Pyrogen contamination

Microbiological aspects of pharmaceuticals are of importance not only to sterile products but to all products, in that gross contamination should be avoided irrespective of how the product is used or administered. Although bacteria, moulds and yeasts constitute the major sources of contamination, pyrogens are also included under this heading. 

Factors to be considered in maldng the selection of chromatography processing steps are cost, sample volume, protein concentration and sample viscosity, degree of purity of protein product, presence of nucleic acids, pyrogens, and proteolytic enzymes. Ease with which different types of adsorbents can be washed free from adsorbed contaminants and denatured proteins must also be considered. 

Disadvantages The protein expressed is accumulated within the cell matrix (intracellular) the protein does not undergo posttranslational modifications (resulting in proteins that may be structurally different or less useful to humans) the presence of lipopolysaccharides (pyrogens—microbial substances that cause fever) is likely to contaminate the product and there is a need for more extensive chromatographic purification. 

USP XXIV specifies the limits and method of testing for chemical and pyrogenic contaminants for various compendial classifications of water, such as purified water and water for injection. 

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