Sterility Assurance Level
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Sterility Assurance Level
In microbiology, sterility assurance level (SAL) is the probability that a single unit that has been subjected to sterilization nevertheless remains nonsterile. It is never possible to prove that all organisms have been destroyed, as the likelihood of survival of an individual microorganism is never zero. So SAL is used to express the probability of the survival. For example, medical device manufacturers design their sterilization processes for an extremely low SAL, such as 10−6, which is a 1 in 1,000,000 chance of a non-sterile unit. SAL also describes the killing efficacy of a sterilization process. A very effective sterilization process has a very low SAL. Terminology Mathematically, SALs are probabilities, often very small but (by definition) always lying between zero and one. So when they are expressed in scientific notation their exponents are negative, as for instance, "The SAL of this process is 10−6". But the term ''SAL'' is sometimes also used to refer to a sterili ...
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Microbiology
Microbiology () is the scientific study of microorganisms, those being unicellular (single cell), multicellular (cell colony), or acellular (lacking cells). Microbiology encompasses numerous sub-disciplines including virology, bacteriology, protistology, mycology, immunology, and parasitology. Eukaryotic microorganisms possess membrane-bound organelles and include fungi and protists, whereas prokaryotic organisms—all of which are microorganisms—are conventionally classified as lacking membrane-bound organelles and include Bacteria and Archaea. Microbiologists traditionally relied on culture, staining, and microscopy. However, less than 1% of the microorganisms present in common environments can be cultured in isolation using current means. Microbiologists often rely on molecular biology tools such as DNA sequence based identification, for example the 16S rRNA gene sequence used for bacteria identification. Viruses have been variably classified as organisms, as they have ...
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Probability
Probability is the branch of mathematics concerning numerical descriptions of how likely an Event (probability theory), event is to occur, or how likely it is that a proposition is true. The probability of an event is a number between 0 and 1, where, roughly speaking, 0 indicates impossibility of the event and 1 indicates certainty."Kendall's Advanced Theory of Statistics, Volume 1: Distribution Theory", Alan Stuart and Keith Ord, 6th Ed, (2009), .William Feller, ''An Introduction to Probability Theory and Its Applications'', (Vol 1), 3rd Ed, (1968), Wiley, . The higher the probability of an event, the more likely it is that the event will occur. A simple example is the tossing of a fair (unbiased) coin. Since the coin is fair, the two outcomes ("heads" and "tails") are both equally probable; the probability of "heads" equals the probability of "tails"; and since no other outcomes are possible, the probability of either "heads" or "tails" is 1/2 (which could also be written ...
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Sterilization (microbiology)
Sterilization refers to any process that removes, kills, or deactivates all forms of life (particularly microorganisms such as fungi, bacteria, spores, and unicellular eukaryotic organisms) and other biological agents such as prions present in or on a specific surface, object, or fluid. Sterilization can be achieved through various means, including heat, chemicals, irradiation, high pressure, and filtration. Sterilization is distinct from disinfection, sanitization, and pasteurization, in that those methods reduce rather than eliminate all forms of life and biological agents present. After sterilization, an object is referred to as being sterile or aseptic. Applications Foods One of the first steps toward modernized sterilization was made by Nicolas Appert, who discovered that application of heat over a suitable period slowed the decay of foods and various liquids, preserving them for safe consumption for a longer time than was typical. Canning of foods is an extension of the ...
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Medical Device
A medical device is any device intended to be used for medical purposes. Significant potential for hazards are inherent when using a device for medical purposes and thus medical devices must be proved safe and effective with reasonable assurance before regulating governments allow marketing of the device in their country. As a general rule, as the associated risk of the device increases the amount of testing required to establish safety and efficacy also increases. Further, as associated risk increases the potential benefit to the patient must also increase. Discovery of what would be considered a medical device by modern standards dates as far back as c. 7000 BC in Baluchistan where Neolithic dentists used flint-tipped drills and bowstrings. Study of archeology and Roman medical literature also indicate that many types of medical devices were in widespread use during the time of ancient Rome. In the United States it wasn't until the Federal Food, Drug, and Cosmetic Act (F ...
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Scientific Notation
Scientific notation is a way of expressing numbers that are too large or too small (usually would result in a long string of digits) to be conveniently written in decimal form. It may be referred to as scientific form or standard index form, or standard form in the United Kingdom. This base ten notation is commonly used by scientists, mathematicians, and engineers, in part because it can simplify certain arithmetic operations. On scientific calculators it is usually known as "SCI" display mode. In scientific notation, nonzero numbers are written in the form or ''m'' times ten raised to the power of ''n'', where ''n'' is an integer, and the coefficient ''m'' is a nonzero real number (usually between 1 and 10 in absolute value, and nearly always written as a terminating decimal). The integer ''n'' is called the exponent and the real number ''m'' is called the '' significand'' or ''mantissa''. The term "mantissa" can be ambiguous where logarithms are involved, because it is a ...
