Technical Note addresses the requirements and methods for insuring optimum synchronisation and alignment of process data for process analytical technology (PAT)
Symbion Systems's technical note SN-503, 'Perspectives on data synchronization and alignment for PAT.
The technical note is in two parts.
The first part discuss methods for coordinating the collection of data from diverse instrumental methods such as near-infrared (NIR) spectroscopy, FTIR spectroscopy, Raman spectroscopy, HPLC, and temperature measurement.
This is made possible by the use of process analytical software such as Proficy RX (GE Fanuc Automation) or Symbion-DX or RX (Symbion Systems).
The second part provides an approach to dealing with data that has already been stored or processes that are not amenable to the controlled coordination of instruments.
According to the US FDA, Process Analytical Technology or PAT is "a framework for innovative pharmaceutical manufacturing and quality assurance"..
Implementation of PAT often involves disparate measurements of a given process.
One is often faced with the need to insure that all of the measurements refer to the same process state, or at least to states which are related in a well defined and validatable fashion.
Poor synchronisation or alignment of observations can significantly devalue the quality of models or inferences which can be made.
The task is compounded by the fact that some types of measurements - eg, spectroscopy - will involve data acquisition over an extended period of time while others - such as chromatography - involve time delays between sample acquisition and reporting of the measurement to the data system.
Proficy RX and Symbion-DX and RX provide a comprehensive capability for the control of diverse analytical instruments and the processing of analytical data.
These programmes thus provide the tools needed to implement the required data synchronisation and alignment.