SmithBio’s customized cGMP compliant pilot- and production scale processing systems are designed for aseptic operation and are easy to validate.
Our processing systems are designed for industrial automated processing where they provide the necessary stability, flexibility, and maintainability.
SmithBio customized processing systems are being used for bacterial fermentation and for batch, fed batch and perfusion cell cultivation applications using suspended cells, adherent microcarrier cells or fixed bed cultivation modes.
The dedicated GAMP compliant operation and control platform is used for all SmithBio automated systems of any type or volume, from laboratory research BioTopsystems to full production processing skids of >10.000L. This greatly simplifies the operation of different processing skids during upscaling, reduces the need for operator training and allows for error-free and easy transfer of process analytical data.
SmithBio automated processing systems have a sterile design and can be docked with a separate CIP or SIP system for on-line cleaning or sterilization. The product contact tanks and reactors are made of AISI 316L stainless-steel with surface polishing Ra 0.8 μm, which allows for a more efficient CIP (on-line cleaning) process. The systems are equipped with process control features such as sensors for control of temperature, pressure, fluid level, pH, DO, and other similar sensors. The control unit houses the electrical components and the Industrial computer PLC.
For convenience during operation and maintenance, all necessary piping is mounted on an open stainless-steel frame, stationary or mobile. The open-frame design allows for easy access of components and helps to save equipment space.
All systems are customized to meet your User Requirements Specification (URS), and are handed over after successful installation, commissioning, and system validation (IQ/OQ), with documentation included. Upon request production qualification (PQ) and registration support can be offered.
Our experienced team of automation engineers and project support engineers have an in-depth understanding of industrial processing and have successfully completed many systems integration and processing equipment installation projects.
Our after-sales and technical support team is available to support you with any questions or need related to process design and optimization, or instrument related operation, installation, training, and technical support.