Fully customized process liquid handling systems allow different options to be integrated into a core platform. Each system is optimized to the column diameter and process requirements.
The versatile Bio-Rad process chromatography skid 00 can be customized for different applications using a core platform and integrating optional hardware. Each system is optimized to the column diameter and process requirements. To learn more click on the video.
The Bio-Rad process chromatography station 00 includes Bio-Rad's process skid 00, the industry's first compact skid designed for small-scale GMP biopharmaceutical manufacturing. It also incorporates one of Bio-Rad's process chromatography columns and Bio-Rad's new prep station, which enables media transfer and column lifting. This compact design can be scalable to larger skids.
The Bio-Rad process chromatography station 00 can be adapted to process requirements by integrating options for the Bio-Rad process skid 00 and selecting the appropriate process column. Depending on the column type, the prep station is equipped to drive the following:
Components of the Bio-Rad Process Chromatography Station 00
A Warm Welcome Bio-Rad Laboratories welcomes you to our pilot-scale development laboratory for process chromatography. Located at Bio-Rad corporate headquarters in Hercules, California, on the southeastern shore of the San Pablo Bay, the laboratory offers access to state-of-the-art chromatography equipment and media and to the expertise of our team of separations scientists and engineers. Working with laboratory staff, you will have the opportunity to operate chromatography hardware, optimize your packing procedures, and review optimal solutions for your manufacturing processes.
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Bio-Rad InPlace process-scale chromatography columns are designed for industrial applications with contained filling, packing, unpacking, and cleaning for safe and hygienic column operation. To learn more about Bio-Rad InPlace columns, click on the video.
Bio-Rad InPlace process-scale chromatography columns are designed for industrial applications and allow contained filling, packing, unpacking, and cleaning in place. The columns have a sanitary design, variable height adaptor, inflatable seal, and special low-shear valves for safe slurry transfer.
The Bio-Rad InPlace columns have been designed so that the packing, unpacking, and cleaning-in-place features do not interfere with the bed support, distribution system, and column tube, thus allowing optimum performance during any operation. These columns are directly scalable and retain the same general design from pilot to manufacturing scale. For instance, slurry valves can be added or removed to correlate with column diameter so that the efficiency of packing and unpacking in place is kept across the entire range of dimensions.
Bio-Rad InPlace columns are available in many standard sizes, and custom-made columns can be built in any tube height up to 1,200 mm or any diameter up to 2 m. The scale and scope of a project will seldom pose a constraint. Bio-Rad InPlace columns are available with glass, stainless steel, or acrylic column tubes.
Optimal Column Performance:
An All-In-Place System
The Bio-Rad InPlace column is designed to be operated with the Bio-Rad media transfer device to enable:
To pack the column, the variable height adaptor is raised to its highest position, and slurried medium is pumped through the slurry valves into the column. The low-shear valves are specially designed to minimize damage to chromatography media during transfer. Buffer or slurry can be pumped through the slurry valves to maintain agitation, thereby reducing settling, if necessary. The column is packed by axial compression, flow or a combination of both, for optimal bed packing. The slurry valves can be rinsed while the column is packed to prepare for unpacking.
Before the unpacking operation begins, the bed is reslurried in the upflow/downflow mode while the piston is raised to its highest position. The slurry is then pumped out through the slurry valves, and when it is unloaded completely, the cleaning jets can be used to rinse the column. The powerful jets ensure that no medium or residue remains on any contact surface and help to sanitize the column.
* Columns with internal diameters >1,400 and <400 mm are available as special orders. ** Higher pressure rating can be proposed as a special order.
Variable Height Adaptor and Optional Packing Motor
Bio-Rad InPlace columns use a variable height adaptor with an adjustable central screw mechanism. This design fits any column diameter from pilot to manufacturing scale. The adaptor allows either axial compression or flow packing, or both, while the central screw mechanism allows simple yet precise adjustment of the bed height.
Bio-Rad offers optional packing motors for all column diameters. A motor is strongly recommended for column diameters of 200–1,000 mm and is standard for columns >1,000 mm. The use of a Bio-Rad packing motor allows automatic movement (upward and downward) of the adaptor and controllable speed axial compression packing, which makes packing reproducible, easier, and faster.
