Glossary Terms (Simple List)
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Static Monitoring
Monitoring of the environment in the absence of normal operations. This includes having the equipment installed and operational when no personnel are present. Per the EU and ISO standards, this is synonymous with “at rest.” (TR13)
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Static Record Format (FDA)
A fixed-data document such as a paper record or an electronic image.(TR80)
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Static Record Format (MHRA)
A "fixed" record such as paper or pdf. (TR80)
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Static Record Format (WHO)
A static record format, such as a paper or pdf record, is one that is fixed and allows little or no interaction between the user and the record content (TR80)
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Statistically Determined Limits
Limits calculated from historical data that takes into account the distribution of the data (i.e., normal, log-normal, exponential, etc), the variability of the data, and the sample size of the data set. These can be two-sided or one-sided. The mean (average) plus and/or minus 3 standard deviations or a confidence interval for the mean are not statistically correct methods for setting these limits. The correct method is to calculate a statistical tolerance interval as described in Hahn and Meeker, 1991. (TR38)
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Steam Air Mixture (SAM) Process
A sterilization process in which the heating medium used to heat the load is in a mixture of air and steam that is typically used for liquid loads. This addition of air results in an air overpressure condition. (TR01)
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Steam Heat-treated Wooden Pallets
Pallets in which the wood has been heated to achieve a minimum core temperature of 56 °C (132.8 °F) for at least 30 min. Pallets treated via this method bear the initials HT (heat treated) near the International Plant Protection Convention (IPPC) logo. This is one of the methods required for international shipment. (TR55)
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Steam in Place Cycle
A sequence of defined steps and operating parameters (e.g., time, temperature, and pressure) performed in situ on equipment and/or systems to provide a given sterility assurance level (SAL) or defined sanitization level. (TR61)
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Steam Orifice
A specifically sized hole (e.g., 1/32 or 1/
Supply Chain inch diameter) to allow condensate or steam to pass through. [Synonyms: flow orifice, steam bleed.] (TR60)
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Steam Sterilization
Sterilization by flowing saturated steam through a vented vessel or system. (TR45)