The Biotechnology market is ever changing and on the leading edge of technology changes. New products are continuously under development and agitation and mixing is used throughout the process. A process may require any or a combination of the following: blending, solids handling including incorporation/dissolving/suspension, mass transfer, and solids and heat transfer. The scale for Biotechnology reactors and support units range from a few liters to several cubic meters and from small laboratory units to large scale fermenters. Biotechnology applications also require vendors who have strong R&D departments and laboratory facilities, polished and aseptic designs, easy drainability and cleanability designs, material validation, quality control programs specific to the project, and are able to meet governing specifications and directives such as FDA, USP, ASME-BPE, and cGMP requirements.
Chemineer, Kenics, and Greerco products are utilized throughout the Biotechnology applications. Chemineer has experience in designs including large fermenters with BT-6 impellers, small bottom entering bio-reactors, Kenics static mixer heat exchangers and in-line tubular reactors, and Greerco high shear mixers. New mixing concepts such as CleanSweep, which allows sealing of the tank contents without the use of mechanical seals, has been utilized in pharmaceutical manufacturing.
In addition to the process and mechanical requirements, quality control reports and material traceability is vital for the proper validation of the process. Chemineer can provide a quality control dossier specific to the project to enable the end-user to meet validation requirements and meet start-up and production requirements.