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 45: Depth Filtration (3)
- TR 69: Bioburden/Biofilm Management (2)
- TR 47: Virus Spikes/Virus Clearance (1)
- TR 51: Biological Indicators (1)
- TR 61: Steam in Place (1)
- TR 62: Manual Aseptic Processes (1)
- TR 67: Objectionable Microorganisms (1)
- TR 70: Cleaning/Disinfection Programs (1)
- TR 13: Environmental Monitoring (1)
- TR 22: Aseptic Process Simulation (1)
- TR 44: QRM: Aseptic Processes (1)
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Bioburden
The total number of microorganisms per unit of material prior to sterilization. (TR13) Total number of viable microorganisms on or in a health care product prior to sterilization. (TR22)(TR61)(TR62) A population of viable microorganisms in a fluid prior to sterilizing filtration. (TR26) A measure of the contaminating organisms found in or on a given amount of material before it undergoes a sterilization process. (TR45) (TR70) The number of detectable microorganisms (bacteria and fungi) with which an object is contaminated. It is measured in CFU (colony forming units). (TR47) The number of viable, contaminating microorganisms present on a product immediately prior to decontamination. (TR51) Viable microbial contaminants associated with personnel manufacturing environments (air and surfaces), equipment, product packaging, raw materials (including water), in-process materials, and finished products. (TR 67) (TR 69)
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Downstream Side (of Filter)
The effluent side of the process step (filter). (TR45) The filtrate or outlet side of the filter. (TR26)
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Endotoxin
Lipopolysaccharides from the cell walls of bacteria, the most potent of which derive from Gram-negative organisms. When injected, they are known to cause a febrile, or fever-producing reaction that can cause severe patient reactions, and on occasion, can be fatal. (TR26) (TR44) Pyrogenic lipopolysaccharide component of Gram-negative bacterial cell walls. (TR69)
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Microorganism
A microbe; a free-living organism too small to be seen by the naked eye. (TR45) (TR26)