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 1: Validation: Moist Heat (4)
- TR 30: Parametric Release (2)
- TR 54: QRM:Manufacturing Operations (1)
- TR 60: Process Validation (1)
- TR 69: Bioburden/Biofilm Management (1)
- TR 70: Cleaning/Disinfection Programs (1)
- TR 13: Environmental Monitoring (1)
- TR 54-5: Quality Risk Management for the Design, Qualification, and Operation of Manufacturing Systems (1)
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Parametric Release
A sterility release system based upon effective control, monitoring, documentation, and batch records review of a validated sterilization process cycle in lieu of release procedures based upon end-product sterility testing. (TR01) (TR3) (TR13) A sterility release program based on effective control, monitoring and documentation of a validated sterile-product manufacturing process where sterility release is based on demonstrated achievement of critical operational parameters and performance attributes in lieu of end-product sterility testing. (TR30)
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Penetration Probe
A probe placed in contact with the load item or inside a container of liquid to measure the temperature of the load item or liquid. (TR01) A thermocouple placed in contact with the load item to measure the temperature of the load item. (TR3)
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Physical Qualification
A component of performance qualification that demonstrates that predetermined physical requirements, including temperature distribution and heat penetration, are achieved consistently throughout the load. (TR01)(TR03)
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Process Qualification
Documented verification that a system is capable of consistently performing or controlling the activities of the processes it is required to perform or control, according to written and preapproved specifications, while operating in its specified operating environment. (TR3)
Confirming that the manufacturing process as designed is capable of reproducible commercial manufacturing. (TR54) (TR60) (TR54-5)
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Product-specific Design Approach
A sterilization design approach that is based on the characteristics of the bioburden (on or in the load) and the heat sensitivity of the product that delivers the lethality needed to achieve a PNSU of 10-6 on or in the items to be sterilized. (TR01) (TR3) (TR30)
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Pyrogen
Any substance capable of eliciting a febrile (or fever) response upon injection or infection (as in endotoxin released in vivo by Gram-negative bacteria. (TR3) Fever-producing substance (TR69) A material that elicits a pyrogenic response (fever). (TR70)