance of robustness, quality and supply, track record of use of film in GMP operations, validation guide available
FeatureBenefits
Advanced, full function, small footprint controller with touchscreen interface Easy to use, but with powerful control capabilities (below).Touchscreen simplifies setup, calibration, operation, alarms, trending and process data collection
3 thermal mass flow gas controllers Accurate 3 gas mixing and flow control, programmable
Full function control software
  • Powers intuitive graphical displays, including synoptic view, summary screen, trend graphing
  • Enables automatic process control of agitation, temperature, pH, DO, gas flow and mixture
  • Allows on-screen calibration for sensors and pumps
  • Supports user definable P&I settings for fine tuning of process control loops
  • Customizable alarms for process monitoring
  • Customizable loop trending for up to 8 variables, simultaneously
  • Stores up to 10 user-definable recipes Assigns peristaltic process pumps for additions and harvest
  • CFR21 Part 11 compatible.Multilevel security to limit setpoint control access
Integrated USB ports Rapid, easy data collection and software updates
Convenient access to utility connections Quick set up and easy maintenance
In-line container pressure monitor with relief valve System robustness – prevents over pressuring of biocontainer
 


Tubing management system In-process sampling Drain and optical sensors
Tubing management system In-process sampling Drain and optical sensors
 
 

XRS 20 Bioreactor System Specifications

 
Allegro XRS 20 Biocontainer Minimum Working Volume 2 L
Maximum Working Volume 20 L
Irradiated Gamma:dose 25-40 Kgray
控制员 Control Station Controls up to 32 control loops; stores 10 recipes and 8 process variables for trend graphing.Includes an industrial touchscreen monitor/user interface, 3 built-in pumps & connectors for all utilities & communications signals.
Touchscreen Interface/Display 25.4 cm (10 in.)LED monitor
Temperature Indication Digital display in 0.1 °C increments
Range From 8 °C above ambient temperature to 40 °C (ambient temperature defined as 10 to 30 °C)
控制 P&I control for heating.Heating is assured via the heater mat and cooling via ambient temperature.
Sensor Platinum RTD probe
Agitation Drive Stepper motors
Indication Digital display in 1 rpm increments.
Range 1 - 35 rpm
Angle -15° to +15° in both X and Y directions
控制 Stepper motor controlled
Exhaust 过滤器 0.2 μm disposable filter (integrated with biocontainer)
Exhaust Heater Silicone heater mat
Aeration 3-Gas System Up to 3 gases (Air, O2, CO2, or Mixture), Thermal Mass Flow Control
Sparger Gas sparged into biocontainer headspace
Inlet Filter 0.2μm disposable filter (integrated with biocontainer)
pH Indication Digital display in 0.01 pH increments
Range 6 - 8 pH
控制 P&I
Sensor Non-invasive optical pH probe
DO Indication Digital display in 0.1% increments
Range 0 - 200%
控制 3-gas P&I control
Sensor Non-invasive optical DO probe
Pump 1 Assignable peristaltic pump
Fixed speed (14 rpm) or variable duty cycle
Available control modes:Off, On, Prime.
  Pumps 2 & 3 Assignable peristaltic pumps
Fixed speed (109 rpm) or variable duty cycle
Available control modes:Off, On, Prime.
公用设施 气体 68.9 mbar (1 PSIG) maximum
Electrical Requirements Control Station 100-240 VAC, 50/60 Hertz, Single phase, 13 amp
Reactor Platform 105-230 VAC, 50-60 Hertz, Single phase, 13 amp
Power Rating, Reactor Platform 1150 W
Net Weight Control Station 20 kg (44 lb)
Reactor Platform 78 kg (171.6 lb)
Overall Dimensions
XRS Control Cabinet
29.5 cm W X 40.6 cm D X 66.8 cm H
(11.6 in. wide X 16 in. deep X 26.3 in. high)
Overall Dimensions
Reactor Platform
90 cm W X 60 cm D X 62 cm H
(35.4 in. wide X 23.6 in. deep X 23.6 in. high)
Allow for the lid's 20cm overhang at the rear of the platform, and factor in an additional 37 cm to the overall height when the lids are open.
External Computer Connections Ethernet port supplied for future connection to supervisory host computer
Fuses 2 Cooper Bussmann S505-10-R 5 x 20 mm 10 A fuses
合规性 See Section 5.1 Instructions For Use USD 2875
Ambient Operating Conditions 10 – 40 °C, up to 80% relative humidity, non-condensing
 

Allegro XRS 20 biocontainer
Allegro XRS 20 biocontainer supplied as a complete, ready-to-use, single-use system

