Support, Training, and Know-How
Tarpon is dedicated to assisting you in successfully implement BioSMB technology. Therefore, we offer a full suite of service packages to help you go from ‘bench to 20,000L’.
SUPPORT. Support options include, but are not limited to:
- Assistance in converting batch process to BioSMB
- Assistance in method development and optimization
- Assistance in quality systems
- Consulting on batch records or other paperwork needed for cGMP operation
- Support of a first cGMP run
VALIDATION. Tarpon offers a process validation package to support the use of BioSMB technology for cGMP applications. We offer:
- GMP documentation.
- GMP Services including IQ/OQ/IPQ performed on-site.
- Equipment qualification is performed by GMP-trained, qualified service engineers when the system is installed in its selected operating environment.
Process Simulation Modeling Software
Our Process Simulation tool is designed to run a process simulation as if it were a virtual experiment. It uses the configuration files generated by the method creator for the BioSMB control software and the results are stored in the same format as the BioSMB data produced during a production run or experiment. You can then view and evaluate the data by using the same software.
This software allows you to:
- Refine and define the design space and in QbD studies
- Design process validation experimentation to define parameters prior to the experiment
- Increase process support; your processes can be preconfigured beforehand and analyzed afterward
- Test protocols before running a production run or experiment
Economic Modeling Software
There are two approaches used by Tarpon to determine both experimental setup and savings achieved in converting a batch process to a BioSMB process and in determining the estimated cost savings of consumables, labor, operations, and capital achieved by implementing BioSMB technology in your facility. Each model can be customized or a BioSMB data input area can be added to an existing model already in use. Model inputs can be customized and adjusted to correctly simulate your biomanufacturing cost structure, labor rates, operational variables, and a host of other inputs.
Installation and Training
Tarpon engineers will assist you in every aspect of the installation and start-up of your BioSMB system. Onsite training and conversion of your present batch process to a BioSMB process are included. Field service contracts are also available.