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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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TR 85: Enhanced Test Methods - Visible Particle Detection/Enumeration Closures/Containers

Shape factor (SF)/Circularity

Provides information on the roundness of a particle. The SF value is between 0 and 1, where 1, represents a circle. A is the area of the particle and p is the perimeter. (TR85)

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Rect A

The longest side length when a rectangle is constructed around the particle. (TR85)

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Subvisible particle

A particle with a size <100 µm in diameter. (TR85)

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Aspect Ratio

The length of a particle or fiber divided by its width. (TR85)

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Area

Measured surface area of a flat projection of a particle.(TR85)

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Feret Min and Max

Feret Min is the minimum distance between parallel tangents at opposing particle borders. Feret Max is the maximum distance between parallel tangents at opposing particle borders.

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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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Intrinsic Particles

Those particles that arise from sources related to the formulation, packaging, or assembly processes. In each of these cases, the particle material (e.g., glass, stainless steel, rubber, or gasket material) could be identified as a known product-contact material. (TR78) A particle that comes from within the primary process. These are qualified product contact materials and are often associated with the primary packaging components. They are unplanned but not unexpected.(TR85)

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Ready-To-Use

A marketing term often used to describe the benefits of single-use technology or SUS. This designation has no regulatory or scientific basis supporting suitability for use and the end user is responsible to evaluate and determine if appropriate quality requirements are met for their application. (TR66) Washed and sterilized components supplied in a package suitable for transfer into an aseptic processing area and used with sterile injectable products without further processing. (TR85)

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Particle

Any discrete unit of material structure; a discernible mass having an observable length, width, thickness, size and shape. (TR45) (TR26) Foreign material which is unintended and either removable from the surface of a primary packaging component or freely moving within a filled and sealed pharmaceutical dosage form. The term particle is used interchangeably with “particulate” and “particulate matter” without any intended difference in meaning. (TR85)

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Membrane

A thin, microporous medium used to remove particles and microorganisms from a fluid stream under pressure. (TR26) Analytical technique to collect particles from a liquid sample on a membrane filter followed by manual examination (sizing and counting) with a microscope. (TR85)

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