If a production process is clearly understood and all variables known then it will be possible to produce a product safely and efficiently. This requires an understanding of the process variability as well as the variability of materials added to the production. All critical sources of variability should be identified and explained. Due to the complex nature of Pharmaceutical products traditional Physical measurements such as Pressure and Temperature are not always enough to achieve this understanding. With the introduction of process analyzers and MVA techniques a better understanding has been achieved leading to development of many ‘Islands’ of PAT with each analyzer manufacturer producing single analyzer based PAT solutions examples being moisture predictions or particle size measurement. ABB has provided a platform which will bring together the many ‘Islands of PAT’ providing a powerful tool to look at the complete process.
Quantified Risk Based Approach
A quantified risk based approach typically requires the proposal of a ‘Design Space’ by the applicant which is then subjected to regulatory assessment and approval. Quality and business related attributes need to be identified. Critical attributes need to be controlled and non critical attributes should be monitored. The Design Space may require the use of multiple process analyzers from multiple vendors. Each analyzer family having its own Human Machine Interface (HMI) with its own data extraction technique with the capability of supporting a finite number of Chemometric packages. This can be a time consuming process and may lead to problems when trying to synchronise data samples. ABB has provided a platform which collects data from multiple manufacturer’s analyzers and interfaces with existing modelling packages.
Solving Today’s Problems with Tomorrows Tools
ABB has embraced the PAT challenge and has invested in the creation of a purpose built platform capable of tight integration with proven ABBs 800xA Process Control and FTSW NIR technologies. ABB has recognised the need for standards in analyser communication and data extraction and as well as working with other analyser manufacturers has developed a tool kit to allow third party analysers to be interfaced to ABBs FTSW analyser controller. PAT Methods are designed and tested in a common environment with a common historian storing the data in an S88 compatible manner allowing the user to make batch to batch and unit to unit comparisons.
The ABB PAT method allows for the inclusion of third party models e.g. Umetrics and maintains a complete record of the execution of the method including raw ‘spectral’ data, predicted values, DCS values, stats, electronic signatures, audit trail and version control
Why ABB ?