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))
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
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