The aim of this work was to develop an integrated process analytical technology (PAT) approach for a dynamic pharmaceutical co-precipitation process characterization and design space development. A dynamic co-precipitation process by gradually introducing water to the ternary system of naproxen–Eudragit ...
Wu, H., White, M. & Khan, M. A. Quality-by-Design (QbD): An integrated process analytical technology (PAT) approach for a dynamic pharmaceutical co-precipitation process characterization and process design space development.Int. J. Pharm.405, 63–78 (2011). ArticleCASPubMedGoogle Scholar S...
The concept of "design space" has been proposed in the ICH Q8 guideline and is gaining momentum in its application in the biotech industry. It has been defined as "the multidimensional combination and interaction of input variables (e.g., material attributes) and process parameters that have ...
We characterized the production bioreactor process and defined the design space by applying risk assessment to determine potential critical process parameters (CPPs) impacting critical quality attributes (CQAs). Characterization studies were subsequently performed using a qualified scaled-down model (SDM) ...
Table 1 Mean growth rate µ, production rate rp, cell-specific production rate qp, space–time yield STY and maximum product concentration Cpmax for the batch processes (n = 3) and the 55-h steady-state phase of the perfusion process with a macrosparger. Literature data for stable ...
Process Characterization 来自 Springer 喜欢 0 阅读量: 115 作者: L Sansoni 摘要: The complete characterization of quantum devices is a fundamental task of quantum information science. The characterization of single- and two-qubit devices is particularly important, in fact single-qubit gates and ...
These parameters are based on design characterization and are not tested. Table 10. VCC Static and Transient Tolerance for Loadline A Icc (A) Voltage Deviation from VID Setting (V)1,2,3 Maximum Voltage Typical Voltage Minimum Voltage 0 0.000 5 -0.007 -0.019 -0.027 -0.038 -0.047 10 -0.015...
A unified approach supports lab-to-plant applications for spectroscopy, particle system characterization, precise reactor control, and calorimetry. Read more Need Help with Your Application? Our Experts Are Ready to Assist If you have questions or need help with your technical application, our team...
Nevertheless, material exchanges entail specific challenges: the number of flows to manage, their potentially different nature and characterization, and the number of actors involved (i.e., the various industries that take part in the system, the requirements from the administration and other third ...
solid metal alloys should be developed in the future. Simulation accuracy may be impacted through a more detailed characterization of the true part boundary conditions, especially the heat convection over the entire surface. After the simulated temperature decreases below the solidus temperature, the ...