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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Spore Log Reduction (SLR)
The number of log reductions (10-fold changes) of spores from the initial population. For the overkill sterilization method, one targets a spore log reduction of 12 to achieve 1 x 10-6 probability of a survivor when using a biological indicator having a population of 1 x 106. (TR61)

Source: TR 61: Steam in Place

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

System Integrity Test
Any test designed to detect leaks or other breaches in system integrity that might compromise operator safety or system sterility (or sanitary status). [Synonym: leak test.] (TR61)

Source: TR 61: Steam in Place

Manufacturing Validation Quality Risk Management/QRM Sterile Processing

System Integrity Test (System Pressure Hold Test)
A system integrity test in which the system is pressurized to a predetermined level with filter sterilized compressed air or other compressed gas, after which the system is isolated and the amount of pressure loss over time is measured. (TR61)

Source: TR 61: Steam in Place

Manufacturing Validation Quality Risk Management/QRM Sterile Processing

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)

Source: TR 13: Environmental Monitoring

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

Overkill Design Approach
A sterilization design approach where minimal information is required about the product bioburden. A worst-case bioburden assumption is used to determine the delivered lethality needed to achieve a PNSU of 10-6 on or in the items being sterilized. When using this approach, the qualification program must demonstrate that both the FBIO and FPHYS are greater than 12 minutes. The required lethality may vary regionally. (Note: For typical SIP systems, the FPHYS will need to be greater than the FBIO.) (TR01) (TR3) (TR30) (TR61)

Source: TR 1: Validation: Moist Heat

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

Operational Qualification (OQ)
Documented verification that the equipment or systems, as installed or modified, perform as intended throughout the anticipated operating ranges. (TR14) (TR61) (TR64) (TR72) The documented verification that the facilities, systems and equipment, as installed or modified, perform as intended throughout the anticipated operating ranges. (TR54-5) Documented verification that the equipment or systems, as installed or modified, perform as intended throughout the anticipated operating ranges (17). (TR60-3)

Source: TR 14: Validation: Protein Purification Chromatography

Manufacturing GMP/Good Manufacturing Processes/cGMP Validation Quality Risk Management/QRM Technology Transfer

Operating Parameters (Key Parameters)
Values that are controlled and/or measured and are used to assure the ongoing “state of control” and consistency of runs. Failure to meet a key process parameter should result in an investigation with a documented rationale for the disposition of the load. (TR01) (TR3) (TR51) (TR48) Values that are controlled and/or measured and are used to assure the ongoing “state of control” of steam in place cycles. Failure to meet a key process parameter should result in an investigation. (TR61)

Source: TR 1: Validation: Moist Heat

Manufacturing GMP/Good Manufacturing Processes/cGMP Validation Quality Risk Management/QRM Technology Transfer

DT Value
The time in minutes required for a onelogarithm, or 90%, reduction of the population of microorganisms used as a biological indicator under specified lethal conditions. For steam sterilization, the D-value should always be specified with a reference temperature, DT . For example, a BI system with a D121°C = 1.4 minutes requires 1.4 minutes at 121°C to reduce the population by one logarithm.(TR1) (TR61)

Source: TR 1: Validation: Moist Heat

Manufacturing Microbiology Validation Quality Risk Management/QRM Sterile Processing

Deadlegs
An area of entrapment in the vessel or piping run that could lead to contamination of the product due to insufficient exposure to moist heat. (TR61)

Source: TR 61: Steam in Place

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

Cycle Development
A series of activities performed for the purpose of defining or confirming the cycle parameters (e.g., time, temperature, pressure) necessary to ensure sanitization or sterilization. (TR61)

Source: TR 61: Steam in Place

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

Cool-Down Phase
The phase of a sterilization cycle that occurs after completion of the exposure phase. Parameters of a cool-down phase are typically defined in order to meet applicable user requirements for load cooling and drying. (TR01) The phase of a sterilization cycle that occurs after completion of the exposure phase. [Synonym: post-conditioning phase, slow exhaust phase, drying phase, equalization phase] (TR48) The phase of an SIP cycle that occurs after completion of the exposure phase. Parameters (e.g., time, temperature, pressure) of a cool-down phase are typically defined in order to meet applicable user requirements for system cooling and drying. (TR61)

Source: TR 1: Validation: Moist Heat

Manufacturing Validation Quality Risk Management/QRM Sterile Processing

Critical Control Point
A step at which control can be applied and that is essential to prevent or eliminate a pharmaceutical quality hazard or reduce it to an acceptable level. (TR54-4) (TR61)

Source: TR 54-4: QRM: Biotech Drug Substance

Biotechnology Manufacturing GMP/Good Manufacturing Processes/cGMP Validation Quality Risk Management/QRM Technology Transfer

Biological Qualification
A component of performance qualification that demonstrates, by use of biological indicators, that the required lethality (FBIO) is achieved consistently throughout the load. (TR1) (TR3) (TR30) A component of performance qualification that demonstrates, by use of biological indicators, that the required lethality (FBIO) or spore log reduction (SLR) is achieved consistently throughout the sterilized or sanitized portion of the SIP system. (TR61)

Source: TR 1: Validation: Moist 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