ISPE Glossary of Pharmaceutical and Biotechnology Terminology

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A fever-producing substance.

Publication Source: American Society of Mechanical Engineers (ASME), Bioprocessing Equipment (BPE) - 2009 Revision

Publication Date:


A foreign substance that produces a fever response in humans and animals, hence the name pyrogen (heat producing). Chemically, the lipopolysaccharide outer layer of gram-negative bacteria. Bacterial pyrogens were at one time believed to be toxic substances released when bacterial cells disintegrate and are therefore still referred to as endotoxins. Parenteral drugs must be essentially pyrogen free.

See also: Lipopolysaccharide (LPS)


An agent capable of inducing an increase in body temperature; usually refers to fever caused by bacterial endotoxins.

Publication Source: ISPE Baseline® Guide, Vol. 3: Sterile Manufacturing Facilities (First Edition)

Publication Date: 2011


Trace organics which are used as markers of bacterial growth or contamination. Produced by various bacteria and fungi. Critical pharmaceutical and biotechnological processes have restrictions on contamination by these substances, usually at levels near the limit of detection. Primarily polysaccharide (made of linked sugars) in nature. Fever producing substances when administered parenterally to man and certain animals.

Publication Source: ISPE Baseline® Guide, Vol. 4: Water and Steam Systems (Second Edition)

Publication Date: 2011

See also: Endotoxin

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