Peak Biotech Pilot and Process Scale Customized Chromatography Equipment for the Pharmaceutical and Biotech Industry

Peak Biotech A/S is company with focus on pilot- and process scale customized chromatography equipment for the Pharmaceutical and Biotech industry.

Easy handling DAC columns

Peak DAC high performance columns have variable bed length and are designed for low to high pressure applications. The columns are designed with internal hydraulic compression, which makes the construction space saving. Especially when beds are packed, this is a strength due to high mobility, e.g. through door openings.

Same distributor and frit construction in the top and bottom of the column allow both up and down flow directions and ensure an even distributed flow through the packed bed.

General DAC column specification

Specifications include:

• Column diameter 50mm – 1,600mm
• Packed bed length 50mm – 1,500mm
• Design pressure 2bar – 100bar
• Design flow according to customer requirement
• High performance packing
• Special designed distributor design ensures even flow across the bed
• Slurry inlet valve for quick and easy packing
• Slurry outlet valve for quick and easy unpacking, without opening the column
• Repacking without opening the column
• Reproducible packing each time
• The packing can be automated

Column sanitary design

Inlet and outlet valve in sanitary design, connections are sanitary design with minimized dead volumes inside columns allowing complete CIP flexibility.

Mobile construction makes it possible to move the columns around within the facility, e.g. when necessary to do column packing in one area and production in another area. There is easy installation and connection to other equipment.

They feature removable frit plates for easy replacement, in order to cleaning purpose or product change. Frit plates are available within a range of frit pore sizes from 2µ to 75µm.

Column materials and construction

• All columns are CE-marked and cGMP compliant
• Parts in product contact: Stainless Steel 316L, duplex or hastelloy
• PEHD or PTFE sealings in FDA approved materials (USP Class VI is optional)
• Construction codes: PED for Europe
• ASME for US
• Design codes: ASME BP
• Chromatography systems

Low, medium and high pressure chromatography systems

Peak Biotech LC systems are available for low, medium and high pressure chromatography applications, in pilot to production scale.

The systems are designed for continues or batch processing and in compliance with all relevant standards within the pharmaceutical and biotech industry. The systems are custom designed to fit the customer requirements with many different configurations and options.

Systems are available in linear gradient, step gradient or isocratic version. High focus on safety and ergonomic design.

General system specification include:

• Flow rate from 6 l/h – 5,000 l/h
• Design pressure 2bar – 100bar
• Gradient performance
• High accuracy gradient mixing loop with feedback from conductivity, NIR or other inline instrument
• Inline mixing from 0% – 100% with accuracy below 1% of FS (full scale)
• Inline degassing gradient loop
• Systems are available in gradients or isocratic versions

Materials and construction code

Standard systems are fabricated in stainless steel and all used components are fully documented and tested. Systems are available in explosion proof versions that fulfil the requirements for Europe (ATEX) or US (Class One Div xx). Systems for Europe are CE marked and designed according to ASME BPE

The systems are mobile and can be moved around within the facility. Easy installation and connection for quick start-up.

Automation and design focus

Fully automated with Peak control software based on Siemens PCS7 and in compliance with all relevant standards like CFR Part 11, GAMP5 and S.88. Curve analyzing software included for analyzing e.g. UV curve.

Fully automated batch software contains: master recipe, batch data, report creation and job scheduling. Simple and efficient methods optimization. Manual operation is possible as is user control.

Handshake with buffer, product supply and collection systems are possible. Connection is possible to overall factory network for back-up, user administration and exchange of date.

The design focus is to keep it simple and robust. There is a focus on reproducibility and reliable design with background in the importance of production capability for the customer. Industrial focus relates to service and maintenance.