ISPE Glossary of Pharmaceutical and Biotechnology Terminology

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Aseptic

Asepsis or sterile. The state of being free of contaminating organisms (bacteria, fungi, algae and all micro-organisms except viruses) but not necessarily free of internal symbionts.

Publication Source: Food and Agricultural Organization of the United Nations (FAO)
Publication Date: 1999

See also: Axenic

Aseptic

Free of pathogenic (causing or capable of causing disease) microorganisms.

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

Publication Date:

Aseptic

Not sterile, but contaminants controlled within established acceptable limits.

Publication Source: ISPE Baseline® Guide, Vol. 6: Biopharmaceutical Manufacturing Facilities

Publication Date: 2004

Aseptic

Processing conditions designed to achieve a sterile product.

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

Publication Date: 2011

Aseptic

(PDA TR 22) Free from disease-producing microorganisms.

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

Publication Date: 2011

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