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 26: Sterilizing Filtration of Liquids (3)
- TR 61: Steam in Place (2)
- TR 69: Bioburden/Biofilm Management (2)
- TR 13: Environmental Monitoring (2)
- TR 47: Virus Spikes/Virus Clearance (1)
- TR 51: Biological Indicators (1)
- TR 62: Manual Aseptic Processes (1)
- TR 67: Objectionable Microorganisms (1)
- TR 70: Cleaning/Disinfection Programs (1)
- TR 14: Validation: Protein Purification Chromatography (1)
- TR 22: Aseptic Process Simulation (1)
- TR 43: Glass Defects (1)
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Autoclave
A chamber for steam sterilization. (TR45)
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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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Deionized Water
Water treated by passing through both cation- and anion-exchange resin beds, or a mixed-resin bed to remove both positive and negative ions. (TR45)
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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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Fermentation Broth
The fluid and all constituents in a fermentation vessel prior to separation. (TR45)
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Limulus Amebocyte Lysate (LAL) Test
Endotoxin detection and quantitation can be accomplished at high sensitivity and specificity using reagents manufactured from Limulus Amebocyte Lysate, a biological reagent prepared from horseshoe crabs and offered in a variety of formulations. (TR45)
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Microorganism
A microbe; a free-living organism too small to be seen by the naked eye. (TR45) (TR26)
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Sanitization
Reduction of microbial contaminants to safe levels as judged by public health requirements for the specific country. (TR13) A significant reduction in bioburden, achieved in chromatography by the use of bactericidal agents, such as sodium hydroxide (NaOH), hydrochloric acid (HCl), ethanol (EtOH), and isopropanol (IPA). (TR14) The process of reducing microbial levels by treatment at less than defined sterilizing conditions. Typically water at 80 °C or a chemical treatment is used to perform sanitization of process components. (TR45) A process that reduces the number of viable microorganisms to a defined level. (TR61) (TR69)