Attachment A- Technical Specifications.pdf

NGC™ Chromatography Systems - Sole Source Specifications

BioRad Laboratories is the original manufacturer and sole supplier of the NGC Chromatography systems

The NGC family of chromatography systems is suitable for both analytical and preparative purification applications. There are multiple NGC system configurations with optional valve and detector module upgrades. The base system includes two pump modules, a mixer, a sample injection valve and a combined UV and conductivity module along with all the accessories required to run the system. The system includes ChromLab™ software for instrument control, method creation and data evaluation. A computer capable of running Windows 7 or higher is required for control.

Figure 1.

Summary:

The system includes a choice of 10 mL or 100 mL pump heads with dual piston design. All-PEEK pump heads ensure biocompatibility and chemical inertness. The system is provided pre-plumbed with 1/16th inch PEEK tubing. It includes a point-to-plumb feature (Figure 2) with LED light guides to connect tubing correctly. The system includes an accurate high pressure gradient mixer. Variable volume mixer barrel design enables efficient mixing across all flow rates.

Columns can be connected using 10-32 (1/16th inch) fittings. Adaptors are available to connect columns that require alternate fitting sizes.

The system includes UV or UV/Vis and integrated conductivity detection. The single UV monitor includes a LED lamp for detection at 255nm or 280 nm. The UV/Vis detector has Deuterium and Tungsten lamps, for simultaneous detection at up to four wavelengths (190-800 nm). Both are designed for easy lamp replacement. A 5 mm flow cell is provided with the system and 2 mm and 10 mm flow cells are available as optional accessories.

Table 1: Summary of the NGC system component specifications

NGC F10 Systems NGC F100 Systems

Flow Rate Range 0.001-10 ml/min 0.5-20 ml/min in High Flow mode (H.F.)

0.01-100 ml/min 1.0-200 ml/min in High Flow mode (H.F.)

Pump Flow Rate accuracy ± 1.5 % at

0.1 to 10 ml/min, <600 psi (<4.1 MPa), 0.5-3.7 cP

± 1.0 % at

1.0 to 100 ml/min, <600 psi (<4.1 MPa), 0.5-3.7 cP

Gradient Flow Rate Range 0.1-10 ml/min 0.5-20 ml/min (H.F.)

0.5 – 100 ml/min 5.0-200 ml/min (H.F.)

Gradient Composition Accuracy ± 0.5% at 3-97% B; 0.25-10 ml/min ± 1.0% at 5-95% B; 0.5-20 ml/min (H.F.)

± 0.8% at 5-95% B; 1.0-100 ml/min ± 1.0% at 5-95% B; 5.0-175 ml/min (H.F.)

Operating Pressure Maximum 3,650 psi (25.2 MPa) 1,450 psi (10 MPa)

Pressure Pulsation < 1% at 2 ml/min (1,000 psi) < 3% at 10 ml/min (1,000 psi)

Pressure Accuracy ± 2% ± 2%

Operating Viscosity Range (System Pump)

0.35-10 cP 0.35-10 cP

Operating Viscosity Range (Sample Pump)

0.35-10 cP 0.35-10 cP

Single Wavelength Detection 255 nm or 280 nm 255 nm or 280 nm

Multiple Wavelength Detection Up to 4 wavelengths (190-800 nm) Up to 4 Wavelengths (190-800 nm)

Absorbance Range 0-3,000 mAU 0-3,000 mAU

Linearity ≤ 5% between 0-2 AU ≤ 5% between 0-2 AU

Conductivity Flow Cell 6 uL 6 uL

Conductivity Range 0.01 to 999.99 mS/cm 0.01 to 999.99 mS/cm pH range 1-14 1-14 pH Measurement Accuracy ± 0.1 pH units ± 0.1 pH units

Outlet Option Up to 2 valves (22 fractions/ports) Up to 2 valves (22 fractions/ports)

Buffer Inlet Options Up to 2 valves (16 buffers/ports) Up to 2 valves (16 buffers/ports)

Sample Inlet Options Up to 2 valves (15 samples/ports) Up to 2 valves (15 samples/ports)

Column Switching Valve Options Up to 3 valves (15 columns) Up to 3 valves (15 columns)

Air Sensors Up to 8 Up to 8

Operating Temperature range 4-40 ºC 4-40 ºC

NGC™ Chromatography Systems Sole Source Features and Performance The NGC is a single instrument platform that scales and adapts to meet user requirements as they change over time.

