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PDA Technical Glossary

PDA Technical Reports are highly valued membership benefits because they offer expert guidance and opinions on important scientific and regulatory topics and are used as essential references by industry and regulatory authorities around the world. These reports include terms which explain the material and enhance the reader’s understanding.

The database presented here includes the glossary terms from all current technical reports. The database is searchable by keyword, topic, or by technical report. Each definition provided includes a link to the source technical report within the PDA Technical Report Portal.

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Displaying results 51 - 72 of 72

Microbial Identification

The determination of the genus, and species when possible, to which a laboratory or manufacturing isolate belongs. (TR13)

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Microbiological Examination Tests

The compendial tests for microbial enumeration and absence of specified microorganisms as found in USP <61> Microbiological Examination of Nonsterile Products: Microbial Enumerations Tests and USP <62> Microbiological Examination of Nonsterile Products: Tests for Specified Microorganisms. (TR67)

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Microbiological Identification

Biochemical characterization of isolated colonies to determine the isolate genus and, where feasible and appropriate, the species. (TR22)

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Microdosing Studies

Studies designed to speed up the development of promising drugs by establishing early on whether the drug or agent behaves in human subjects as was expected from preclinical studies. May include the administration of single subtherapeutic doses of the study drug to a small number of subjects (10 to 15) to gather preliminary data on the agent’s pharmacokinetics and pharmacodynamics. A Microdosing study gives no data on safety or efficacy, being by definition a dose too low to cause any therapeutic effect. (TR56)

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Microfiltration (MF)

Pressure-driven, membrane-based separation process in which particles and dissolved macromolecules (typically 0.1 &mum or larger) are retained. (TR15)

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Microorganism

A microbe; a free-living organism too small to be seen by the naked eye. (TR45) (TR26)

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Microorganism of Concern

A bacterium, yeast, or mold that, due to it prominence in product recalls, infection outbreaks, nosocomial infections, and the clinical literature, results in a multifactor risk assessment to determine whether the microorganism is objectionable if it is present in a specific nonsterile product. (TR67)

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Microprocessor

One of the five major components of a TCU, the unit interfaces with temperature sensors in the discharge and return air and adjusts the output rate of active cooling or heating to achieve the setpoint temperature. (TR64)

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Minimum Acceptable Cycle (MAC)

The minimum cycle conditions (in terms of delivered minimum lethality or minimum time and temperature) that would be considered acceptable. (TR01) (TR61)

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Mixed Load

A load that contains multiple item item types representing various sterilization challenges. For example, some load items may have air removal challenges, while others pose a challenge due to their mass. (TR01)

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Mock Soil

A soil which is used in place of the manufactured product during a cleaning validation protocol (also called a “surrogate” soil). (TR29)

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Mock Soiling

A process of soiling the equipment for a cleaning validation protocol in which soil is applied to the equipment surfaces to simulate the condition of the soil on those surfaces following typical product manufacturing. (TR29)

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Model Scoring

The process of evaluating a machine learning model's performance using metrics such as accuracy, precision, recall, and F1 score. Effective model scoring ensures that predictions are valid and trustworthy.

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Model Training

The phase in machine learning where a model learns patterns and relationships from training data, enabling it to make predictions for unseen data. Proper model training ensures generalization and reliability in real world applications.

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Moist Heat

Steam, steam-air mixtures, and superheated water used for sterilization. (TR01)

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Moisture Content of Wood

The moisture content of wood is calculated by the following formula: Moisture content = (Mg-Mod)/Mod. Where Mg is the green mass of the wood and Mod is its oven-dry mass (the attainment of constant mass generally after drying in an oven set at 103 ± 2 °C for 24h). The equation can also be expressed as a fraction of the mass of the water and the mass of the oven-dry wood rather than a percentage. For example, 0.59 kg/kg (oven-dry basis) expresses the same moisture content as 59% (oven-dry basis). (TR55)

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Mollicutes

A class of bacteria which lack a cell wall. Mollicutes are small, typically about 0.1-0.5 &mum in size, and vary in form (trivial name: mycoplasma) (TR50)

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Monodispersed particles

Particles of uniform size in a dispersed phase. In the case of viruses, this term refers to free virus particles not agglomerated to other viruses or proteins in solution. (TR41)

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Most Probable Number (MPN) Method

A statistical method of estimating the number of viable organisms suspended in a liquid. (TR51)

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Multi-Use System (MUS)

An engineered process equipment solution for process management and unit operations designed for repeated use. (TR66)

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Mycoplasma Reduction Filter

A sterilizing grade filter that also provides a log reduction value (or a titer reduction value) for a specified test mycoplasma according to the PDA Mycoplasma Consensus Method. (TR75)

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Precision Medicine

An approach to medical treatment and healthcare that customizes interventions based on the individual patient’s characteristics, often leveraging AI for personalized diagnostics and tailored treatment plans.

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Displaying results 51 - 72 of 72