Allegro XRS 20 Biocontainer Tubing & Connection Specifications

 
用途 Tubing Type Length 尺寸 连接
Spare addition port Thermo-elastomer 50 mm (2 in.) 4.8 mm ID x 7.9 mm OD
(316 in.ID x 516 in.OD)
Swabable female luer
Gas inlet tube Thermo-elastomer 858 mm (34 in.) 4.8 mm ID x 7.9 mm OD
(316 in.ID x 516 in.OD)
0.2 μm filter with tapered hose tail
Platinum Cured Silicone 50 mm (2 in.) 6.35 mm ID x 11.11 mm OD
(14 in.ID x 716 in.OD)
Main liquid addition tube Thermo-elastomer 800 mm (32 in.) 3.18 mm ID x 6.4 mm OD
(18 in.ID x 14 in.OD)
6.35 mm
(1⁄4 in.)MPC
Platinum Cured Silicone 500 mm (20 in.) 6.35 mm ID x 11.11 mm OD
(14 in.ID x 716 in.OD)
Addition tube 2 Thermo-elastomer 800 mm (32 in.) 3.18 mm ID x 6.4 mm OD
(18 in.ID x 14 in.OD)
Female luer
Platinum Cured Silicone 500 mm (20 in.) 3.18 mm ID x 6.4 mm OD
(18 in.ID x 14 in.OD)
Sampling tube Thermo-elastomer 685 mm (27 in.) 4.8 mm ID x 7.9 mm OD
(316 in.ID x 516 in.OD)
Swabable female luer
Platinum Cured Silicone 100 mm (4 in.) 3.18 mm ID x 6.4 mm OD
(18 in.ID x 14 in.OD)
Addition tube 1 Thermo-elastomer 800 mm (32 in.) 4.8 mm ID x 7.9 mm OD
(316 in.ID x 516 in.OD)
Female luer
Platinum Cured Silicone 500 mm (20 in.) 4.8 mm ID x 7.9 mm OD
(316 in.ID x 516 in.OD)
Gas vent tube Thermo-elastomer 913 mm (36 in.) 6.35 mm ID x 11.11 mm OD
(14 in.ID x 716 in.OD)
0.2 μm filter with downstream check valve with 1.3 mm (12 in.) hose tail
Drain tube Platinum Cured Silicone 1283 mm
(50.5 in.)
6.35 mm ID x 11.11 mm OD
(14 in.ID x 716 in.OD)
6.35 mm
(14 in.)MPC
 
 
 

Bi-Axial Rocker for Better Mixing and Mass Transfer

The XRS bioreactor system rocks on two axes simultaneously (Bi-Axial agitation), producing a low turbulence, swirling pattern within the 3-dimensional XRS 20 Biocontainer.Under similar agitation conditions, the XRS system mixes almost 3 times faster than conventional rockers, and demonstrates much higher mass transfer properties as measured by kLa values.

Summary of best mixing times observed in pH equilibration studies, 20 liter working volumes with conventional pH probes1
 
系统 条件 Mixing Time (s)
Conventional Maximum speed and rock angle = 42 rpm, 10.4° 50 to 98 seconds3
XRS 20 75% Max speed, maximum long axis angle, 1/3 short axis angle = 30 rpm, 15° long, 5° short 16 seconds
 


Summary of mass transfer coefficients observed in 20 liter working volumes as measured with nitrogen purge and recovery2
 
系统 条件 KLa per Hour
Conventional Maximum speed and rock angle = 42 rpm, 10.4° 42
XRS 20 Maximum speed and angle = 40 rpmv, 15° long, 15° short 73
 
1 Mixing trial results from 3 repetitions for each device
2 Mass transfer results from 3 repetitions for each device
3 Times significantly different for edge/center measurements
 

Better Mixing, Better Cell Culture Performance

The superior mixing properties due to the design of the 3-D biocontainer and the bi-axial agitation leads to superior cell culture performance in mammalian suspension systems.With faster delivery of nutrients to the cellular micro-environment (and faster removal of metabolites), the XRS 20 System allows cells to attain higher densities, and with higher overall viabilities, leading to much significantly higher protein expression levels.In the batch culture example cited below, with identical media inputs and seeds, the 颇尔 XRS Bioreactor System produced 18% higher cell densities, and 30% more antibody titer compared to conventional rocker technologies.

Summary of side-by-side growth and viability experiments (n=3) at 20 liter working volumes comparing conventional rocker system and 颇尔 XRS 20 system.Simple batch culture of a CHO (Chinese hamster ovary) cell line expressing a monoclonal antibody.
Summary of side-by-side growth and viability
 
 
Part Number 描述
XRS20BR XRS 20 生物反应器系统
XRS20IQOQ XRS 20 Bioreactor System Validation Package IQ/OQ Documentation Package
XRS20REGTREE XRS 20 Bioreactor System Installation Kit
609-40A Allegro XRS 20 Biocontainer (with User-Fit pH Sensor Probe) Pack of 4 each
Allegro XRS 20 Biocontainer Accessories
509-2297 20 Liter, 2D Biocontainer bag with integrated sterilizing filter, Male CPC Connector, gamma irradiated
509-2296 5 Liter, 2D Biocontainer with integrated sterilizing filter, Male Luer Connector, gamma irradiated
509-2295 1 Liter, 2D Biocontainer with integrated sterilizing filter, Male Luer Connector, gamma irradiated
509-2294 500 mL, 2D Biocontainer with integrated sterilizing filter, Male Luer Connector, gamma irradiated
509-0283 “Y” linker, with 2 Female Luer Connections, 1 Male Luer Connector, gamma irradiated
XRS20FOCAB Spare Fiber Optic Cables
 

 


pall,颇尔,XRS 20 生物反应器系统
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