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Pharmaceutical Manufacturing and Packing Sourcer
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Question: What do the pharmaceutical industry, 21st Century warfare, hospital operating theatres and domestic terrorist groups have in common?
Answer: A requirement for an air sampling system to determine the existence and levels of airborne bacteria.
Naturally, the pharmaceutical manufacturing industry's needs vary from the rest, but the principle remains the same - if there is a danger posed by airborne bacteria it must be identified and eradicated. Control of viable particles or micro-organisms which are typical of pharmaceutical manufacturing environments or products has become essential. Bacteria are clearly implicated in the adulteration of pharmaceuticals, medical devices and micro-electronics, and as a consequence, have been isolated from all environments in which they have been found. Evidence suggests that man is the foremost disseminator of micro-organisms in cleanrooms and controlled environments. Some bacteria will be transient, while other populations are unique to a particular individual.
It follows that before contamination can be reduced or controlled, it is imperative that background levels of contamination are identified. Whilst there are finite limits and standard methods for the evaluation of non-viable particulates within the pharmaceutical industry, as yet there is no definite limit or standardisation of methods for the micro-biological evaluation of airborne viable particles.
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