The Design, Construction, Installation and Commissioning of a Large Scale Cell Culture Facility
In November 2004, CSL initiated a project to install a cell culture facility to a capacity of 500L for the production of therapeutic proteins using mammalian cells for use in human clinical trials, being the largest cell culture vessel in Australia. The project was supported by CSL management and in February 2005 it was approved, consisting of the design, construction, installation and commissioning of a 5L, 60L and 500L working volume cell culture bioreactors.
The first step towards building the cell culture facility was to understand the process, hence the research team was heavily involved with establishing the design requirements for the bioreactors, associated equipment and control philosophy. Key design parameters such as vessel configuration, agitation requirements, gases for headspace overlay or sparging, temperature control on vessels, cleaning and sterilisation requirements were determined by the process requirements.
A detailed assessment and continuous review of vendor supplied drawings, layouts, piping and instrumentation diagrams, ensured that the plant not only meet the process requirements but satisfied the operational requirements of the end user.
Finally, consideration was given to the installation process, commissioning and validation strategy of the plant. With the bioreactors being constructed overseas, a plan for the method of installation and connection of services was developed which enabled commissioning to be executed according to plan. This provided an excellent basis for the research team to be trained on the safe use of the plant for research trials using mammalian cells for use in human clinical trials.