Pharmaceutical Microbiology and Biotechnology

Anti-Infective Agents

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Agents that is capable of acting against infection, by inhibiting the spread of an infectious agent or by killing the infectious agent outright, is known as anti-infective agent. Anti-infective is a general term that involves antifungals, antibiotics, anti-bacterial, anti-protozoans and antivirals.

The primary goal of final pharmaceutical product is Quality and Safety. Active Pharmaceutical Ingredients (API’s), used as ingredients in sterile medicinal products, must be sterile unless the final dosage form is terminally sterilized, or produced by a process including a sterilising filtration step. API’s intended for use in parenteral products must also comply with relevant specifications on bacterial endotoxins or pyrogens.

The manufacture of sterile API’s must be strictly controlled in order to reduce the risk of contamination with micro-organisms, endotoxins and particles. If the final dosage form is not to be sterilised by filtration, the API’s should be practically free of particles.