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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Site Acceptance Testing
The SAT is a series of tests that are performed as part of commissioning after the unit has been installed in the final location. (TR48)

Source: TR 48: Moist Heat Sterilizer Systems

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

Steam: Plant Steam
Steam of undefined chemical or biological quality produced from a boiler, usually containing boiler additives, without further treatment. [Synonym: Factory Steam, House Steam, Industrial Steam] (TR48)

Source: TR 48: Moist Heat Sterilizer Systems

Manufacturing GMP/Good Manufacturing Processes/cGMP Sterile Processing

Steam: Pure Steam
Collected condensate that complies with the Compendial requirements for Water for Injecton (WFI). [Synonyms: clean steam, high quality steam] (TR01) (TR61) (TR48)

Source: TR 1: Validation: Moist Heat

Manufacturing GMP/Good Manufacturing Processes/cGMP Sterile Processing

Steam: Process Steam
Process steam is similar to plant steam, except the steam is generated using a controlled feed water source to which no volatile additives (amines or hydrazines) have been introduced. Process steam may be appropriate for moist heat sterilization of liquid loads where the containers are filled and sealed prior to sterilization. (TR48)

Source: TR 48: Moist Heat Sterilizer Systems

Manufacturing GMP/Good Manufacturing Processes/cGMP Sterile Processing

Sterilizer Specification (User Requirement Specification (URS))
A description of features and performance requirements of a system that will fulfill the needs of the end user. (TR48)

Source: TR 48: Moist Heat Sterilizer Systems

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

Sterilizer Specification (Design Specification (DS))
A set of specifications and information related to the installation features including equipment, hardware and software) of the system that will ensure the realization of the user requirements. [Synonym: Detailed Design Specification (DDS] (TR48)

Source: TR 48: Moist Heat Sterilizer Systems

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

Sterilization Cycle
A sequence of defined operating parameters (e.g., time, temperature and pressure) and conditions required to render an item sterile. (TR01) (TR30) (TR48) A sequence of defined operating parameters (e.g., time and temperature) required to render an item sterile. (TR3)

Source: TR 1: Validation: Moist Heat

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

Sterilizer Specification
Documents that define sterilizer system attributes and how they should be met. (TR48)

Source: TR 48: Moist Heat Sterilizer Systems

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

Saturated Steam
Steam that is at a temperature and pressure that corresponds to the vaporization curve of water. It is in a state of equilibrium between being a liquid and a gas, with no entrained liquid water. [Synonym: Dry Saturated Steam] (TR01) (TR48) (TR61)

Source: TR 1: Validation: Moist Heat

Manufacturing GMP/Good Manufacturing Processes/cGMP Microbiology Sterile Processing

Operating Parameters (Critical Parameters)
Values that are controlled and/or measured and are linked to safety and efficacy of a product or the process. Failure to meet a critical parameter should result in rejection of the load. (TR01) (TR3) (TR48) (TR51)

Source: TR 1: Validation: Moist Heat

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

Liquid Load
A load consisting of closed containers of aqueous liquids. The sterilization of the container contents is achieved through transfer of energy through the container into the aqueous liquid. (TR01) (TR30) (TR48)

Source: TR 1: Validation: Moist Heat

Manufacturing GMP/Good Manufacturing Processes/cGMP Validation Sterile Processing

Load Zone
Area within the sterilization chamber where materials to be sterilized may be placed. (TR01) (TR3) (TR48)

Source: TR 1: Validation: Moist Heat

Manufacturing GMP/Good Manufacturing Processes/cGMP Validation Sterile Processing

Maximum Load
The maximum quantity or mass of items permitted in a sterilizer load. (TR01) The maximum quantity or mass of items permitted in a depyrogenation or sterilization load. (TR3) The maximum quantity or mass of products permitted in a validated sterilizer load. (TR30)The maximum quantity or mass of items permitted in a sterilizer load. (TR48)

Source: TR 1: Validation: Moist Heat

Manufacturing GMP/Good Manufacturing Processes/cGMP Validation Sterile Processing

Installation Qualification (IQ)
Documented verification that the equipment or systems, as installed or modified, comply with the approved design, the manufacturer’s recommendations, and/or user requirements. (TR14) (TR42) (TR48) (TR61) (TR64) The documented verification that the facilities, systems and equipment, as installed or modified, comply with the approved design and the manu­facturer’s recommendations. (TR54-5) Documented verification that the equipment or systems, as installed or modified, comply with the approved design, the manufacturer’s recommendations, and/or user requirements (17). (TR60)

Source: TR 14: Validation: Protein Purification Chromatography

Manufacturing GMP/Good Manufacturing Processes/cGMP Validation Sterile Processing

F-Value (Lethality Factor)
A measurement of sterilization effectiveness, the F-value is the calculated equivalent lethality (using a specified z-value), in terms of minutes at a reference temperature (Tref), delivered by a sterilization cycle. (TR1) (TR3) (TR30) (TR48) (TR61)

Source: TR 1: Validation: Moist Heat

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

Good Engineering Practice (GEP)
Documented proven and accepted engineering methods and practices that applied throughout the project life-cycle to deliver solutions that are cost effective, are compliant with regulations and meet the requirements of the user. (TR48) Those established engineering methods and standards that are applied throughout the lifecycle to deliver appropriate and cost-effective solutions. (TR60) (TR54-5)

Source: TR 48: Moist Heat Sterilizer Systems

Biotechnology Manufacturing GMP/Good Manufacturing Processes/cGMP Quality Risk Management/QRM

Electronic Record
A record used for GMP purposes or for regulatory submission that is stored electronically for the purposes of reproduction, retrieval or archival. (TR48)

Source: TR 48: Moist Heat Sterilizer Systems

Biotechnology Manufacturing GMP/Good Manufacturing Processes/cGMP Validation Technology Transfer

Decommissioning
A planned and orderly removal of a facility, operation or system from use. (TR48) The process of retiring equipment/systems/facili­ties from production use. (TR54-5)

Source: TR 48: Moist Heat Sterilizer Systems

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

Cycle Phases
A discrete series of sterilizer process steps (such as, heat-up, exposure and cool-down) performed sequentially that represent a complete sterilization cycle. (TR48)

Source: TR 48: Moist Heat Sterilizer Systems

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

Commissioning
A well planned, documented and managed engineering approach to the start-up and transfer of facilities, systems and equipment to the end-user that results in a safe and functional environment that meets established design and user requirement specifications. Commissioning precedes Qualification and includes three phases: 1. Inspection, testing, and regulation 2. Adjustment and setting of work 3. Functional testing (TR 3) A prescribed number of activities designed to take equipment and systems from a static, substantially complete state to an operable state. (TR 48) A well planned, documented, managed engineering approach to the start-up and turnover of facilities, systems, and equipment to the end-user, that results in a safe and functional environment that meets established design requirements and stakeholder expectations.(TR 54) (TR 54-5)

Source: TR 3: Validation: Dry Heat

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

Air Removal Test
A test used to evaluate air removal and steam penetration in an empty sterilizer that is used for porous/hard goods load sterilization (e.g., Bowie-Dick Test, DART, Lantor Cube, Browns’ Test). (TR01) (TR 48)

Source: TR 1: Validation: Moist Heat

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