Peak Biotech - Company & Product Presentation
Peak Biotech – Company & Product Presentation Peak Biotech Company Profile July 2005 Peak Biotech A/S was founded Location Kvistgaard, Denmark Jacob Nøhr QA Manager (founder) Kim VindManaging Director (founder) Both with many years of experience in delivering equipment to the pharmaceuticals and Biotech industry, also from their earlier jobs.
Peak Biotech – Company & Product Presentation Peak Biotech Chromatography Products Chromatography Low pressure DAC columns 3 / 6 / 10 bar columns Medium pressure DAC columns 20 / 30 bar High pressure DAC columns 70 / 100 bar Fix bed and mechanically compression versions available for all pressure ranges Chromatography Low pressure gradient systems 6 / 10 bar systems Medium pressure gradient systems 20 / 30 bar High pressure gradient systems 80 bar Systems are also available in step or isocratic versions Slurry handling Slurry units for soft media equipment Slurry units for hard silica media
Peak Biotech – Company & Product Presentation Peak Biotech - Other Products / Accessories Piston handling equipment for service & maintenance Handling equipment of columns Bottom handling equipment For low and medium pressure columns Compression units Ultra sonic bath For cleaning of frits with dimensions up to ø1200 Mobile tanks 1 - 500 L Tanks Stationary tanks 1 - 3000 L Buffer systems with preparation and storage Buffer systems tanks In-line buffer preparation systems
Peak Biotech – Company & Product Presentation Chromatography columns - low & medium pressure • Diameters from 100 – 1600 mm Specifications • Low pressure DAC columns 3 / 6 / 10 bar • Medium pressure DAC columns 20 / 30 bar • Slurry inlet valve • Slurry outlet valve • Sealing materials PEHD, PTFE & PEEK • Materials of construction 1.4404, 1.4435, SS316L, SAF2205 • Construction code PED or ASME • Isolated Options • Cooling / heating jacket • USP Class VI approved sealing material • ATEX approved (for use in explosion proof areas)
Peak Biotech – Company & Product Presentation • Easy packing through slurry inlet valve Key features • Easy packing through slurry outlet valve • Uniform distribution system • High performance and reproducibility • Leak detection system • No sealing adjustment • Scalable • Mobile construction
Peak Biotech – Company & Product Presentation Accessory : Slurry Unit for Soft Gel Media
Peak Biotech – Company & Product Presentation Chromatography Columns - high pressure • Diameters from 50 – 1000 mm Specifications • Pressure DAC columns 100 bar • Sealing materials PTFE & PEEK • Material of construction 1.4404, 1.4435, SS316L, SAF2205 • Construction code PED or ASME Options • Column slurry valve • Cooling heating / jacket • USP Class VI approved sealing material • ATEX approved (for use in explosion proof areas)
Peak Biotech – Company & Product Presentation • Easy packing and unpacking Key features • Uniform distribution system • Removable frit design for easy cleaning or replacement • High performance and reproducibility • Leak detection system • No sealing adjustment • Scalable • Mobile construction up to 300 mm • Ergonomic working positions
Peak Biotech – Company & Product Presentation Accessory : Slurry Unit for Silica Media
Peak Biotech – Company & Product Presentation Pressurized Air Feed Column Packing Schematic Pressurized air V06 V05 Reservoir Process connection Tank PI 01 PI02 V03 Tank F01 20 % Etoh Pump V01 V02 Pump Column Column Process connection C-V01
Peak Biotech – Company & Product Presentation LC Column – Cross Section View Pushing Solvent Non-Pressurized Zone (Leak Detection) Frit and Distributor Plate Packed Bed
Peak Biotech – Company & Product Presentation Column Packing 1 – slurry pumped into the column Using Slurry Inlet Valve 2 – piston pressurized & column packed 3 – column packing in progress 4 – column ready for LC use 1 2 3 4
Peak Biotech – Company & Product Presentation Column Packing 1 – slurry loaded into the column (suction) Using Slurry Outlet Valve 2 – piston pressurized & column packed 3 – column packing in progress 4 – column ready for LC use 1 2 3 4
Peak Biotech – Company & Product Presentation Column Packing Loading Through Outlet Flange 1 – load slurry into the open column 2 – close flange & pressurize piston 3 – column packing in progress 4 – column ready for LC use 1 2 3 4
