Biotage® Flash 400 Systems

The ultimate purification system, Isolate up to 8 kg of product per run at 6 L/min

The Biotage® Flash 400 system is a complete skid-mounted system designed for kilogram scale separations. Built to last and engineered to perform, with materials that comply with FDA regulations and cGMP standards. Available in two configurations, supporting 20Kg and 40Kg cartridges, Flash 400 is the first choice of pharmaceutical and contract manufacturing companies around the world for critical purification applications.


Benefits

BIOMARK002.215 - Principles scaling up social

Reliable Scale-Up, Faster

Biotage® Flash 400 systems safely operate at 100 psi enabling fast flow rates and the use of higher viscosity solvents. Our proven, patented radial compression technology ensures near zero “wall effects” and channelling inside each column. This maintains the bed’s stability, rendering cleaner, purer fractions in less time and higher overall product yield.


Radial pressure

Flash 400 cartridges are so-called as they are 400 mm in diameter and routinely operate at flow rates up to 6000 mL/min.  These purification systems allow you to quickly complete scale-up and production runs, saving hours or even days of purification and plant time.


Robust and Safe

Robustness and safety are key factors for any scale up system. Biotage® Flash 400 needs minimal maintenance and its design has proven to be extremely reliable. With operating pressures up to 100 psi, this system supports flow rates up to 6 liters per minute, allowing operators to save days or even weeks of project time, resulting in substantial project cost savings. The Flash 400 system uses pre-packed cartridges and radial compression, and supports two interchangeable barrels for use with either 400 mm x 300 mm (Flash 400M) or 400 mm x 600 mm (Flash 400L) cartridges. One of the compression module sizes is included in the system (the module of the other size can be ordered and is interchangeable as an option). A variety of pre-packed cartridges are available depending on the purification goal and cartridges can be custom packed with the preferred chromatography media for your process. The media in each cartridge is self-contained, improving handling and eliminating exposure to contamination and impurities or potentially high toxicity APIs.

Built and Documented for cGMP Production

All systems come complete with an ASME “UM” stamp, CE certification, and are certified for usage in Japan, Europe and North America. An extensive engineering documentation package, certificate of performance and certificate of compliance for validation filing accompany each system. Professional Biotage service personnel train users on proper operation, and are available for project based or yearly training sessions.

GMP


Safety is Paramount

Safety is a key design criteria on all Biotage flash systems. Designed for use around large quantities of solvents Flash 400 systems can operate in an explosion proof, no sparking rated area. Air driven pump and hoists, proper grounding and pressure relief devices are some of the vital components included with every system. All systems comply with NEC Class 1, Division 1 and 2, Group C and D standards.

non-explosive-icon

Cartridges for Any Application

From routine normal phase flash chromatography to more difficult separations with reversed phase silica, activated carbon, low metal/acid washed silica, Mitsubishi Diaion™ HP20SS resins, ion exchange or other custom packed, client supplied media, Flash 400 systems are capable of addressing almost every purification need.

The Flash 400 system uses pre-packed cartridges and radial compression, and supports two interchangeable barrels for use with either 400 mm x 300 mm (Flash 400M) or 400 mm x 600 mm (Flash 400L) cartridges. One of the compression module sizes is included in the system (the module of the other size can be ordered and is interchangeable as an option). A variety of pre-packed cartridges are available depending on the purification goal and cartridges can be custom packed with the preferred chromatography media for your process. The media in each cartridge is self-contained, improving handling and eliminating exposure to contamination and impurities or potentially high toxicity APIs.  Flash 400 systems are capable of addressing almost every purification need.

Scalable Results

Technologies such as crystallization and adsorption can be difficult and time consuming to scale up. Using the extensive cartridge range from Biotage, reliable results are verifiable and easy to achieve with any separation.  For example a Biotage® SNAP  or SFAR 10 g column (to purify 100 mg quantities) can be used as a basis to purify multi gram and ultimately kg quantities of product using a 40 kg Flash 400 cartridge. Moving up the cartridge range, purifications can be scaled up 4000 times. We recommend increments of 10-fold to provide maximum control and opportunity to optimize further any scale up parameters.

Scale_1




Flash 400 System Part numbers

Part No. Description Pack Size
SF-521-50150 Flash 400L system (with Hoist) 1
SF-521-50070 Flash 400M system (with Hoist) 1



Flash 400 Cartridge Selector

Part No. Description Pack Size
FSUL-0401-50150 Cartridge, (1) HP-Sphere C18 FLASH 400L 1
FSUL-0401-50070 Cartridge, (1) HP-Sphere C18 FLASH 400M 1
C1YR-4021-50155 Flash 400L Cartridge (26Kg) with WAC 2
F400L-0445-50150 Flash 400L Cartridge with Biotage Sfär 60 micron silica,1/pk 1
F400L-0443-50150 Flash 400L Cartridge with Biotage Sfär HC silica, 1pk 1
FT6-2530-50150 Flash 400L Cartridge with HP-20SS 1
F400L-0442-50150 Flash 400L Cartridge with HP-Sphere 1
FL0-1118-50150 Flash 400L Cartridge with KP-C18-HS 1
FK0-1107-50150 Flash 400L Cartridge with KP-Sil 1
FPNH-400L Flash 400L with Biotage KP-NH media, /cs 1
C1YR-4021-50075 Flash 400M Cartridge (13Kg) with WAC 2
F400M-0445-50070 Flash 400M Cartridge with Biotage Sfär 60 micron silica,1/pk 1
F400M-0443-50070 Flash 400M Cartridge with Biotage Sfär HC silica, 1pk 1
F400M-0442-50070 Flash 400M Cartridge with HP-Sphere 1
FPNH-0454-50070 Flash 400M Cartridge with ISOLUTE Flash-NH2, 1/pk 1
FPNH-0454-50150 Flash 400M Cartridge with ISOLUTE Flash-NH2, 1/pk 1
FL0-1118-50070 Flash 400M Cartridge with KP-C18-HS 1
FK0-1107-50070 Flash 400M Cartridge with KP-Sil 1
FPNH-400M Flash 400M with Biotage KP-NH media, 1/pk 1




Specifications

Pipette Calibration Notifications  WEIGHT     455 kg (1000 lbs) typical, depending on configuration

Dimensions 3D  DIMENSIONS     (LxWxH) (Hoist Retracted) : 115 cm x 78 cm x 175cm, (LxWxH) (Hoist Extended) : 115 cm x 78 cm x 241cm

Flow Rate  FLOW RATE RANGE     (pressure controlled, up to 6 L/min) 2-5 L/min recommended

Pressure  INLET PRESSURE RANGE     100 psi (6.9 bar)

Radial pressure  RADIAL COMPRESSION PRESSURE     80-100 psig (552-689 KPa)

Flow  SOLVENT DELIVERY     via pneumatic solvent pump 100 psig (6.9 bar maximum)

Electrical Supply  POWER REQUIREMENTS     N/A – inert gas driven (fully grounded) system

Lagel Info  CERTIFICATIONS     CE, ATEX, ASME

Weight  INSTALLATION FLOOR LOAD REQUIREMENT     1,220 kg/sq. meter, (250 lbs/sq. ft.)