Probability of a Non-Sterile Unit (PNSU)
The number that expresses the probability of occurrence of a non-sterile unit after exposure to a sterilization process. Within the pharmaceutical industry, a design end point better than or equal to the probability of one non-sterile unit in a million units is expected, i.e., PNSU ≤ 10–6. [Synonym: Steriliy Assurance Level (SAL)] (TR01)
Source:
TR 1: Validation: Moist Heat
Manufacturing
GMP/Good Manufacturing Processes/cGMP
Microbiology
Validation
Quality Risk Management/QRM
Sterile Processing
Saturated Steam Process
A sterilization process, typically used for porous/hard goods loads, where the sterilizing medium is saturated steam. (TR01)
Source:
TR 1: Validation: Moist Heat
Manufacturing
GMP/Good Manufacturing Processes/cGMP
Microbiology
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
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
Parametric Release
A sterility release system based upon effective control, monitoring, documentation, and batch records review of a validated sterilization process cycle in lieu of release procedures based upon end-product sterility testing. (TR01) (TR3) (TR13) A sterility release program based on effective control, monitoring and documentation of a validated sterile-product manufacturing process where sterility release is based on demonstrated achievement of critical operational parameters and performance attributes in lieu of end-product sterility testing. (TR30)
Source:
TR 1: Validation: Moist Heat
Manufacturing
GMP/Good Manufacturing Processes/cGMP
Microbiology
Validation
Quality Risk Management/QRM
Sterile Processing
Penetration Probe
A probe placed in contact with the load item or inside a container of liquid to measure the temperature of the load item or liquid. (TR01) A thermocouple placed in contact with the load item to measure the temperature of the load item. (TR3)
Source:
TR 1: Validation: Moist Heat
Manufacturing
GMP/Good Manufacturing Processes/cGMP
Microbiology
Validation
Sterile Processing
Minimum Acceptable Cycle (MAC)
The minimum cycle conditions (in terms of delivered minimum lethality or minimum time and temperature) that would be considered acceptable. (TR01) (TR61)
Source:
TR 1: Validation: Moist Heat
Manufacturing
GMP/Good Manufacturing Processes/cGMP
Microbiology
Validation
Sterile Processing
Technology Transfer
Mixed Load
A load that contains multiple item item types representing various sterilization challenges. For example, some load items may have air removal challenges, while others pose a challenge due to their mass. (TR01)
Source:
TR 1: Validation: Moist Heat
Manufacturing
GMP/Good Manufacturing Processes/cGMP
Microbiology
Validation
Sterile Processing
Technology Transfer
Moist Heat
Heat-up Phase
The phase of a sterilization cycle that occurs prior to the exposure phase. Process parameters are developed for this phase in order to meet applicable user requirements for load conditioning (e.g., air removal and preheating.) (TR01) (TR3) (TR48) (TR61)
Source:
TR 1: Validation: Moist Heat
Manufacturing
Microbiology
Validation
Sterile Processing
F-Value (Lethality Factor) -- FO
A term used when the specific reference conditions of Tref = 121.1°C and z = 10°C are used to calculate the equivalent lethality. For example, when the z-value of the BI is 10°C a cycle with an F(T=121.1°C, z=10°C), or F0, equal to 8 minutes is equivalent (in terms of delivered lethality) to a square wave cycle of 8 minutes at 121.1°C. A square wave cycle that provided an exposure of 25.9 minutes at 160deg;C would also yield an F0 of 8 minutes. (TR1)
Source:
TR 1: Validation: Moist Heat
Manufacturing
GMP/Good Manufacturing Processes/cGMP
Microbiology
Validation
Sterile Processing
F-Value (Lethality Factor) -- FBiological
A term used to describe the delivered lethality, measured in terms of actual kill of microorganisms on or in a BI challenge system. The FBiological-value is calculated as DT × LR, where DT is the D-value of the BI system at the reference temperature (T) and LR is the actual logarithmic reduction (log N0 – log NF) of the BI population achieved during the cycle. (TR1)
Source:
TR 1: Validation: Moist Heat
Manufacturing
GMP/Good Manufacturing Processes/cGMP
Microbiology
Validation
Sterile Processing
Gravity Displacement
A sterilization process based on the principle that cold air within the chamber is heavier than the steam entering and will sink to the bottom of the chamber. As steam enters the chamber, air is pushed out the bottom drain and exits, with the condensate, through a steam trap. (TR01) (TR48) (TR61)
Source:
TR 1: Validation: Moist Heat
Manufacturing
Microbiology
Validation
Sterile Processing
F-Value (Lethality Factor) -- Fphysical
A term used to describe the delivered lethality calculated based on the physical parameters of the cycle. The FPhysical-value is the integration of the lethal rate (L) over time. The lethal rate is calculated for a reference temperature (Tref-) and z-value using the equation: L = 10(T-Tref- )/z. (TR1)
Source:
TR 1: Validation: Moist Heat
Manufacturing
GMP/Good Manufacturing Processes/cGMP
Microbiology
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
Fraction-Negative Methods
Fraction-negative methods use the starting population of a biological indicator (N0) and data in the quantal range to create a two-point line from which the DT-value can be determined. The quantal range is the exposure period over which a set of replicate test units exhibit a dichotomous response – some are positive for growth and the rest are negative for growth. (TR01)
Source:
TR 1: Validation: Moist Heat
Manufacturing
Microbiology
Validation
Sterile Processing
Dryness Value
Dryness Fraction
An absolute measure of the actual latent heat of a sample of steam relative to the theoretical latent heat of saturated steam. (TR01) (TR48)
Source:
TR 1: Validation: Moist Heat
Manufacturing
Microbiology
Validation
Quality Risk Management/QRM
Sterile Processing
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
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
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
