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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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Visually Clean

Absence of materials that would adulterate a product when inspected with the eyes. (TR70)

Source: TR 70: Cleaning/Disinfection Programs

Manufacturing GMP/Good Manufacturing Processes/cGMP Validation Quality Risk Management/QRM Visual Inspection

Sporicide

A compound that destroys all vegetative microorganisms and bacterial and fungal spores. (TR70)

Source: TR 70: Cleaning/Disinfection Programs

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

Sterile

Absence of life; usually refers to absence of viable microorganisms. Note: In practice, no such absolute statement regarding the absence of microorganisms can be proven. (TR22) (TR62) The absence of viable microorganisms. (TR44) (TR70)

Source: TR 22: Aseptic Process Simulation

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

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

Penicylinder

A small, ceramic carrier surface used to hold cultures of microorganisms. Used in antimicrobial effectiveness testing procedures. (TR70)

Source: TR 70: Cleaning/Disinfection Programs

Manufacturing GMP/Good Manufacturing Processes/cGMP Microbiology Validation Sterile Processing

Log Reduction

Log reduction is defined as the first log being 90%, the second log being 9% and the third log being 0.09% of the original inoculums. (TR70)

Source: TR 70: Cleaning/Disinfection Programs

Virus Filtration GMP/Good Manufacturing Processes/cGMP Microbiology Validation Sterile Processing

In-Use Testing (also called In-Situ Testing)

A field study that validates the effectiveness of a disinfecting agent, the trained operators, and the approved operating procedures. (TR70)

Source: TR 70: Cleaning/Disinfection Programs

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

Largest Daily Dose

Maximum daily dose of the next product to be produced in the equipment train. (TR70)

Source: TR 70: Cleaning/Disinfection Programs

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

Gamma Irradiation

The process by which a material is rendered sterile by exposing the material to a radioactive source, such as Cobalt 60. (TR70) Ionizing radiation that can be used to sterilize a material. (TR26)

Source: TR 26: Sterilizing Filtration of Liquids

Manufacturing GMP/Good Manufacturing Processes/cGMP Microbiology Validation 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

Disinfectant

A chemical or physical agent that reduces, destroys, or eliminates vegetative forms of harmful microorganisms but not spores. (TR70)

Source: TR 70: Cleaning/Disinfection Programs

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

Disinfection

The destruction of pathogenic and other kinds of microorganisms by thermal or chemical means. (TR51) (TR70) Process of eliminating nearly all recognized pathogenic microorganisms but not necessarily all microbial forms (e.g., bacterial spores) on inanimate objects. (TR69) The chemical or physical inactivation of a bioburden on inanimate surfaces. Typically this requires a minimum three-log (3-log) reduction of vegetative microorganisms and two-log (2-log) reduction for bacterial spore be achieved in validation. (TR13)

Source: TR 13: Environmental Monitoring

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

Coverage

The appropriate distribution of a chemical agent needed on the equipment surface to be effective. (TR70)

Source: TR 70: Cleaning/Disinfection Programs

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

Contact Time

The minimum amount of time that a sanitizer, disinfectant, or sporicide must be left in complete (wet) contact with the surface to be treated in order to be effective. (TR70)

Source: TR 70: Cleaning/Disinfection Programs

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

Change Control

A formal program that describes evaluation and actions to be taken if a change is proposed or completed to facilities, materials, equipment, and/or processes used in the fabrication, packaging, and testing of drugs, or a proposed or completed change that may affect the operation of the quality or support systems. (TR22) (TR39) (TR52) (TR58) (TR64) (TR 70)

Source: TR 22: Aseptic Process Simulation

Biotechnology GMP/Good Manufacturing Processes/cGMP Packaging Science Validation Quality Risk Management/QRM

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

Aseptic Processing Area (APA)

Controlled environment, consisting of several zones, in which the air supply, facility, materials, equipment and personnel are regulated to control microbial and particulate contamination to acceptable levels. (TR22) (TR28) (TR62) (TR70)

Source: TR 22: Aseptic Process Simulation

Biotechnology Manufacturing Combination Products Filtration GMP/Good Manufacturing Processes/cGMP Microbiology Packaging Science Validation Sterile Processing

Antimicrobial Chemical Agent

Substance used to destroy or suppress the growth of microorganisms, whether bacteria, fungi, or viruses, on inanimate objects and surfaces. (TR70)

Source: TR 70: Cleaning/Disinfection Programs

Biotechnology Manufacturing Combination Products GMP/Good Manufacturing Processes/cGMP Microbiology Validation Sterile Processing

Area Disinfection

Disinfection of floors, walls, ceilings, and other surfaces. (TR70)

Source: TR 70: Cleaning/Disinfection Programs

Biotechnology Manufacturing Combination Products GMP/Good Manufacturing Processes/cGMP Microbiology Validation 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