PDA Technical Glossary
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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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Manufacturing Validation L
Largest Daily Dose
Maximum daily dose of the next product to be produced in the equipment train. (TR70)
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Leak Rate
Leak rate is the quantity of air leakage over time into the sterilizer chamber obtained while performing a chamber leak test. The leak rate should not exceed a level that will inhibit the sterilization process during air removal or vacuum drying stages. (TR03)
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Leak Test
See System Integrity Test. (TR61)
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Length
The measure of the distance along its longest axis. Light obscuration (LO). Analytical technique measuring the size and quantity of subvisible particles. (TR85)
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Lenticular Filters
A filter made up of a series of biconvex cells that are stacked on top of one another with rings between them to prevent bypass between the cells. End-caps are then placed at the top and bottom of the assembly and are held in place with a central core. [Synonyms: Lenticular Cartridge, Modules, Filter Elements, Filter Devices] (TR45)
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Lifecycle
All phases in the life of a product from the initial development through marketing until the product’s discontinuation. (TR54) (TR60) All phases in the life of a product, from the initial development through marketing until the prod­uct is discontinued. (TR60-2)
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Limit
A value for a residue above which a cleaning process would not be acceptable. (TR29) A value for a residue above which a cleaning validation protocol would fail. (TR49)
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Limit Sample
An actual physical unit that is agreed to between the drug manufacturer and the glass manufacturer that defines the approximate maximum degree of acceptability for a specified non-conformance. Creation of limit samples between the user and the manufacturer is optional. (TR43)
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Limit Test
A quantitative test designed to give a positive/negative response. Ideally, a limit test has a high degree of specificity and a low limit of detection. (TR50).
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Limit of Detection (LOD)
The lowest concentration of microorganisms in a test sample that can be detected, but not necessarily quantified, under the stated experimental conditions. (TR33) The lowest amount of analyte in a sample that can be distinguished from the absence of analyte. (TR41) The lowest concentration of analyte that can be unambiguously detected in a sample. For qualitative and for quantitative NAT methods, this value is conventionally expressed as a 95% positive cut-off value, representing the target concentration detected in 95% of repeated tests using a certain assay. (TR50)
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Limit of Quantification
The lowest number of microorganisms in a test sample that can be enumerated with acceptable accuracy and precision under the stated experimental conditions. (TR33)
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Limit, Detection (DL)
The lowest amount of analyte in a sample that can be detected but not necessarily quantitated as an exact value by an individual analytical procedure. [Synonym: Limit of detection (LOD)] (TR57)
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Limit, Quantitation (QL)
The lowest amount of analyte is a sample that can be quantitatively determined with suitable precision and accuracy by an individual analytical procedure. [Synonym: Limit of quantitation (LOQ)] (TR57)
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Linearity
The ability to elicit results that are proportional to the concentration of microorganisms present in the sample within a given range, where accuracy and precision are demonstrated. (TR33) The linearity of an analytical procedure is its ability (within a given range) to obtain test results that are directly proportional to the concentration (amount) of analyte in the sample. (TR57)
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Liquid Load
A load consisting of closed containers of aqueous liquids. The sterilization of the container contents is achieved through transfer of energy through the container into the aqueous liquid. (TR01) (TR30) (TR48)
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Load Monitor
A chemical, physical or biological indicator that provides an indication that a load was exposed to moist heat processing conditions. Note: In the United States, the load monitor must consist of a device in the form of a chemical, physical or biological indicator that is capable of direct measurement, or if appropriate, an indirect measurement of physical lethality delivered to the load. (TR30)
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Load Zone
Area within the sterilization chamber where materials to be sterilized may be placed. (TR01) (TR3) (TR48)
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