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The event will be held at IMA factory, in Bologna (Italy), on October 23-24, 2018, and is intended to share experience between expert and practitioners. After working through a classical graduate engineering apprenticeship and a few positions in industry, he became the R&D European Group Leader for Kraft Foods in relation to new process automation and processing techniques.After a few years at Kraft, Martin decided to set up a process automation business called Optimal (syn TQ).Critical process parameters affecting content uniformity of the API in the final drug product were assessed by means of a Do E study.
In the last section, important regulatory requirements concerning the submission of PAT data and specifics for NIR data are summarised.
Process Analytical Technology for CO2 Capture, Carbon Dioxide Chemistry, Capture and Oil Recovery, Iyad Karamé, Janah Shaya and Hassan Srour, Intech Open, DOI: 10.5772/intechopen.76176.
In Project A, fluid bed granulation processes were investigated by in-line particle size measurements using spatial filtering velocimetry and in-line moisture determination by near infrared spectroscopy (NIRS).
Implementation of these in-line tools significantly enhanced process understanding during development.
This thesis discusses the potential applications of process analytical techniques (PAT) and associated benefits of exploiting such in-line and at-line measurement tools during process development of solid dosage forms using case studies of two different development projects.
The most critical unit operations of the manufacturing process affecting downstream processability and Critical Quality Attributes of the final drug product to a great extent were fluid bed granulation for the first project (Project A) and active coating of tablets for the second project (Project B).One of the objectives of this study was to perform a feasibility assessment regarding the development of a NIRS method for end-point determination of the coating process in real time.Currently, the end-point is estimated by indirect measurements.In-line particle sizing provided insight into the dynamics of particle growth during different phases of fluid bed granulation process: wetting and nucleation, agglomeration and finally a steady-state phase, when agglomeration and attrition are at par.Furthermore, different technologies for particle sizing were compared. We share our knowledge and peer-reveiwed research papers with libraries, scientific and engineering societies, and also work with corporate R&D departments and government entities. Available from: Next chapter By Vânia Maria Borges Cunha, Marcilene Paiva da Silva, Wanessa Almeida da Costa, Mozaniel Santana de Oliveira, Fernanda Wariss Figueiredo Bezerra, Anselmo Castro de Melo, Rafael Henrique Holanda Pinto, Nelio Teixeira Machado, Marilena Emmi Araujo and Raul Nunes de Carvalho Junior We are Intech Open, the world's leading publisher of Open Access books. Our readership spans scientists, professors, researchers, librarians, and students, as well as business professionals.The effect of varying process parameters on resulting granulate particle size was systematically investigated by means of a Design of Experiments (Do E) study, performed as several fractional factorial designs.The developed statistical model obtained from this study could accurately predict the median granulate size (D50) in dependence on the process parameters inlet air temperature and product temperature in the investigated ranges.Higher inlet air temperature has a positive correlation with particle size resulting in increased D50 values, while lower product temperatures yield larger granules.Besides, a NIRS calibration model applying a fibre optic probe and diffuse reflection measuring mode was developed for in-line moisture monitoring during the granulation process.