Achieving Sterility in Medical and Pharmaceutical Products by Nigel Halls

By Nigel Halls

Detailing the clinical rules underlying the fulfillment of sterility, this targeted reference examines either a large spectrum of functional, general sterilization tactics and the tools on hand to verify sterility-assessing the strengths and barriers of every technology.Delineates present regulatory specifications for sterility-emphasizing the significance of aseptic strategies within the clinical institution and the pharmaceutical industry!Achieving Sterility in scientific and Pharmaceutical items discusses sterilization ways that make the most of saturated steam dry warmth ethylene oxide gamma radiation·sterile filtration·and extra!

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Example text

Changes in electrical resislance (conductance. impedance. andlor capacitance) can be monitored and recorded during incubation. or alternatively inslruments can be sci to a threshold value linked to a lower sensitivity of detection. With commercially available instruments the threshold of detection has usually been quoted at around 101 microorganisms per mL. For enumeration of microorganisms. the incubation time required 10 reach the threshold "lrigger" is inversely proportional to the initial concentration of microorganisms in the sample.

Approach to determining nonsterility. Many types of common microorganisms. including E. coli. SalmoneilD, and Stnptococcus fa~calis [2,3] have been shown to be capable of developing viable but nonculturable forms in stressed environments. The first source of evidence for the existence of viable but noncuhurable microorganisms is from the newer technologies of detection. Typically this is where counts of microorganisms by newer technologies fail to correlate with counts by culture methods, or exceed counts obtained by cuhure methods.

An item can exist in only one of two conditions, sterile or nonsterile. Methods are available (sec above) for tesling ilems to determine in which of lbese states the item exists. All technologies involve sacrificing the item or al the very least compromizing its slerilily. After tesling. the ilem is no longer in 3 sterile useable stale. Therefore the value of testing an item must lie wilh Ihe item being a sample or pan of a sample from a greater population or universe about which we are trying to gain infonnalion.

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