Sterilization applications

For food sterilization applications, considerably more design and source technology development is needed, particularly in predicting effects in heterogeneous targets. 

Edwards, L. M., Childers, R. W. Hydrogen peroxide vapor sterilization Applications in the production environment. In. M. J. Groves and R. Murty, eds. Aseptic Pharmaceutical Manufacturing II Applications for the 1990s. Buffalo Grove, IL Interpharm Press, pp. 415-466 (1995). 

These versatile machines are used for liquid clarification, concentration of light slurries, and liquid-liquid separation. They are capable of continuous operation even with high solids concentrations, since the solids phase can be discharged periodically if desired. They can also be arranged as hermetically sealed units for handling hazardous materials or in sterile applications. 

The avoidance of false-negatives is addressed at length in the pharmacopeias. Each batch of medium used in the Test for Sterility must have been shown to be capable of supporting the growth of low inocula of a specified array of microorganisms. Each Test for Sterility applicable to each specific product must be validated by repeated demonstration that the viabilities of low inocula of a specified array of microorganisms are not inhibited by product traces contained in the medium (direct inoculation) or on the membrane filter. 

One of the major drawbacks to the use of plastics is their heat intolerance. Because many plastics will melt or degrade at high temperatures, they are not well-suited to sterile applications. Parenteral drugs in particular require guaranteed sterility, and often this sterility can best be provided by glass containers. 

Several types of radiation find a sterilizing application in the manufacture of pharmaceutical and medical products, principal among which are accelerated electrons (particulate radiation), gamma-rays and UV light (both electromagnetic radiations). The major target for these radiations is believed to be microbial DNA, with damage occur -... 

What are some additives that are helpful in sterilization applications ... 

Crow S, Smith JH 3rd. Gas plasma sterilization application of space-age technology. Infect Cont Hosp Epidemiol 1995 16 483-7. 

In recent years, due to advancements in electronic instrumentation, and accumulated knowledge from the rapidly expanding installed base, reliability of electron beam units has been greatly improved. Beta irradiation, even for sterilization applications is becoming competitive with the traditional gamma processing. 

X-rays find wide applications in X-ray photography and in crystallography. Prolonged exposure of the human body to the rays induces a dangerous form of dermatitis, and even sterility, but controlled exposures are applied to alleviate cancer. 

S. Turco and R. E. King, Sterile Dosage Forms, Their Preparation and Clinical Application, Lea and Eebiager, Philadelphia, Pa., 1974. 

Viscous fluids Sterilized surface required Polished surface required Future expansion required Space restrictions Barrier coolant services Slurry applications... 

The first two categories, clarifying and crossflow filters, have been very well developed and optimized for use in biotechnology and standard wastewater treatment applications. Equipment is easily available for these applications, whether as small 0.2 micron sterilizing filter used to terminally sterilize 100 ml of product solution, or a small 500 ml crossflow filter used to concentrate a small amount of antibody solution. Many vendors of this equipment to wastewater treatment applications have their origins in the CPI (Chemical Process Industries), and have incorporated many of the scale-up and optimization properties developed in much larger units used in large scale chemical production. As a result, these two filtration unit operations are one of the most optimized and efficient used in wastewater treatment. 

Autoclave Vessel for heating materials under high steam pressure. Used for sterilization and other applications. 

More sophisticated applications of a pressurized system combined with a suitable extractor are found in hospital operating theaters. The positive pres-sure produced by sterile air entering the room ensures that all leakages are outward. This outward leakage ensures that contaminated air at a lower pressure in the surrounding rooms will not enter the space. 

Chlorotetrafluoro-ethane (CHCIFCF5) A potential medium pressure refrigerant for chiller applications. It is designed to replace CFC-12 as a diluent in sterilizing gas. A potential replacement for CFC-11 and-12 in rigid foam insulation applications. 

For food and pharmaceutical applications, the microbial count must be reduced to less than 10,000 viable cells per g exopolysaccharide. Treatment with propylene oxide gas has been used for reducing the number of viable cells in xanthan powders. The patented process involves propylene oxide treatment for 3 h in a tumbling reactor. There is an initial evacuation step before propylene oxide exposure. After treatment, evacuation and tumbling are alternated and if necessary the reactor is flushed with sterile nitrogen gas to reduce the residual propylene oxide level below the Food and Drug Administration permitted maximum (300 mg kg 1). The treated polysaccharide is then packaged aseptically. 

The production test showed that the epoxy phenolic enamel was the preferred enamel for coating tinplate containers used in packaging irradiation-sterilized ham and beef. The preferred end-sealing compound for the same application was the blend of cured and uncured isobutylene-isoprene copolymer. 

Where small quantities of high-purity steam is required for electronic chip, pharmaceutical, sterilization, food preparation, and similar process applications, a small risk of steam contamination may exist. This may be caused directly by the use of amine treatments or indirectly through process contaminants or the transport of iron oxides. Consequently, alternative arrangements for steam generation are made. 

Carbon filters find particular application as prefilters for RO and ion-exchange processes in the production of high purity FW. They are also used in clean-steam boilers and other types of steam generators where the steam is ultimately destined for application in food or beverage production, pharmaceuticals, electronics, surgical instrument sterilization, and similar processes. 

Local—pain at injection site, sterile abscess, redness and irritation at the application site with transdermal system... 

Radioisotopes have important commercial applications. For example, americium-241 is used in smoke detectors. Its role is to ionize any smoke particles, which then allow a current to flow and set off the alarm. Exposure to radiation is also used to sterilize food and inhibit the sprouting of potatoes. Radioisotopes that give off a lot of energy as heat are also used to provide power in remote locations, where refueling of generators is not possible. Unmanned spacecraft, such as Voyager 2, are powered by radiation from plutonium. 

EC verification provides an alternative to the model of establishing a certified production QA system. Independent testing of either all devices, or a statistically representative sample of each batch, is conducted by or on behalf of the Notified Body, which then issues a certificate of conformity for the tests conducted. This is not a popular option due to the costs involved. The procedure is not capable of providing adequate assurance as to the sterility of devices. Instead, an assurance of sterility must be based on the application of a production QA system to the sterilisation process. 

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