Contaminants microbial

Microorganisms are ubiquitous, thus microbial contamination is the rule the total absence of microbes, ie, sterility, is the exception. Many microorganisms might be considered mainstream, growing under typical ambient conditions, but there are almost always strains that are capable of surviving and multiplying under the extremes of pH, salinity, pressure, and temperature. 

Sanitization is a cleaning procedure that reduces microbial contaminants on certain surfaces to safe or relatively safe levels, as defined by the EPA or pubHc health authorities. The article is usually cleaned with hot water and various germicidal detergents. Sanitization can be safe for a product in contact with intact skin or for food utensils, but it is not considered safe for articles to be inserted in the human body. Effective sanitization is a requirement in the processing of reusable medical suppHes before packaging and sterilization. It is also a requirement in the maintenance of utensils and containers used for food preparation. 

Dextrose yield, however, can be increased by conducting saccharification at a lower soHds level where the reverse reaction is minimized. Eor instance, dextrose yields of 98.8, 98.2, 97.5, and 96.9% dry basis can be achieved at soHds levels of 10, 15, 20, and 25%, respectively (10). Low soHds operation, however, is not used commercially owing to problems associated with microbial contamination and cost of water removal. Dextrose level can be increased by 0.5—1.5% at normal reaction soHds by using an enzyme such as puUulanase (11) or a B. megaterium amylase (12) in conjunction with... 

Contamination. Manufacturers of cosmetics must be careful to guard against chemical and microbial contamination. Chemical contamination, which may result from the presence of undesirable impurities in raw materials, is avoidable by adhering to rigid specifications for raw materials. Compendial specifications and pubHcations by the CTFA and other professional societies form the basis of most intracompany raw material specifications. Moreover, all packaging components must meet not only physical and design specifications but also such chemical requirements as extractables and absence of dust and similar contaminants (see Packaging, cosLffiTics and pharmaceuticals). 

Decorative eye cosmetic products have been reported to be subject to pathogenic microbial contamination. Regulatory agencies in several countries, therefore, permit the use of mercury-containing preservatives in eye makeups. The infections reported were to a large extent caused by contamination during use, and the introduction of self-sterilising preparations seems warranted. 

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. 

Relative thermal resistance for the different types of microorganisms encountered in typical environments associated with fermentation broths is shown in Table 24-3. Bacterial spores are far more resistant to moist heat than are any other type oi microbial contaminants thus, a sterilization cycle based on the destruction of bacterial spores should destroy all life. 

In the holding section of a continuous sterilizer, correct exposure time and temperature must be maintained. Because of the distribution of residence times, the actual reduction of microbial contaminants in the holding section is significantly lower than that predicted from plug flow assumption. The difference between actual and predicted reduction in viable microorganisms can be several orders of magnitude therefore, a design based on ideal flow conditions may fail. 

The problem of cthyleno-oxidc residues has already been pointed out in the section on Microbial contamination . 

Maximum Residual Disinfectant Level (MRDL) - The highest level of a disinfectant allowed in drinking water. There is convincing evidence that addition of a disinfectant is necessary for control of microbial contaminants. 

Microbial Contaminants For microbial contaminants that may present public health risk, the MCLG is set at zero because ingesting one protozoa, virus, or bacterium may cause adverse health effects. EPA is conducting studies to determine whether there is a safe level above zero for some microbial contaminants. So far, however, this has not been established. 

Loss of product as a result of microbial contamination is very much greater. 

Packaging Similarly, information on the closure/packaging systems must be provided in terms of material specification, suitability/compatibility with the pharmaceutical product, dimensional specifications, water impermeability, and so on. Defence against microbial contamination should be discussed in the context of either packaging of sterile product or use of preservatives as appropriate. 

Some bioreactor systems must be completely protected from microbial contamination, meaning that not a single alien bacterium or virus particle can be allowed to penetrate the system. Reliable and economical systems need to be developed to achieve this level of contamination prevention. Along with the need for prevention is the need to be able to detect contamination at a level of a few microorganisms in a hundred kiloliters of medium. This degree of detection is not yet achievable. Research could vastly improve the crude detection methods that are used today. 

The first chapter in this section provides a unique account of the ecology, i.e. distribution, survival and life-style, of microorganisms in the factory environment, and should enable process designers, controllers and quality control personnel to comprehend, trace and eradicate the sources of failure due to extraneous microbial contaminants in the finished product. Much of the information given here is applicable to hospital manufacture also, and this is extended in a contribution (Chapter 19) dealing with contamination in hospital pharmaceutical products and in the home. 

Synthetic raw materials are usually free from all but incidental microbial contamination. 

To minimize microbial contamination, all floors should be easy to clean, impervious to water and laid on a flat surface, hi some areas it be necessary for the floor to slope towards a drain, in which case the gradient should be such that no pools of water form. Any joints in the floor, necessary for expansion, should be adequately sealed. The floor-to-wall junction should be coved. 

Many medicines contain a wide variety of ingredients, often in quite complex physicochemical states, included to create formulations which are efficacious, stable and sufficiently elegant to be acceptable to patients. Should microbial contaminants survive manufacture, or enter during storage or use they are likely to meet conditions which are often conducive to survival and even replication of an appreciable assortment of non-fastidious bacteria, ftingi and yeasts, and microbial spoilage may ensue unless steps are taken to control it. Microbial spoilage may include ... 

Microbial contaminants will usually need to be able to attack ingredients of a medicine and create substrates necessary for biosynthesis and energy production before they can replicate to levels where obvious spoilage becomes apparent since, for example, 10 microbes will have an overall degradative effect around 10 time faster than one cell. However, growth and attack may well be localized in surface moisture films or very unevenly distributed within the bulk of viscous formulations such as creams. Early... 

British Pharmacopoeia 99y) Appendix XVIB Tests for Microbial Contamination, A184-A190 (and BP 1993, 1995 Addendum, pendixXIV B, A405-A406). London HMSO. (3.4)... 

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