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 3: Validation: Dry Heat (2)
- TR 48: Moist Heat Sterilizer Systems (1)
- TR 52: Supply Chain GDP (1)
- TR 53: Stability Testing New Drug Products (1)
- TR 54: QRM:Manufacturing Operations (1)
- TR 54-2: QRM: Packaging Labeling (1)
- TR 54-3: QRM: Drug Products (1)
- TR 60: Process Validation (1)
- TR 61: Steam in Place (1)
- TR 62: Manual Aseptic Processes (1)
- TR 70: Cleaning/Disinfection Programs (1)
- TR 73: Prefilled Syringe User Requirements for Biotech Applications (1)
- TR 85: Enhanced Test Methods - Visible Particle Detection/Enumeration Closures/Containers (1)
- TR 30: Parametric Release (1)
- TR 54-5: Quality Risk Management for the Design, Qualification, and Operation of Manufacturing Systems (1)
- TR 45: Depth Filtration (1)
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F-Value (Lethality Factor)
A measurement of sterilization effectiveness, the F-value is the calculated equivalent lethality (using a specified z-value), in terms of minutes at a reference temperature (Tref), delivered by a sterilization cycle. (TR1) (TR3) (TR30) (TR48) (TR61)
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F-Value (Lethality Factor) -- FBiological
A term used to describe the delivered lethality, measured in terms of actual kill of microorganisms on or in a BI challenge system. The FBiological-value is calculated as DT × LR, where DT is the D-value of the BI system at the reference temperature (T) and LR is the actual logarithmic reduction (log N0 – log NF) of the BI population achieved during the cycle. (TR1)
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F-Value (Lethality Factor) -- FO
A term used when the specific reference conditions of Tref = 121.1°C and z = 10°C are used to calculate the equivalent lethality. For example, when the z-value of the BI is 10°C a cycle with an F(T=121.1°C, z=10°C), or F0, equal to 8 minutes is equivalent (in terms of delivered lethality) to a square wave cycle of 8 minutes at 121.1°C. A square wave cycle that provided an exposure of 25.9 minutes at 160deg;C would also yield an F0 of 8 minutes. (TR1)
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F-Value (Lethality Factor) -- Fphysical
A term used to describe the delivered lethality calculated based on the physical parameters of the cycle. The FPhysical-value is the integration of the lethal rate (L) over time. The lethal rate is calculated for a reference temperature (Tref-) and z-value using the equation: L = 10(T-Tref- )/z. (TR1)
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F-Value (Lethality Factor)-- FH
A term used when the specific reference conditions of Tref = 160°C and z=20°C are used to calculate the equivalent lethality. For example, when the z-value of the BI is 20°C a process with an F(T=160°C, z=20°C), or FH, equal to 8 minutes is equivalent (in terms of delivered lethality) to a square wave process of 8 minutes at 160°C. A square wave process that provided an exposure of 45.2 minutes at 145°C would also yield an FH of 8 minutes. (TR3)
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Fault Tree Analysis (FTA)
A deductive technique used to analyze the causes of faults (defects). The technique visually models how logical relationships between failures, human errors, and external events can combine to cause specific faults. (TR54) (TR54-2) (TR54-3) (TR54-5)
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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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Fermentation Broth
The fluid and all constituents in a fermentation vessel prior to separation. (TR45)
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Finished Materials
This term refers to items such as drug substances, drug products, finished product held in bulk before final packaging, and clinical trial materials that are likely to be stored for significant periods of time and are also subject to the risks of distribution. (TR53)
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First Air
Refers to the air exiting at the face of HEPA filters. Based on the airflow through HEPA filters and its unidirectional air flow the air exiting at the filter face is for the purposed of aseptic processing free of particulate contamination (both viable and non-viable). (TR70)
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First Air (First Work Location)
The work location first in the path of HEPA filtered air. (TR62)
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First Expiration, First Out (FeFo)
A method of controlling inventory to ensure that the material with the shortest remaining shelf-life is distributed first. (TR52)
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Formal Experimental Design (Synonym – Design of Experiments)
A structured, organized method for determining the relationship between factors affecting a process and the output of that process. (TR60)
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Formative Usability Evaluation
Observed actual or simulated use of early prototypes to help reliably identify product conceptspecific, use-related hazards that may have been missed by other methods. (TR73)