Background During a series of visits to pharmaceutical and fine chemical plants, a SpotView system was used to develop preliminary calibrations for various APIs, excipients, and cleaning materials. The calibrations were based on sets of spectra collected from standard coupons. In the first case, the calibration was challenged with a set of samples that had been independently prepared, some spik...

The U.S. FDA [1] process validation guidance document released in 2011 increased the emphasis on continued process verification: “ongoing assurance is gained during routine production that the process remains in a state of control”. Until recently, in a washing system, conductivity analysis was the only on-line method used to monitor the quality of the final rinse water. Now, developments in th...

In recent years, cleaning validation has achieved a position of increasing in the pharmaceutical industry. It provides assurance to the cleaning procedure that ensures equipment is consistently cleaned from the product, detergent and microbial residues to an acceptable level to avoid cross-contamination and adulteration of drug product with other active ingredients. The aim of this study was to...

Surgical instruments are often strongly contaminated with patients' blood and tissues, possibly containing pathogens. The reuse of contaminated instruments without adequate cleaning and sterilization can cause postoperative inflammation and the transmission of infectious diseases from one patient to another. Thus, based on the stringent sterility requirements, the development of highly efficien...

The cleaning process in the surface mount assembly line of power modules had been found to insufficiently remove solder flux residue from printed circuit board (PCB) assemblies after the process of reflow soldering. This thesis details the development of an optimized cleaning process that effectively removes solder flux residue from PCB assemblies. The first stage of this study involves the exp...