Flow Distribution System
The adaptor and bottom endpiece of Bio-Rad InPlace columns comprise a unique flow distribution system that enhances packing and operational performance. The standard filter is stainless steel with 20 µm porosity for uniform flow and minimal product retention. The distributor plate directs the flow across the filter quickly and evenly. This combination of distributor plate and filter ensures optimal, uniform flow distribution across the bed and through the column at any flow rate.
The design of the Bio-Rad InPlace adaptor seal provides added security against leakage and inefficient packing by ensuring uniform pressure throughout the seal. All columns have a pressure line through which the seal can be inflated with compressed gas (air or nitrogen). If preferred, a liquid pump can be installed so that inert fluids can be used for inflation instead of gas.
Regulatory Support and Quality Assurance
Bio-Rad's manufacturing procedures mandate full documentation of each step and every component in compliance with U.S. and European regulations. The original documentation and one electronic copy are included with each column. Bio-Rad maintains controlled copies. Bio-Rad InPlace chromatography columns are manufactured in compliance with engineering standards for pressure vessels, and each column comes with CE certification. The Bio-Rad manufacturing facility is certified according to ISO 9001:2000 standards. Manufacturing files for each project include:
Bio-Rad EasyPack process-scale chromatography columns are designed for industrial applications. These open columns have variable bed-height adaptors, inflatable seals, and fixed bottom endpieces. Their sanitary design ensures hygienic performance and thorough cleaning. All Bio-Rad EasyPack columns come with a complete set of regulatory support documentation.
From pilot to manufacturing scale, Bio-Rad EasyPack columns are directly scalable. To minimize scale-up and development time, these columns have the same basic design for all column configurations. Standard column dimensions include tube lengths of 300, 600, and 900 mm and diameters from 100 to 1,400 mm. Columns are available with borosilicate glass, 316L stainless steel, or acrylic column tubes. Columns may be customized to any length up to 1,200 mm or any diameter up to 2 m.
Variable Height Adaptor With Central Screw Adjustment Mechanism
Bio-Rad EasyPack columns have a centralized variable height adaptor for all column diameters up to 1,000 mm, from pilot to manufacturing scale. With its adjustable central screw mechanism, the adaptor allows either axial compression, flow packing, or both. Additionally, the adjustable adaptor provides the flexibility to accommodate any chromatography support at any bed height with a single column.
Unique Flow Distribution System
The adaptor and bottom endpiece of Bio-Rad EasyPack columns have a unique flow distribution system that enhances packing and operating performance and ensures uniform distribution at all flow rates.
The standard filter is stainless steel with a 20 µm porosity for uniform flow and minimal product retention. A distributor plate directs the flow across the filter quickly and evenly. This distributor plate and filter combination ensures optimal, uniform flow distribution across the bed and through the column.
Inflatable Seal Design
The design of the Bio-Rad EasyPack adaptor seal provides added security against leakage and poor packing by ensuring uniform pressure throughout the seal. The adaptor seals on all columns are inflated with compressed gas (air or nitrogen) as standard. If preferred, a liquid pump can be installed so that inert fluids can be used for inflation instead of gas.
The Bio-Rad manufacturing procedures ensure that each step and every component are fully documented. The qualification documentation package allows production in compliance with U.S. and European regulations. The original documentation and one electronic copy are included with each column. Bio-Rad maintains controlled copies. Bio-Rad EasyPack chromatography columns are manufactured in compliance with engineering standards for pressure vessels, and each column comes with CE certification. The Bio-Rad manufacturing facility is certified according to ISO 9001:2000 standards.
Bio-Rad Packing Motor
Bio-Rad offers an optional packing motor for all column diameters. The motor ensures quick and precise control when raising and lowering the adaptor. The packing motor makes it possible for one person to pack large-diameter columns. A motor is strongly recommended for column diameters of 200–1,000 mm and is standard for column diameters greater than 400 mm.
In addition to offering a standard line of columns, Bio-Rad specializes in working with customers to design and manufacture custom columns. Customization may include modification to column dimensions, pressure rating, valves, ports, material, jacketing, etc. Bio-Rad EasyPack columns are easily upgradable to Bio-Rad InPlace process chromatography columns, which allow packing, unpacking, and cleaning in place. Please contact your local Bio-Rad sales representative for ordering information.
* Standard tube heights available: 600 and 900 mm.
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