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FP-2000TM System Features

FP-2000TM is a complete turnkey bioprocessing solution which is fabricated, produced, delivered and qualified within 8 -12 months. It consists of eight main components:

The pre-qualified facility including the shell and core, mechanical, electrical/IT, plumbing, pharmaceutical interiors and processing equipment;

  • Capital services; FP-2000TM can be either bought or leased;
  • Technology platforms for the production of the MAbs and Vaccines;
  • The database, including all relevant documentation and the standard operating procedures and preventive maintenance protocols;
  • Training services in facility operations and an experienced operator staff for facility commissioning and start-up;
  • Process qualification and validation services;
  • Service level agreements to support preventive maintenance programs;
  • A turn-key solution whereby product quality and quantities are guaranteed against a fixed COG.
  • FP-2000sTM will be assembled to be “fit for purpose” bioprocessing units. They are designed using design loads that enable the structure to be placed in diverse geographic regions ranging from earthquake zones like San Francisco to cyclone regions like Taiwan.

80% of FP-2000’sTM system design is standardized. This includes mechanical, electrical, IT, gas, and plumbing systems, as well as the utilities and pharmaceutical finishes.

The basic layout and room adjacencies within FP-2000TM, the pressure regimes, the room classifications, and the routing concepts are based on both international regulatory guidance and industry best practices.

Standard modules are being designed for items like equipment wash and sterilization, mechanical/electrical systems, media and buffer preparation, upstream and harvest/purification processing suites, primary gowning, and personnel/material airlocks.

Spatial and layout requirements are being established for 2 different “biotypes”– biosafety level 1-and 2 and biosafety Level 3. The biotypes have been designed to support the production of different types of biopharmaceutical product groups; namely, vaccines and monoclonal antibodies.

Result

The result is a fixed, industry-standard modular architecture for bioprocessing and support areas. The modular design allows for “snap-in” components needed for up-grades and expansion of production activities.

FP-2000sTM can be assembled, disassembled and moved from one location to another if needed.

The FP-2000TM utilities, process, mechanical, electrical and IT systems are being engineered to be compliant with the major international codes and standards: International Building Code (IBC), International Council of Harmonization (ICH), and International Society of Pharmaceutical Engineers (ISPE) Baseline Guides.

FP-2000’sTM accelerated construction, modular nature and single use technology provide pricing alternatives which potentially comprise a 25% to 40% discount over current options.

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