What do we mean by "sterility"? 1995

J Sharp
John Sharp Consultants, Woodley Berks., United Kingdom.

In a "President's Comment" (PDA Newsletter, August 1993) James Akers referred to such numbers, and numerical statements, as: 10(-3), 10(-6), 1cfu/m3, 3cfu/Rodac plate, 90 feet per minute, 0.005 inches of water, 80 degrees C, 20 air changes per hour, and 0.1% with 95% level of confidence. He posed the question "Where did all these numbers come from?" These are, of course all numbers instantly recognisable by those acquainted with the art and science of parenteral manufacture. They are accepted (essential?) parameters of various aspects of this process. But Akers's question carries with it the implicit answer: "They just seemed like a good idea at the time." One might similarly add: 100, 10,000, 100,000, 115 degrees C for 30 minutes, 121 degrees C for 15 minutes, and so on.

UI MeSH Term Description Entries
D004364 Pharmaceutical Preparations Drugs intended for human or veterinary use, presented in their finished dosage form. Included here are materials used in the preparation and/or formulation of the finished dosage form. Drug,Drugs,Pharmaceutical,Pharmaceutical Preparation,Pharmaceutical Product,Pharmaceutic Preparations,Pharmaceutical Products,Pharmaceuticals,Preparations, Pharmaceutical,Preparation, Pharmaceutical,Preparations, Pharmaceutic,Product, Pharmaceutical,Products, Pharmaceutical
D012996 Solutions The homogeneous mixtures formed by the mixing of a solid, liquid, or gaseous substance (solute) with a liquid (the solvent), from which the dissolved substances can be recovered by physical processes. (From Grant & Hackh's Chemical Dictionary, 5th ed) Solution
D013242 Sterilization The destroying of all forms of life, especially microorganisms, by heat, chemical, or other means.

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