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 77: The Manufacture of Sterile Pharmaceutical Products Using Blow-Fill-Seal Technology (3)
- TR 73: Prefilled Syringe User Requirements for Biotech Applications (2)
- TR 54-4: QRM: Biotech Drug Substance (1)
- TR 66: Single-Use Systems (1)
- TR 14: Validation: Protein Purification Chromatography (1)
- TR 26: Sterilizing Filtration of Liquids (1)
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Dynamic (in operation)
BFS machine line fully operational and filling, with the number of allowed operating personnel present as during normal running conditions. (TR77)
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Elastomer
Thermoplastic material formulation (that may or may not contain rubber/natural latex) derived from elastic polymer; often used interchangeably with the term “rubber.” (TR73)
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Leachable
A chemical component that migrates from a contact surface into a drug product or process fluid during storage or normal use conditions. The term leachable is often erroneously used to describe an extractable. (TR14) (TR26) Leachables are organic and inorganic chemical entities that migrate from a packaging/delivery system, packaging component, or packaging material of construction into an associated drug product under normal conditions of storage and use or during accelerated drug product stability studies. Leachables are typically a subset of extractables or are derived from extractables. (TR54-4) Chemical substances that are leached, from product-contact or non-product-contact materials, under typical process conditions and detected in final dosage. Leachables may be a subset of extractables, and can include their reaction or breakdown products. (TR66) Organic or inorganic chemical entity that migrates from pharmaceutical container closure system components into a drug product formulation. (TR73)
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Mandrel
Specialized filling needles on certain BFS machines which also act to form the container. (TR77)
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Parison
The “tube” of polymer extruded by the BFS machine from which the containers are formed. (TR77)