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J Sharp

Publications and source records attributed to J Sharp.

62 records · Page 4Linked to original sources
PubMedDate not supplied

Environmental microbial challenges to an aseptic Blow-Fill-Seal process--a practical study.

A Blow-Fill-Seal machine, set to aseptically fill sterile liquid TSB medium into 20 ml plastic containers, was subjected to a series of environmental microbial challenges in order to evaluate the effects of the room environment, and of the actions of persons in the room, on the sterility of the product. Despite a series of relatively severe stresses to the system, none of the units filled (approximately 44,000) were found, following incubation, to display growth.

Air Microbiology↗
PubMedDate not supplied

What do we mean by "sterility"?

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.

Pharmaceutical Preparations↗