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
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
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
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
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
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
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