Sterilization
Process that completely destroys or removes all forms of microbial life, including spores.
Aseptic Processing
Manufacturing method where sterile products are produced by combining sterile components in a sterile environment.
Terminal Sterilization
Sterilization of a product in its final sealed container, achieving a Sterility Assurance Level (SAL).
Sterility Assurance Level (SAL)
The probability of a single viable microorganism occurring on an item after sterilization, typically 10^-6.
Bioburden
The number and type of viable microorganisms present on or in a product prior to sterilization.
D-value (Decimal Reduction Time)
Time required at a specific temperature to reduce a microbial population by 90% (one log cycle).
F0-value (F-naught)
The equivalent time in minutes at 121.1°C of saturated steam sterilization delivered to a product.
Biological Indicator (BI)
A standardized preparation of resistant microorganisms (spores) used to monitor a sterilization process's effectiveness.
Chemical Indicator (CI)
A device that changes color or physical state when exposed to one or more sterilization process parameters.
Autoclave
Equipment that uses saturated steam under pressure for moist heat sterilization.
Dry Heat Sterilization
Sterilization method using hot air, suitable for heat-stable materials, oils, or powders.
Ethylene Oxide (EO) Sterilization
Low-temperature gaseous sterilization for heat and moisture-sensitive products.
Radiation Sterilization
Sterilization using ionizing radiation (e.g., Gamma, E-beam) for medical devices and pharmaceuticals.
Filtration Sterilization
Removal of microorganisms from liquids or gases by passing them through a filter with a pore size of 0.22 micrometers or smaller.
Depyrogenation
Process, often using high dry heat, to remove bacterial endotoxins (pyrogens) from materials.
Sterilization Validation
Documented evidence that a sterilization process consistently delivers product meeting predetermined SAL and quality attributes.
Media Fill (Aseptic Process Simulation)
Test to validate an aseptic process by filling sterile culture media and incubating for microbial growth detection.
Cleanroom
A controlled environment with a low concentration of airborne particles, classified by particle count.
Parametric Release
Product release based on the successful completion of a validated sterilization cycle's critical parameters, instead of sterility testing.
Overkill Sterilization
A sterilization cycle designed to deliver a greater lethality than theoretically required to achieve the target SAL, often accounting for worst-case bioburden.
Steam-in-Place (SIP)
Sterilization of processing equipment and systems using saturated steam without disassembly.
Vaporized Hydrogen Peroxide (VHP)
A low-temperature gaseous sterilization method primarily used for surface decontamination in isolators and cleanrooms.
Bioburden Control
Strategies and practices implemented to minimize the microbial load on products prior to the final sterilization step.
Sterility Test
A quality control test performed on a sample of the sterilized product to confirm the absence of viable microorganisms.