Glossary Terms (Simple List)
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Steam Trap
A self-actuating, automatic device that removes condensate and air from the system. (TR61)
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Steam: Plant Steam
Steam of undefined chemical or biological quality produced from a boiler, usually containing boiler additives, without further treatment. [Synonym: Factory Steam, House Steam, Industrial Steam] (TR48)
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Steam: Process Steam
Process steam is similar to plant steam, except the steam is generated using a controlled feed water source to which no volatile additives (amines or hydrazines) have been introduced. Process steam may be appropriate for moist heat sterilization of liquid loads where the containers are filled and sealed prior to sterilization. (TR48)
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Steam: Pure Steam
Collected condensate that complies with the Compendial requirements for Water for Injecton (WFI). [Synonyms: clean steam, high quality steam] (TR01) (TR61) (TR48)
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Steam-in-Place (SIP)
The process of applying clean pressurized steam to a stationary piece of equipment in order to sterilize it. (TR41)
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Steribag
Sealing bag made at least partly of steam-permeable material to wrap and seal containers for sterilization (e.g., tub-nest configurations). (TR73)
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Sterile
Absence of life; usually refers to absence of viable microorganisms. Note: In practice, no such absolute statement regarding the absence of microorganisms can be proven. (TR22) (TR62)
The absence of viable microorganisms. (TR44) (TR70)
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Sterile Boundary
The sterile boundary is the demarcation in a system between the portion of the system that requires sterile contact surfaces (e.g., sterile side of filters and downstream piping) and the rest of the system (e.g., upstream side of filters, condensate drain lines). (TR61)
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Sterile/Microbial Barrier
The purported location on a container closure system beyond which no microorganism can pass under conditions qualified for the barrier. (TR86) -
Sterility Assurance
The probability or likelihood that something is sterile. (TR44)