Quality attributes contamination

Installation and operational qualification work includes verification of temperature, pressure, and flow rates, instrument calibration, and thorough flushing of the entire system to remove oil, metal particles, and other contaminants. The type of testing and acceptance limits listed in the validation protocol may vary from firm to firm however, compressed air with product contact should be tested for such quality attributes as hydrocarbons, water vapor, and microbial content (typically less than 0.1 CFU/cu. ft.)... 

HSI, and it ranges within the wave band of 400-1000 nin for a visible-near-infrared (VIS-NIR) spectrum or a 1000-1700nm range for NIR. and it has been used to detect defects, contaminants, and quality attributes of fruits, vegetables, and meat products (Gowen et al., 2007). 

Definition of the API in terms of its critical quality attributes. Among the attributes that should be considered are chemical purity qualitative and quantitative impurity profiles physical characteristics such as particle size, bulk and tap density polymorphic forms moisture and solvent content homogeneity and microbial quality (if the product is susceptible to microbial contamination). 

Performance parameters reflect the outcome of a given step and indicate that the process gave the desired result [14] or quality attribute. They are uncontrolled performance variables [15] without a control action [35]. Their natural variation is defined by operating history specifically, their variability is characterized from known historical data or estimated based on similar process performance [35]. Similarly, output variables reflect the step outcome and indicate performance was acceptable in terms of performance attributes for the step (e.g., titer and yield) or properties of the product stream (e.g., product homogeneity, purity, contaminant levels, and chromatography peak shape) [3,14]. Still another term used is critical Ys (analogous to dependent variables), defined as product and process output variables that relate to critical quality attributes (CQAs), which are measurable outputs of each process step that are used to provide evidence that the step performed correctly [37]. 

Process validation starts with the identification of product quality attributes and justification of acceptance criteria, followed by a review of the risk analysis, execution of process development runs, and compilation of clinical material manufacturing data to set specifications considering process variability [11]. There is a greater focus on process validation for downstream steps rather than for upstream steps because downstream steps are associated with virus removal. Process validation is just one approach used to control virus contamination, however others include cell bank characterization, in-process testing, inactivation procedures, control of raw materials, containment, and postmarket surveillance [6]. 

Additionally, color may also serve as a key to cataloging a food as safe. Undesirable colors of meats, fruits, and vegetables warn us about potential dangers or at least of the presence of undesirable flavors. Color and other sensory attributes are even misused as indicators for safety. Walker and co-authors demonstrated that in small and medium enterprises, more than 50% of food handlers thought that they could tell whether food was contaminated with food poisoning bacteria by sight, smell, and taste. Color is thus used as a way to identify a food and judge its quality."... 

The widespread use of -hexanc as an extractant in the laboratory creates problems in interpreting concentration readings at low levels. Even with good quality control, it may often be impossible to determine whether to attribute a measured value to the actual levels in a sample or to contamination from M-hexanc in the laboratory environment (Otson et al. 1994). For the most part, -hexane is not a common target analyte from water or soil samples. While data based on ambient air samples or sampling in the air of various workplace or residential environments are more numerous, most EPA regulatory programs rely on bulk measurements of total hydrocarbons or total volatile compounds rather than on measurements of specific compounds such as -hexane (Bishop et al. 1994 DeLuchi 1993). 

Water-quality deterioration can be attributed to water pollution or contamination. Water pollution is generally defined as any physical, chemical, or biological alteration in water quality that has a negative impact on living organisms. In the stricter sense, pollution can be defined as the transfer of any substance to the environment. However, there is a tolerance limit for each pollutant, since zero-level pollution is economically and technically unpractical. The most important kinds of water quality deterioration are the following. 

We have found that rigorous sorbent pretreatment procedures (e.g., Soxhlet extraction and thermal desorption) in concert with a well-established quality control program will successfully control potential contamination effects arising from the sample collection media. Furthermore, a well-executed quality control program will permit identification of spurious data points attributable to media contamination when and if they do occur. 

The use of chemical aids and technologies to stabilize lipids also represents a need to evaluate the balance between positive attributes that may reduce the risk of exposure to dietary oxidized lipids, or alternatively, negative consesquences, such as generation of tran -fatty acids derived from selective hydrogenation of vegetable oils. This chapter is intended to update the information on topics of toxicity and safety of fats and oils described earlier (6), as they relate to (1) natural consitutents of fats and oils (2) derived products of oxidation and hydrogenation (3) occurance of natural and pollutant contaminants and (4) additives used to preserve the stability, functionality, and nutritional quality of many constituents present in fats and oils. 

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