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The system may be preassembled before a bioburden reduction/microbial control step or assembled by a user by connecting presterilized subassemblies through the use of aseptic connections. Dosimetric Release: The determination that a product is sterile based on physical irradiation process data rather than sterility testing. False Positive Sterility Test Result: Test result that is incorrectly interpreted to indicate that the test article contained viable organisms and that the article was not sterile. Commonly, such a result will derive from faulty sample handling or test execution or from an interaction between a sample and the microbial growth medium that causes the medium to become turbid. Irradiation: Application of ionizing radiation capable of destroying microbial bioburden. Microbial Control: Assembly of products in a controlled clean environment followed by exposure to gamma radiation. This process reduces bioburden load but does not support a sterile label claim. Sample Item Portion SIP: Defined portion of a product assembly or component. Sterile: Free from viable microorganisms. Sterility Assurance Level SAL: In practice, the sterile state cannot be proven. Instead, sterility is expressed as the probability of a single viable microorganism occurring on an item after sterilization 1.
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