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 33: Rapid Micro Methods (2)
- TR 47: Virus Spikes/Virus Clearance (1)
- TR 50: Alt. Methods Mycoplasma Testing (1)
- TR 53: Stability Testing New Drug Products (1)
- TR 62: Manual Aseptic Processes (1)
- TR 67: Objectionable Microorganisms (1)
- TR 70: Cleaning/Disinfection Programs (1)
- TR 29: Validation: Cleaning (1)
- TR 45: Depth Filtration (1)
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False Negative
A test result that is erroneously classified in a negative category (e.g., the absence of a viable microbial detection result when viable microorganisms are present). (TR33)
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False Positive
A test result that is erroneously classified in a positive category (e.g., a viable microbial detection result when viable microorganisms are not present). (TR33)
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Fastidious strain (isolate)
A population of microorganisms having complex nutritional requirements and thus difficult to cultivate. (TR50)
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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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Focus Forming Unit (FFU)
A measure of virus infectively based on formation of a region or “focus”, of infected cells within a monolayer culture that is caused by viruses that do not kill their host, but rather transform them. The number of foci is directly correlated to the number of infectious virus particles. (TR47)
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Frank (Canonical) Pathogens
Microorganisms responsible for infection in healthy individuals (i.e., individuals with normal operative and functional host defense mechanisms) that may be acquired from exposure to other infected people or animals, environmental reservoirs (exogenous) or the individual’s normal (endogenous) microbial flora. (TR67)
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Free Drained Equipment
No visible water pool in the equipment or line when viewed under appropriate lighting conditions (but may contain water droplets). (TR29)