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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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User Requirements

Requirements defined by the end user that provide the basis for the development of the equipment specification. They combine the product, process, regulatory, and business needs of a manufacturing system. (TR54-5)

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Unit Operation

A discrete step or manipulation in a manufacturing process where process and operating parameters are defined to achieve a specific process objective. [Synonym: process step] (TR74)(TR14)

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Unidirectional Air Flow Hood (UAFH)

A cabinet designed to protect materials from operator and environmental contamination. Also referred to as laminar air flow hood. (TR62)

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Ultrafiltration Membranes

Membranes that retain particles whose sizes are measured by molecular weight, with retention ranges from 1,000 to 1,000,000 (Daltons). (TR41)

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Unwanted Event or Condition

Lack of sterility assurance or an unacceptable level of endotoxin that could result in harm to the patient. (TR44)

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Upstream

The influent side of the filter. (TR45) (TR26)

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Use-related Risk Analysis

A systematic assessment of all of the user steps involved in using the device with particular consideration of the potential use errors, their associated clinical consequences along with the risk-mitigation strategies, and the method of validating the risk-mitigation strategies. (TR73)

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Ultracentrifugation

Subjection of material to an exceedingly high g-force. The technique can be used to band or sediment virus particles. (TR47)

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Ultrafiltration (UF)

A pressure-driven, membrane-based separation process in which a semipermeable membrane is used to retain high molecular weight solutes, while low molecular weight solutes are allowed to pass through the membrane. (TR15)

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