Microbial contamination issue

Microbial contamination issues are particularly significant for excipients to be used in sterile products. 

A recently published book provides an excellent survey of issues that relate to contamination with endotoxins (present in both viable and nonviable bacteria), their released cell wall constituents, and also viable bacteria in the pharmaceutical industry [1]. It is important to know both the content of the work environment (e.g., indoor air) and the pharmaceutical products themselves. The former provides information on possible sources of microbial contamination and the latter the purity of the final commercial product (or precursors in various stages in its preparation). In some cases it is vital to know the actual bacterial species involved in contamination culture-based methods are standard microbiological techniques which were the focus of Jimenez [1] and thus will not be discussed further. Any contamination (e.g., with endotoxins), regardless of the species of origin, is of utmost of importance (e.g., in determining the safety of a batch of antibiotics to be administered intravenously). This is determined optimally by non-culture-based methods. 

Many studies have examined the issue of microbial contamination of fluorescein-anesthetic solutions designed for clinical use. Although most have directly inoculated the liquid solution, it seems more useful to consider the evidence of contamination from products retrieved from clinical use and from direct contamination... 

During development of the manufacturing process, an experienced microbiologist should be consulted as to the potential for microbial contamination of the product. Issues may include the selection of appropriate pharmaceutical ingredients, the ability of the manufacturing steps to control microbial contamination, the validation of sterilization processes, the cleaning and sanitization of process equipment, the adequacy of... 

Closed systems provide for complete separation between the environment in which personnel (uniformly accepted as the primary source of contamination in aseptic environments) are located from that in the materials are processed. Theoretically, if a sterile BPC could be processed in its entirety within closed systems, there would no possibility of microbial contamination. In marked contrast to the closed system is the open system , perhaps best defined by what it is not. Essentially, an open system lacks one or more of the features of a closed system, thus leaving it vulnerable to the potential ingress of contamination. One substantial issue associated with these definitions is establishing that a system remains closed over the length of the production campaign. 

Corporate limits on the range are set, for example, at an average of 200 microorganisms per square foot, with 300 as the upper limit. Customarily, no requirements exist for the lower limit on the range, because it is irrelevant to the topic of excessive microbial contamination, the issue of concern. Figure 4 presents the plotted range chart. 

Prevention in Atlanta estimates that food-borne illness causes as many as 9000 deaths per year. Irradiation provides one way to reduce microbial contamination in food. It does not solve the problem of careless handling of food by processors, and long-term studies on humans have not yet been concluded regarding irradiated food supplies. Once again, we face the issue of balancing benefit and risk. 

AWWA. 1999. Water Quality and Treatment, 5th ed. New York McGraw-Hill. An introductory chapter deals with U.S. standards and regulations, and successive chapters deal succinctly with treatment methods and issues of corrosion and microbial contamination in distribution systems. 

Another indicator of the vitahty of this scientific topic is the number of reviews that has flourished over the last years no less than 23 reviews have been pubhshed since 2007 Most deal with hyperspectral (HS) techniques for food and agrofood quality and safety inspection [4-18] and, except for Kim et al. [14], who focus on shortwave NIR and visible, they generally include not only NIR HS vision but also visible, Raman, and fluorescence imaging. Others focus on one type of commodity, such as fruit [19-21], meat [6], hams [22], wine wastes [23], or one specific issue such as fecal and microbial contamination [24]. 

The indigenous microbial population is quite different in the home and in hospitals. Pathogenic organisms are found much more frequently in the latter and consequently are isolated more often from medicines used in hospital. Usually, there are fewer opportunities for contamination in the home, as patients are generally issued with individual supplies in small quantities. 

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