Quality and process control

Technology package Information typically provided to a toller by their client delineating specifications for the equipment, chemicals, processing and quality control for a toll. Process safety information is a subset of the technology package. 

Improvements in process and quality control made significant contributions to the transition from iron to steel as the major ferrous construction material over a century and a half ago. For most of that time red lead was relied upon, and not without a remarkable degree of success, as the rust-inhibitive pigment in anti-corrosive paints. In the last twenty years, however, there has been a similar dramatic change from such simple paints as red lead to synthetic polymer coatings which have as complex a technology as steel manufacture itself. 

Improved processes and quality control have helped to establish these new coating materials but the care necessary for successful use has to be appreciated. Sections 11.1 and 11.2 have shown how necessary it is to remove millscale before coating and how scale-free surfaces may still retain seeds of further corrosion even when apparently cleaned well. The percentage of premature failures with sophisticated systems is still high, even on apparently well-prepared surfaces and there is a strong case for effective inspection at each stage of coating operations. 

H.W. Siesler, Proceedings SPQ-98 (Spectroscopy in Process and Quality Control), Advanstar, London (1998). 

The most perspective are the methods based on application of nonequilibrium low-temperature plasma [3], They have a number of advantages smaller dimensions of the equipment, opportunity to automate both the process and quality control of processed environment, low involvement of human resources, opportunity to use new solutions, though poorly investigated, but having useful potential and properties. The basis for the process is the contact plasma discharge on the surface of a liquid phase formed between an electrode in gas phase and surface of the liquid, in which the second electrode is immersed. 

Reduction in the number of chemical processing steps allows for significant reduchon in the amount of in-process and Quality Control (QC) analysis of raw materials and intermediates required in the semi-synthetic route. Reduced handling and storage/disposal of cytotoxic samples by operators and analysts reduces opportunities for hazardous exposure. 

The interaction of neutrons for the measurement of moisture or hydrogeneous content on relatively small size samples, of an order suitable for lab purposes or for in-plant process and quality control, has been the subject of only a... 

Pudelko-Koerner, C. (1998) Quantitative near-infrared reflectance spectroscopy of sennosides from Sennae fructus angustifoliae in in-process and quality control including method validation Pharmazeutische Industrie 60, 1007-1012. 

Polymers are typically complex mixtures in which the composition depends on polymerization kinetics and mechanism and process conditions. To obtain polymeric materials of desired characteristics, polymer processing must be carefully controlled and monitored. Furthermore, one needs to understand the influence of molecular parameters on polymer properties and end-use performance. Molar mass distribution and average chemical composition may no longer provide sufficient information for process and quality control nor define structure-property relationships. Modern characterization methods now require multidimensional analytical approaches rather then average properties of the whole sample [1]. 

Production Process and Quality Control The production process includes the following ... 

Data interpretation and processing can be complicated. In addition, software to handle hyphenated methodologies are still under development, and many laboratories find it more convenient to write their own software. As a result, most hyphenated polymer separation instrumentation are limited presently to research laboratories rather than to plant environments. Continued developments in digital electronics, laser-based detector technology, and computer data acquisition and processing will result eventually in easy to use, automated hyphenated instrumentation for process and quality control. 

Figure 1 presents what may be referred to as the near-infrared method validation pyramid. Ritchie [11] presented this idea at the Ninth International Diffuse Reflectance Conference (Chambersburg) in 1998. Since then, he has presented it at the Spectroscopy in Process and Quality Control Conference (SPQ) in 1999, the Eastern Analytical Symposium (EAS) in 1999, and the Pittsburgh Conference and Exposition on Analytical Chemistry and Applied Spectroscopy (PittCon) in 2000. 

A similar paper was published by Pudelko-Komer [32] using the reflection analysis of sennosides in the parent plant as a way to address process and quality control concerns for validation. Ritchie and Ciurczak discussed the validation steps involved in a quantitative method at a recent quality-specific meeting [11]. Modification, or reinterpretation, of existing guidelines was suggested. 

G. E. Ritchie and E. W. Ciurczak, Validating a Near-Infrared Spectroscopic Method, Proc. Spectroscopy in Process and Quality Control Conference, New Brunswick, NJ, October, 1999. 

C. Pudelko-Korner, Quantitative Near-Infrared-Reflection-Spectroscopy of Sennosides in Sennae fructus angustifoliae in Processing and Quality Control as well as Validation of these Methods, Pharma Technol. J., 19(1), 57-67 (1998). 

The release of herbal medicines should be authorized by aperson who has been trained in the specific features of the processing and quality control of herbal materials, herbal preparations and finished herbal products. 

Ritchie, G. E. and Ciurczak, E. W. Validating a near-infrared spectroscopic method. In Spectroscopy in Process and Quality Control Conference Proceedings, East Brunswick NJ, 1999. 

---