Risk control, microbial

Utilities such as gases and air piped to reaction vessels are filtered (<0.2/rm filters) to control the risk of microbial contamination. Water is considered a... 

Microbial activities are by far the most difficult factor of instability when handling natural products. All products have an incurred microbial activity (e.g. soils, sediments, sludge) or represent perfect culture media for microbes (e.g. food, feed, human, animal or plant tissues). Bacteria, viruses, moulds, fungi, parasites etc. may also present a risk for the health of the producer or the end-user of the material. In order to eliminate or control microbial activity two possibilities exist kill the microbes... 

In 1965, a study by Altemeir and Culbertson determined the risk factors associated with surgical infections surgical infection risk (1) varies directly in proportion to the dose level of the microbial contaminants, (2) varies directly with the virulence of the microorganism(s), and (3) varies inversely with the immunological competence of the patient in controlling microbial invaders [9]. 

Due to its versatility, sulfur dioxide is also a widely used food additive. It controls microbial decay and prevents reaction with oxygen, thus reducing the risk of browning. Sulfur dioxide also preserves the vitamin C content of food. So, plenty of scientists are interested in sulfur dioxide for plenty of reasons. 

To reduce risks of microbial contamination, aseptic processing is executed in a controlled environment, in which the air supply, facility, materials, equipment and personnel are regulated to control microbial and particulate contamination to acceptable levels [3]. Contact between product and environment should be minimised, sterile equipment should be used, and there should be two consecutive filtration processes through sterile 0.2 pm filters. The first filter will minimise the microbial challenge to the second filter, which should be just before the sterile final container. The shelf-life of the product is often restricted and it may be stored in the refrigerator to further reduce the risks of microbial growth. 

During vinification, SO2 has historically represented one important tool used by winemakers to control microbiological growth. Due to health concerns (Yang and Purchase, 1985), some wineries have reduced usage dramatically, with a possible increased risk of microbial spoilage. 

Quality assurance and the control of microbial risk in medicines... 

Human illness, as a result of microbial infection, is an ever-increasing public health crisis. Children often represent the most at-risk population. Worldwide every year billions of cases of microbial infection occur and millions of deaths can be directly attributed to microbial pathogens.1 The Centers for Disease Control estimates that microbial infections are the fourth leading cause of death in the United States, with approximately 75,000 deaths attributable to microbial pathogens annually.2 Not only are there serious physical health effects associated with microbial infections, but the cost of health care associated with microbial infections is shocking. For example, in the United States alone, upper respiratory tract infections in children under the age of 15 account for more than 50 million visits to a doctor s office each year.3... 

In this paper I have tried to show that measurement of health benefits attributable to TSCA is not feasible. I hope that in doing so I have not belabored the obvious. For new chemicals and for most existing chemicals, prospective evaluation of health benefits to be achieved by various exposure controls will have to be based on extrapolation from microbial and animal data. However, while such extrapolation may be useful in a qualitative sense, quantitative risk assessment techniques involve considerable uncertainty, and in any case have not been developed for chronic effects other than cancer. 

The degree of environmental control of particulate and microbial contamination of the production premises should be adapted to the product and the production step, bearing in mind the level of contamination of the starting materials and the risk to the finished product. 

Preservatives In addition to those processing controls mentioned above (Section 3.1.4.3), the sterility of a product may be maintained through the addition of antimicrobial preservatives. Preservation against microbial growth is an important aspect of multidose parenteral preparations as well as other formulations that require preservatives to minimize the risk of patient infection upon administration, such as infusion products [52], Aqueous liquid products are prone to microbial contamination because water in combination with excipients derived from natural sources (e.g., polypeptides, carbohydrates) and proteinaceous active ingredients may serve as excellent media for the growth [57], The major criteria for the selection of an appropriate preservative include efficiency against a wide spectrum of micro-... 

The manufacture of sterile products is universally acknowledged to be the most difficult of all pharmaceutical production activities to execute. When these products are manufactured using aseptic processing, poorly controlled processes can expose the patient to an unacceptable level of contamination. In rare instances contaminated products can lead to microbial infection resulting from products intended to hasten the patient s recovery. The production of sterile products requires fastidious design, operation, and maintenance of facilities and equipment. It also requires attention to detail in process development and validation to ensure success. This chapter will review the salient elements of sterile manufacturing necessary to provide acceptable levels of risk regarding sterility assurance. 

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