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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 86: Industry Challenges and Current Technologies for Pharmaceutical Package Integrity Testing

Container Closure System (CCS)

The sum of packaging components (primary and secondary) and materials that together contain and protect a product.(TR86)

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Deterministic Leak Test Method

A method in which the leakage event being detected or measured is based on phenomena that follow a predictable chain of events. In addition, the measure of leak detection is based on physicochemical technologies that are readily controlled and monitored, yielding objective quantitative data. (TR86)

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Labeling

The process by which a label is affixed to a packaging component. (TR85)

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Container Closure Integrity Test (CCIT)

A package leak test (either physicochemical or microbiological) that detects the presence of a package breach or gap. Some tests may also be able to identify the magnitude and/or location of the leak (the term container closure integrity test is synonymous with package leak test or package integrity test for the purposes of this TR). (TR86)

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Destructive

A method in which a sample cannot be subsequently utilized in any other analytical method or processed to a final product. (TR86)

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Nondestructive

A method in which a passing sample can subsequently be utilized in additional analytical methods or processed to a final product. (TR86)

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Maximum Allowable Leak Limit (MALL)

The greatest gap or leak rate that does not put product quality at risk (2). (TR86)

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Package integrity

Is the measure of the ability of the package to prevent product loss or maintain product sterility and the ability to maintain the internal environment (2). (TR86)

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Sterile/Microbial Barrier

The purported location on a container closure system beyond which no microorganism can pass under conditions qualified for the barrier. (TR86)

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