Sterilization typical conditions

Examples of typical conditions employed in the sterilization of pharmaceutical and medical products... 

Extraciables testing may be done on each individual component or material of manufacture, or on the composite assembly. The purpose of extraciables testing is to determine the amount of material that can be extracted in water and in the range of solvents for which the manufacturer claims suitability. Extraction conditions should include a simulation of those processes that may affect the materials prior to use the most obvious of these for sterilizing filters is steam sterilization. Typically, filters are autoclaved and then immersed in water or whatever solvent at 20 C and agitated for a defined period. Some extractions with volatile solvents may be done at higher temperatures and may include refluxing. 

Typical conditions, to which gamma-sterilized prosthetic components may be subjected, are summarized as follows ... 

The packaging for the military s ration, the Meal, Ready-To-Eat (MRE) has stringent performance requirements which must be met in order for the food to maintain quality and nutrition. The MRE must have a shelf life of three years at 27°C or six months at 38°C. [1] The military specification requires that the oxygen transmission rate (OTR) of the packaging must not exceed 0.06 cc/mVday and the water vapor transmission rate (WVTR) must not exceed 0.01 g/mVday. Also, the MRE food pouches are retorted at 121°C (250°F) for 30 to 60 minutes, which are the typical conditions required to kill microorganisms and sterilize the contents. [2, 3]... 

Microorganisms are ubiquitous, thus microbial contamination is the rule the total absence of microbes, ie, sterility, is the exception. Many microorganisms might be considered mainstream, growing under typical ambient conditions, but there are almost always strains that are capable of surviving and multiplying under the extremes of pH, salinity, pressure, and temperature. 

P.Y.83 shows good to very good resistance to most solvents which are typically found in application media. Recrystallization is therefore rare under common processing conditions, even in highly transparent types. Resistance to clear lacquers, calandering, and sterilization are consequently excellent. 

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