The NGC is available as a pre-plumbed system that can be upgraded as per user requirements.

NGC systems have the following features:

Modular Design:

The NGC system has a unique modular design which allows researchers to:

Select components such as pumps, detectors, and valves to customize their purification system to meet their automation needs.

Modules are plug-and-play without cable connectors.

Modules can be placed at any location on the system.

Integrated sample pump conserve precious lab bench space.

Upgrade their system at any time without having to pay for unnecessary features up front or purchase a new system later.

Repair the system by mailing in the defective module in exchange for a new one, which minimizes down time and ensures meeting critical deadlines.

Service is not required to add, move or replace modules.

LED displays on the module confirm real time system status at a glance.

Tier-Expansion Feature:

Tiers with 5- single module bays are available to expand the NGC system vertically.

The NGC system supports up to two additional Tiers or 10 additional single modules to expand automation capability.

Point-to-Plumb™ Feature:

ChromLab software includes a point-to-plumb feature which connects the fluidic scheme to LED lights on each module, indicating the correct position for connecting the tubing and facilitating error free system set

up. (See Figure 2)

Figure 2.

Tier-Rotate™ Feature:

The Tier Rotate™ feature enables optimal placement of valves and detectors to minimize hold up volume and improve peak resolution (Figure 3).

Figure 3. Tier Rotate

Tiers with 5 module bays each are available to expand the NGC system to up to four tiers, to add up to 10 additional modules.

Touch screen:

The NGC system includes a touch screen which

Allows quick access to system control when the control PC is located remotely (via network). This includes:

o Manual purification experiments o Editing a run in progress o Real time status updates o Device calibration

Can be mounted on either side of the system or on a stand for easy access, if the NGC system is placed inside a refrigerator.

Gradient Pumps:

All-PEEK pump heads ensure biocompatibility and chemical inertness.

Swappable F-10 or F-100 dual piston pump modules covers small and prep scale purifications.

The F100 system are factory plumbed with 1/16 th x 0.03 inch PEEK (green) and the F10 system are factory plumbed with 1/16 th x 0.02 inch PEEK (orange) tubing.

Detectors:

The NGC offers UV, conductivity and pH detection. The UV detector modules include integrated conductivity monitors.

The single wavelength detector o Two wavelength selection, 280nm or 255 nm o LED lamp, which is designed for long life and easy replacement.

The multi-wavelength detector o Simultaneous four wavelength monitoring between 190-800 nm o Includes a tungsten and deuterium lamp, both designed for easy replacement

The UV & UV/Vis detectors on both F10 and F100 systems include a 5 mm flow cell. 2 mm (prep) and 10 mm (analytical) flow cells are available as options. The conductivity monitor includes a flow cell volume of 6 uL.

The pH Valve includes

An Ag/AgCl pH probe for accurate measurement of pH (± 0.1 pH units).

Automated switching between bypass and pH probe.

Calibration ports for easy routine calibration without the need to remove the probe from the system.

External Detectors (3 rd party):

The NGC system supports up to two external detectors via the SIM module.

Signal Input: External detector signals can be imported into the chromatogram, scaled and provided with customized names via ChromLab software.

Signal Output: The NGC system is capable of UV signal output to third party detectors, such as the MALs particle size analyzer, via the SIM module.

Mixer:

The NGC mixer is a post-pump high pressure gradient mixer. Variable volume mixer barrels are available to provide efficient gradient mixing at high flow rates.

Sample Loading:

NGC Sample Injection Valve allows both sample loop and sample pump to be plumbed at the same time.

Sample loops o Static loops (25 uL to 5 mL) o Dynaloops (25 or 90 ml)

Sample pump o Ideal for sample volumes greater than 7 mL o Can be used with Inlet Valves for injecting multiple samples o Flow rate range of 0.03 to 100 ml/min o Backpressure range of 0 to 1,450 psi (0 to 10 MPa) o Pressure pulsation at 1 ml/min is ± 5% o Pressure accuracy is ± 2% o Flow rate accuracy is ± 2% o Viscosity range is 0.35 to 10 cP

C-96 autosampler, with or without peltier cooling, for automated loading of multiple small volume samples o 84 x 1.5 ml vials, 3 x 10 ml vials (standard tray) o 96 x 1.5 ml vials (optional tray) o 24 x 10 ml vials (optional tray, Prep kit)

Sample Inlet Valve:

Each NGC sample inlet valve, used in conjunction with the sample pump, allows selection of up to 8 samples or buffer.