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Multiplicative Inverse
In mathematics, a multiplicative inverse or reciprocal for a number ''x'', denoted by 1/''x'' or ''x''−1, is a number which when Multiplication, multiplied by ''x'' yields the multiplicative identity, 1. The multiplicative inverse of a rational number, fraction ''a''/''b'' is ''b''/''a''. For the multiplicative inverse of a real number, divide 1 by the number. For example, the reciprocal of 5 is one fifth (1/5 or 0.2), and the reciprocal of 0.25 is 1 divided by 0.25, or 4. The reciprocal function, the Function (mathematics), function ''f''(''x'') that maps ''x'' to 1/''x'', is one of the simplest examples of a function which is its own inverse (an Involution (mathematics), involution). Multiplying by a number is the same as Division (mathematics), dividing by its reciprocal and vice versa. For example, multiplication by 4/5 (or 0.8) will give the same result as division by 5/4 (or 1.25). Therefore, multiplication by a number followed by multiplication by its reciprocal yiel ...
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Log Reduction
Log reduction is a measure of how thoroughly a decontamination process reduces the concentration of a contaminant. It is defined as the common logarithm of the ratio of the levels of contamination before and after the process, so an increment of 1 corresponds to a reduction in concentration by a factor of 10. In general, an -log reduction means that the concentration of remaining contaminants is only times that of the original. So for example, a 0-log reduction is no reduction at all, while a 1-log reduction corresponds to a reduction of 90 percent from the original concentration, and a 2-log reduction corresponds to a reduction of 99 percent from the original concentration. Mathematical definition Let and be the numerical values of the concentrations of a given contaminant, respectively before and after treatment, following a defined process. It is irrelevant in what units these concentrations are given, provided that both use the same units. Then an and -log reduction is achie ...
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Logarithm
In mathematics, the logarithm is the inverse function to exponentiation. That means the logarithm of a number  to the base  is the exponent to which must be raised, to produce . For example, since , the ''logarithm base'' 10 of is , or . The logarithm of to ''base''  is denoted as , or without parentheses, , or even without the explicit base, , when no confusion is possible, or when the base does not matter such as in big O notation. The logarithm base is called the decimal or common logarithm and is commonly used in science and engineering. The natural logarithm has the number  as its base; its use is widespread in mathematics and physics, because of its very simple derivative. The binary logarithm uses base and is frequently used in computer science. Logarithms were introduced by John Napier in 1614 as a means of simplifying calculations. They were rapidly adopted by navigators, scientists, engineers, surveyors and others to perform high-a ...
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Order Of Magnitude
An order of magnitude is an approximation of the logarithm of a value relative to some contextually understood reference value, usually 10, interpreted as the base of the logarithm and the representative of values of magnitude one. Logarithmic distributions are common in nature and considering the order of magnitude of values sampled from such a distribution can be more intuitive. When the reference value is 10, the order of magnitude can be understood as the number of digits in the base-10 representation of the value. Similarly, if the reference value is one of some powers of 2, since computers store data in a binary format, the magnitude can be understood in terms of the amount of computer memory needed to store that value. Differences in order of magnitude can be measured on a base-10 logarithmic scale in “decades” (i.e., factors of ten). Examples of numbers of different magnitudes can be found at Orders of magnitude (numbers). Definition Generally, the order of magnitude ...
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Assays
An assay is an investigative (analytic) procedure in laboratory medicine, mining, pharmacology, environmental biology and molecular biology for qualitatively assessing or quantitatively measuring the presence, amount, or functional activity of a target entity. The measured entity is often called the analyte, the measurand, or the target of the assay. The analyte can be a drug, biochemical substance, chemical element or compound, or cell in an organism or organic sample. An assay usually aims to measure an analyte's intensive property and express it in the relevant measurement unit (e.g. molarity, density, functional activity in enzyme international units, degree of effect in comparison to a standard, etc.). If the assay involves exogenous reactants (the reagents), then their quantities are kept fixed (or in excess) so that the quantity and quality of the target are the only limiting factors. The difference in the assay outcome is used to deduce the unknown quality or quantity of ...
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Microbiology Terms
Microbiology () is the scientific study of microorganisms, those being unicellular (single cell), multicellular (cell colony), or acellular (lacking cells). Microbiology encompasses numerous sub-disciplines including virology, bacteriology, protistology, mycology, immunology, and parasitology. Eukaryotic microorganisms possess membrane-bound organelles and include fungi and protists, whereas prokaryotic organisms—all of which are microorganisms—are conventionally classified as lacking membrane-bound organelles and include Bacteria and Archaea. Microbiologists traditionally relied on culture, staining, and microscopy. However, less than 1% of the microorganisms present in common environments can be cultured in isolation using current means. Microbiologists often rely on molecular biology tools such as DNA sequence based identification, for example the 16S rRNA gene sequence used for bacteria identification. Viruses have been variably classified as organisms, as they have be ...
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