Pyrogens

Sterility is not the only attribute related to contamination significant in parenteral products. Parenteral products have to meet limits on pyrogens and on nonviable particles.

Pyrogens are substances which, when injected in sufficient amounts into the mammalian body, will cause a rise in body temperature. Most deaths arising from the contaminated infusion fluids of the 1970s were caused by pyrogenic shock, rather than as a result of bacterial septicaemia.

The most significant source of pyrogens is microbiological, specifically lipopolysaccharide fractions of the cell envelope of Gram-negative bacteria. These substances are referred to as bacterial endotoxins. Practically, the term bacterial endotoxin can be regarded as synonymous with the term pyrogen.

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