All sterilization claims must be processed according to the following Federal guidelines: 2025

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All items to be sterilized should be arranged so all surfaces will be directly exposed to the sterilizing agent. Thus, loading procedures must allow for free circulation of steam (or another sterilant) around each item.
SIP sterilization includes three phases: heat up, temperature hold, and cool down. The minimum temperature for sterilization is 121 C (250 F) with a hold of at least 30 minutes. The impact of the SIP test method on both temperature and pressure across the filtration train are summarized below.
i) Separate the sharp instruments from the blunt instruments. ii) Instruments should be cleaned as soon as possible after their use, especially simcoe cannula. iii) Instruments should be thoroughly cleaned by washing in sterile.
SIP sterilization includes three phases: heat up, temperature hold, and cool down. The minimum temperature for sterilization is 121 C (250 F) with a hold of at least 30 minutes.
Standard steam sterilization is generally carried out at 250 F (121 C) for 1520 min. Faster or immediate to use (flash) sterilization is generally carried out at 270 F (134 C) and greater for 34 min, typically without wrap or packaging.
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The two common steam-sterilizing temperatures are 121C (250F) and 132C (270F). These temperatures (and other high temperatures)830 must be maintained for a minimal time to microorganisms.
In general, EPA regulates disinfectants and sterilants used on environmental surfaces, and not those used on critical or semicritical medical devices; the latter are regulated by FDA.
Verification activities used to monitor and control the sterilization process may include: bioburden testing, Biological Indicator (BI) testing, Chemical Indicator (CI) testing, process control record review, sterilant residue testing, and endotoxin testing.

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