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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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Magnetic Capture Hybridization (MCH)

A purification method based on sequence-specific hybridization of labeled nucleic acid probes with targeted regions of test article nucleic acids, followed by magnetic bead capture. (TR50)

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Mandrel

Specialized filling needles on certain BFS machines which also act to form the container. (TR77)

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Matrix Spike Control

An internal control in which an amplifiable amount of nucleic acid is added to a test article to determine inhibition of the PCR. This addition is usually performed pre-extraction and should provide a weak signal 100% of the time. Also known as “interference control”. (TR50)

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Maximum Load

The maximum quantity or mass of items permitted in a sterilizer load. (TR01) The maximum quantity or mass of items permitted in a depyrogenation or sterilization load. (TR3) The maximum quantity or mass of products permitted in a validated sterilizer load. (TR30)The maximum quantity or mass of items permitted in a sterilizer load. (TR48)

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Media

The part of the filter through which fluid passes that retains particles during filtration. (TR45)

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Micro-condensation

The formation of very fine layers of condensation often invisible to the naked eye. (TR51)

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Microbial Classification

The arrangement of microorganisms into taxonomic groups based on their similarities and relationships. (TR13)

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Microbial Count Determination

A test performed to quantify the number of microorganisms present in a sample of material. Standard microbial methods are utilized to estimate the number of colony forming units (CFU) per unit mass or volume. (TR28)

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Microbial Enumeration

Compendial test for microbial counts using the plate-count, membrane-filtration or most probable number methods described in USP <61> Microbiological Examination of Nonsterile Products: Microbial Enumerations Tests. (TR67)

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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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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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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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Moist Heat

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

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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)