Contaminants microbial counts

Softened water is often used for washing containers before filling with liquid or semi-solid preparations and for cooling systems. Unless precautions are taken, the microbial count in a cooling system or jacketed vessel will rise rapidly and if faults develop in the cooling plates or vessel wall, contamination of the product may occur. 

Other Important Considerations with Membranes Oxidizers such as sodium hypochlorite (i.e., CIO2), bromine, iodine, and ozone, which are typically used in the disinfection of wastewater, are not well tolerated by thin-hlm membranes. Such disinfectants can thus influence the efficacy of membranes in removing contaminants such as PPCPs. Furthermore, membranes can become fouled by microorganisms that can metabolize the membrane material. Thus, microbial counts of >100 cells/mL can be problematic. Likewise, dead-cell debris can also cause fouling. Membranes can also be fouled by heavy metals such as chromium. Thus, if heavy metals are deemed a problem, they should be precipitated from the wastewater prior to the filtration with membranes. 

In the general chapter on microbial attributes of nonsterile pharmaceutical products, the guidance suggests that the presence of microbial contaminants in nonsterile products [25] can reduce or inactivate the therapeutic activity of the product and has the potential to adversely effect the health of the patients and recommends manufacturers to ensure that contamination levels are as low as possible for finished dosage forms. Microbial enumeration limits for raw materials (total aerobic microbial count and total combined yeasts and molds count) and finished dosage forms are described. For inhalation, nasal, and topical routes of administration, tests for total aerobic microbial count and total combined and yeast and mold count,... 

The final quality of chilli spice powder is assessed by a number of different parameters. Colour and pungency levels are the most obvious parameters assessed, but sweetness and flavour of non-pungent paprika powders are also important. In addition, the spice trade may specify limits of impurity, levels of microbial counts of, for example, fungi, yeasts, Salmonella and coli forms, particle size and moisture content, among others. The main desired characters are colour, pungency and less extraneous contamination in relation to their biochemistry, assessment and desired levels. Table 14.5... 

The microbial contamination of products must be as low as possible before sterilization. This can be realized by the use of starting materials with a low microbial count and by performing a microbial reducing treatment of the product, such as filtration. 

Recall that observational data are obtained by nonexperimental methods. There are times a researcher may collect data (x and y) within the environment to perform a regression evaluation. For example, a quality assurance person may suspect that a relationship exists between warm weather (winter to spring to summer) and microbial contamination levels in a laboratory. The microbial counts (y) are then compared with the months, x(l -6), to determine whether this theory holds (Figure 2.6). 

It is important that a preoperative skin prep be effective in greatly reducing the populations of normal skin flora, as well as numbers of contaminative microorganisms at the proposed surgical site. At dry skin sites, the microbial populations generally average about 1 X 10 CFU/cm. At moist skin sites, average microbial counts are about 1 X 10 CFU/cm. There is, however, tremendous variability between humans at these sites. 

Potential level of microbial contamination (total aerobic microbial count, total yeast and mould count)... 

Both the Institute of Petroleum and the ASTM acknowledge the lack of generally accepted criteria for what would be considered significant microbial contamination. The Institute of Petroleum indicates that microbial counts in the water bottom of 10 -10 CFU/L bacteria, 10 -10 CFU/L yeasts, 10 CFU/L molds and 10 CFU/L SRB, either alone or in combination, are considered to represent microbial contamination (Institute of Petroleum, 1996). The ASTM suggests that counts of 10 CFU/ml can be, in many cases, accepted in the water bottom but any microorganisms detected in the fuel should suggest the need for corrective measures (ASTM, 2001). The ASTM also cautions that microbial counts should be routinely monitored and if problems with fuel chemistry, performance or physical appearance are also noted then corrective action should be considered. 

Microbial contamination, especially by salmonellas, is a risk when sprouts are produced commercially for human consumption. For recombinant protein production, seeds can be washed with water and surface-sterilized using hypochlorite solution. Sprouts can also be surface-sterilized during sprouting, by the addition of mild hypochlorite solution directly into the growth medium. Eventually, the hypochlorite is diluted out with pure water or growth medium. In our experiment on plate count agar [28], the sprouts showed no bacterial growth after sterilization with 1% sodium hypochlorite. 

The tests for microbial limits and recommendations for microbial quality criteria of raw materials, excipients, drug substances, and pharmaceutical products have been established in pharmacopoeial compendia for over 30 years. These tests are listed in the USP 24 Chapter (61) Microbial Limits Tests and in the Ph. Eur. 3rd ed.. Biological Tests 2.6.12 and 2.6.13, Microbial Contamination of Products Not Required to Comply with the Test for Sterility (total viable count, tests for specified microorganisms) and the JP XIII 30 Microbial Limit Test. 

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