Microbial contamination, limits

Saniti r is a chemical agent used on inanimate objects that reduces the number of microbial contaminants to safe limits as judged by pubHc health requirements. 

Microbial contamination is limited in the presence of the organic solvent. 

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. 

When action limits are exceeded, the QA manger will investigate the cause of the problem, take action to correct it, assess the impact of the microbial contamination on products manufactured with the water, and document the results of the investigation. 

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,... 

Biogenic amines can be found in processed meat products as a consequence of microbial activity related to the fermentation involved in their processing, but amines can be also found in poor-quality raw materials as a consequence of microbial contamination. Therefore the BA content in cooked meat (not fermented) products might serve as a useful indicator of the hygienic quality of the meat employed for its elaboration. However, this relationship for ripened meat products is rather complex, since the ability to produce BAs of the fermentative microflora need to be well known before limits can be set. According to the few studies performed on BAs in meat products,... 

However, the nucleic acid-based assays for the detection of food pathogens show problems regarding the sensitivity of the polymerase enzyme to environmental contaminants, difficulties in quantification, the generation of false-positives through the detection of naked nucleic acids, non-viable microorganisms or contamination of samples in the laboratory, and may limit the use of PCR for the direct detection of microbial contamination. 

Although it would seem reasonable to apply the electronic noses for measuring biological variables such as metabolic products and microbial activity, only a limited number of studies have been described. Of these, the following can be mentioned detection of infection bacteria activity in ulcers [10], microbial contamination in meat [11], classification of microbial strains [12,13], and monitoring of bioreactors [ 14]. 

Another problem with conventional fermenters concerns foaming. In traditional systems, the introduction of large quantities of gas into the vigorously agitated fermentation liquor often produces great quantities of foam in the reaction vessel. Biological reactors are particularly susceptible to foaming because of the surfactant properties of most biomolecules. This foam severely limits the usable volume of the vessel and can render the fermentation process inoperable and microbially contaminated when the gas flow exit lines become filled with foam. All of these problems have a substantially adverse influence upon the yield and cost-eflectiveness of conventional fermentation processes. 

In general, bioburden counts in parenteral solutions are obtained by conducting the total aerobic counts and total yeast and mold counts as specified in the USP microbial limits test (61) or an equivalent test [72], In addition, membrane filtration of larger than specified volumes may also be used to detect any microbial contamination when sample results are expected to contain a negligible number of microbial flora or in the presence of potential confounding factors, such as antimicrobial... 

Microbial Specifications These specifications are determined by the manufacturer. The USP Chapters 61,62, and 1111 present the microbial limits to assess the significance of microbial contamination in a dosage form [53], However, the USP... 

Municipal water plants provide limited treatment, mostly intended to make the water safe to drink. A lot of contaminants, such as salts, dissolved gases, and organic materials contained in natural sources, remain in the municipal water supply. In addition, chlorine or other disinfectants are often added as part of the treatment process to control microbial contamination. For many critical applications required in pharmaceutical plants, such water quality is not sufficient, and further treatment is necessary. 

Limits for microbial contamination as set by the DCA. Pathogenic bacteria such as staph, aureus, pseudomonas aeruginosa, E.coli and salmonella should not be present. 

In recent years, efforts have been undertaken to conserve water due to the growing demand for a limited resource. As a result, water reuse is being employed, especially in the Western United States. Water reuse is when wastewater generated from a community is reclaimed for a beneficial use such as irrigation for ornamental or agricultural crops, decorative water features, industrial application and with advanced treatment potable water. The use of reclaimed water may expose the public to chemical and microbial contamination from the wastewater stream. Therefore, for each type of beneficial reuse, treatment standards are being established to protect public health. 

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