Quality control chemical process development system

The creation of a process to meet FDA requirements is a multidisciplinary activity. Although the Chemical Process Development organization generates the core process, its shaping and implementation to meet the needs of all other parties involved (particularly Regulatory, Manufacturing, Pharmaceutical Sciences, and Quality Assurance) requires an extraordinary level of collaboration. The principal objective is to produce, and to demonstrate that you have indeed produced, a high-quality API in a well-controlled system of operations. 

Many technical solutions developed for PA in the chemical industry consequently also apply to the pharmaceutical industry. Analyzer systems and implementation principles are essentially the same in both industries. Nevertheless, there are two distinct technical differences even in API manufacturing that make PA in the pharmaceutical industry standout the absence of continuous manufacturing processes, and the well-established work process for testing including a relative abundance of quality control laboratory resources. 

The fabrication of composite laminates having a thermosetting resin matrix is a complex process. It involves simultaneous heal, mass, and momentum transfer along with chemical reaction in a multiphase system with time-dependent material properties and boundary conditions. Two critical problems, which arise during production of thick structural laminates, are the occurrence of severely detrimental voids and gradients in resin concentration. In order to efficiently manufacture quality parts, on-line control and process optimization are necessary, which in turn require a realistic model of the entire process. In this article we review current progress toward developing accurate void and resin flow portions of this overall process model. 

In the era of single-loop control systems in chemical processing plants, there was little infrastructure for monitoring multivariable processes by using multivariate statistical techniques. A limited number of process and quality variables were measured in most plants, and use of univariate SPM tools for monitoring critical process and quality variables seemed appropriate. The installation of computerized data acquisition and storage systems, the availability of inexpensive sensors for typical process variables such as temperature, flow rate, and pressure, and the development of advanced chemical analysis systems that can provide reliable information on quality variables at high frequencies increased the number of variables measured at... 

Each one of the previous issues can influence the performance of the processing technique and the resulting composite in a variety of ways. Insufficient cure may result in a low and a consequent creep under stress. Inadequate flow may result in high levels of porosity or large voids. Online sensor systems permit process control [19] and are a useful tool toward improved quality in composites manufacture. Dielectric techniques have achieved the greatest success as commercial in-process monitoring systems. Optical-fiber methods show promise for further development, most notably where distinct features in chemical spectra can be obtained. 

In addition to the availability of affordable, efficient, and long-term reliable membranes, necessary elements for the practical application of MR systems include optimal reactor design, up-scale process analysis, catalyst optimization, as well as reliable, chemically inert and cost-effective sealants. Searching for better membrane materials, developing effective membrane synthesis methods for better quality control - especially in large-scale production - and improving chemical and structural stability of the current membrane materials will continue to be the focus of active research in these areas. 

Many materials are complex mixtures of multiple molecular species and components and each component can be in multiple chemical or physical states. Realtime determination of the components and their properties is important for the understanding and control of the manufacturing processes. This paper reviews a recently developed technique of 2D NMR of diffusion and relaxation and its application to identify components of materials. This technique may have further applications for the study of biological systems and in industrial process control and quality assurance. 

---