The NGC system supports up to two sample inlet valves for up to 15 different samples.

Buffer Inlet Valve:

The NGC buffer inlet valve allows selection of up to 8 buffers per valve.

The NGC system supports up to two buffer inlet valves for up to 16 different buffers, ideal for method development.

User has the flexibility to use these valves with pump A or pump B or both.

In the presence of buffer blending, the user can choose between automated blending and manually prepared buffers.

Buffer Blending Valve:

Buffer Blending Mode: The NGC buffer blending valve allows for accurate and automated blending of buffers using concentrated stock solutions. This enables rapid pH scouting using 45 pre-programmed buffers within ChromLab.

High Flow Mode: The buffer blending valve can also be used in High Flow mode to create salt gradients at double the flow rates than what the system pumps are capable of.

Column Switching Valve:

The NGC column switching valve module can hold up to 5 columns for quick column scouting and reverse flow applications.

The valve has a column bypass function, allowing the system to be primed or cleaned without the need to remove the column.

The NGC system supports up to three Column Switching Valves for up to 15 columns.

Each column switching valve can measure pre-column and delta column pressure for the column(s) that are placed in-line.

Fraction collection:

The BioFrac fraction collector is available with collection formats ranging from microplates, tubes to bottle size collection. An ice bath rack is available to help maintain sample integrity.

Outlet Valve:

The NGC outlet valve allows for collection of up to 11 large volume fractions.

The NGC system supports up to two outlet valves capable of collecting up to 22 large volume fractions either with or without the BioFrac fraction collector.

Air Sensors:

The NGC system supports up to 8 air sensors which can be used to measure end-of-buffer or end-of-sample events. While ChromLab automatically reacts to air sensing events, LED lights on the air sensor module provides visual indication of when air is detected.

Column Clamps:

Magnetic column clamps are included which attach to any surface on the NGC system. These allow flexibility in the placement of columns on the front or sides of any NGC system configuration.

Cold Box/Room Compatibility:

The NGC system easily fits into a single-door "deli" fridge and connects to the controller via a single Ethernet cable. Monitor stand and longer Ethernet cables are available for mounting the Touch Screen on the exterior of the deli box.

ChromLab™ Software Sole Source Features and Performance

ChromLab is a single software package for instrument control, method creation, and data evaluation and is used for all NGC systems. It is not necessary to purchase software packages when additional modules are added. The unique fluidic scheme selector allows users to quickly modify the fluidic scheme to match any physical changes to the system (Figure 4).

Figure 4.

ChromLab’s unique mapping feature allows users to easily map multiple valve modules to the exact physical location on the system hardware (Figure 5).

Figure 5.

ChromLab can run in manual mode and saves the data generated by manual runs.

ChromLab’s method editor provides application/method templates or method creation using a drag and drop phase library.

Methods may be run in time, volume, or column volume units.

ChromLab’s columns library includes a list of most commonly used columns and properties from both Bio-Rad and GE (Figure 6), making it an open platform.

Figure 6.

ChromLab also allows users to add and delete their own custom columns to the column library (Figure 7)

Figure 7.

Gradients can be edited using text or adjusting the phase parameters in the graphical display (Figure 8).

Figure 8.

Method parameters may be edited while a run is in progress.

Multiple methods can be queued to run sequentially without intervention.

Scouting enables automated single parameter scouting of methods based on Flow rate, %B, Duration, pH, Column and Sample, to rapidly identify optimal conditions (Figure 9)

Figure 9.

Tandem Templates enable easy automation of multiple step purification protocols using multiple columns in sequence (Figure 10).

Figure 10.

Data evaluation offers 1-click peak integration and calculation of peak parameters such as o Retention time and retention volume o Height o Area o Width at Half Height o Asymmetry o Concentration (with known extinction coefficient) o Purity (280/255 ratio)

Peak to Fraction tracking feature allows users to visually locate the tube in which their peak fraction is located.

Heat maps enable users to visually identify fraction tubes with the highest concentration or purity (Figure 11).

Figure 11.

Fraction pooling calculates the protein concentration/purity of a pool of fractions in the rack.

1-Click to stack or overlay multiple chromatograms for quick comparison of various runs.

1-click peak integration of multiple chromatograms is possible simultaneously (Figure 12).

Figure 12.

When selecting run data, the software provides a thumbnail image of the selected chromatogram (Figure 13)

Figure 13.

External detector names can be customized along with their units, within System Setting (Figure 14)

Figure 14.