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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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Sanitizer

A compound that will reduce the number of vegetative microorganisms to a safe level as determined by public health requirements. Normally a reduction of 103 in vegetative microorganisms is obtained. (TR70)

Source: TR 70: Cleaning/Disinfection Programs

Biotechnology Manufacturing GMP/Good Manufacturing Processes/cGMP Microbiology Validation Quality Risk Management/QRM Sterile Processing

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)

Source: TR 70: Cleaning/Disinfection Programs

Biotechnology Manufacturing GMP/Good Manufacturing Processes/cGMP Microbiology Validation Quality Risk Management/QRM Sterile Processing

Environmental Monitoring (EM)

Describes the processes and activities that need to take place to characterize and monitor the quality of the environment. (TR70) Monitoring for nonviable particulates and/or microorganisms where the result meets or exceeds the alert and/or action level or limit. (TR88)

Source: TR 70: Cleaning/Disinfection Programs

Biotechnology Manufacturing GMP/Good Manufacturing Processes/cGMP Microbiology Validation Quality Risk Management/QRM Sterile Processing

Depyrogenation

The destruction and/or removal of bacterial endotoxins. A depyrogenation process should demonstrate at least 99.9% or a 3-log endotoxin reduction. (TR3) Removal or destruction of pyrogens. (TR70)

Source: TR 3: Validation: Dry Heat

Biotechnology Manufacturing GMP/Good Manufacturing Processes/cGMP Microbiology Validation Quality Risk Management/QRM Sterile Processing

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)

Source: TR 13: Environmental Monitoring

Biotechnology Manufacturing GMP/Good Manufacturing Processes/cGMP Microbiology Validation Quality Risk Management/QRM Sterile Processing

Airlock

A room that controls the airflow between two rooms of different classification. (TR 70)

Source: TR 70: Cleaning/Disinfection Programs

Biotechnology Manufacturing Combination Products GMP/Good Manufacturing Processes/cGMP Microbiology Validation Quality Risk Management/QRM Sterile Processing