Contamination, microbiological

Open-loop systems have inherently long residence times which may be detrimental if the retentate is susceptible to degradation by shear or microbiological contamination. A feed-bleed or closed-loop configuration is a one-stage continuous membrane system. At steady state, the upstream... 

Drinking water suppHed to carbonated soft drink manufacturing faciUties from private or municipal sources must comply with all regulatory requirements. Treated water must meet all U.S. Environmental Protection Agency primary maximum contaminant levels and may also be subject to additional state requirements. Treated water is routinely analyzed for taste, odor, appearance, chlorine, alkalinity, iron, pH, total dissolved soHds, hardness, and microbiological contamination. 

For all humidifiers, full consideration should be given to the possibility of the growth of fungi, algae, bacteria, and in particular Legionella pneumophila, the microbiological contamination that causes humidifier fever, etc. 

NOTE Compare this with similar problems in CW systems—those of easily and accurately (and at low-cost) determining levels of microbiological contamination. In most CW systems, apart from a general maintenance quality indicator, the levels of bulk water planktonic organisms tend to have little relevance to sessile organism-biofilm reactions occurring at the metal-water interface. 

Railings L.O., Ringertz O., Silverstolpe L. Emerfeldt F. (1966) Microbiological contamination of medicinal preparations. 1965 Report to the Swedish National Board of Health. Acta Pharm Suecica, 3,219-228. 

Rules and Guidance for Pharmaceutical Manufacturers and Distributors (1997) London HMSO. Spooner D.F. (1996) Hazards associated with the microbiological contamination of cosmetics, toiletries andnon-sterile pharmaceuticals. Iw.Microhial Quality Assurance in Cosmetics, Toiletries andNon-sterile Pharmaceuticals, 2nd edn (eds R.M. Baird S.F. Bloomfield), pp. 9-27. London Taylor Francis. 

Each lot of a component, drug product container, or closure that is liable to microbiological contamination that is objectionable in view of its intended use shall be subjected to microbiological tests before use. 

The coatings and additives utilised during paper processing are also a significant source of microbiological contamination. The types that are frequently used are ... 

Many changes have occurred over the last 20 years within the European paper making industry. Most systems have now changed from acidic processing to alkaline and the majority have closed up their processing, i.e. the water is now recycled within the plant and not discharged. Hence microbiological contamination have shifted in favour of bacterial strains (due to alkaline conditions) and also increased due to continuous re-introduction of these species and food sources back into the process. 

Although there are many biocide alternatives available on the market, for example enzyme technology or bio-dispersants, there appears to be a continued requirement for the use of biocides in order to reduce the levels of microbiological contamination entering the paper making process. The increased awareness of environmental and safety aspects will continue to play an important role on the selection of biocides for paper making processes. The use of legislation to select biocides must be done in parallel with each plants internal risk assessment. No one biocide active will meet all the criteria set out by different European countries and hence the use of these actives must be carefully assessed on a plant by plant basis. 

These activities, allied with the use of effective broad-spectrum biocides, will at least decrease incidences of microbiological contamination and at best eliminate such infections altogether. 

Another area of interest is that of microbiological contamination of solid dosage forms, which is thought to arise chiefly from raw materials rather than the... 

Further sampling should be carried out to ensure potency, lack of microbiological contamination, identity, and the like. It should be noted that because of the above, approved components must therefore be stored to prevent contamination, and that the oldest stock should be used first, and that rejected... 

Scientific Committee on Food (SCF), European Commission (2002), Risk Profile on the Microbiological Contamination of Fruits and Vegetables Eaten Raw, Report. 

Coolant systems are an integral part of container formation and serve to cool the molds and, if applicable, the parison clamp assembly. Coolant, although not in direct contact with product pathways, is in close proximity to the containers, and maintenance should be carried out to prevent leakage. Coolant systems are prone to microbiological contamination and should be routinely treated to keep the bioburden imder eontrol. They should be regularly sampled and tested for bioburden to ensure continuous compliance to a predefined specification. 

Appropriate procedures, designed to prevent microbiological contamination of compounded drug products purporting to be sterile, shall be established and followed. Such procedures shall include validation of any sterilization process. 

Subpart B, Organization and Personnel 211.22 Responsibilities of the quality control unit 211.25 Personnel qualifications 211.113 Control of microbiological contamination Subpart F, Production and Process Controls Subpart I, Laboratory Controls 211.167 Special testing... 

According to 211.113 Control of microbiological contamination, pharmaceutical manufacturers need written procedures describing the systems designed to prevent objectionable microorganisms in both nonsterile and sterile drug products. All sterilization processes used to manufacture parenteral drugs need to be validated. 

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