Bioreactors are key equipment used for the manufacturing of biopharmaceutical products from live organisms such as microbes and mammalian cells.
They are used to manufacture products such as:
GMP Engineering has subject matter expertise in scaling-up and scaling-out biological processes that employ bioreactors, including upstream separation and downstream purification process equipment.
With in-house process engineering experience and capability, we provide complete solutions encompassing basic and detailed design, equipment specification development, fabrication management, and commissioning/qualification of the process equipment. We also bring to bear our expertise in knowing how bioreactors operate and how to optimize the design for client specific needs.
Process equipment can be designed, fabricated, and tested as skidded units prior to delivery to the client’s manufacturing site. This provides a controlled fabrication process compliant with Good Manufacturing Practices (GMPs) while the facility is being constructed. This methodology provides both schedule and cost benefits.
Multiple equipment units can be designed to be assembled and interconnected on a SuperSkid which includes a local control system, shared operator platform and single tie-in points for utilities. This minimizes installation complexity and chance for errors at the client’s site.
SuperSkids are designed to be factory tested prior to shipping. A Factory Acceptance Test (FAT) provides the client with verification that the design meets the User Requirement Specification (URS) and Functional Design Specification (FDS). During the FAT the equipment is checked for mechanical, electrical, instrumentation and control system completeness in addition to operating performance through dynamic testing.
Once the skid arrives on site, it's ready for plug-and-play installation. Often the FAT can be leveraged as part of the client’s overall commissioning and qualification strategy.
Very large and complex Superskids can be factory fabricated in transportable modules for shipment via truck and air to the client’s site. Modules are designed with mating flanges that allow them to be interconnected on-site like a Lego set without the need of specialized equipment or installation crew.
The SuperSkid shown in the video consists of an equipment train integrating a 80 L Seed Bioreactor, 500 L Production Bioreactor and a 500 L Refrigerated Hold Tank for aseptic storage of the product.
Some of its unique features include:
The SuperSkid utilizes a fully automated process control system. These systems are integrated with batch software and SCADA system and are ready to be integrated into the MES. Instrumentation and controls include:
GMP Engineering is a boutique process engineering, project management and consulting company focused on custom design, project development and integration of process critical infrastructure and equipment for the biopharmaceutical and GMP compliant industries.
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