Microbiological contamination prevention

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... 

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. 

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. 

Pigment slurries are one of the major components in paints and coatings that contribute to or affect the performance of a formulation. The nature of pigment slurries makes them extremely susceptible to microbiological contamination that can degrade the final formulation. Often biodeterioration can be prevented with plant sanitation and the use of a preservative, but formulators must not rely on the precept that a particular preservative that works today will always remain effective down the road. In complex environments, contaminants can enter the system at different points, or a formulation change may render the original preservative less effective. Manufacturers must remain aware of trends in the industry to ensure their products are properly protected. 

Water storage tank vent filters must be equipped with a sterilizing air filter in order to prevent the air, which displaces water drawn from the tank, from microbiologically contaminating the water. The filter must be hydrophobic in order to prevent condensation from blinding the filter and preventing air entry or escape from the tank. It also must have a mean porosity of less than 1 pm. 

Cellulose ethers are hydrophilic polymers that are widely used as a pharmaceutical excipient [319]. They are generally considered to be stable in the solid state when kept in closed containers under normal environmental conditions [320] and the standards established by official pharmacopoeias for their storage are accordingly not particularly stringent The United States Pharmacopoeia [321] and British Pharmacopoeia [322] merely require that they can be stored in closed containers, without specifying further measures for prevention of water uptake or microbiological contamination. The microorganisms most frequently... 

Failure to meet measures to prevent microbiological contamination of pharmaceutical preparations may have dramatic consequences. A major health issue related to microbiologicaUy contaminated pharmaceutical preparations was the 2012 New England... 

Eye ointments and eye gels are packaged in small, sterile tubes with a rounded cannula. A tube should contain no more than 5 g of eye ointment. The tube screw cap should provide a reliable closure to prevent microbiological contamination [28]. Eye ointment tubes are also regularly used to dispense nose ointments and nose gels. 

The water reservoir is at an ideal temperature for microorganisms to grow. Therefore effective measures should be taken to prevent microbiological contamination. The indications in Sect. 28.5 apply. 

The differences between these guidelines and standards are not huge. They aU focus on preventing microbiological contamination and more or less on medication errors, e.g. due to incorrect calculations. This chapter only discusses preventing microbiological contamination. 

Microbiological contamination, mainly due to fecal contamination, is the main cause of illness or infection associated with swimming pool water. Acceptable microbiological water quality is maintained, in particular, by good hygiene practices, efficient filtration, and disinfection. An exhaustive analysis of risks and preventive measures in recreational water environments is provided in Ref. [1]. 

The metal snrfaces of the filter plates and the expanded metal inserts and filter frames, in contact with the wine during processing, are preferably made from 316 stainless steel with smooth polished surfaces to prevent microbiological contamination. The first stage at which wine is filtered is likely to be at the time of first racking. 

Sterile aqueous D-sorbitol solutions are fermented with y cetobacter subo >gichns in the presence of large amounts of air to complete the microbiological oxidation. The L-sorbose is isolated by crystallisation, filtration, and drying. Various methods for the fermentation of D-sorbitol have been reviewed (60). A.cetobacter suboyydans is the organism of choice as it gives L-sorbose in >90% yield (61). Large-scale fermentations can be carried out in either batch or continuous modes. In either case, stefihty is important to prevent contamination, with subsequent loss of product. 

One of the reasons why it is important to remove suspended solids in water is that the particles can act as a source of food and housing for bacteria. Not only does this make microbiological control much harder but, high bacteria levels increase the fouling of distribution lines and especially heat transfer equipment that receive processed waters (for example, in one s household hot water heater). The removal of suspended contaminants enables chemical treatments to be at their primary jobs of scale and corrosion prevention and microbial control. 

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