Peak Biotech – Company & Product Presentation Column Un-Packing Through Slurry Outlet Valve (works only for Soft-gel media) 1 – retract piston & draw solvent in 2 – re-slurry the packing bed 1 2 3 3 – pressurize / lower piston again 4 – pump the re-slurried media out 5 – column ready for next packing 4 5
Peak Biotech – Company & Product Presentation 1 – remove the outlet flange Column Un-Packing 2 – turn column & pressurize piston Through Outlet Flange 3 – column un-packing in progress 4 – column bed pushed out 1 2 3 4
Peak Biotech – Company & Product Presentation Chromatography Systems - low pressure • Flow rates 6 – 5000 l/h Specifications • Pressure rates 0 – 6 bar • Gradient loop with feedback for conductivity sensor • 4 Buffer inlets, 1 product and 5 fractions • Sealing materials PTFE or EPDM • Material of construction 1.4404, 1.4435, SS316L • ATEX / Class One div 2 (for use in explosion proof areas) Options • Extra inlets and outlets • Extra instrumentation before and after the column • Recycle option • Filter module in-line • Heat exchanger • Sample / Injection loop • Nitrogen blowing of product lines
Peak Biotech – Company & Product Presentation • Gradient performance with high accuracy Key features • Fully automated, CFR Part 11 and GAMP 4 compliant • Mobile construction • Complete unit, tested and documented • Compact and reliable • Flexible control • Easy maintenance • Sanitary design
Peak Biotech – Company & Product Presentation Typical Chromatography systems - low pressure Vent Vent Line Bubble Trap Additional Switching Buffer Buffer 3 Buffer 4 Valve Sample Inlets BT NIR NIR 0-100 % Booster PI NIR Column Pumps LT LT LT PT Gradient Column Buffer 1 PI Mixing Sample Loop Buffer Inlets PI Loading Pump Buffer 2 Waste Waste Flow UV 4 Fractions Fraction 1 Flow UV Fraction 2 Fraction 3 Fraction 4
Peak Biotech – Company & Product Presentation Chromatography systems - medium and high pressure • Flow rates 6 – 5000 l/h for medium pressure Specifications • Flow rates 6 – 1000 l/h for high pressure • Pressure rates 0 – 20 bar & 0 - 80 bar • Gradient loop with feedback for NIR, mass or conductivity • 4 Buffer inlets, 1 product and 5 fractions • Sealing material PTFE • Material of construction 1.4404, 1.4435, SS316L • ATEX / Class One div 2 (for use in explosion proof areas) Options • Extra inlets and outlets • Extra instrumentation before and after the column • Recycle option • Filter module in-line • Heat exchanger • Sample / Injection loop • Nitrogen blowing of product lines
Peak Biotech – Company & Product Presentation • Gradient performance with high accuracy Key features • Fully automated, CFR Part 11 and GAMP 4 compliant • Mobile construction • Complete unit, tested and documented • Compact and reliable • Flexible control • Easy maintenance • Sanitary design
Peak Biotech – Company & Product Presentation Typical Chromatography System - medium & high pressure Vent Vent Line Column Bubble Trap Additional Switching Buffer Valves Buffer 3 Buffer 4 Inlets Sample BT NIR NIR PT 0-100 % Booster PI NIR Pumps LT LT LT Gradient Column Buffer 1 PI Sample Mixing Loop Loading Buffer Inlets PI Column Pump Buffer 2 Waste Waste Flow UV 4 Fractions Fraction 1 Flow UV Fraction 2 Fraction 3 Fraction 4
Peak Biotech – Company & Product Presentation Chromatography System - medium & high pressure with additional options installed Vent Line Vent N 2 N2 Bubble Trap Column Additional Switching Buffer Valves NIR Buffer 3 Buffer 4 Inlets Sample BT NIR PT 0-100 % PI LT PI LT PI NIR T01 T02 LT LT LT Gradient Solvent Column Mixing Sample Tanks Loop Loading Column Pump Waste Waste Flow UV 4 Fractions Fraction 1 Flow UV Fraction 2 Fraction 3 Fraction 4
Peak Biotech – Company & Product Presentation Chromatography System - medium & high pressure with additional options installed Vent Line Vent N 2 N2 Additional Sample Buffer Inlets LT Loop CTY NIR Buffer 3 Buffer 4 Buffer 5 Buffer 6 Sample BT NIR Conductivity 0-100 % PI LT PI LT CT NIR T01 T02 PI LT LT LT LT LT Gradient pH °C Solvent Mixing Column Sample pH PT Tanks Loop Loading Temp Column Pump N 2 N2 Waste Waste Flow UV PT pH CTY 9 Fractions Fraction 1 Flow UV PT pH CT Fraction 2 Detection Fraction 3 Fraction 4 Fraction 5 Fraction 6 Fraction 7 Fraction 8 Fraction 9
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