Single Source Solution

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Single Source BioTech Manufacturing Partner

Dakota Systems currently engineers and manufactures an extensive range of Biotech process-critical machinery including CIP, Filtration, Pump Skids, Chromatography, Fermentors and Cell Culture Reactors. Through compliance with current Good Manufacturing Practices (cGMP) to Final Acceptance Test (FAT), Dakota provides a comprehensive, single source BioTech Manufacturing Partner. As a single-source provider your company can rely on Dakota’s designs for repeatable results. Our documentation allows us to adapt to your needs whether you need identical machinery or if you need to develop your next-generation equipment to stay competitive in an evolving marketplace.

The Dakota Systems Difference Serves the Bio Industry by:

  • Leveraging years of experience and expertise in the ultra-high purity manufacturing industry and applying the best practices to the Bio Life Science industry.
  • Capability to deliver a fully assembled product from engineering, to welding, wiring, assembly through testing.
  • Our quality team supplies documentation to comply with the validation needs of the Bio marketplace
  • Each customer is assigned a project manager giving them a single point of contact who is leading a team of industry experts to complete each project.

Dakota Systems dedicates itself to the continued improvement of manufacturing process to improve our customers’ bottom line. We strategically implement programs to help us identify the individual challenges of each of our customers and work to eliminate potential risks in their supply chain. Some of the programs implemented include Lean
Manufacturing training to help our staff work strategically through each project. We also have ECO and CRM programs designed specifically to tie in with our ERP system. These programs allow us to quickly adapt to the evolving needs of our customers’ next generation products or to review a customers’ entire history. Each effort we make is to help our customer realize they can turn to Dakota Systems as their “go-to” partner in their supply chain.

Let your engineers and scientists focus on what they do best – delivering world class bio-pharmaceutical products, and let Dakota Systems apply our design and manufacturing expertise to deliver systems that meet and exceed your expectations.

Good Manufacturing Practice

Good Manufacturing Practice or GMP (also referred to as ‘cGMP’ or ‘current Good Manufacturing Practice’) is a term that is recognized worldwide for the control and management of manufacturing and quality control testing of foods, pharmaceutical products, and medical devices. These standards remind manufacturers that they must employ technologies and systems which are up-to-date in order to comply with the regulation. Dakota Systems works closely with our clients to insure the latest and most reliable technologies and components having a proven history are installed in our biopharmaceutical process systems. Please contact us for more information regarding our list of technology suppliers.

Capabilities

The type of custom Biopharmaceutical systems currently engineered and fabricated by Dakota includes a broad range of Biopharmaceutical skids – CIP, Filtration, Pump Skids, Chromatography, Ferment and Cell Culture Reactors. From the employment of cGMP (practices) to FAT testing, Dakota provides a comprehensive, single source solution.

Our personnel expertise includes design engineers and project management that will insure your system is fabricated, assembled, tested and packaged while managing aggressive schedules and changing design elements. Our installed base is a testament to our commitment in providing systems that deliver repeatable process results day after day for biological, pharma industry and research scientists.

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Example Life Science Systems